BETTAMOUSSE 0.12% Pianka skórna

Treść ulotki

1. Bettamousse 1 mg/g (0.1%) cutaneous foam
   1. What is Bettamousse and what is it used for
   2. What you need to know before using Bettamousse
   3. How to use Bettamousse
   4. Possible side effects
   5. How to store Bettamousse
   6. Contents of the pack and other information

Bettamousse 1 mg/g (0.1%) cutaneous foam

Betametasone

Read this leaflet carefully before you start 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

called Bettamousse

Contents of this leaflet:

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

1. What is Bettamousse and what is it used for

Bettamousse contains the active ingredient betamethasone as valerate.
Bettamousse belongs to a group of medicines called corticosteroids (abbreviated as
“steroids”).
Bettamousse is used to treat skin disorders of the scalp, such as psoriasis
(reddish patches of raised skin covered with silvery scales), which can cause
itching, tightness or skin irritation. Bettamousse works by reducing inflammation
(redness, itching and pain). It is important to use this medicine to prevent damage
to the skin and the development of infections.

2. What you need to know before using Bettamousse

Do not use Bettamousse

• If you are allergic to betamethasone valerate or any of the other ingredients of this medicine (listed in section 6). Some of these ingredients (stearyl alcohol, cetyl alcohol and propylene glycol) may cause local skin reactions (such as contact dermatitis).

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• If you suffer from any type of scalp infection, unless this is already being treated.
• On a child under the age of 6 years.

If any of the above situations apply to you, consult your doctor or pharmacist.

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

• you suffer from any type of skin infection.
• you have open wounds on the scalp.
• you experience blurred vision or other visual disturbances.
• you are taking other medicines, including those obtained without a prescription.

Contact your doctor if you experience blurred vision or other visual disturbances

Children and adolescents
Do not use this medicine in children under 6 years of age.

Other medicines and Bettamousse
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

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

Driving and operating machinery
No effects on driving or operating machinery have been reported.

Bettamousse contains cetyl alcohol and stearyl alcoholwhich may cause local skin
reactions (e.g. contact dermatitis).

Bettamousse contains propylene glycolwhich may cause skin irritation.

3. How to use Bettamousse

Use this medicine following exactly the instructions of your doctor or pharmacist. The dose will be clearly indicated on the doctor's prescription. If you have any doubts, consult your doctor or pharmacist.

Remember:
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• Use the lowest possible dose of Bettamousse for the shortest possible time.
• Avoid contact with the eyes. If Bettamousse comes into contact with the eyes, rinse them well with cold water. If your eyes continue to burn, contact your doctor.
• Avoid contact with the inside of the nose and mouth.
• Avoid contact with open wounds.

The recommended dose is:
Adults

• A quantity of foam no larger than a golf ball.
• Massage the affected areas of the scalp twice a day (morning and evening).
• If no improvement occurs after 7 days, stop using Bettamousse and consult your doctor again.

Children over 6 years

• The dose depends on body weight.
• The usual dose for children is lower than that for adults. For example, for a child with a body weight equal to half that of an adult, use no more than “half a golf ball” of foam.
• Massage the affected area of the scalp twice a day (morning and evening).
• Do not use Bettamousse for more than 5-7 days in children. If symptoms have not improved, consult your doctor again.

Do not use in children under 6 years

When symptoms improve
For adults and children: as soon as you observe an improvement in symptoms, Bettamousse can be applied only once a day. If the condition continues to improve, it may be advisable to apply Bettamousse once every two-three days, to prevent symptoms from recurring.

Infections
If you suffer from a skin infection, your doctor will prescribe another medicine to treat it. In the meantime, your doctor may also advise you to stop using Bettamousse. If you are not sure how much foam to use, ask your doctor or pharmacist.

Instructions for use:
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• 1. Remove the cap

• 2. Turn the container upside down and spray the required amount of foam onto a clean saucer or other similar surface. The foam dissolves when it comes into contact with the skin, therefore it must not be sprayed directly onto the hand.

