Fusapielbeta

Patient Information Leaflet

Fusapielbeta 20 mg/g + 1 mg/g cream

(fusidic acid and betamethasone)
Generic Medicine
Please read all of this leaflet carefully before you use 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Fusapielbeta is and what it is used for

Fusapielbeta contains two different types of medicines. One medicine is called fusidic acid and is a type of antibiotic.
The other medicine is called betamethasone. It is a type of corticosteroid (steroid). These two medicines work simultaneously in different ways.
Fusapielbeta works as follows:

• The antibiotic kills germs (bacteria) that cause infections
• The corticosteroid reduces swelling, redness, or itching of the skin.

Fusapielbeta is used to treat:

• Conditions in which the skin is inflamed (eczema or dermatitis) and also infected by germs (bacteria).

If you do not notice any improvement after 7 days, stop using the cream and consult your doctor.

2. What you need to know before using Fusapielbeta

Do not use Fusapielbeta

• If you are allergic to fusidic acid or betamethasone, or to any of the other ingredients of this medicine (listed in section 6).
• To treat infected dermatitis in children under one year of age.
• To treat acne vulgaris.
• To treat a skin condition called rosacea. This consists of redness and inflammation of the nose and cheeks. Ask your doctor if you are unsure.
• To treat a skin condition called perioral dermatitis. This is a red, blotchy rash around the lips or chin.
• To treat skin conditions caused solely by bacteria, such as boils and pustules.
• To treat skin conditions caused by tuberculosis (TB) or syphilis.
• To treat a skin condition caused by viruses, such as herpes or chickenpox.
• To treat a skin condition caused by fungi, such as athlete’s foot or more generalized fungal infections, for example candidiasis.

Warnings and precautions
Talk to your doctor or pharmacist before using Fusapielbeta:

• Do not use the cream on yourself or on a child for longer than 2 weeks; this is to avoid bacteria becoming resistant to the antibiotic and to prevent the steroid from causing unwanted effects.
• Be especially careful if you need to apply this medicine near your eyes or a child’s eyes. If the cream gets into the eye, it may cause increased pressure in the eye, which could lead to vision loss (glaucoma).
• If you use the cream for a long time or in large amounts, you may be more likely to experience stronger side effects. Your skin may also become more sensitive to the medicine.
• Do not use this medicine for prolonged periods on the face.
• Unless otherwise instructed by your doctor, do not apply Fusapielbeta to open wounds or sensitive areas such as the nostrils, ears, lips, or genitals.
• Unless otherwise instructed by your doctor, do not apply Fusapielbeta to thin areas of skin, skin ulcers, broken veins, or acne.
• The adrenal glands may stop functioning properly. Symptoms include fatigue, depression, and anxiety. This effect is usually reversible by stopping the use of Fusapielbeta.

Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Fusapielbeta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

• If you are pregnant or suspect you may be pregnant: fusidic acid/betamethasone should not be used during pregnancy unless specifically prescribed by your doctor.
• If you are breastfeeding, fusidic acid/betamethasone may be used by women who are breastfeeding, but the cream should not be applied to the breast to avoid accidental ingestion by the infant.

Inform your doctor if you become pregnant while using this medicine.
Driving and using machines
This medicine usually has very little effect on the ability to drive or operate machinery. Ask your doctor if any side effects occur that may require caution when driving or operating machinery.
Fusapielbeta contains cetyl stearyl alcohol and chlorocresol

• Cetyl stearyl alcohol: may cause local skin reactions (e.g., contact dermatitis).
• Chlorocresol: may cause allergic reactions.

Ask your doctor if you have any concerns about any of the ingredients in this medicine.

