Common

PACKAGE LEAFLET

for

®
Fucidin H cream
MRP: DK/H/0130/001

1
 Package leaflet: Information for the user
®
Fucidin H
20 mg/g + 10 mg/g
Cream

Fusidic acid and hydrocortisone acetate

Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
- 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 only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet

®
1. What Fucidin H is and what it is used for
®
2. What you need to know before you use Fucidin H
®
3. How to use Fucidin H
4. Possible side effects
®
5. How to store Fucidin H
6. Contents of the pack and other information

®
1. What Fucidin H is and what it is used for
®
Fucidin H cream combines the antibacterial action of fusidic acid (antibiotic) with the anti-
inflammatory effect of hydrocortisone acetate (corticoid).

It is used for the topical treatment of infected atopic dermatitis (commonly known as eczema, a skin disease
accompanied by inflammation, reddening, exudation or scabs and itching, frequently of an allergic origin).

You must talk to a doctor if you do not feel better or if you feel worse.

®
2. What you need to know before you use Fucidin H
®
Do not use Fucidin H:
- if you are allergic to fusidic acid, sodium fusidate, hydrocortisone acetate or any of the other
ingredients of this medicine (listed in section 6).
- if you have a skin infection primarily caused by bacteria, fungi or virus (such as herpes or varicella)
- if you have tuberculosis
- if you have dermatitis around the mouth
- if you have rosacea (severe flushing of the skin on the face)

2
Warnings and precautions
®
Talk to your doctor or pharmacist before and during use of Fucidin H
® ®
- Fucidin H should be applied with care when used near the eyes. Fucidin H must not enter the eyes
- Contact your doctor if you experience blurred vision or other visual disturbances
®
- The use of Fucidin H is limited to 2 weeks. Long-term treatment may result in risk of
increased side effects and risk of antibiotic resistance, e.g. your skin may become thin
®
- Fucidin H might mask potential symptoms of infections
®
- Fucidin H might make you more susceptible to infection, aggravation of existing
infection and activation of latent infection

Children and adolescents

®
Fucidin H should be used with care in children.
®
Other medicines and Fucidin H
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.

Use during pregnancy and lactation should be evaluated and decided upon by a doctor.

®
Fucidin H should be used with caution during pregnancy.
®
Fucidin H can be used during breast-feeding, but it is recommended to avoid using it on the breast.

Driving and using machines

®
The treatment with Fucidin H cream should not affect to the ability to drive and use machines.
®
Fucidin H contains butylhydroxyanisole (E320), cetyl alcohol and potassium sorbate (E202)
These ingredients may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also
cause irritation to the eyes and mucous membranes (such as nasal passages and lips).

®
3. How to use Fucidin H

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.

The recommended dose for children, adolescents and adults is:

Carefully apply a thin layer of cream to the affected area of the skin, three times daily.
®
Fucidin H must not be used for more than 2 weeks.
Wash your hands carefully after applying this medicine, unless your hands are the area being treated.
®
If you use more Fucidin H than you should
If you have applied more cream than you should, consult your doctor or pharmacist.
®
If you forget to use Fucidin H
In case you forget to apply the cream at your regular time, apply it as soon as possible and continue as usual.

®
If you stop using Fucidin H
If you forget to use this medicine, use it as soon as you remember. Then next use this medicine at the usual

3
time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (affects 1 to 10 users in 100)

reaction at the application site (e.g. skin irritation, skin burning or itching)

Uncommon side effects (affects 1 to 10 users in 1,000)

hypersensitivity
contact dermatitis
aggravation of
eczema rash

Frequency not known (cannot be estimated from the available data)

blurred vision

Other side effects caused by prolonged treatment of mild corticoids like hydrocortisone include:
thinning of the skin (skin
atrophy) dermatitis
stretch marks (striae)
dilatation of the small blood vessels on the
skin persistent facial redness (rosacea)
redness of the skin
(erythema) depigmentation
excessive growth of the hair (hypertrichosis)
excessive sweating (hyperhidrosis)
bruises
Systemic side effects of mild corticosteroids, like hydrocortisone, include adrenal suppression
especially during prolonged topical administration
complications if administered too close to the eye (i.e. raised intra-ocular pressure and glaucoma)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By
reporting side effects you can help provide more information on the safety of this medicine.

®
5. How to store Fucidin H
Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Can be used for 3 months after first opening

Do not store above 30°C

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

4
6. Contents of the pack and other information
®
What Fucidin H contains
- The active substances are fusidic acid and hydrocortisone acetate. Each gram of cream contains
20 mg of fusidic acid and 10 mg of hydrocortisone acetate.
- The other ingredients are butylhydroxyanisole (E320), cetyl alcohol, glycerol (85 per cent), liquid
paraffin, potassium sorbate (E202), polysorbate 60, white soft paraffin, all-rac-α-tocopherol,
hydrochloric acid and purified water.
®
What Fucidin H looks like and contents of the pack
®
Fucidin H is a white cream.
Each package contains a tube with 5, 15 or 30 grams of cream.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

LEO Pharma A/S
Industriparken 55
DK-2750 Ballerup
Denmark

Manufacturer
LEO Laboratories Limited, Cashel Road, Dublin 12 (Ireland).

This medicinal product is authorised in the Member States of the EEA under the following names:
®
Fucidin -Hydrocortison: Denmark, Belgium, Finland, Iceland, Luxembourg, Norway and Sweden
®
Fucidin H: Greece, Italy, Germany, Czech Republic, Estonia, Ireland, Latvia, Lithuania, Malta, Slovak
Republic, United Kingdom, Hungary
®
Fucidine H: Portugal, Spain
®
Fucidin +hydrocortisone: Netherlands

This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>

Detailed information on this medicine is available on the web site of {name of MA/Agency (link)}