Finacea 15% Gel

Finacea
15 % Gel

Azelaic acid

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 
  1. What Finacea 15 % Gel is and what it is used for
  


• 
  2. Before you use Finacea 15 % Gel
  


• 
  3. How to use Finacea 15 % Gel
  


• 
  4. Possible side effects
  


• 
  5. How to store Finacea 15 % Gel
  


• 
  6. Further information
  

What Finacea 15 % Gel is and what it is used for

Finacea 15 % Gel contains the active substance azelaic acid and belongs to the group of anti-acne preparation for external (cutaneous) use. Finacea 15 % Gel is for the relief of mild to moderate papulopustular acne of the face and the treatment of papulopustular rosacea.

Papulopustular acne and rosacea are associated with inflamed papules and pustules.

Before you use Finacea 15 % Gel

Do not use Finacea 15 % Gel

• if you are allergic (hypersensitive) to the active substance azelaic acid or any of the other ingredients of Finacea 15 % Gel. Please see section “6. Further information”.

Take special care with Finacea 15 % Gel

Finacea 15 % Gel is for external (cutaneous) use only. Take care to avoid contact with the eyes, mouth and other mucous membranes. In the event of an accidental contact, wash the eyes, mouth and/or affected mucous membranes with large amounts of water. You should consult a doctor or pharmacist if an eye irritation persists. Please wash your hands after each application of Finacea 15 % Gel.

Finacea 15 % Gel is not recommended for use in children below age 12 due to a lack of data on safety and efficacy.

Taking other medicines

It has not been studied whether Finacea 15 % Gel affects or is affected by other medicines. Do not apply other medicines or treatments to your face at the same time as Finacea 15 % Gel.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

There is limited experience from use of the active substance azelaic acid during pregnancy. If you are pregnant or breast-feeding, your doctor will decide whether you can use Finacea 15 % Gel.

Infants must not come into contact with treated skin or breast.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Finacea 15 % Gel has no influence on the ability to drive and use machines.

Important information about some of the ingredients of Finacea 15 % Gel

Benzoic acid is mildly irritating to the skin, eyes and mucous membranes.

Propylene glycol may cause skin irritation.

How to use Finacea 15 % Gel

Always use Finacea 15 % Gel exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Finacea 15 % Gel is intended for external (cutaneous) use only.

Method of administration

Before you apply Finacea 15 % Gel, clean the skin thoroughly with water and dry. You may use a mild skin-cleansing agent.

Do not use air- and water-tight (occlusive) dressings or wrappings, and wash your hands after applying the gel.

Usual dosage and frequency of administration

Apply Finacea 15 % Gel sparingly to the affected skin areas twice a day (in the morning and in the evening) and massage it gently into the skin.

Approximately 2.5 cm, which is equal to 0.5 g of gel, is sufficient for the entire face.

To achieve an optimal effect of the treatment it is important to use Finacea 15 % Gel continuously over the entire period of treatment.

In the event of an irritation of the skin (see section 4. “Possible side effects”), reduce the amount of gel per application or the frequency of use of Finacea 15 % Gel to once a day until the irritation ceases. If necessary, you should interrupt the treatment temporarily for a few days.

Duration of treatment

The duration of use of Finacea 15 % Gel can vary from person to person and also depends on the severity of the skin disorder.

Your doctor will tell you how long you should use Finacea 15 % Gel.

Acne:
You can use Finacea 15 % Gel over several months depending on the effect of the treatment. In general, you may notice a distinct improvement within 4 weeks.

In case of no improvement after 1 month or if the acne becomes worse, you should discontinue Finacea 15 % Gel and consult your doctor.

Rosacea:
You can use Finacea 15 % Gel over several months depending on the effect of the treatment.

You may notice a distinct improvement within 4-8 weeks of the treatment.

In case of no improvement after 2 months or if the rosacea becomes worse, you should discontinue Finacea 15 % Gel and consult your doctor.

If you use more Finacea 15 % Gel than you should

Even if you have accidentally used more Finacea 15 % Gel than you should, a harmful effect (intoxication) is unlikely.

Please continue as prescribed and ask your doctor if you are not sure.

If you forget to use Finacea 15 % Gel

Do not use twice the amount to make up for a forgotten treatment. Continue as prescribed by your doctor.

If you stop using Finacea 15 % Gel

If you stop using Finacea 15 % Gel your skin disease can get worse. Please ask your doctor before you stop using Finacea 15 % Gel.

If you have any further questions on the use of Finacea 15 % Gel, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Finacea 15 % Gel can cause side effects, although not everybody gets them.

Skin irritations may occur.

In the majority of cases, the irritation symptoms are mild or moderate and their frequency decreases during the course of therapy.

The reported side effects on the skin are listed below, based on the following frequency scheme:

very common: affects more than 1 user in 10

common: affects 1 to 10 users in 100

uncommon: affects 1 to 10 users in 1,000

rare: affects 1 to 10 users in 10,000

very rare: affects less than 1 user in 10,000

not known: frequency cannot be estimated from the available data

Acne:

Very common: Burning/stinging

Common: Itching (pruritus), abnormal redness of the skin (erythema)/skin irritation, dry skin, scaling

Uncommon: Skin reaction due to an external agent (contact dermatitis), skin discoloration

Rosacea:

Very common: Burning/stinging, itching (pruritus)

Common: Dry skin/scaling, rash

Uncommon: Skin reaction due to an external agent (contact dermatitis), facial swelling (edema)

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Finacea 15 % Gel

Keep out of the reach and sight of children.

Do not use Finacea 15 % Gel after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of that month.

Finacea 15 % Gel does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Finacea 15 % Gel contains

• The active substance is azelaic acid (Each gram of Finacea 15 % Gel contains 150 mg of azelaic acid).


• The other ingredients are lecithin, triglycerides (medium chain), polysorbate 80, propylene glycol, carbomer 980, sodium hydroxide, disodium edetate, purified water and benzoic acid (E210).

What Finacea 15 % Gel looks like and contents of the pack

Finacea 15 % Gel is a white to yellowish-white opaque gel.

Finacea 15 % Gel is available in pack sizes of 5, 30 or 50 g of gel.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Intendis GmbH

Max-Dohrn-Straße 10

D-10589 Berlin

Manufactured by:

Intendis Manufacturing S.p.A.

Via E. Schering 21

20090 Segrate (Milan)

Italy

The distributor in the UK is:

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

Finacea: United Kingdom, Portugal, Denmark, Sweden, Norway, Iceland, Italy, Spain

Skinoren: Germany, Finland, Ireland

This leaflet was last approved in January 2010

Great Britain 82602756

Eucreas

Eucreas may be available in the countries listed below.

