Fucibet 20 mg/g + 1 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fucibet 20 mg/g + 1 mg/g cream
fusidic acid and betamethasone
Read the entire leaflet carefully before you start using this medicine, because 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 others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Fucibet is and what it is used for
- What you need to know before using Fucibet
- How to use Fucibet
- Possible adverse effects
- How to store Fucibet
- Contents of the pack and other information
1. What Fucibet is and what it is used for
Fucibet cream combines the antibacterial action of fusidic acid (an antibiotic) with the anti-inflammatory effect of a corticosteroid, betamethasone (as valerate).
It is used for local treatment, in adults and children, of eczematous dermatitis, such as: atopic eczema, infantile eczema, discoid eczema (circular patches), stasis eczema (eczema on the legs that appears in some patients with hypertension), contact eczema, and seborrheic eczema, in which a secondary bacterial infection has been confirmed or is suspected.
You should consult a doctor if your condition worsens or does not improve after 14 days.
2. What you need to know before using Fucibet
Do not use Fucibet:
- if you are allergic to fusidic acid, sodium fusidate, betamethasone (as valerate), or to any of the other ingredients of this medicine (listed in section 6).
Fucibet contains a corticosteroid, betamethasone (as valerate), therefore it should not be used in the following situations:
- if you have a systemic fungal infection,
- if you have only a skin infection caused by fungi, viruses, or bacteria,
- if you have tuberculosis,
- if you have perioral dermatitis,
- if you have rosacea (marked redness of the facial skin).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Fucibet.
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The use of Fucibet should be limited to 14 days. Long-term treatment may increase the risk of adverse effects; for example, thinning of the skin may occur, as well as a risk of masking infections for which this medicine would not be appropriate.
- Caution should be exercised depending on the site of application due to the possible systemic absorption of the medicine, which could lead to disturbances in adrenal gland function; see section 4 Possible adverse effects.
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Fucibet should be applied with caution when used near the eyes. If accidental contact with the eyes occurs, rinse the eyes thoroughly with plenty of water and consult an ophthalmologist if necessary (see section 4).
- Contact your doctor if you experience blurred vision or other visual disturbances.
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Fucibet may increase susceptibility to infections, worsen existing infections, and reactivate latent infections.
Children and adolescents
Fucibet should be used with caution in children and adolescents, as they may be more susceptible to developing Cushing's syndrome (a condition characterized by a rounded face, fat accumulation, delayed wound healing, fatigue, etc.) due to increased absorption through the skin. Prolonged treatments, large amounts of medication, and occlusion of the affected area should be avoided; see section 3 below.
Using Fucibet with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Interaction with other systemically administered medicines is considered minimal.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy; your doctor will assess the benefit of treatment for the mother against the risk to the unborn child.
This medicine may be used during breastfeeding, but it is recommended to avoid applying the medicine to the breasts.
Driving and using machines
The influence of this medicine on the ability to drive and use machines is none or negligible.
Fucibet contains cetostearyl alcohol and chlorocresol
This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.
This medicine may cause allergic reactions because it contains chlorocresol.
3. How to use Fucibet
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Administration: for cutaneous use.
The recommended dose for adults and pediatric population (children and adolescents) is:
Carefully apply a thin layer of cream to the affected area, two or three times a day, for up to 14 days.
In adults, treatment of more resistant lesions may be reinforced by applying this medicine under occlusive dressing. In such cases, overnight occlusion is generally considered an appropriate option.
In children and adolescents, no occlusive dressing should be used, nor should large amounts of the product be applied to cover the treatment area.
After applying this medicine, wash your hands thoroughly, unless your hands are the area being treated.
If you use more Fucibet than you should
If you have applied more cream than you should, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Fucibet
If you forget to apply the cream at the scheduled time, apply it as soon as possible and continue according to the usual regimen.
If you stop treatment with Fucibet
If you forget to apply this medicine, do so as soon as you remember. Perform the next application according to the usual regimen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Fucibet can cause adverse effects, although not everyone experiences them.
Uncommon adverse effects (may affect up to 1 in 100 people):
- allergic reactions
- contact dermatitis
- worsening of eczema
- burning sensation on the skin
- itching
- dry skin
- pain at the application site
- irritation at the application site
Rare adverse effects (may affect up to 1 in 1,000 people):
- redness
- urticaria
- skin rash
- swelling at the application site
- formation of blisters at the application site
Adverse effects with frequency not known (cannot be estimated from the available data):
- blurred vision
Other adverse effects caused by prolonged treatment with potent corticosteroids may include:
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adrenal gland function disorders characterized by the following symptoms: fatigue, depression, and anxiety
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increased intraocular pressure and glaucoma, especially if applied near the eyes for prolonged periods
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skin-related adverse effects such as: thinning of the skin (cutaneous atrophy), dermatitis (including contact dermatitis and acneiform dermatitis), perioral dermatitis, stretch marks (striae), dilation of small blood vessels in the skin (telangiectasia), rosacea, redness, excessive hair growth (hypertrichosis), excessive sweating (hyperhidrosis), and depigmentation. Small bruises (ecchymoses) may also appear following prolonged use of topical corticosteroids.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via 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 Fucibet
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 indicated.
Discard the tube 3 months after first opening. Record the date of opening in the box provided on the outer packaging.
Do not store above 30 °C. Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, 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 Fucibet
- The active substances are fusidic acid and betamethasone (as valerate).
Each gram of cream contains 20 mg of fusidic acid and 1 mg of betamethasone (as valerate).
- The other components are white vaseline, cetyl stearyl alcohol, liquid paraffin, macrogol cetyl stearyl ether, sodium dihydrogen phosphate dihydrate, chlorocresol, sodium hydroxide, all-rac-α-tocopherol and purified water.
Appearance of the product and contents of the pack
Fucibet is a white cream.
Each cardboard pack contains an aluminium tube with a polyethylene screw cap containing 30 or 60 grams of cream.
Only some pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios LEO Pharma, S.A.
Via Laietana 33, 7º
08003 Barcelona
Spain
Manufacturer
LEO Laboratories Limited
Cashel Road
Dublin 12 (Ireland)
LEO Pharma Manufacturing Italy S.r.l.
Via E. Schering 21
20054 Segrate (MI)
Italy
Date of the most recent revision of this package leaflet: August 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es