FUSAPIELBETA 20 mg /G + 1 Mg/G Крем

Содержание инструкции

1. Fusapielbeta 20 mg/g + 1 mg/g cream
   1. What is Fusapielbeta and what is it 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

Fusapielbeta 20 mg/g + 1 mg/g cream

(fusidic acid and betamethasone)
Generic Medicine
Read this leaflet carefully before 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 they have the same symptoms as you, as 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 Fusapielbeta is and what it is used for
• 2. What you need to know before you use 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 is Fusapielbeta and what is it 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 together in different ways.
Fusapielbeta works in this way:

• 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 common acne.
• To treat a skin condition called rosacea. This consists of redness and inflammation of the nose and cheeks. Ask your doctor if you are not sure.
• To treat a skin condition called perioral dermatitis. This is a reddish rash around the lips or chin.
• To treat skin conditions caused only 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 widespread infections caused by a fungus, for example candidiasis.

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

• Do not use the cream on you or a child for more than 2 weeks; this is to prevent bacteria from becoming resistant to the antibiotic and to avoid the steroid causing unwanted effects.
• Pay particular attention if you need to use this medicine near your eyes or those of a child. If the cream gets into the eye it can cause an increase in pressure in the eye which can lead to loss of vision (glaucoma).
• If you use the cream for a long period or in large quantities, there is a possibility of having more intense side effects. Your skin may also become more sensitive to the medicine.
• Do not use this medicine on the face for long periods of time, unless your doctor has told you to.
• Unless your doctor has told you to, do not use Fusapielbeta on open wounds or on sensitive areas such as the nostrils, ears, lips or genitals.
• Unless your doctor has told you to, do not use Fusapielbeta on thin areas of skin, on skin ulcers, on open veins or acne.
• The adrenal glands may stop working properly. The symptoms are fatigue, depression and anxiety. The 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 available without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

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

Tell 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 vehicles or use
machinery. Ask your doctor if any side effect occurs that may require
caution when driving vehicles and using machinery.

Fusapielbeta contains cetostearyl alcohol and chlorocresol

• Cetostearyl alcohol. It may cause local skin reactions (e.g. contact dermatitis).
• Chlorocresol. It may cause allergic reactions.

Ask your doctor if you are concerned about any of the ingredients of this medicine.

3. How to use Fusapielbeta

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.

How to apply Fusapielbeta
This medicine must only be used on your skin or a child’s skin. Do not swallow it or allow it to
enter the body.
Remove the cap. Check that the seal is not broken before using it for the first time. Then
push the tip of the cap through the tube’s seal.
Always wash your hands before using Fusapielbeta. Apply a thin layer of the medicine
to the affected areas. If you are using it on your face, be careful to avoid your eyes.
Unless you are using the cream to treat your hands, always wash them after using Fusapielbeta.
If the medicine accidentally gets into your eyes, you must wash them immediately
with cold water. Then, if possible, perform an eye wash with eye drops. You may feel burning
in your eye. If you begin to have vision problems or if your eye is painful, contact
your doctor immediately.

How much Fusapielbeta to use
Your doctor will tell you how much Fusapielbeta you should use.
The usual duration of treatment is up to two weeks. Ask your doctor before using
this medicine for longer.
You should notice an improvement even after a few days of using the cream. If there is no
improvement after 7 days, you should stop using the cream and return to your doctor.
Usually you should use the medicine twice a day. Use it in the morning and in the evening. To remember
to use the medicine, it may be helpful to use it when you perform another regular action, such as
brushing your teeth.
If you have been told to cover the skin with a bandage or dressing, you may not need to use the
medicine as often. In a small child, a diaper can act as a bandage. Follow
your doctor’s advice.

Adults and children
Your doctor must tell you the dose that is suitable for you or for the child. If your doctor has told you
the amount of cream to use, follow their advice. If not, the following instructions
can help you use the right amount.
You can use your index finger to measure how much Fusapielbeta to use. Squeeze the cream along your finger,
from the tip to the first joint. This amount is defined as “fingertip unit”.
The usual number of fingertip units needed to cover the different parts of the body is described
below. If you need to use a little more or a little less, do not worry. If you are using the cream
for a child, still use an adult’s finger to measure the “fingertip unit”.

FOR A CHILD FROM 1 TO 10 YEARS:

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. Afterwards use the
medicine at the usual time. Do not use a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek urgent medical assistance if any of the following symptoms occur. It may be a sign of an allergic reaction:

• Difficulty breathing
• Swelling of the face, eyelids, lips, tongue or throat
• Severe skin rash.

Other possible side effects

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

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

• Itching and inflammation of the skin at the application site of the medicine
• 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):

• 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 veins near the surface of the skin become visible
• Changes in hair growth
• Excessive sweating
• Rash with red spots around the mouth or chin
• Lightening of skin color
• 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 clouding of the lens in the eye (cataract)
• The adrenal glands may stop working properly. Symptoms are feeling unwell, stomach pain, headache, poor weight gain, lack of energy, fatigue, depression and anxiety.

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

• Blurred vision.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the packaging after SCAD. The expiry date refers to the last day of that month.
• Do not use for more than 6 months from first opening. Note the date of first opening of the tube in the space provided on the carton.
• Do not store the medicine at a temperature above 30° C.

Do not dispose of this medicine in wastewater 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 Fusapielbeta contains

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

Description of the appearance of Fusapielbeta and contents of the pack
Fusapielbeta is a soft cream ranging in colour from white to off-white 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 Milan

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 Member States of the European Economic Area with the
following denominations