AGISTEN V 2 % VAGINAL CREAM

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

CLOTRIMAZOLE

Dostupné s:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

ATC kód:

G01AF02

Léková forma:

VAGINAL CREAM

Složení:

CLOTRIMAZOLE 2 %

Podání:

VAGINAL

Druh předpisu:

Required

Výrobce:

PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL

Terapeutické skupiny:

CLOTRIMAZOLE

Terapeutické oblasti:

CLOTRIMAZOLE

Terapeutické indikace:

Broad spectrum antimycotic with fungicidal action

Datum autorizace:

2015-02-28

Informace pro uživatele

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed
with a doctor’s prescription only
AGISTEN V 2%
VAGINAL CREAM
CLOTRIMAZOLE 2%
Inactive ingredients and allergens in the
preparation - see section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY
BEFORE USING THE MEDICINE. This leaflet
contains concise information about the
medicine. If you have further questions, refer
to the doctor or pharmacist.
This medicine has been prescribed to treat
you. Do not pass it on to others. It may harm
them, even if it seems to you that their medical
condition is similar.
The medicine is intended for adolescent girls
and women between the ages of 16 and 60.
Patients under the age of 16 or over the age
of 60 – consult the doctor.
The symptoms generally pass after 7 days of
treatment. If there is no improvement in your
condition within 3 days, consult the doctor.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Broad spectrum antifungal medicine.
THERAPEUTIC GROUP: Imidazole antifungal.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE:
∙ if you are sensitive (allergic) to the active
ingredient, to cetostearyl alcohol, to any
of the other ingredients included in the
medicine or to other antifungal agents
from the same family.
∙ when menstruating, since the treatment
may be less effective.
SPECIAL WARNINGS REGARDING USE OF THE
MEDICINE
During treatment, abstain from vaginal
intercourse, as the disease can be transmitted
to your partner.
This medicine may reduce the effectiveness
of contraceptives made of rubber, such
as: condoms or diaphragms made of
latex. Therefore, it is recommended to use
alternative contraceptives for at least 5 days
after using the medicine.
Do not use tampons, vaginal douching
preparations, spermicides or other vaginal
preparations during the course of treatment. BEFORE TREATMENT WITH AGISTEN V 2%
VAGINAL CREAM, INFORM THE DOCTOR IF:
∙ you are sensitive to any food or medicine.
∙ you are unsure if you have a fungus or this is
the first time

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 .NAME OF THE MEDICINAL PRODUCT
Agisten V 2% Vaginal Cream
2 .QUALITATIVE AND QUANTITATIVE COMPOSITION
Cltorimazole 2%
Excipient with known effect: Cetostearyl alcohol, Benzyl alcohol
For full list of excipients, see section 6.1
3 .PHARMACEUTICAL FORM
VAGINAL CREAM
4 .CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Broad spectrum antimycotic with fungicidal action
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
One applicator charge daily (approximately 5 g) should be introduced
as deep as
possible into the vagina before retiring for 3 consecutive days. This
is best
achieved when lying on the back
.
Male Partner
The vaginal cream should be applied 2-3 times a day in a thin layer on
the penis
for balanitis (whether symptomatic or asymptomatic). The normal period
of
treatment is 1-2 weeks.
GENERALLY
•
If symptoms persist for more than 7 days the patient may have a
medical
condition that requires treatment by a doctor
•
The treatments can be repeated if necessary however recurrent
infections
may indicate an underlying medical cause, including diabetes or HIV
infections. Patients should seek the medical advice if symptoms return
within
2 months
•
Since the vagina and vulva are usually both affected, a combination
treatment
(treatment of both of these areas) should be performed
•
Treatment during the menstrual period should not be performed. The
treatment should be finished before the onset of menstruation
•
If the labia and adjacent areas are simultaneously infected, local
treatment
with an external cream should also be given. The sexual partner should
also
undergo local treatment if symptoms, e.g. pruritus, inflammation, etc.
are
present
•
Do not use tampons, intravaginal douches, spermicidies or other
vaginal
products while using this product
.
•
Avoidance of vaginal intercourse is recommended while using this
product
because the infection could be transferred to your partner, and the
effectiveness and safety of latex products such as condoms and
diaphragms
may be reduce