Clobavate 0.05% ointment

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Clobetasone butyrate

Dostupné z:

Teva UK Ltd

ATC kód:

D07AB01

INN (Medzinárodný Name):

Clobetasone butyrate

Dávkovanie:

500microgram/1gram

Forma lieku:

Cutaneous ointment

Spôsob podávania:

Cutaneous

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 13040000; GTIN: 5060032243009 5060032242996

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
CLOBAVATE 0.05% W/W OINTMENT
Clobetasone Butyrate
continued
overleaf
EAS3315d
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. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What is Clobavate and what is it used for
2. What you need to know before you use Clobavate
3. How to use Clobavate
4. Possible side effects
5. How to store Clobavate
6. Contents of the pack and other information
1. WHAT IS CLOBAVATE AND WHAT IS IT USED FOR
Clobavate Ointment contains the active ingredient clobetasone
butyrate. This belongs to a group of
medicines called steroids. It helps to reduce swelling and irritation.
Clobavate Ointment is used to help reduce the redness and itchiness of
certain skin problems. It is used for
mild skin problems or to keep your skin problems under control. These
skin problems include eczema,
dermatitis or insect bites. It is also used to help reduce
inflammation of the outer ear.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLOBAVATE
DO NOT USE CLOBAVATE:
-
if you are allergic (hypersensitive) to clobetasone butyrate or any of
the other ingredients of this medicine
(listed in Section 6)
-
to treat any of the following skin problems, it could make them worse:
- viral infections, such as cold sores, herpes or chicken pox
- fungal infections, such as ringworm, athletes foot or thrush
- skin blisters or sores that are caused by an infection
- itchy skin which is not inflamed
-
if a dressing is applied to a child under one year of age
-
if you suffer from skin conditions such as acne, rosacea (redness of
the

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clobavate 0.05% w/w Ointment
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains clobetasone butyrate 0.05% w/w (0.5 mg/g)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Ointment
Opaque ointment.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clobavate is suitable for the treatment of corticosteroid sensitive
dermatoses,
including atopic eczema, photodermatitis, otitis externa, primary
irritant and allergic
dermatitis (including napkin rash), intertrigo, prurigo nodularis,
seborrhoeic
dermatitis and insect bite reactions.
Clobavate may be used as maintenance therapy between courses of one of
the more
active topical steroids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, Elderly, Children and Infants
Ointment
Ointments are especially appropriate for dry, lichenified or scaly
lesions. Apply thinly
and gently rub in using only enough to cover the entire affected area
once or twice a
day until improvement occurs, then reduce the frequency of application
or change the
treatment to a less potent preparation. Allow adequate time for
absorption after each
application before applying an emollient.
Therapy with topical corticosteroids should be gradually discontinued
once control is
achieved and an emollient continued as maintenance therapy.
Rebound of pre-existing dermatoses can occur with abrupt
discontinuation of topical
corticosteroids especially with potent preparations.
Duration of treatment for adults and elderly
Continuous daily treatment for longer than four weeks is not
recommended. If the
condition worsens or does not improve within four weeks, treatment and
diagnosis
should be re-evaluated.
Paediatric population
Children are more likely to develop local and systemic adverse
reactions of topical
corticosteroids and, in general, require shorter courses and less
potent agents than
adults.
Care should be taken when using clobetasone to ensure the amount
applied is the
minimum that provides therapeutic benefi