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

Compare Procanbid with other medications

• Arrhythmia