UK matches:

• Eucreas 50 mg/850 mg and 50 mg/1000 mg film-coated tablets (SPC)

Ingredient matches for Eucreas

Metformin

Metformin is reported as an ingredient of Eucreas in the following countries:

• Slovenia

Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Eucreas in the following countries:

• Austria


• Denmark


• Finland


• France


• Germany


• Greece


• Ireland


• Netherlands


• Norway


• Sweden


• United Kingdom

Vildagliptin

Vildagliptin is reported as an ingredient of Eucreas in the following countries:

• Austria


• Denmark


• Finland


• France


• Germany


• Greece


• Ireland


• Netherlands


• Norway


• Slovenia


• Sweden


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Logicin

Logicin may be available in the countries listed below.

Ingredient matches for Logicin

Oxymetazoline

Oxymetazoline hydrochloride (a derivative of Oxymetazoline) is reported as an ingredient of Logicin in the following countries:

• Australia


• Hong Kong

International Drug Name Search

Progesterone

In some countries, this medicine may only be approved for veterinary use.

In the US, Progesterone (progesterone systemic) is a member of the drug class progestins and is used to treat Amenorrhea, Endometrial Hyperplasia - Prophylaxis, Perimenopausal Symptoms, Premature Labor, Progesterone Insufficiency, Seizures and Uterine Bleeding.

US matches:

• Progesterone


• Progesterone Gel


• Progesterone Insert


• Progesterone Oil


• Progesterone vaginal

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

G03DA04

CAS registry number (Chemical Abstracts Service)

0000057-83-0

Chemical Formula

C21-H30-O2

Molecular Weight

314

Therapeutic Category

Progestin

Chemical Name

Pregn-4-ene-3,20-dione (WHO)

Foreign Names

• Progesteronum (Latin)
• Progesteron (German)
• Progestérone (French)
• Progesterona (Spanish)

Generic Names

• Progesterone (OS: BAN, DCIT, JAN)
• Progestérone (OS: DCF)
• BP 14 (IS)
• Corpus-luteum-Hormon (IS)
• Lutogynon (IS)
• Pregn-4-ene-3,20-dione (IS: WHO)
• Prolusteron (IS)
• Progesteron (PH: Ph. Eur. 6)
• Progesterone (PH: BP 2010, JP XIV, Ph. Int. 4, USP 32, Ph. Eur. 6)
• Progestérone (PH: Ph. Eur. 6)
• Progesteronum (PH: Ph. Int. 4, Ph. Eur. 6)

Brand Names

• Agolutin
  Biotika, Czech Republic; Biotika, Slovakia



• Belgest
  Blubell, India



• Ciclosterona
  Lusa, Peru



• CIDR (veterinary use)
  Pfizer, Austria; Pfizer, Poland; Pfizer Animal Health, Belgium; Pfizer Animal Health, Luxembourg; Pfizer Animal Health, New Zealand; Pfizer Animal Health, South Africa; Pfizer Santé Animale, France



• Crinone
  Columbia, United States; Douglas, New Zealand; EMD Serono, Canada; Merck, Switzerland; Merck, Spain; Merck, Finland; Merck, Croatia (Hrvatska); Merck, Indonesia; Merck, Italy; Merck, Sweden; Merck Serono, Australia; Merck Serono, Denmark; Merck Serono, United Kingdom; Merck Serono, South Africa; Serono, Argentina; Serono, Bangladesh; Serono, Bahrain; Serono, Brazil; Serono, Czech Republic; Serono, Germany; Serono, Greece; Serono, Ireland; Serono, Israel; Serono, Sri Lanka; Serono, Luxembourg; Serono, Norway; Serono, Peru; Serono, Portugal; Serono, Russian Federation; Serono, Singapore; Serono, Turkey; Serono, Taiwan; Serono, Venezuela; Serum Institute, India



• Cue Mare (veterinary use)
  Bomac, New Zealand



• Cue Mate (veterinary use)
  Bioniche Animal Health A/Asia, Australia; Bomac, New Zealand



• Cuerpo Amarillo Fuerte
  Hormona, Mexico



• Cyclogest
  Actavis, United Kingdom; Actavis, Singapore; Alpharma, Bahrain; Alpharma, Oman; Alpharma, Tunisia; Aventis, South Africa; Sanofi-Aventis, Thailand



• Cygest
  Actavis, Indonesia



• Darstin
  Seid, Spain



• Di-Pro (Progesterone and Estradiol)
  Organon, Turkey



• Eazi Breed CIDR (veterinary use)
  ART, United Kingdom; Pfizer Animal Health, Australia; Pfizer Animal Health, Switzerland; Pfizer Animal Health, New Zealand; Pharmacia & Upjohn vet, United States



• Eazi-Breed CIDR Cattle Insert (veterinary use)
  Pharmacia & Upjohn vet, United States



• Emmenovis (Progesterone and Estradiol)
  Vister Spa, Ethiopia



• Endometrin
  Ferring, Hong Kong; Ferring, Israel; Ferring, United States



• EP Hormone (Progesterone and Estradiol)
  ASKA SeiyakuAsuka, Japan



• Esolut
  Angelini, Italy



• Estima
  Effik, France



• Geslutin PNM
  Medicamenta, Ecuador



• Geslutin
  Asofarma, Mexico; Tecnofarma, Colombia; Tecnofarma, Peru



• Gester
  Merck, Argentina



• Gestone
  Ferring, Israel; Nordic Pharma, United Kingdom; Paines & Byrne, United Arab Emirates; Paines & Byrne, Bahrain; Paines & Byrne, Cyprus; Paines & Byrne, Libya



• Hormoral
  ABL, Peru; Silesia, Chile



• Lugesteron
  Leiras, Finland



• Luteina
  Adamed, Poland



• Lutes (Progesterone and Estradiol)
  Mochida, Japan



• Luteum
  ASKA SeiyakuAsuka, Japan



• Lutogynestryl
  Sanofi-Aventis, Ecuador



• Mafel
  Raymos, Argentina



• Mastoprofen
  Antibiotice, Romania



• Menaelle
  Théramex, Monaco



• Menovis (Progesterone and Estradiol)
  Teofarma, Italy



• Naturogest
  German Remedies, India



• Nomestrol (Progesterone and Estradiol 3-benzoate)
  Vijosa, Guatemala; Vijosa, Honduras; Vijosa, Nicaragua; Vijosa, El Salvador



• Ornisteril (veterinary use)
  Laboratoires Biové, France



• Premastan
  CORNE, Mexico



• Prid Alpha (Progesterone and Dimeticone)
  Ceva, Austria



• Prid (Progesterone and Estradiol (veterinary use))
  Ceva, Germany



• Prid (veterinary use)
  Biokema, Switzerland; Ceva, Belgium; Ceva, Germany; Ceva, France; Ceva, Netherlands; Orion, Finland



• Pridoestrol (Progesterone and Estradiol (veterinary use))
  Ceva, France



• Prochieve
  Columbia, United States



• Progeffik
  Effik, Spain; Effik, Italy



• Progehormon
  Mochida, Japan



• Progenar-Gele
  Menarini, Portugal



• Progendo
  Gynopharm, Chile; Gynopharm, Colombia; Recalcine, Ecuador; Vivax, Venezuela



