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Bettamousse

Document: leaflet MAH BRAND_PLPI 16369-1510 change

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


PACKAGE LEAFLET: INFORMATION FOR THE USER BETTAMOUSSE® 0.1% W/W CUTANEOUS FOAM (betamethasone valerate)

Your medicine is known as the above but will be referred to as Bettamousse throughout the remainder of this leaflet.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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.

Bettamousse contains the active substance Betamethasone as valerate.

Bettamousse belongs to a group of medicines called corticosteroids ('steroids' for short).

Bettamousse is used to treat skin disorders of the scalp such as psoriasis (raised red patches of skin covered in silvery scales) that may feel itchy, tight or sore. Bettamousse works by reducing inflammation (redness, itching and soreness). It is important to use this medicine to prevent damage to the skin and infections from developing.

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 (e.g. contact dermatitis).

•    If you have any kind of infection of the scalp, unless this is already being treated

•    On a child under 6 years of age.

If any of the above applies to you, talk to your doctor or pharmacist. Warnings and precautions

Talk to your doctor or pharmacist before using Bettamousse if:

•    You have any kind of skin infection

•    You have open wounds on your scalp

•    You are taking any other medicine, including medicines obtained without a prescription.

Children and adolescents

Do not give this medicine to children under the age of 6 years.

Other medicines and Bettamousse

Tell your doctor or pharmacist if you are taking, using, have recently taken or used or might take or use any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

There are no known effects on driving or using machines.

Bettamousse contains Cetyl Alcohol and Stearyl Alcohol which may cause local skin reactions (e.g. contact dermatitis)

Bettamousse contains propylene glycol which may cause skin irritation.'

Always use this medicine exactly as your doctor or pharmacist has told you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. Check with your doctor or pharmacist if you are not sure.

Remember:

   Use as little Bettamousse as possible for the shortest possible time

•    Avoid contact with your eyes. If Bettamousse gets into your eyes, rinse well with cold water. If your eyes continue to sting, contact your doctor

•    Avoid contact with the inside of your nose and mouth

•    Avoid contact with any open wounds.

The recommended dose is

Adults:

•    No more than a golfball sized amount of mousse

•    Massage into the affected areas of the scalp twice a day (in the morning and evening)

   If there is no improvement in your condition after 7 days, stop using Bettamousse and see your doctor again.

Use in children over 6 years of age:

•    The dose depends on their physical size

•    The usual dose for children is less than for adults. For example, for a child half the size of an adult, use no more than half a golf ball sized amount of mousse

•    Massage into the affected area of the scalp twice a day (in the morning and evening)

   Do not use Bettamousse for more than 5 to 7 days on children. If the symptoms have not improved see your doctor again

Do not use in children under 6 years of age

As symptoms improve

For adults and children: Where there is some improvement in symptoms, Bettamousse can be applied just once a day. If the condition continues to get better, it may be possible to apply Bettamousse once every few days, to keep the symptoms from coming back.

Infections

If you have a skin infection your doctor will give you another medicine to treat the infection.

Whilst you have an infection, your doctor may tell you to stop using Bettamousse.

If you are not sure about how much mousse to use, ask your doctor or pharmacist.

Instructions for use:

1. Remove the cap

2. Turn the can upside down and squirt the required amount of mousse onto a clean saucer or something similar. The mousse melts when it touches your skin, so do not squirt it in your hand.

3. Massage the mousse into the affected areas of your scalp, and not your hair. Allow your hair to dry naturally.

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