3. How to use Fusapielbeta

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to apply Fusapielbeta
This medicine is for topical use only on your skin or that of a child. Do not swallow or allow it to enter the body.
Remove the cap. Check that the seal is intact before first use. Then press the tip of the cap through the seal of the tube.
Always wash your hands before using Fusapielbeta. Apply a thin layer of the medicine to the affected areas. If applying to the face, take care to avoid the eyes.
Unless you are treating the hands, always wash your hands after using Fusapielbeta.
If the medicine accidentally comes into contact with the eyes, rinse them immediately with cold water. Afterwards, if possible, perform an eye irrigation with an eye wash solution. You may experience eye burning. If you develop vision problems or eye pain, contact your doctor immediately.
How much Fusapielbeta to use
Your doctor will tell you how much Fusapielbeta to use.
The usual duration of treatment is up to two weeks. Consult your doctor before using this medicine for a longer period.
You should notice improvement within a few days of starting treatment. If there is no improvement after 7 days, stop using the cream and consult your doctor.
Usually, the medicine should be used twice daily—once in the morning and once in the evening. To help you remember, it may be useful to apply the cream at the same time as another regular activity, such as brushing your teeth.
If you have been advised to cover the treated skin with a dressing or bandage, you may not need to apply the medicine as frequently. In a young child, a diaper may act as a dressing. Follow your doctor’s advice.
Adults and children
Your doctor will determine the appropriate dose for you or the child. If your doctor has specified the amount of cream to use, follow their instructions. If not, the following guidance may help you use the correct amount.
You can use your index finger to measure the amount of Fusapielbeta to apply. Squeeze the cream along the length of your finger, from the fingertip to the first joint. This amount is known as a “fingertip unit”.
The usual number of fingertip units required to cover different areas of the body is described below. Slight variations in the amount used are not a cause for concern. When applying the cream to a child, still use an adult finger to measure the fingertip unit.

FOR A CHILD FROM 1 TO 10 YEARS OF AGE:

If you use more Fusapielbeta than you should
Inform your doctor immediately if you have used more Fusapielbeta than you should. It may be necessary to stop using this medicine.

If you forget to use Fusapielbeta
If you forget to use this medicine, use it as soon as you remember. Then continue using the medicine at your usual time. Do not use a double dose to make up for the forgotten dose.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
You must seek urgent medical attention if you experience any of the following symptoms.
You may be having an allergic reaction:

• You have difficulty breathing
• You have swelling of the face, eyelids, lips, tongue or throat
• A severe skin rash appears.

Other possible side effects

• All the problems listed below are more likely if the medicine is used for a long time, in large amounts, or on skin folds (such as under the arms or under the breasts).
• These problems are more likely in children, especially very young children. They are also more likely if the skin is covered with a dressing, bandage or diaper.

Uncommon (may affect up to 1 in 100 people):

• Itching and skin inflammation at the application site
• Burning sensation
• Itching
• Worsening of eczema
• Dry skin
• Pain at the application site
• Irritation at the application site

Rare (may affect up to 1 in 1,000 people):

• Hives
• Redness of the skin
• Skin rash
• Swelling at the application site
• Blisters at the application site

Some side effects are known to be caused by betamethasone (a steroid), one of the components of Fusapielbeta. You should inform your doctor if any of the following side effects occur:

• Thinning of the skin
• Stretch marks
• Small blood vessels near the skin surface become visible
• Changes in hair growth
• Excessive sweating
• Rash with red spots around the mouth or chin
• Lightening of skin colour
• Redness of the skin, nose or mouth
• Loss of vision caused by damage to the optic nerve in the eye due to increased pressure inside the eye (glaucoma), or by clouding of the eye's lens (cataract)
• The adrenal glands may stop functioning properly. Symptoms include feeling unwell, stomach ache, headache, poor weight gain, lack of energy, tiredness, depression and anxiety.

Not known (frequency cannot be estimated from the available data):

• Blurred vision.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fusapielbeta

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
• Do not use for more than 6 months after first opening. Record the date of first opening of the tube in the space provided on the carton.
• Do not store this medicine at temperatures above 30°C.

Do not dispose of this medicine 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 Fusapielbeta contains

• The active substances are fusidic acid and betamethasone.
• Fusapielbeta contains 20 mg/g of fusidic acid and 1 mg/g of betamethasone valerate.
• The other components are: macrogol cetostearyl ether, cetostearyl alcohol, chlorocresol (see section 2 “Fusapielbeta contains cetostearyl alcohol and chlorocresol”), liquid paraffin, disodium hydrogen phosphate dihydrate, white soft paraffin, all-rac-α-tocopherol, purified water and sodium hydroxide.

Description of the appearance of Fusapielbeta and the contents of the pack
Fusapielbeta is a soft cream, white to off-white in colour, contained in an aluminium tube with a white polypropylene cap.
Fusapielbeta is available in tubes of 5 g, 15 g, 30 g and 60 g.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary

This medicinal product is authorised in the European Economic Area Member States under the following names