• Progest
  Elea, Argentina



• Progestan
  Koçak, Turkey



• Progesteron Dak
  Nycomed, Denmark



• Progesteron Gräub (veterinary use)
  Gräub, Switzerland



• Progesteron Streuli
  Streuli Pharma, Switzerland



• Progesteron Stricker (veterinary use)
  Stricker, Switzerland



• Progesteron
  Kade, Germany



• Progesteron (veterinary use)
  CP-Pharma, Germany



• Progesterona L.CH.
  Chile, Chile



• Progesterona
  Bestpharma, Chile; Biosano, Chile; Sanderson, Chile



• Progestérone Biogaran
  Biogaran, France



• Progesterone Biologici
  Biologici, Singapore



• Progesterone Injection
  Watson, United States



• Progestérone Merck
  Mylan, France



• Progesterone Powder
  Paddock, United States; X-Gen, United States



• Progestérone Ratiopharm
  Ratiopharm, France



• Progestérone Retard Pharlon
  Schering, Tunisia



• Progestérone Sandoz
  Sandoz, France



• Progestérone Teva
  Teva Santé, France



• Progesterone
  APP, United States; Biopharm, Georgia; Cytex, Canada; Orion, Australia; PharmaForce, United States; Watson, United States



• Progesterone (veterinary use)
  Intervet, United Kingdom; Jurox, Australia



• Progesteron-K Streuli (Progesterone and Lidocaine (veterinary use))
  Streuli Vet, Switzerland



• Progesteron-K Streuli (veterinary use)
  Streuli Vet, Switzerland



• Progestin
  Vijosa, Guatemala; Vijosa, Nicaragua; Vijosa, Panama; Vijosa, El Salvador



• Progestogel
  Azevedos, Portugal; Besins, Belgium; Besins, France; Besins, Georgia; Besins, Luxembourg; Besins, Russian Federation; Besins, Tunisia; Besins, Vietnam; Biopas, Ecuador; Kade/Besins, Germany; Lab. Besins, Romania; Vifor, Switzerland



• Progeston
  Fuji Yakuhin, Japan



• Progestosol
  Seid, Spain



• Progro S (Progesterone and Estradiol (veterinary use))
  Pro Beef Australia, Australia



• Proluton
  Schering, Argentina



• Prometrium
  Rottapharm, Italy; Schering-Plough, Canada; Solvay, United States; Unimed, United States



• Prontogest
  Amsa, Italy



• Prosphere
  AF, Mexico



• Susten
  Sun, Sri Lanka; Sun, Myanmar



• Synovex (Progesterone and Estradiol (veterinary use))
  Fort Dodge Animale Health, United States; Fort Dodge Australia, Australia



• Utrogest
  Kade/Besins, Germany



• Utrogestan
  Besins, Belgium; Besins, Czech Republic; Besins, France; Besins, Georgia; Besins, Hungary; Besins, Israel; Besins, Luxembourg; Besins, Netherlands; Besins, Poland; Besins, Russian Federation; Besins, Singapore; Besins, Tunisia; Besins, Vietnam; Biopas, Ecuador; Biopas, Venezuela; CORNE, Mexico; Farmoquimica, Brazil; Ferring, United Kingdom; Jaba, Portugal; Lab. Besins, Romania; Meda, Austria; Medias, Croatia (Hrvatska); Sanofi-Aventis, Ireland; Seid, Spain; Solvay, Germany; TTY Biopharm, Taiwan; Vifor, Switzerland



• Utrogestran
  Faran Laboratories, Greece



• Vasclor
  Verisfield, Greece



• Vermagest (Progesterone and Estradiol 3-benzoate)
  Vijosa, Honduras; Vijosa, Nicaragua; Vijosa, El Salvador



• Vit Estérone (Progesterone and Tocopherol, α- (veterinary use))
  Laboratoire Vétoquinol, France

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Flossac

Flossac may be available in the countries listed below.

Ingredient matches for Flossac

Norfloxacin

Norfloxacin is reported as an ingredient of Flossac in the following countries:

• Italy

International Drug Name Search

Prednisolon Nycomed

Prednisolon Nycomed may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Prednisolon Nycomed

Prednisolone

Prednisolone is reported as an ingredient of Prednisolon Nycomed in the following countries:

• Austria


• Georgia


• Norway

International Drug Name Search

Procanbid Controlled-Release

Pronunciation: proe-KANE-a-mide
Generic Name: Procainamide
Brand Name: Examples include Procanbid and Pronestyl-SR

Taking Procanbid Controlled-Release for a prolonged period of time may lead to the development of antibodies in your blood that are sometimes associated with autoimmune diseases such as lupus. If you experience butterfly-shaped rash on the face, swollen or tender joints, unexplained fever, or severe or persistent tiredness, seizures, or mental or mood changes, contact your doctor.

Procanbid Controlled-Release should only be used to treat life-threatening irregular heartbeat. It has been associated with an increased risk of death when used to treat non-life-threatening irregular heartbeat. Talk with your doctor for more information.

Procanbid Controlled-Release may cause severe and sometimes fatal blood problems (eg, bone marrow suppression, low blood platelet or white blood cell levels, anemia). These side effects have occurred most often during the first 12 weeks of therapy. Lab tests, such as complete blood cell counts, may be performed weekly for the first 3 months of therapy and then periodically to monitor for these side effects. If you experience fever, chills, sore throat, mouth sores or irritation, or unusual bruising or bleeding, contact your doctor immediately. Your risk may be greater if you already have bone marrow or blood problems.

Procanbid Controlled-Release is used for:

Treating certain abnormal heart rhythms.

Procanbid Controlled-Release is an antiarrhythmic. It works by stabilizing the heart rhythm in conditions in which the heart is beating too fast or in an irregular rhythm (antiarrhythmic effect).

Do NOT use Procanbid Controlled-Release if:

• you are allergic to any ingredient in Procanbid Controlled-Release


• you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a local anesthetic (eg, procaine)


• you have complete heart block, lupus, or certain severe abnormal heart rhythms (eg, torsades de pointes)


• you are taking astemizole, cisapride, dofetilide, a phenothiazine (eg, chlorpromazine), a phosphodiesterase type 5 inhibitor (eg, sildenafil), terfenadine, or ziprasidone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Procanbid Controlled-Release:

Some medical conditions may interact with Procanbid Controlled-Release. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of liver or kidney disease; heart block, congestive heart failure, QT prolongation, or other heart problems; bone marrow problems; blood problems (eg, low blood platelet or white blood cell levels); myasthenia gravis; or digitalis (digoxin) toxicity

Some MEDICINES MAY INTERACT with Procanbid Controlled-Release. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Antiarrhythmics (eg, amiodarone, quinidine), anticholinergics (eg, hyoscyamine), arsenic, astemizole, cisapride, dofetilide, droperidol, H₂ antagonists (eg, cimetidine), ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, chlorpromazine), phosphodiesterase type 5 inhibitors (eg, sildenafil), pimozide, quinolone antibiotics (eg, ciprofloxacin), serotonin receptor antagonists (eg, dolasetron), terfenadine), trimethoprim, or ziprasidone because the risk of side effects, including irregular heartbeat, may be increased


• Neuromuscular blockers (eg, succinylcholine) because actions or side effects may be increased by Procanbid Controlled-Release

This may not be a complete list of all interactions that may occur. Ask your health care provider if Procanbid Controlled-Release may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Procanbid Controlled-Release:

Use Procanbid Controlled-Release as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Procanbid Controlled-Release may be taken on an empty stomach or with food.


