ClobaDerm 0.05% ointment

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Clobetasol propionate

Saadav alates:

Auden McKenzie (Pharma Division) Ltd

ATC kood:

D07AD01

INN (Rahvusvaheline Nimetus):

Clobetasol propionate

Annus:

500microgram/1gram

Ravimvorm:

Cutaneous ointment

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13040000; GTIN: 5060032242781 5060032242798

Infovoldik

PATIENT INFORMATION LEAFLET
CLOBADERM
®
500 MICROGRAMS/G
CREAM & OINTMENT (CLOBETASOL PROPIONATE)
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 ClobaDerm is and what it is used for?
2. What you need to know before you use ClobaDerm
3. How to use ClobaDerm
4. Possible side effects
5. How to store ClobaDerm
6. Contents of the pack and other information
1. WHAT CLOBADERM IS AND WHAT IT IS USED FOR?
ClobaDerm belongs to a group of medicines called steroids. It helps to
reduce
swelling and irritation.
ClobaDerm is used to help reduce the redness and itchiness of certain
skin
problems. These skin problems include eczema, psoriasis and dermatitis
that have
not responded to milder steroid creams or ointments.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CLOBADERM
DO NOT USE CLOBADERM:
• if you are allergic to clobetasol propionate or any of the other
ingredients of this
medicine (listed in Section 6)
• on a child under 1 year old
• to treat any of the following skin problems, it could make them
worse:
• acne
• severe flushing of skin on and around your nose (rosacea)
• spotty red rash around your mouth (perioral dermatitis)
• itching around your back passage or private parts - unless your
doctor has
told you to do so
• 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.
Do not use this medicine if any of the above apply to you. If you are
not sure, tal

Toote omadused

OBJECT 1
CLOBADERM 0.05% W/W OINTMENT
Summary of Product Characteristics Updated 26-Jan-2018 | Auden
Mckenzie (Pharma Division) Ltd (a
subsidiary of Actavis PLC)
1. Name of the medicinal product
ClobaDerm 500 micrograms/g Ointment
2. Qualitative and quantitative composition
1 g of ointment contains 0.5 mg of clobetasol 17-propionate (500
micrograms/g).
Excipients with known effect:
Also contains 50 mg of propylene glycol in each gram of ointment.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Ointment
Opaque ointment.
4. Clinical particulars
4.1 Therapeutic indications
Short courses for the treatment of more resistant dermatoses such as
psoriasis (excluding widespread
plaque psoriasis), recalcitrant eczemas, lichen planus, discoid lupus
erythematosus, and other skin
conditions which do not respond satisfactorily to less active
steroids.
4.2 Posology and method of administration
Posology
Adult and children
Apply sparingly to the affected area once or twice daily until
improvement occurs. As with other highly
active topical steroid preparations, therapy should be discontinued
when control is achieved. In the more
responsive conditions this may be within a few days. The application
frequency should be gradually
reduced.
Repeated short courses of ClobaDerm may be used to control
exacerbations. If continuous steroid
treatment is necessary, a less potent preparation should be used.
In very resistant lesions, especially where there is hyperkeratosis,
the anti-inflammatory effect of
ClobaDerm can be enhanced, if necessary, by occluding the treatment
area with polythene film.
Overnight occlusion only is usually adequate to bring about a
satisfactory response. Thereafter
improvement can usually be maintained by application without
occlusion.
Rarely, occlusion is necessary. In cases where an occlusive dressing
is applied, caution is needed in order
to avoid the risk of local and systemic adverse events.
APPLICATION TO THE FACE
Courses should be limited to five days if possible and occlusion
should