Fucicidin H

Italy
Brand name Fucicidin H
Form cream
Active substance / Dosage
FUSIDIC ACID
HYDROCORTISONE ACETATE
Prescription type Prescription only
ATC code
D07CA01
Registration number 034560
Manufacturer LEO PHARMA A/S
Fucicidin H cream

Package Leaflet: Information for the User
FUCIDIN H
20 mg/g + 10 mg/g cream
fusidic acid / hydrocortisone acetate
Please read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effects, including 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 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

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

Fucidin H cream combines the antibacterial activity of fusidic acid (an antibiotic) with the anti-inflammatory effect of hydrocortisone acetate (a corticosteroid).
It is used for the topical treatment of infected atopic dermatitis (commonly known as eczema, a skin condition associated with 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, sodium fusidate, hydrocortisone acetate, or to any of the other ingredients of this medicine (listed in section 6).
  • if you have a skin infection primarily caused by bacteria, fungi, or viruses (such as herpes or chickenpox)
  • if you have tuberculosis
  • if you have perioral dermatitis
  • if you have rosacea (severe redness of the skin of the face).

Warnings and precautions

  • Consult your doctor or pharmacist before using Fucidin H.
  • Fucidin H should be applied carefully around the eye area. Fucidin H must not enter the eyes.
  • The use of Fucidin H is limited to 2 weeks. Prolonged treatment may increase the risk of adverse 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
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Use during pregnancy and breastfeeding should be evaluated and decided by a doctor.
Fucidin H should be used with caution during pregnancy.
Fucidin H may be used during breastfeeding, but it is recommended to avoid applying it to the breast area.
Driving and using machines
Treatment with Fucidin H cream does not affect the ability to drive or operate machinery.
Fucidin H contains butylated hydroxyanisole (E320), cetyl alcohol, and potassium sorbate (E202)
These components may cause local skin reactions (e.g., contact dermatitis). Butylated hydroxyanisole may also cause irritation of the eyes and mucous membranes (such as the nasal passages and lips).

3. How to use Fucidin H

Use this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for children, adolescents and adults is:
Carefully apply a thin layer of cream to the affected area of skin, three times a day.
Fucidin H must not be used for longer than 2 weeks.
Wash your hands thoroughly after each application, unless your hands are the area being treated.
If you use more Fucidin H than you should
If you have used more cream than you should have, 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, then continue treatment as usual.
If you stop using Fucidin H
If you forget to use this medicine, use it as soon as you remember. Then take your next dose at the usual time.
If you have any doubts about how to use Fucidin H, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody experiences them.

Common adverse reactions (affecting 1 to 10 patients in 100)
Reaction at the application site (e.g. skin irritation, skin burning, or itching)

Uncommon adverse reactions (affecting 1 to 10 patients in 1000)
Hypersensitivity
Contact dermatitis
Worsening of eczema
Skin rash

Other adverse reactions caused by prolonged treatment with mild corticosteroids such as hydrocortisone include:

  • Skin thinning (cutaneous atrophy)
  • Dermatitis
  • Stretch marks (striae)
  • Dilation of small blood vessels in the skin
  • Persistent facial redness (rosacea)
  • Skin redness (erythema)
  • Depigmentation
  • Excessive hair growth (hypertrichosis)
  • Excessive sweating (hyperhidrosis)
  • Bruising
  • Systemic adverse effects caused by mild corticosteroids such as hydrocortisone, including adrenal suppression, especially during prolonged topical administration
  • Complications if administered too close to the eyes (e.g. increased intraocular pressure and glaucoma)

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

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 stated on the carton after "Exp". The expiry date refers to the last day of the month. Use within 3 months of first opening.
Store below 30 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents 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 components are butylhydroxyanisole (E320), cetyl alcohol, glycerol (85%), liquid paraffin, potassium sorbate (E202), polysorbate 60, white vaseline, all-rac- \alpha -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 Authorization Holder
LEO Pharma A/S
Industriparken 55
DK–2750 Ballerup
Denmark
Licensee in Italy: LEO Pharma S.p.A., Via Amsterdam 125 - 00144 Rome, Italy

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

This medicinal product is authorized in the European Economic Area countries 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, Slovakia, United Kingdom, Hungary.
Fucidine H: Portugal, Spain.
Fucidin+hydrocortison: The Netherlands.