Clotrimazole 1% cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clotrimazole

Available from:

Teva UK Ltd

ATC code:

D01AC01

INN (International Name):

Clotrimazole

Dosage:

10mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 13100200; GTIN: 5017007370611 5017007370666

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE USER
CLOTRIMAZOLE CREAM 1%
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Always use this medicine exactly as
described in this leaflet or as your
doctor or pharmacist has told you.
• Keep this leaflet. You may need to read
it again.
• Ask your pharmacist if you need more
information or advice.
• You must contact a doctor if your
symptoms worsen or do not improve.
• 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 Clotrimazole is and what it is
used for
2. What you need to know before you use
Clotrimazole
3. How to use Clotrimazole
4. Possible side effects
5. How to store Clotrimazole
6. Contents of the pack and other
information
1. WHAT CLOTRIMAZOLE IS AND WHAT IT
IS USED FOR
The active substance is clotrimazole.
Clotrimazole belongs to a group of
medicines called imidazoles and is an
antifungal agent which fights the cause of
fungal skin infections.
Clotrimazole is used to treat fungal skin
infections such as ringworm, athlete’s foot,
fungal nappy rash and fungal sweat rash. It
is also used to relieve irritation of the vulva
(external thrush) or the end of the penis,
which may be associated with thrush.
When Clotrimazole is applied to the
infected area of skin it works by destroying
the fungus or yeast which has caused the
infection.
IF YOU ARE UNSURE WHETHER YOU (OR YOUR
BABY IF TREATING NAPPY RASH) HAVE ONE
OF THESE FUNGAL SKIN INFECTIONS, SEEK THE
ADVICE OF YOUR DOCTOR OR PHARMACIST.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE CLOTRIMAZOLE
DO NOT USE CLOTRIMAZOLE:
•
if you (or your baby if treating nappy
rash) are allergic to clotrimazole or any
of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
using Clotrimazole if you have used a
cream containing clotrimazole or a similar
med

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Clotrimazole 1% Cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tube contains 1%w/w Clotrimazole.
Each 1 g of cream contains 10 mg of clotrimazole.
Excipient with known effect: cetostearyl alcohol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cream
A smooth white cream.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the treatment of:
i.
All dermatomycoses due to moulds and other fungi (e.g. _Trichophyton_
species)
ii.
All dermatomycoses due to yeasts (_Candida_ species). These include
ringworm (tinea)
infections (e.g. athlete’s foot), paronychia, pityriasis versicolor,
erythrasma and intertrigo.
iii.
Skin diseases showing secondary infection with these fungi.
iv.
Candidal nappy rash, vulvitis and balanitis.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
There is no separate dosage schedule for the young or elderly.
Method of administration
The cream should be applied thinly and evenly to the affected area 2
– 3 times daily and rubbed in
gently. A strip of cream (½ cm long) is enough to treat an area of
about the size of the hand.
If the feet are infected, they should be thoroughly washed and dried,
especially between the toes,
before applying the cream.
Treatment should be continued for at least one month for dermatophyte
infections, or for at least two
weeks for candidal infections.
.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Do not use the cream to treat nail or scalp infections.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This product contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact
dermatitis).
Instruct patients not to smoke or go near naked flames - risk of
severe burns. Fabric (clothing,
bedding, dressings etc) that has been in contact with this product
burns more easily and is a serious
fire hazard. Washing clothing and bedding may reduce product build-up
but not totally remove it.