Read all of this leaflet carefully beforeyou start using this medicine because it

contains importantinformation for you.• Keep this leaflet. You

may need to read it again.

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

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

• If you get any side effects, talk to yourdoctor or pharmacist or nurse. Thisincludes any possible side effects notlisted in this leaflet. See section 4.

• In this leaflet, Bettamousse 1mg/g(0.1%) cutaneous foam will be called Bettamousse.

What is in this leaflet1. What Bettamousse is and what it is

used for2. What you need to know before you

use Bettamousse3. How to use Bettamousse4. Possible side effects5. How to store Bettamousse6. Contents of the pack and other

information.

1. What Bettamousse is andwhat it is used forBettamousse contains the activesubstance Betamethasone as valerate.Bettamousse belongs to a group ofmedicines called corticosteroids(‘steroids’ for short).Bettamousse is used to treat skindisorders of the scalp such as psoriasis(raised red patches of skin covered insilvery scales) that may feel itchy, tightor sore. Bettamousse works by reducinginflammation (redness, itching andsoreness). It is important to use thismedicine to prevent damage to the skinand infections from developing.

2. What you need to knowbefore you use Bettamousse

Do not use Bettamousse:• If you are allergic to betamethasone

valerate or any of the otheringredients of this medicine (listed insection 6). Some of these ingredients(stearyl alcohol, cetyl alcohol andpropylene glycol) may cause local skinreactions (e.g. contact dermatitis).

• If you have any kind of infection ofthe scalp, unless this is already beingtreated

• On a child under 6 years of age.If any of the above applies to you, talkto your doctor or pharmacist.Warnings and precautionsTalk to your doctor or pharmacistbefore using Bettamousse if:• You have any kind of skin infection• You have open wounds on your scalp• You experience blurred vision or other

visual disturbances

symptoms have not improved see yourdoctor again

Do not use in children under 6 years ofage

As symptoms improveFor adults and children: Where there issome improvement in symptoms,Bettamousse can be applied just once aday. If the condition continues to getbetter, it may be possible to applyBettamousse once every few days, tokeep the symptoms from coming back.

InfectionsIf you have a skin infection your doctorwill give you another medicine to treatthe infectionWhilst you have an infection, yourdoctor may tell you to stop usingBettamousse.If you are not sure about how muchmousse to use, ask your doctor orpharmacist.

Instructions for use:1. Remove the cap.

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

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

1mg/g (0.1%) Cutaneous foam Betamethasone

Package leaflet: Information for the user

• You are taking any other medicine,including medicines obtained withouta prescription.

Children and adolescents

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

Do not give this medicine to childrenunder the age of 6 years.Other medicines and BettamousseTell your doctor or pharmacist if you aretaking, using, have recently taken orused or might take or use any othermedicines.Pregnancy and breast-feedingIf you are pregnant or breast-feeding,think you may be pregnant or areplanning to have a baby, ask yourdoctor or pharmacist for advice beforetaking this medicine.Driving and using machinesThere are no known effects on drivingor using machines.Bettamousse contains Cetyl Alcohol andStearyl Alcohol which may cause localskin reactions (e.g. contact dermatitis)Bettamousse contains propylene glycolwhich may cause skin irritation.

3. How to use Bettamousse

Always use this medicine exactly as yourdoctor or pharmacist has told you. Yourdose will be shown clearly on the labelthat your pharmacist puts on yourmedicine. Check with your doctor orpharmacist 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, rinsewell with cold water. If your eyescontinue to sting, contact your doctor

• Avoid contact with the inside of yournose and mouth

• Avoid contact with any open wounds.

The recommended dose isAdults:• No more than a golfball sized amount

of mousse• Massage into the affected areas of the

scalp twice a day (in the morning andevening)

• If there is no improvement in yourcondition after 7 days, stop usingBettamousse and see your doctoragain.

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 childhalf the size of an adult, use no morethan half a golf ball sized amount ofmousse

• Massage into the affected area of thescalp twice a day (in the morning andevening)

• Do not use Bettamousse for morethan 5 to 7 days on children. If the

4. Wash your hands immediately afterusing the mousse.

5. Do not wash your hair straight afterapplying the mousse. Let the moussework overnight or through the day.

6. You can wash and dry your hairimmediately before applying the mousse.

This product is flammable. Do not useBettamousse near a naked flame ordirect source of heat. Do not smokewhile using or holding the can.