• Swallow Procanbid Controlled-Release whole. Do not break, crush, or chew before swallowing.


• Take Procanbid Controlled-Release regularly to receive the most benefit from it.


• Continue to use Procanbid Controlled-Release even if you feel well. Do not miss any doses.


• If you miss a dose of Procanbid Controlled-Release, take it as soon as possible. If it is almost time for our next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Procanbid Controlled-Release.

Important safety information:

• Procanbid Controlled-Release may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Procanbid Controlled-Release.


• Drinking alcohol may decrease the effectiveness of Procanbid Controlled-Release. Check with your doctor before drinking alcohol.


• Do not exceed the recommended dose or use Procanbid Controlled-Release for longer than prescribed without checking with your doctor.


• Do not suddenly stop taking Procanbid Controlled-Release without checking with your doctor.


• Procanbid Controlled-Release may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Procanbid Controlled-Release may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Procanbid Controlled-Release.


• Procanbid Controlled-Release may interfere with certain lab tests. Make sure your doctor and laboratory personnel know you are using Procanbid Controlled-Release.


• With some brands of Procanbid Controlled-Release, you may see what looks like the original tablet in your stool. This is normal.


• LAB TESTS, including heart function tests, complete blood cell counts, and serum ANA titers, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Procanbid Controlled-Release with caution in the ELDERLY because they may be more sensitive to its effects.


• Use Procanbid Controlled-Release with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Procanbid Controlled-Release during pregnancy. Procanbid Controlled-Release is excreted in breast milk. Do not breast-feed while you are taking Procanbid Controlled-Release.

Possible side effects of Procanbid Controlled-Release:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bitter taste.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); butterfly-shaped rash on the face; chest pain; dark urine; depression; diarrhea; dizziness or lightheadedness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hallucinations; loss of appetite; mood or mental changes; mouth sores or irritation; muscle pain or weakness; nausea; pale stools; seizures; stomach pain; severe or persistent tiredness; shortness of breath; swollen or tender joints; unusual bruising or bleeding; unusual tiredness or weakness; vomiting; wheezing; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Procanbid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; fast or irregular heartbeat; irregular or difficult breathing; severe drowsiness; tremor.

Proper storage of Procanbid Controlled-Release:

Store Procanbid Controlled-Release between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Procanbid Controlled-Release out of the reach of children and away from pets.

General information:

• If you have any questions about Procanbid Controlled-Release, please talk with your doctor, pharmacist, or other health care provider.


• Procanbid Controlled-Release is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Procanbid Controlled-Release. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Procanbid resources

• Procanbid Side Effects (in more detail)
• Procanbid Use in Pregnancy & Breastfeeding
• Drug Images
• Procanbid Drug Interactions
• Procanbid Support Group
• 0 Reviews for Procanbid - Add your own review/rating

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sodium fusidate and hydrocortisone acetate

Please read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects become serious, or you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.

In this leaflet:

• 1. What Fucidin H Ointment is and what it is used for


• 2. Before you use Fucidin H Ointment


• 3. How to use Fucidin H Ointment


• 4. Possible side effects


• 5. How to store Fucidin H Ointment


• 6. Further information

What Fucidin H Ointment Is And What It Is Used For

Fucidin H Ointment contains two different types of medicine. One medicine is called sodium fusidate. It is a type of antibiotic. The other medicine is called hydrocortisone acetate. It is a type of corticosteroid (steroid). These two medicines work at the same time in different ways.

Fucidin H Ointment works by:

• The antibiotic killing germs (bacteria) that cause infections.


• The corticosteroid reducing any swelling, redness or itchiness of your skin.

Fucidin H Ointment is used to treat:

• Conditions where the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria).

Before You Use Fucidin H Ointment

Do not use Fucidin H Ointment

• If you are allergic (hypersensitive) to fusidic acid, sodium fusidate or hydrocortisone acetate.


• If you are allergic (hypersensitive) to any of the other ingredients in your medicine. You can find a list of these ingredients in section 6 of this leaflet.


• To treat a skin condition called acne rosacea. This is redness and inflammation over your nose and cheeks. Ask your doctor if you are unsure.


• To treat a skin condition called perioral dermatitis. This is a red spotty rash around your mouth or chin.


• To treat skin conditions caused by tuberculosis or syphilis.


• To treat skin conditions caused only by bacteria, such as boils or spots.


• To treat a skin condition caused by a virus, such as cold sores or chickenpox.


• To treat a skin condition caused by a fungus, such as athlete’s foot.

Take special care with Fucidin H Ointment

• Take special care if you are going to use this medicine near your eyes or the eyes of a child.


• If you use the ointment over a long time or in large amounts it may make the chance of getting any side effects higher. Also your skin may get more sensitive to this medicine.


• You must not use the medicine for a long time on your face.


• Unless your doctor has told you to, you must not use Fucidin H Ointment on open wounds or sensitive areas such as the nostrils, ears, lips or genitals.


• Unless your doctor has told you to, you must not use Fucidin H Ointment on thin skin, skin ulcers, broken veins or acne.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription.

Pregnancy and breast-feeding

Please ask your doctor or pharmacist for advice before using Fucidin H Ointment:

• If you are pregnant, or think you are pregnant.
  You must not use your medicine for a long time or in large amounts. You must ask your doctor for advice.

• If you are breast-feeding.

Tell your doctor if you become pregnant while using this medicine.

Driving and using machines

Usually your medicine will have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.

Important information about some of the ingredients of Fucidin H Ointment

Fucidin H Ointment contains:

• Lanolin (wool fat). This may give you an itchy rash and inflammation on your skin where your medicine is used.


• Cetyl alcohol. This may give you an itchy rash and inflammation on your skin where your medicine is used.

Please ask your doctor if you are worried about any of the ingredients in this medicine.

How To Use Fucidin H Ointment

Always use Fucidin H Ointment exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

How to put on Fucidin H Ointment

This medicine is only for using on your skin or the skin of a child. Do not swallow it. Do not put it inside your body.

Remove the cap. Check the seal is not broken before you first use the ointment. Then push the spike in the cap through the seal on the tube.

Always wash your hands before using Fucidin H Ointment. Rub the medicine gently on the skin. If you use it on your face be careful to avoid your eyes.

