Bettamousse 1mg/g (0.1% w/w) Cutaneous Foam

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Betamethasone
Available from:
PCO Manufacturing Ltd.
ATC code:
D07AC; D07AC01
INN (International Name):
Betamethasone
Dosage:
1 (0.1%) milligram(s)/gram
Pharmaceutical form:
Cutaneous foam
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Corticosteroids, potent (group III); betamethasone
Authorization status:
Authorised
Authorization number:
PPA0465/209/001
Authorization date:
2008-02-22

Package leaflet: Information for the user

Bettamousse

®

1mg/g (0.1%)

Cutaneous Foam

Betamethasone

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.

In this leaflet, Bettamousse 1mg/g (0.1%) cutaneous foam

will be called Bettamousse.

What is in this leaflet:

What Bettamousse is and what it is used for

What you need to know before you use Bettamousse

How to use Bettamousse

Possible side effects

How to store Bettamousse

Contents of the pack and other information

1.

What Bettamousse is and what it is used for

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.

2.

What you need to know before you use 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 (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 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

3.

How to use Bettamousse

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 to your hand.

3. Massage the mousse into the affected

areas of your scalp, and not your hair.

Allow your hair to dry naturally.

4. Wash your hands immediately after

using the mousse.

5. Do not wash your hair straight

after applying the mousse. Let the

mousse work overnight or through

the day.

6. You can wash and dry your hair

immediately before applying the mousse.

This product is flammable. Do not use

Bettamousse near a naked flame or direct source of heat. Do

not smoke while using or holding the can.

Medical check-ups

If you use this medicine for a long period of time, your doctor

may ask you to have check-ups. These are to make sure that

your medicine is working properly and that the dose you are

taking is right for you.

If you use more Bettamousse than you should

Wash your scalp straight away and start again. It is unlikely that

you will suffer side-effects from using too much on one

occasion. If you are concerned, contact the nearest hospital

casualty department or your doctor. Using more than the

recommended dose of Bettamousse for a long time can lead to

a number of side effects (see section 4.)

If you forget to use Bettamousse

Do not use a double dose to make up for a forgotten dose.

Simply take the next dose as planned.

If you stop using Bettamousse

Do not stop using Bettamousse without first talking to your

doctor. Your condition may return after you stop using

Bettamousse. If this happens, talk to your doctor as soon as

possible. If you have any further questions about the use of this

medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines Bettamousse can cause side effects, although

not everybody gets them.

Stop using Bettamousse and seek immediate medical help

if you have any of the following symptoms:

Headache

Stinging

Itching

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

Infection of the skin

Thinning of the skin

Marking of the skin (such as darkspots or lines)

Red rash on the face

Bruising easily.

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

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 be estimated 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 of Bettamousse for a long

time:

Extra hair growth

Changes in skin colour

Irregular periods in women,

Water retention (bloated feeling)

Mood changes or sleep problems

Blurred vision or pain in the eye

Stomach upsets or discomfort

Acne

Headaches

These effects are more likely to happen in children, and if

dressings are applied to cover the scalp after Bettamousse has

been applied. The frequency of these effects on prolonged use

in unknown.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or

nurse. This includes any possible side effects not listed in this

leaflet. You can also report side effects directly via HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353

1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-

mail: medsafety@hpra.ie. 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 on the label. The

expiry date refers to the last day of the month,

Do not store above 25° C

Do not refrigerate. Protect from sunlight and any other sources

of direct heat as this product is very flammable

Do not pierce or burn the can, even when empty.

Do not throw away any medicines via wastewater or household

waste. Ask your pharmacist how to throw away medicines you

no longer use. These measures will help protect the

environment.

6.

Contents of the pack and other information

What Bettamousse contains

The active substance is betamethasone (as valerate) 1mg/g

(0.1%).

The other ingredients are cetyl alcohol, stearyl alcohol,

polysorbate 60, ethanol, purified water, propylene glycol, citric

acid anhydrous, potassium citrate and butane/propane.

What Bettamousse looks like and contents of the pack

Bettamousse is a white cutaneous foam mousse. The container

consists of an aluminium can with a valve and a clear cap. The

can contains 100g of the mousse.

Parallel Product Authorisation Number:

Bettamousse 1mg/g (0.1% w/w) Cutaneous Foam –

PPA 465/209/1

Manufacturers:

Pharmasol Limited, North Way, Walworth Industrial Estate,

Andover, Hampshire SP10 5AZ, United Kingdom or Aerosol

Service Italiana S.r.l. - Via del Maglio N° 6 – Valmadrera, 23868

LECCO, Italy or Recipharm Ltd., Ashton-under-Lyne,

Lancashire, OL79RR, United Kingdom.

Product procured from within the EU, repackaged and

distributed by the PPA holder:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath,

Ashbourne, Co. Meath

Bettamousse is a registered trademark of RPH Pharmaceuticals

AB

Date of leaflet preparation by PCO Manufacturing: October

2015

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Bettamousse 1mg/g (0.1% w/w) Cutaneous Foam

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Betamethasone 1mg/g (0.1% w/w) as valerate

Excipients contains:

Cetyl alcohol 1.1% w/w

Stearyl alcohol 0.5% w/w

Propylene glycol 2.0% w/w

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cutaneous foam

Product imported from Italy:

Appearance: White, foam mousse

4 CLINICAL PARTICULARS

As per PA 1638/009/001

5 PHARMACOLOGICAL PROPERTIES

As per PA 1638/009/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetyl alcohol

Stearyl alcohol

Polysorbate 60

Ethanol

Purified Water

Propylene glycol

Citric acid anhydrous

Potassium Citrate

Butane/Propane

6.2 Incompatibilities

Not applicable

6.3 Shelf life

The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on

the market in the country of origin.

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6.4 Special precautions for storage

Do not store above 25°C. Do not refrigerate.

6.5 Nature and contents of container

Pressurised container

Aluminium can with clear cover cap, with a net weight of 100g.

6.6 Special precautions for disposal and other handling

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/209/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of First Authorisation: 22nd February 2008

10 DATE OF REVISION OF THE TEXT

October 2015

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