Lotriderm cream

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Clotrimazole; Betamethasone dipropionate

Saadav alates:

Stephar (U.K.) Ltd

ATC kood:

D07CC01

INN (Rahvusvaheline Nimetus):

Clotrimazole; Betamethasone dipropionate

Annus:

10mg/1gram ; 640microgram/1gram

Ravimvorm:

Cutaneous cream

Manustamisviis:

Cutaneous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 13040000

Infovoldik

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.
Your medicine is called Lotriderm Cream and will be
referred to as Lotriderm Cream throughout the
leaflet.
WHAT IS IN THIS LEAFLET:
What Lotriderm Cream is and what it is
used for
What you need to know before you use
Lotriderm Cream
How to use Lotriderm Cream
Possible side effects
How to store Lotriderm Cream
Contents of the pack and other information
WHAT LOTRIDERM CREAM IS AND WHAT IT IS
USED FOR
Lotriderm Cream contains the active ingredients
0.064% w/w betamethasone dipropionate
(equivalent to 0.05 % w/w betamethasone) and
1.0% w/w clotrimazole. Betamethasone belongs to a
group of medicines called topical corticosteroids
which are used on the surface of the skin to reduce
the redness and itchiness caused by certain skin
problems. Clotrimazole is a topical anti-fungal
medicine used to treat some fungal infections of the
skin.
Lotriderm Cream is used for the short-term
treatment of certain fungal infections of the skin,
when redness and itchiness may also be a problem.
WHAT YOU NEED TO KNOW BEFORE YOU
USE LOTRIDERM CREAM
DO NOT USE LOTRIDERM CREAM
•
if you are allergic to betamethasone
dipropionate, clotrimazole or any of the other
ingredients of this medicine (listed in section 6).
•
if your skin becomes irritated, or you develop an
allergic reaction.
•
on any other skin infections as it could make them
worse, especially rosacea (a skin condition
affecting the face), acne, dermatitis (skin
inflammation) around the mouth, nappy rash or
other skin infections.
WARNINGS AND P

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
LOTRIDERM 0.05% w/w/1.0% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Betamethasone dipropionate 0.064% w/w*
(* equivalent to 0.05% betamethasone)
Clotrimazole 1.0% w/w
Excipients with known effect
Cetostearyl alcohol,
Propylene glycol, 100mg/g of cream
Benzyl alcohol, 10mg/g of cream
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Cream
Smooth, uniform, white to off-white cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term topical treatment of tinea infections due to Trichophyton
rubrum;
T. mentagrophytes; Epidermophyton floccusum and Microsporum canis;
candidiasis due to Candida albicans.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and children over the age of 12 years. Topical administration
twice daily
for two weeks (tinea cruris, tinea corporis and candidiasis) or for
four weeks
(tinea pedis).
Paediatric population
Lotriderm cream is not recommended for children under the age of
twelve years.
Method of administration
Topical administration only.
4.3
CONTRAINDICATIONS
Lotriderm is contraindicated in those patients with a history of
sensitivity to
any of its components or to other corticosteroids or imidazoles.
If irritation or sensitisation develops with the use of Lotriderm
cream,
treatment should be discontinued and appropriate therapy instituted.
Lotriderm is contraindicated in facial rosacea, acne vulgaris,
perioral
dermatitis, napkin eruptions and bacterial or viral infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Local and systemic toxicity is common especially following long
continued
use on large areas of damaged skin and in flexures. If used on the
face,
courses should be limited to 5 days.
LOTRIDERM CREAM SHOULD NOT BE USED WITH OCCLUSIVE
DRESSING.
Topical corticosteroids may be hazardous in psoriasis for a number of
reasons
including rebound relapses following the development of tolerance,
risk of
generalised pustular psoriasis and local and systemic toxicity due