Unless you are using the ointment to treat your hands, always wash your hands after using Fucidin H Ointment.

If you accidentally get any medicine in your eye, wash it out with cold water straight away. Then bathe your eye with eyewash if possible. Your eye may sting. If you start to have any problems with your sight or your eye is sore, contact your doctor immediately.

How much Fucidin H Ointment to use

Your doctor will tell you how much Fucidin H Ointment to use.

The usual treatment time is up to two weeks. Ask your doctor before using this medicine for any longer.

You should notice your skin improve after just a few days of using the ointment. If there is no improvement after 7 days you should stop using the ointment and go back to your doctor.

Usually, you should use this medicine twice each day. Use it in the morning and evening. To remind you to use the medicine it may help to use it when you do another regular action, such as brushing your teeth.

If you have been told to cover the skin with any dressings or bandages you may not need to use the medicine so often. A nappy on a baby may act as a dressing. Follow the advice of your doctor.

Adults and children:

Your doctor should tell you the dose that is right for you or the child. If your doctor has told you the amount of ointment to use then keep to this advice. If not, the following guide will help you to use the correct amount.

You can use your first (index) finger to measure how much Fucidin H Ointment to use. Squeeze the ointment along your finger from the tip to the first joint as shown in the diagram. This is called a fingertip unit.

The usual number of finger tip units you need to cover different parts of the body is shown in the diagrams. If you need to use a little more or a little less do not worry. If you are using the ointment on a child still use an adult finger to measure out the fingertip unit.

For an adult:

For application to the face and neck- 2 and a half fingertip units of cream.

For application to the back of the trunk- 7 fingertip units of cream.

For application to the front of the trunk- 7 fingertip units of cream.

For application to one arm (not including the hand)- 3 fingertip units of cream.

For application to both sides of one hand- 1 fingertip unit of cream.

For application to one leg (not including the foot)- 6 fingertip units of cream.

For application to one foot- 2 fingertip units of cream.

For a child under 11 years:

For a child aged three to six months:



For application to the face and neck- 1 fingertip unit of cream.

For application to one arm and hand- 1 fingertip unit of cream.

For application to one leg and foot- 1 and a half fingertip units of cream.

For application to the front of the trunk- 1 fingertip unit of cream.

For application to the back of the trunk, including the buttocks- 1 and a half fingertip units.

For a child aged one to two years:



For application to the face and neck- 1 and a half fingertip units of cream.

For application to one arm and hand- 1 and a half fingertip units of cream.

For application to one leg and foot- 2 fingertip units of cream.

For application to the front of the trunk- 2 fingertip units of cream.

For application to the back of the trunk, including the buttocks- 3 fingertip units.

For a child aged three to five years:



For application to the face and neck- 1 and a half fingertip units of cream.

For application to one arm and hand- 2 fingertip units of cream.

For application to one leg and foot- 3 fingertip units of cream.

For application to the front of the trunk- 3 fingertip units of cream.

For application to the back of the trunk, including the buttocks- 3 and a half fingertip units.

For a child aged six to ten years:



For application to the face and neck- 2 fingertip units of cream.

For application to one arm and hand- 2 and a half fingertip units of cream.

For application to one leg and foot- 4 and a half fingertip units of cream.

For application to the front of the trunk- 3 and a half fingertip units of cream.

For application to the back of the trunk, including the buttocks- 5 fingertip units.

If you forget to use Fucidin H Ointment

If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual time.

If you have any further questions about using this medicine, please ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Fucidin H Ointment can cause side effects, although not everybody gets them.

Important side effects to look out for:

You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:

• 
  You have difficulty breathing
  


• 
  Your face or throat swell
  


• 
  Your skin develops a severe rash.
  

Other possible side effects:

Any of the problems listed below are more likely if the medicine is used for a long time, in large amounts or on skin folds (such as armpits or under breasts).

These problems are more likely in babies and children. They are also more likely if the skin is covered with a dressing or bandage or nappy.

Skin problems

• Rash.


• Burning and stinging feeling.


• Skin irritation.


• Itching skin.


• Worsening of your eczema.


• Thinning of the skin.


• Small veins near the surface of the skin become visible.


• Stretch marks.


• Itchy rash and skin inflammation in the area where the medicine is used.


• Inflammation or swelling of the hair root (folliculitis).


• Changes in growth of your body hair.


• Red spotty rash around the mouth or chin.


• Lightening of your skin colour.


• Skin of the face may become puffy.

If any of the side effects become serious or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

How To Store Fucidin H Ointment

• Keep out of the reach and the sight of children.


• Do not use Fucidin H Ointment after the expiry date on the carton. The expiry date is the last day of that month.

Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need any more. If you do this you will help
protect the environment.

Further Information

What Fucidin H Ointment contains

• There are two active ingredients, sodium fusidate and hydrocortisone acetate.
  
  Fucidin H Ointment contains 2% sodium fusidate and 1% hydrocortisone.
  

• The other ingredients are cetyl alcohol, lanolin (wool fat), liquid paraffin and white soft paraffin.

You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet.

What Fucidin H Ointment looks like and contents of the pack

Fucidin H Ointment is an off-white ointment.

Fucidin H Ointment comes in tubes of 30 g and 60 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

LEO Laboratories Limited

Princes Risborough

Bucks.

HP27 9RR

UK

Manufacturer:

LEO Laboratories Limited

Dublin 12

Ireland

This leaflet was last revised in March 2008.

Registered Trade Mark

LEO

017565 - 05

Fenistil Cold Sore Cream

1. Name Of The Medicinal Product

Fenistil Cold Sore Cream

2. Qualitative And Quantitative Composition

Eeach gram of the cream contains:

Active substance: 10 mg penciclovir

Excipients: cetostearyl alcohol, propylene glycol

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Cream

Smooth white cream of homogeneous appearence

4. Clinical Particulars

4.1 Therapeutic Indications

Fenistil Cold Sore Cream is indicated for the treatment of herpes simplex virus infections of the lips and face (herpes labialis) in adults and children over 12 years of age.

Immunocompromised patients: Fenistil Cold Sore Cream.is not recommended for use in immunocompromised patients; such patients should consult a physician concerning the treatment of any infection.

4.2 Posology And Method Of Administration

Adults (including the elderly) and children over 12 years of age:

Fenistil Cold Sore Cream should be applied at approximately two hourly intervals during waking hours, (approximately 8 times a day). Treatment should be continued for 4 days. If the condition gets worse or does not improve after 4 days treatment, seek medical advice.

Treatment should be started as early as possible after the first sign of an infection.

Children (under 12 years):

No work has been carried out in children below 12 years of age.

4.3 Contraindications

Known hypersensitivity to penciclovir, famciclovir or the other constituents of the formulation, eg. propylene glycol.

