Bettamousse 1mg/g (0.1%) cutaneous foam

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Betamethasone valerate

Available from:

RPH Pharmaceuticals AB

ATC code:

D07AC; D07AC01

INN (International Name):

Betamethasone valerate

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:

Marketed

Authorization date:

1998-11-13

Patient Information leaflet

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
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 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).
-
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 infec

Summary of Product characteristics

Health Products Regulatory Authority
24 October 2022
CRN00CY2N
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bettamousse 1mg/g (0.1%) cutaneous foam
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of foam contains 1 mg of betamethasone (0.1 %) as valerate.
Excipients with known effect:
Cetyl Alcohol 1.1% w/w
Stearyl Alcohol 0.5% w/w
Propylene Glycol (E1520) 2.0% w/w
Ethanol 57.79% w/w
For the full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous foam
White, foam mousse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bettamousse is indicated for steroid responsive dermatoses of the
scalp, such as psoriasis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ADULTS, THE ELDERLY AND CHILDREN (OVER THE AGE OF SIX YEARS):
No more than a "golf-ball" sized amount of mousse (containing
approximately 3.5mg betamethasone), or proportionately less
for children twice daily (in the morning and evening) until the
condition improves. If there is no improvement after 7 days,
treatment should be discontinued. Once the condition has improved,
application is reduced to once a day and after daily
treatment it may be possible to maintain improvement by applying even
less frequently.
_Paediatric population_
In children over the age of 6 years, this product should not, in
general, be used for longer than 5 to 7 days.
Method of administration
For topical use.
Shake the can well before use. Remove the cap, invert the can and
dispense required amount of mousse onto a clean saucer or
something similar. Dispensing directly onto hands should be avoided as
the mousse will begin to melt when it touches skin.
Massage sparingly into the affected areas of the scalp. Wash hands
immediately after use. Do not wash hair immediately after
use, allow the mouse to work overnight or through the day.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Bacterial, fungal, parasitic or viral infections of the scalp unless
simultaneous treatment is in