AGISTEN PASTE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLOTRIMAZOLE

Available from:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC code:

D01AC01

Pharmaceutical form:

PASTE

Composition:

CLOTRIMAZOLE 1 %

Administration route:

DERMAL

Prescription type:

Not required

Manufactured by:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Therapeutic group:

CLOTRIMAZOLE

Therapeutic area:

CLOTRIMAZOLE

Therapeutic indications:

For treatment of abrasions and skin infections caused by species of fungi sensitive to clotrimazole .

Authorization date:

2022-01-31

Summary of Product characteristics

PRESCRIBING
INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Agisten Paste
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clotrimazole 1.0% w/w.
Excipients with known effect: Wool fat.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A white to cream colored paste for topical use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For treatment of abrasions and skin infections caused by species of
fungi sensitive to
clotrimazole
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
To ensure complete healing, treatment should be continued for about 2
weeks after
the disappearance of the subjective symptoms. The following are the
usual periods of
treatment:
Dermatomycoses
3-4 weeks
Erythrasma
2-4 weeks
Pityriasis versicolor
1-3 weeks
Candida vulvitis and balanitis
1-2 weeks
A thin layer should be applied to the affected sites and gently rubbed
in 2-3 times daily. A
strip of paste ½ cm long is sufficient to treat an area about the
size of a hand.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Do not use to treat nail or scalp infections.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Laboratory tests have suggested that, when Clotrimazole paste is used
together, this
product may cause damage to latex contraceptives. Consequently the
effectiveness of
such contraceptives may be reduced. Patients should be advised to use
alternative
precautions for at least five days after using this product.
4.6
PREGNANCY AND LACTATION
Fertility:
No human studies of the effects of clotrimazole on fertility have been
performed;
however, animal studies have not demonstrated any effects of the drug
on fertility.
Pregnancy:
There is a limited amount of data from the use of clotrimazole in
pregnant women.
Animal studies with clotrimazole have shown reproductive toxicity at
high oral
doses (see section 5.3). At the low systemic exposures of clotrimazole
following
topic