FUCIDIN 15 G Krem

Treść ulotki

1. FUCIDIN H
   1. What is Fucidin H and what is it used for
   2. What you need to know before using 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

FUCIDIN H

20 mg/g + 10 mg/g cream
fusidic acid / hydrocortisone acetate

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Fucidin H and what is it used for

Fucidin H cream combines the antibacterial activity of fusidic acid (antibiotic) with the anti-inflammatory effect of hydrocortisone acetate (corticosteroid).
It is used for the topical treatment of infected atopic dermatitis (commonly known as eczema, a
skin condition accompanied by inflammation, redness, oozing or crusting and itching, often of
allergic origin).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Fucidin H

Do not use Fucidin H:

• if you are allergic to fusidic acid, fusidate sodium, hydrocortisone acetate or any of the other ingredients of this medicine (listed in section 6).
• if you have a skin infectionmainly caused by bacteria, fungi or viruses (such as herpes or chickenpox)
• if you have tuberculosis
• if you have dermatitis around the mouth
• if you have rosacea (severe redness of the facial skin).

Warnings and precautions

• Talk to your doctor or pharmacist before using Fucidin H.
• Fucidin H should be applied with caution in the areas near the eyes. Fucidin H should not get into the eyes.
• The use of Fucidin H is limited to 2 weeks. Prolonged treatments may determine an increased risk of side effects and the risk of antibiotic resistance, for example your skin may become thin.
• Fucidin H may mask symptoms of a potential infection
• Fucidin H may increase your susceptibility to infections, worsen existing infections and activate latent infections.

Children and adolescents
Fucidin H should be used with caution in children.

Other medicines and Fucidin H
Tell your doctor or pharmacist if you are taking or have recently taken or might take any
other medicines.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Use during pregnancy and breastfeeding must be assessed and established by a doctor.
Fucidin H should be used with caution during pregnancy.
Fucidin H can be used during breastfeeding but it is recommended to avoid using it on the breast.

Driving and operating machinery
Treatment with Fucidin H cream does not affect the ability to drive vehicles and operate machinery.

Fucidin H contains butyl hydroxyanisole (E320), cetyl alcohol and potassium sorbate (E202)
These ingredients may cause local skin reactions (e.g. contact dermatitis). Butyl
hydroxyanisole may also causeirritation of the eyes and mucous membranes (such as the nasal cavities and lips).

3. How to use Fucidin H

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for children, adolescents and adults is:
Apply a thin layer of cream carefully to the affected skin area, three times a day.
Fucidin H should not be used for more than 2 weeks.
Wash your hands thoroughly after each application, unless your hands are the area to be treated.

If you use more Fucidin H than you should
If you have used more cream than you should, consult your doctor or pharmacist.

If you forget to use Fucidin H
If you forget to apply the cream at the scheduled time, apply it as soon as possible and then continue the treatment as usual.

If you stop using Fucidin H
If you forget to use this medicine, use it as soon as you remember. Subsequently use the medicine at the usual time.
If you have any doubts about the use of Fucidin H, consult 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 (may affect up to 1 in 10 people)
reaction at the application site (for example, skin irritation, skin burning or itching)
Uncommon side effects (may affect up to 1 in 1000 people)
hypersensitivity
contact dermatitis
worsening of eczema
skin rash
Other side effects caused by prolonged treatment with mild corticosteroids like hydrocortisone
include:

• thinning of the skin (skin atrophy)
• dermatitis
• stretch marks (striae)
• dilation of small blood vessels on the skin
• persistent facial redness (rosacea)
• skin redness (erythema)
• depigmentation
• excessive hair growth (hypertrichosis)
• excessive sweating (hyperhidrosis)
• bruising
• systemic side effects caused by mild corticosteroids like hydrocortisone, include adrenal suppression especially during prolonged topical administration
• complications if administered too close to the eyes (e.g. increased intra-ocular pressure and glaucoma).

If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.

5. How to store Fucidin H

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date refers to the last day of the month. Use within 3 months of first opening.
Store at a temperature below 30 °C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fucidin H contains

• The active ingredients 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%), liquid paraffin, potassium sorbate (E202), polysorbate 60, white soft paraffin, all-rac-  -tocopherol, hydrochloric acid and purified water.

Description of the appearance of Fucidin H and contents of the pack
Fucidin H is a white cream.
Each pack contains a tube with 5, 15 or 30 g of cream.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
LEO Pharma A/S
Industriparken 55
DK–2750 Ballerup
Denmark
Marketing Authorisation Holder for Italy: LEO Pharma S.p.A. Via Amsterdam 125 -00144 Roma

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

This medicinal product is authorised in the Member States of the European Economic Area with 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+hydrocortison: Netherlands.