Bettamousse 0.1% cutaneous foam

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Betamethasone valerate

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

D07AC01

INN (International Name):

Betamethasone valerate

Dosage:

1mg/1gram

Pharmaceutical form:

Cutaneous foam

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13040000

Patient Information leaflet

•
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.
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.
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 onl

Summary of Product characteristics

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 betamethasone (0.1 %) as valerate
Excipients with known effect:
Cetyl Alcohol 1.10 % w/w, Stearyl alcohol 0.50 % w/w) and Propylene
glycol 2.00 %
w/w
For a 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
To be massaged into the affected areas of the scalp. Patients should
be advised to use
the product sparingly.
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 initiated.
Dermatoses in children under six years of age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes, open wounds and mucosae. Do not use near
a naked
flame.
The least amount of mousse required to control the disease should be
used for the
shortest possible time. This should minimise the potential for long
term side effects.
This is particularly the case in children, as adrenal suppression can
oc