Medical check-upsIf you use this medicine for a longperiod of time, your doctor may askyou to have check-ups. These are tomake sure that your medicine isworking properly and that the doseyou are taking is right for you.

If you use more Bettamousse than youshouldWash your scalp straight away andstart again. It is unlikely that you willsuffer side-effects from using too muchon one occasion. If you are concerned,contact the nearest hospital casualtydepartment or your doctor.Using more than the recommendeddose of Bettamousse for a long timecan lead to a number of side effects(see section 4).

If you forget to use BettamousseDo not use a double dose to make upfor a forgotten dose. Simply take thenext dose as planned.

If you stop using BettamousseDo not stop using Bettamousse withoutfirst talking to your doctor.Your condition may return after youstop using Bettamousse. If thishappens, talk to your doctor as soon aspossible.If you have any further questions onthe use of this medicine, ask yourdoctor or pharmacist.

4. Possible side effectsLike all medicines Bettamousse cancause side effects, although noteverybody gets them.

Stop using Bettamousse and seekimmediate medical advice if you haveany of the following symptoms:

• Headache• Stinging• Itching.Uncommon: may affect up to 1 in 100

people)• Infection of the skin• Thinning of the skin• Marking of the skin (such as dark

spots or lines)• Red rash on the face•• Blurred vision.

Bruising easily

Rare: may affect up to 1 in 1,000people)• Sensitivity reactions such as itching,

redness and stinging• Lighter or darker patches of skin• Hair loss• Infection of the hair follicles• Red spots on the skin.

Not known: frequency cannot beestimated from the available data• Worsening of the scalp condition,

causing pus-filled ulcers to form• Acne• Purple stained skin• Rash around the mouth.

Effects of using a high dose ofBettamousse for a long time:• Extra hair growth• Changes in skin colour• Irregular periods in women, • Water retention (bloated feeling)• Mood changes or sleep problems• Stomach upsets or discomfort • Acne• Headaches.These effects are more likely to happenin children, and if dressings are appliedto cover the scalp after Bettamoussehas been applied. The frequency ofthese effects on prolonged use isunknown.Reporting of side effectsIf you get any side effects, talk to yourdoctor or pharmacist or nurse. Thisincludes any possible side effects notlisted in this leaflet. United Kingdom: You can also reportside effects directly via Yellow CardScheme on the MHRA website(www.mhra.gov.uk/yellowcard). Byreporting side effects you can helpprovide more information on the safetyof this medicine.

5. How to store BettamousseKeep this medicine out of the sight andreach of children.Do not use Bettamousse after theexpiry date on the label. The expirydate refers to the last day of thatmonth.Do not store above 25oC. Do not refrigerate. Protect from sunlight andany other sources of direct heat as thisproduct is very flammable.Do not pierce or burn the can, evenwhen empty.Do not throw away any medicines viawastewater or household waste. Askyour pharmacist how to throw awaymedicines you no longer use. These

measures will help protect theenvironment.

6. Contents of the pack andother information

What Bettamousse containsThe active substance is betamethasone(as valerate) 1 mg/g (0.1 %).The other ingredients are cetyl alcohol,stearyl alcohol, polysorbate 60,ethanol, purified water, propyleneglycol, citric acid anhydrous,potassium citrate, and butane/propane.

What Bettamousse looks like andcontents of the packBettamousse is a white cutaneous foammousse.Bettamousse comes in an aluminiumcan with a valve and a clear cap. Itcomes in two sizes, 50 g or 100 g.

Not all pack sizes may be marketed.

Marketing Authorisation HolderRPH Pharmaceuticals AB,Lagervägen 7,136 50 Jordbro, Sweden

ManufacturersAerosol Service Italia S.r.l.Via del Maglio No. 6Valmadrera23868 LECCOItaly

Recipharm LtdAshton-under-LyneLancashire, OL7 9RR UK

If this leaflet is difficult to see or reador you would like it in a differentformat, please contact:RPH Pharmaceuticals AB, Lagervägen 7,136 50 Jordbro,Sweden

This leaflet was last revised December 2019

EX00126

Recipharm Uppsala ABBjörkgatan 30SE-751 82 UppsalaSweden