4.4 Special Warnings And Precautions For Use

The cream should only be used on cold sores on the lips and around the mouth. It is not recommended for application to the mucous membranes, such as in the mouth or eye, or on the genitals. It must not be used in ocular or genital herpes. Particular care should be taken to avoid contact with the eyes.

Patients with particularly severe cold sores should be encouraged to seek medical advice.

Patients should be advised to avoid transmitting the virus, particularly when active lesions are present.

Immunocompromised patients (eg AIDs patients or bone marrow transplant recipients) should be encouraged to consult a physician in case oral therapy is indicated.

The cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). It also contains propylene glycol, which may cause skin irritation.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Clinical trial experience has not identified any interactions resulting from concomitant administration of topical or systemic drugs with Fenistil Cold Sore Cream.

4.6 Pregnancy And Lactation

There is unlikely to be any cause for concern regarding adverse effects when the cream is used in pregnant and/or lactating women as systemic absorption of penciclovir following topical administration of Fenistil Cold Sore Cream has been shown to be minimal (see Section 5.2).

Animal studies have not shown any embryotoxic or teratogenic effects with penciclovir given intravenously (at doses greater than 1200 times those recommended for clinical use via topical application), nor were there any effects on male and female fertility and general reproductive performance (at doses greater than 1600 times those recommended for clinical use via topical application). Studies in rats show that penciclovir is excreted in the breast milk of lactating females given oral famciclovir (famciclovir; the oral form of penciclovir, is converted in vivo to penciclovir). There is no information on excretion of penciclovir in human milk.

Since the safety of penciclovir in human pregnancy has not been established, Fenistil Cold Sore Cream should only be used during pregnancy or in nursing mothers on the advice of a doctor, if the potential benefits are considered to outweigh the potential risks associated with treatment.

4.7 Effects On Ability To Drive And Use Machines

Adverse effects on the ability to drive or operate machinery have not been observed.

4.8 Undesirable Effects

Fenistil Cold Sore Cream has been well-tolerated in human studies. Clinical trial experience has shown that there was no difference between Fenistil Cold Sore Cream and placebo in the rate or type of adverse reactions reported. In particular, application site reactions (eg transient burning, stinging, numbness) occurred in less than 3% of patients in each group in the pivotal clinical trials.

Post-marketing surveillance from penciclovir cream has revealed isolated cases of hypersensistivity reactions, such as allergic dermatitis, rash, urticaria, pruritis and oedema.

No cases of photosensitivity were reported in the pivotal clinical trials.

4.9 Overdose

No untoward effects would be expected even if the entire contents of a container of Fenistil Cold Sore Cream were ingested orally; penciclovir is poorly absorbed following oral administration. However, some irritation in the mouth could occur. No specific treatment is necessary if accidental oral ingestion occurs.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Penciclovir has demonstrable in vivo and in vitro activity against herpes simplex viruses (types 1 and 2) and varicella zoster virus. In virus-infected cells penciclovir is rapidly and efficiently converted into a triphosphate (mediated via virus-induced thymidine kinase). Penciclovir triphosphate persists in infected cells for more than 12 hours where it inhibits replication of viral DNA and has a half-life of 9, 10 and 20 hours in cells infected with varicella zoster virus, herpes simplex virus type 1 and herpes simplex virus type 2 respectively. In uninfected cells treated with penciclovir, concentrations of penciclovir triphosphate are only barely detectable. Accordingly, uninfected cells are unlikely to be affected by therapeutic concentrations of penciclovir.

In clinical studies, Fenistil treated patients healed 30% faster than placebo (up to one day earlier), pain resolution was 25-30% faster (median improvement of up to one day) and infectivity resolved up to 40% faster (one day earlier) than placebo.

5.2 Pharmacokinetic Properties

Following application of Fenistil Cold Sore Cream in a human volunteer study at a daily dose of 180mg penciclovir (approximately 67 times the proposed daily clinical dose), to occluded and abraded skin for 4 days, penciclovir was not quantifiable in plasma and urine.

5.3 Preclinical Safety Data

General toxicology

Topical application of 5% Fenistil Cold Sore Cream for 4 weeks to rats and rabbits was well tolerated. There was no evidence of contact sensitisation in guinea pigs.

A full programme of studies has been completed using intravenous penciclovir. These studies did not raise any safety concerns regarding topical use of Fenistil Cold Sore Cream. There is a minimal systemic absorption of penciclovir following topical administration.

The results of a wide range of mutagenicity studies in vitro and in vivo indicates that penciclovir does not pose a genotoxic risk to man.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White soft paraffin

Liquid paraffin

Cetostearyl alcohol

Propylene glycol

Cetomacrogol 1000

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2g aluminium tubes - 3 years.

6.4 Special Precautions For Storage

Store at temperatures not exceeding 30°C.

Do not freeze.

6.5 Nature And Contents Of Container

2g aluminium tube.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Novartis Consumer Health (UK) Limited

Wimblehurst Road

Horsham

West Sussex RH12 5AB

UK

Trading as: Novartis Consumer Health

8. Marketing Authorisation Number(S)

PL 00030/0215

9. Date Of First Authorisation/Renewal Of The Authorisation

23^rd August 2006

10. Date Of Revision Of The Text

5 November 2009

Legal category: P

Braxan

Braxan may be available in the countries listed below.

Ingredient matches for Braxan

Amiodarone

Amiodarone hydrochloride (a derivative of Amiodarone) is reported as an ingredient of Braxan in the following countries:

• Mexico

International Drug Name Search

Naloxone Hydrochloride Injection

Naloxone Hydrochloride Injection may be available in the countries listed below.

Ingredient matches for Naloxone Hydrochloride Injection

Naloxone

Naloxone hydrochloride (a derivative of Naloxone) is reported as an ingredient of Naloxone Hydrochloride Injection in the following countries:

• Australia


• New Zealand

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Proxalyoc

Proxalyoc may be available in the countries listed below.

Ingredient matches for Proxalyoc

Piroxicam

Piroxicam is reported as an ingredient of Proxalyoc in the following countries:

• France


• Tunisia

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Ondansetron Pliva

Ondansetron Pliva may be available in the countries listed below.

Ingredient matches for Ondansetron Pliva

Ondansetron

Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Ondansetron Pliva in the following countries:

• Hungary

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Nilstat

Nilstat is a brand name of nystatin, approved by the FDA in the following formulation(s):

NILSTAT (nystatin - suspension; oral)

• 
  Manufacturer: GLENMARK GENERICS
  
  Approved Prior to Jan 1, 1982
  
  Strength(s): 100,000 UNITS/ML ^[RLD][AA]

Has a generic version of Nilstat been approved?

