CLOTRIPIN Cream 1

Land: Tanzania

Sprog: engelsk

Kilde: Tanzania Medicinces & Medical Devices Authority

Aktiv bestanddel:

Clotrimazole

Tilgængelig fra:

PINNACLE LIFE SCIENCE PRIVATE LIMITED, INDIA

ATC-kode:

Aniinfectives and antiseeptics/ excluding combinat

INN (International Name):

Clotrimazole

Dosering:

1

Lægemiddelform:

Cream

Fremstillet af:

Pinnacle Life Science Limited, INDIA

Produkt oversigt:

Physical description: White coloured, smooth homogeneous cream; Local technical representative: Abacus Pharma Africa Limited (8473)

Autorisation status:

Registered/Compliant

Autorisation dato:

2021-03-29

Produktets egenskaber

Page 1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Strength: 1 % w/w
Brand Name: CLOTRIPIN CREAM
INN Name: Clotrimazole Cream BP 1 % w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole BP ................ 1
%
w/w Cream Base ............... q.s.
For full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM:
Cream – Semi-solid dosage form
◆
DESCRIPTION:
White coloured smooth homogeneous cream.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
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.
Page 2
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 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
To be used only if candidal vulvitis has previously been confirmed by
a doctor.
The patient should be referred for medical advice if:
1. Previous history of STD or exposure to partner with STD.
2. More than two previous attacks in the last 6 months.
3. Known hypersensitivity to imidazoles or other vaginal antifungal
products.
4. Pregnancy or s