Fucidin H Ointment

Fucidin H Ointment

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.

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Amiodarone

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

• Mexico

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Naloxone Hydrochloride Injection

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

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Naloxone

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

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Proxalyoc

Proxalyoc may be available in the countries listed below.

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Piroxicam

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Ondansetron

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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.

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• 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)