• 3. Massage the foam into the affected areas of the scalp, but not into the hair. Allow hair to dry naturally.

• 4. Wash your hands immediately after using the foam.

• 5. Do not wash your hair immediately after applying the foam, leave it to act overnight or throughout the day.
• 6. You can wash and dry your hair immediately before applying the foam. This product is flammable. Do not use Bettamousse near a flame or a direct source of heat. Do not smoke during use or while holding the container.

Medical checks
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If you are using the medicine for a long period of time, your doctor may subject you to regular checks, in order to verify that the medicine is working correctly and that the dose you are using is suitable for your case.

If you use more Bettamousse than you should
Immediately wash your scalp and start again. It is unlikely that you will suffer any undesirable effects from using an excessive amount of medicine on a single occasion. If, however, you are worried, contact the nearest emergency room or your doctor.
Prolonged use of an excessive amount of Bettamousse can cause a number of undesirable effects (see section 4).

If you forget to use Bettamousse
Do not use a double dose to make up for the missed dose. Simply take the next dose, as prescribed.

If you stop treatment with Bettamousse
Do not stop treatment with Bettamousse without first consulting your doctor. The condition may recur after you have stopped using Bettamousse. If this happens, consult your doctor as soon as possible.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bettamousse can cause side effects, although not everybody gets them.
If any of the following symptoms occur, stop using Bettamousse and seek
immediate medical attention:

• Headache
• Burning
• Itching

Uncommon: may affect up to 1 in 100 people

• Skin infection
• Thinning of the skin
• Skin spots (in the form of patches or dark lines)
• Reddish rash on the face
• Easy bruising
• Blurred vision

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

• Hypersensitivity reactions such as itching, redness and burning

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• Patches of skin that are lighter or darker
• Hair loss
• Infection of hair follicles
• Red spots on the skin

Not known: frequency cannot be estimated based on available data

• Worsening of scalp conditions, with the formation of pus-filled ulcers
• Acne
• Purple spots on the skin
• Rash around the mouth

Effects resulting from prolonged use of a high dose of Bettamousse:

• Excessive hair growth
• Changes in skin color
• Menstrual irregularities in women
• Fluid retention (feeling of swelling)
• Mood changes or sleep disturbances
• Stomach upset or gastric discomfort
• Acne
• Headache

These effects are more likely to occur in children, and in cases where, after
application of Bettamousse, dressings that cover the scalp are used.
The frequency of these effects, resulting from prolonged use, is unknown.

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Bettamousse

Keep this medicine out of the sight and reach of children.
Do not use Bettamousse after the expiry date which is reported on the label. The expiry date
refers to the last day of that month.
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Do not store at a temperature above 25°C. Do not refrigerate. Protect from sunlight
and from all other direct sources of heat, as this product is extremely
flammable.
Do not puncture or burn the container, even when it is empty.
Do not dispose of any 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 Bettamousse contains

• The active ingredient is betamethasone (in the form of valerate) 1 mg/g (0.1%)
• The other ingredients are cetyl alcohol, stearyl alcohol, polysorbate 60, ethanol, purified water, propylene glycol, anhydrous citric acid, potassium citrate, and butane/propane.

Description of the appearance of Bettamousse and contents of the pack
Bettamousse is a white, foamy mousse for cutaneous use.
Bettamousse is available in an aluminum container equipped with a valve and a transparent cap
It is available in two sizes: 50 g or 100 g.

Marketing Authorisation Holder
Giuliani S.p.a.
Via Palagi, 2
20129 Milan

Manufacturers
Pharmasol Limited
North Way, Walworth Industrial Estate
Andover, Hampshire SP10 5AZ
United Kingdom
Aerosol Service Italiana S.r.l.
Via del Maglio No. 6
23868 Valmadrera (Lecco)
Italy
Recipharm Ltd
Ashton-under-Lyne
Lancashire, OL79RR
United Kingdom
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