Yes. The following products are equivalent to Nilstat:

nystatin suspension; oral

• 
  Manufacturer: ACTAVIS MID ATLANTIC
  
  Approval date: July 14, 1982
  
  Strength(s): 100,000 UNITS/ML ^[AA]


• 
  Manufacturer: FOUGERA
  
  Approval date: June 7, 1984
  
  Strength(s): 100,000 UNITS/ML ^[AA]


• 
  Manufacturer: HI TECH PHARMA
  
  Approval date: February 28, 1994
  
  Strength(s): 100,000 UNITS/ML ^[AA]


• 
  Manufacturer: TARO
  
  Approval date: February 29, 1988
  
  Strength(s): 100,000 UNITS/ML ^[AA]


• 
  Manufacturer: VINTAGE PHARMS
  
  Approval date: June 28, 2005
  
  Strength(s): 100,000 UNITS/ML ^[AA]


• 
  Manufacturer: VISTAPHARM
  
  Approval date: June 25, 1998
  
  Strength(s): 100,000 UNITS/ML ^[AA]


• 
  Manufacturer: VISTAPHARM
  
  Approval date: March 7, 2011
  
  Strength(s): 100,000 UNITS/ML ^[AA]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Nilstat. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

There are no current U.S. patents associated with Nilstat.

See also...

• Nilstat Consumer Information (Cerner Multum)
• Nilstat Drops Advanced Consumer Information (Micromedex)
• Nystatin Consumer Information (Wolters Kluwer)
• Nystatin Powder Consumer Information (Wolters Kluwer)
• Nystatin Suspension Consumer Information (Wolters Kluwer)
• Nystatin Consumer Information (Cerner Multum)
• Mycostatin Suspension Advanced Consumer Information (Micromedex)
• Nadostine Advanced Consumer Information (Micromedex)
• Nadostine Sucrose-Free Advanced Consumer Information (Micromedex)
• Nilstat Powder Advanced Consumer Information (Micromedex)
• Nyaderm Advanced Consumer Information (Micromedex)
• Pms-Nystatin Advanced Consumer Information (Micromedex)
• Nystatin Advanced Consumer Information (Micromedex)

Odanet

Odanet may be available in the countries listed below.

Ingredient matches for Odanet

Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Odanet in the following countries:

• Greece

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Acido clodronico

Acido clodronico may be available in the countries listed below.

Ingredient matches for Acido clodronico

Clodronic Acid

Acido clodronico (DCIT) is also known as Clodronic Acid (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Colestid Orange

Colestid Orange 5.0g

Colestipol hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.



• If you have any further questions, ask your doctor or pharmacist.



• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.



• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Colestid Orange is and what it is used for



• 2. Before you take Colestid Orange



• 3. How to take Colestid Orange



• 4. Possible side effects



• 5. How to store Colestid Orange



• 6. Further information

What Colestid Orange Is And What It Is Used For

Colestid Orange is a 'lipid lowering agent'. Colestid Orange is one of a group of medicines called bile acid sequestrants. The active ingredient is colestipol hydrochloride.

Colestid Orange is used to help lower the level of cholesterol in your blood. Your doctor will have recommended a special diet to you in order to help you lose weight since this is very important in lowering your cholesterol levels. Your doctor has given you Colestid Orange since the diet on its own is not lowering your cholesterol enough. It is still very important that you follow your special diet even when taking Colestid Orange. You can find out more about cholesterol from The British Heart Foundation whose address is given at the end of this leaflet.

Before You Take Colestid Orange

Do not take Colestid Orange:

• if you are allergic (hypersensitive) to colestipol hydrochloride or any of the other ingredients of Colestid Orange (see section 6 for a list of ingredients).

Take special care with Colestid Orange

Tell your doctor if you have any of these problems:

• an under-active thyroid gland



• nephrotic syndrome (a kidney problem where you get protein in your urine and too much fluid collecting in your body)



• too much or too little protein in your blood



• liver problems e.g. jaundice



• diabetes



• phenylketonuria eg you are on a special diet that is low in phenylalanine

Taking other medicines

There are some medicines that may interact with Colestid Orange and it can affect the way they work. Tell your doctor about other medicines you are taking before you start your Colestid Orange.

It is especially important to tell your doctor if you are taking the following medicines:

• heart drugs e.g. digoxin, digitoxin



• beta-blockers e.g. propranolol - for high blood pressure, angina, migraine or anxiety symptoms



• water tablets ('diuretics') e.g. chlorothiazide or furosemide - usually for heart or kidney problems



• antibiotics e.g. tetracycline hydrochloride and penicillin G



• another cholesterol-lowering medicine called gemfibrozil

Your doctor may need to change your dose of these medicines. If you are taking propranolol, your doctor will need to check your dose when you start taking Colestid Orange and also when you stop.

Please tell your doctor or pharmacist if you are taking or recently have taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, or are planning to become pregnant, or if you are breast-feeding. Your doctor may stop your treatment.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Your ability to drive or operate machinery is not affected by taking Colestid Orange

Important information about some of the ingredients of Colestid Orange

Colestid Orange contains 32.5 mg aspartame which contains (18.2 mg phenylalanine) per sachet. This needs to be taken into consideration in people suffering from a condition known as phenylketonuria, since excessive amounts of aspartame may interfere with the control of this condition. If you suffer from phenylketonuria you should discuss this with your doctor before taking Colestid Orange.

How To Take Colestid Orange

Always take your medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Colestid Orange must not be taken as a dry powder and must be mixed with a drink or taken with liquid food. The Colestid Orange powder should be mixed thoroughly with at least 100 ml of water or another still drink such as orange or skimmed milk. Alternatively, Colestid Orange can be taken with soup or cereal or with pulpy fruit such as grapefruit, provided that there is at least 100 ml or more of liquid.

Colestid Orange has an orange/vanilla smell. It is flavoured with orange and vanilla and contains artificial sweeteners.

Your doctor will advise you on the amount of Colestid Orange you should take, and when.

Most people start by taking one to two sachets of Colestid Orange per day. Your doctor may increase your dose each month until your cholesterol reaches the best level for you. Do not change the number of sachets you take unless your doctor tells you to. Do not take more than 6 sachets (30 grams) a day. If you are prescribed more than two sachets per day, it may be preferable to take Colestid Orange as two separate doses, leaving several hours between e.g. with breakfast and an evening meal.

Taking Colestid with other medicines

If you have other medicines to take, make sure you take them at least one hour before or four hours after your Colestid Orange except if you are taking gemfibrozil, take this at least two hours before or after your Colestid Orange.

You may have to take Colestid Orange every day for a long time. It is important that you stick to your recommended diet as well as taking your Colestid Orange.

Colestid Orange does not actually dissolve and it therefore has a "gritty" texture, especially if it is not well mixed with the liquid you are using. The "grittiness" of Colestid Orange is much more obvious in "dilute" drinks such as water or fruit juice. Some people mix up Colestid Orange the night before to improve results.

Use by Children

Colestid Orange will not normally be given to children. Ask your doctor for more information if they have prescribed Colestid Orange for a child in your care. If children or young adults are given this medicine, your doctor will need to check their growth and development regularly.

If you take more Colestid Orange than you should

Never take more Colestid Orange than your doctor has told you. If you do, tell your doctor because you may get constipation.

