CANESTEN 1 VC CREAM

Country: Հարավաֆրիկյան Հանրապետություն

language: անգլերեն

source: South African Health Products Regulatory Authority (SAHPRA)

MAH:

Bayer (Pty) Ltd û Isando

dosage:

See ingredients

pharmaceutical_form:

CREAM

composition:

EACH 5 g VAGINAL CREAM CONTAINS CLOTRIMAZOLE 0,5 g

authorization_status:

Registered

authorization_date:

1987-04-11

PIL

Page 1 of 6
SCHEDULING STATUS
S1
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
CANESTEN
®
1 VC is available
without
a doctor’s prescription, for you to treat a mild illness.
Nevertheless, you still need to use CANESTEN
®
1 VC carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Do not share CANESTEN
®
1 VC with any other person.

Ask your pharmacist if you need more information or advice.

You must see a doctor if your symptoms worsen or do not improve after
7 days.
WHAT CANESTEN
® 1 VC CONTAINS

The active substance is Clotrimazole 500 mg/5 g

The other ingredients are benzyl alcohol 1 % (as a preservative),
cetostearyl alcohol, cetyl
palmitate, isopropyl myristate, polysorbate 60, sorbitan monostearate
and purified water.
WHAT CANESTEN
® 1 VC IS USED FOR
For the relief of vaginal itching, burning, discharge and possibly
pain associated with vaginal yeast
infections (vaginal thrush).
BEFORE USING CANESTEN
® 1 VC
DO NOT USE CANESTEN
® 1 VC:

If you are allergic to clotrimazole or to any of the ingredients in
CANESTEN
®
1 VC

If you are under 12 years of age

If you are having your menstrual period.
CANESTEN
®
1 VC
Vaginal Cream 10 %
Page 2 of 6
TAKE SPECIAL CARE WITH CANESTEN
® 1 VC:

If you have a fever, lower abdominal pain, back pain, foul smelling
vaginal discharge, nausea,
vaginal bleeding, and/or associated shoulder pain, you should consult
your doctor.

Avoid vaginal intercourse while using CANESTEN
®
1 VC as it may result in vaginal infection
and your partner could become infected.

If symptoms persist for more than 7 days you may have a condition that
requires medical
treatment. You should consult your doctor.

You
should
not
use
tampons,
intravaginal
douches,
spermicides
or
other
vaginal
preparations while using CANESTEN
®
1 VC.

CANESTEN
®
1 VC may reduce the effectiveness and safety of latex (rubber)
products such
a

SPC

Page 1 of 6
SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM:
CANESTEN
®
1 VC
Vaginal Cream
COMPOSITION:
ACTIVE INGREDIENT:
Clotrimazole 500 mg/5 g
INACTIVE INGREDIENTS:
Benzyl alcohol 1 % (as preservative), cetostearyl alcohol, cetyl
palmitate,
isopropyl myristate, polysorbate 60, sorbitan monostearate and
purified water.
CATEGORY AND CLASS:
A 20.2.2. Fungicides
PHARMACOLOGICAL ACTION:
PHARMACODYNAMICS PROPERTIES
Clotrimazole acts against fungi by inhibiting ergosterol synthesis.
Inhibition of ergosterol synthesis
leads to structural functional impairment of the fungal cytoplasmic
membrane.
Clotrimazole has a broad antimycotic spectrum of action in vitro and
in vivo, which includes
dermatophytes, yeast and moulds.
PHARMACOKINETIC PROPERTIES
A pharmacokinetic investigation after vaginal application reported
that 3 – 10 % of clotrimazole is
absorbed.
INDICATIONS:
Infections of the genital region (vaginitis) caused by Candida.
S1
Page 2 of 6
CONTRAINDICATIONS:

Hypersensitivity to clotrimazole or to any of the excipients of
CANESTEN
®
1 VC (Vaginal
Cream).
WARNINGS AND SPECIAL PRECAUTIONS:
If symptoms persist for more than 7 days, the patient should be
evaluated by a medical practitioner.
Recurrent infections may indicate an underlying medical cause.
Patients should seek medical advice
if symptoms return within 2 months.
Treatment during the menstrual period should not be performed. The
treatment should be completed
before the onset of menstruation.
Tampons, intravaginal douches, spermicides or other vaginal products
should not be used while using
CANESTEN
®
1 VC.
Avoidance of vaginal intercourse is recommended in case of vaginal
infection and while using
CANESTEN
®
1 VC as the partner could become infected.
CANESTEN
®
1 VC is intended for use by adults and children 12 years of age and
older only.
CANESTEN
®
1 VC MAY REDUCE THE EFFECTIVENESS AND SAFETY OF LATEX PRODUCTS SUCH AS
CONDOMS
AND DIAPHRAGMS WHEN APPLIED ON THE GENITAL AREA (WOMEN:
INTRAVAGINALLY, LABIA AND ADJACENT
AREA OF THE VULVA; MEN: PR