Fucidine H, 20 mg/g + 10 mg/g cream
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Fucidine H
20 mg/g + 10 mg/g
cream
fusidic acid and hydrocortisone acetate
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet as 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 other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Contents of the leaflet
- What Fucidine H is and what it is used for
- What you need to know before using Fucidine H
- How to use Fucidine H
- Possible side effects
- How to store Fucidine H
- Contents of the pack and other information
1. What Fucidine H is and what it is used for
Fucidine H cream combines the antibacterial action 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 characterized by inflammation, redness, exudation or crusting, and itching, often of allergic origin).
You should consult a doctor if your condition worsens or does not improve.
2. What you need to know before using Fucidine H
Do not use Fucidine 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 only a bacterial, fungal, or viral skin infection (such as herpes or chickenpox)
- if you have tuberculosis
- if you have perioral dermatitis (inflammation around the mouth)
- if you have rosacea (marked redness of the facial skin).
Warnings and precautions
Consult your doctor or pharmacist before and during treatment with Fucidine H.
- Fucidine H should be used with care when applied near the eyes. Fucidine H must not enter the eyes.
- Contact your doctor if you experience blurred vision or other visual disturbances.
- The use of Fucidine H is limited to 2 weeks. Long-term treatment may increase the risk of adverse effects and the risk of antibiotic resistance; for example, skin thinning may occur.
- Fucidine H may mask potential symptoms of infections.
- Fucidine H may increase your susceptibility to infections, worsen existing infections, or reactivate latent infections.
Children and adolescents
Fucidine H should be used with caution in children.
Use of Fucidine H with other medicines
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Its use during pregnancy and breastfeeding should be evaluated and decided by a doctor.
Fucidine H should be used with caution during pregnancy.
Fucidine H may be used during breastfeeding, but it is recommended to avoid application on the breasts.
Driving and using machines
Treatment with Fucidine H cream does not affect the ability to drive or operate machinery.
Fucidine H contains butylated hydroxyanisole (E320), cetyl alcohol, and potassium sorbate (E202).
These components may cause local skin reactions (such as contact dermatitis). Butylated hydroxyanisole may also cause irritation of the eyes and mucous membranes (such as nasal passages and lips).
3. How to use Fucidine H
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose in children, adolescents and adults is:
Carefully apply a thin layer of cream to the affected area, three times a day.
Fucidine H must not be used for longer than 2 weeks.
After applying this medicine, wash your hands thoroughly, unless your hands are the area being treated.
If you use more Fucidine H than you should
If you have applied more cream than you should have, consult your doctor or pharmacist.
If you forget to use Fucidine H
If you forget to apply the cream at the scheduled time, apply it as soon as possible and continue according to the usual schedule.
If you interrupt treatment with Fucidine H
If you forget to apply this medicine, do so as soon as you remember. Carry out the next application according to the usual schedule.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Frequent adverse effects (affecting between 1 and 10 out of every 100 people)
- reaction at the application site (e.g. skin irritation, burning sensation, and itching)
Uncommon adverse effects (affecting between 1 and 10 out of every 1,000 people)
- hypersensitivity
- contact dermatitis
- worsening of eczema
- skin rash (rash)
Adverse effects with unknown frequency (frequency cannot be estimated from available data)
- blurred vision
Other adverse effects caused by prolonged treatment with moderately potent corticosteroids such as hydrocortisone include:
-
thinning of the skin (cutaneous atrophy)
-
dermatitis
-
stretch marks (striae)
-
dilation of small blood vessels in the skin
-
persistent facial redness (rosacea)
-
redness of the skin (erythema)
-
loss of skin pigmentation (depigmentation)
-
excessive hair growth (hypertrichosis)
-
excessive sweating (hyperhidrosis)
-
bruising
-
systemic adverse effects of moderately potent corticosteroids such as hydrocortisone, including adrenal suppression, especially during prolonged topical treatment
-
complications if applied too close to the eyes (e.g. increased intraocular pressure and glaucoma)
Reporting of adverse effects:
If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fucidine H
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
Discard 3 months after first opening.
Do not store above 30 °C.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Fucidine H
- 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 percent), liquid paraffin, potassium sorbate (E202), polysorbate 60, white soft paraffin, all-rac-α-tocopherol, hydrochloric acid and purified water.
Appearance of the product and contents of the pack
Fucidine H is a white cream.
Each pack contains a tube with 5, 15 or 30 grams of cream.
Only some pack sizes may be marketed.
Marketing Authorization Holder
LEO Pharma A/S, Industriparken 55, DK-2750 Ballerup (Denmark).
Manufacturer
LEO Laboratories Limited, Cashel Road, Dublin 12 (Ireland).
LEO Pharma Manufacturing Italy S.r.l., Via E. Schering 21, 20054 Segrate (MI), Italy.
This medicinal product is authorised in the European Economic Area Member States under the following names:
Fucidin®-Hydrocortisone: 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® + hydrocortisone: Netherlands
Date of the most recent review of this leaflet: August 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).