If you forget to take Colestid Orange

Don't worry. Take your next sachet (or sachets) at the usual time.

Do not take a double dose to make up for a forgotten dose.

Colestid Orange Side Effects

Like all medicines, Colestid Orange can cause side-effects, although not everyone gets them.

Tell your doctor if you experience any of the following side effects and they do not go away:

• constipation, which is usually mild and does not last for long. Eating more fibre and drinking plenty of fluid usually helps. Sometimes it can be more severe and cause a blockage in your colon. If this happens you might need some treatment like an enema, to relieve the blockage. Tell your doctor if you think you have this problem. Constipation can make piles (haemorrhoids) worse and you may notice blood in your stools. Tell your doctor immediately if this happens.



• stomach discomfort,



• belching,



• wind,



• nausea (feeling sick)



• sickness or diarrhoea.

Other side effects

Rarely, some people have noticed the following side-effects, Tell your doctor immediately if any of these happen.

• stomach ulcers and bleeding stomach ulcers. These will cause severe stomach pains and if these start to bleed you may pass very dark stools or bring up blood if you are sick.



• inflammation of the gall bladder, gallstones or yellowish skin.



• chest pain, angina-like feelings or you may feel your heart beat speeding up.



• allergy effects like a rash, itchy skin or hives..



• aches and pains in your joints and muscles, especially your fingers and toes. You may also feel backache.



• headaches, some of which may feel quite severe (migraine, sinus headache) or feel dizzy and light-headed. You may also have difficulty sleeping,.



• not feel like eating, feeling tired and weak, have a shortness of breath, or swelling of your hands and feet.

Colestid Orange affects the way that your body absorbs fats and some 'fat-soluble' vitamins (A,D,E and K). Your doctor may give you a vitamin supplement if they think this could be happening.

The levels of some fats and enzymes in your blood may rise. This is usually temporary.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

How To Store Colestid Orange

Keep out of the reach and sight of children.

Do not use Colestid Orange after the expiry date which is stated on the label. The expiry date refers to the last day of the month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further Information

What Colestid Orange contains

• The active substance is colestipol hydrochloride



• The other ingredients are
  
  • Mannitol E421
  
  
  • Methylcellulose (15CPS) E461
  
  
  • Citric Acid E330
  
  
  • Orange Durarome Wonf
  
  
  • Aspartame Powder E951
  
  
  • Maltol
  
  
  • Ethyl Vanillin
  
  
  • Beta Carotene 1% E160a
  
  
  • Glycerol E422
  
  
  • Purified Water
  
  
  

What Colestid Orange looks like and the contents of the pack

• Colestid Orange is yellow granules for oral suspension with orange particles.



• Colestid Orange comes in boxes of 30 sachets. Each 7.5 g sachet contains 5 g of the active substance, colestipol hydrochloride.

Marketing Authorisation Holder and Manufacturer

Pharmacia Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

Manufacturer

Pfizer Service Company BVBA

10 Hoge Wei

1930 Zaventem

Belgium

More information about cholesterol

If you would like any more information about changing your lifestyle to lower your cholesterol you can contact:

The British Heart Foundation

14 Fitzhardinge Street

London

W1H 4DH

Tel.:020 7935 0185

This leaflet was last approved in 05/2008

Colestid is a registered trademark – Pharmacia Limited.

Ref CL 4_0

Fybogel Lemon

1. Name Of The Medicinal Product

Fybogel Lemon.

2. Qualitative And Quantitative Composition

A sachet contains 3.5 g ispaghula husk BP.

3. Pharmaceutical Form

Granules.

4. Clinical Particulars

4.1 Therapeutic Indications

Clinical Indication: for the treatment of patients requiring a high fibre regimen: for example, for the relief of constipation, including constipation in pregnancy and the maintenance of regularity; for the management of bowel function in patients with colostomy, ileostomy, haemorrhoids, anal fissure, chronic diarrhoea associated with diverticular disease, irritable bowel syndrome and ulcerative colitis.

4.2 Posology And Method Of Administration

Fybogel Lemon is intended for oral administration in a suspension in a drink of water. The granules should be stirred into a glass of water and taken as soon as possible, preferably after meals.

Adults and children over 12 years:	One sachet morning and evening.
Elderly:	There is no indication that dosage needs to be modified for the elderly.
Children aged 6 to 12 years:	Half to one level 5 ml spoonful depending on size and age, morning and evening. If there has been no bowel movement after three days of treatment the doctor should be consulted.
Children under 6 years:	To be taken only when prescribed by a doctor, half to one level 5 ml spoonful depending on age and size, morning and evening.

4.3 Contraindications

Fybogel Lemon is contra-indicated in cases of intestinal obstruction, faecal impaction and colonic atony such as senile mega-colon.

4.4 Special Warnings And Precautions For Use

Due to its aspartame content Fybogel Lemon should not be given to patients with phenylketonuria.

If symptoms persist consult a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Fybogel Lemon may be used during pregnancy and lactation since the ispaghula husk is not absorbed from the gastrointestinal tract.

4.7 Effects On Ability To Drive And Use Machines

Not applicable in view of its physical mode of action

4.8 Undesirable Effects

A small amount of abdominal distension and flatulence may sometimes occur.

4.9 Overdose

In the event of overdosage conservative measures should be taken. The patient may notice abdominal discomfort and flatulence, and attention should be paid to maintaining an adequate fluid intake.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Ispaghula husk is capable of absorbing up to 40 times its own weight in water in vitro, and part of its activity can be attributed to its action as a simple bulking agent. In addition, colonic bacteria are believed to use the hydrated material as a metabolic substrate. This results in an increase in the bacterial cell mass with consequent softening of the faeces.

5.2 Pharmacokinetic Properties

The mode of action of Fybogel Lemon is physical and does not depend on absorption into the systemic circulation.

5.3 Preclinical Safety Data

No preclinical findings relevant to the prescriber have been reported.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Potassium bicarbonate	USP
Sodium bicarbonate	Ph Eur
Citric acid	Ph Eur
Riboflavin sodium phosphate	Ph Eur
Aspartame	Ph Eur
Lemon flavour no. 1	HSE
Lemon flavour no. 4	HSE
Saccharin Sodium	Ph Eur
Polysorbate 80	Ph Eur
Silica colloidal anhydrous	Ph Eur

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store below 30°C in a dry place.

6.5 Nature And Contents Of Container

Sachets of paper/aluminium foil/polythene laminate. One, seven, ten or thirty sachets in a cardboard outer. (Pack sizes printed in bold are currently sold).

6.6 Special Precautions For Disposal And Other Handling

Fybogel Lemon granules are to be dispersed in water forming a drink.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

HULL,

HU8 7DS,

England.

8. Marketing Authorisation Number(S)

PL 00063/0024.

9. Date Of First Authorisation/Renewal Of The Authorisation

24th April, 1995 / 20th August, 1997.

10. Date Of Revision Of The Text

19/01/2007