CANESTEN DUOPAK COMBINATION OF DOSAGE FORMS

Šalis: Pietų Afrika

kalba: anglų

Šaltinis: South African Health Products Regulatory Authority (SAHPRA)

Prieinama:

Bayer (Pty) Ltd û Isando

Dozė:

See ingredients

Vaisto forma:

COMBINATION OF DOSAGE FORMS

Sudėtis:

Referred to CLOTRIMAZOLE A

Autorizacija statusas:

Registered

Leidimo data:

1998-06-08

Pakuotės lapelis

Page 1 of 7
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S1
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:
CANESTEN
® DUOPAK
Vaginal Tablet 500 mg and Cream 100 mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
CANESTEN
®
DUOPAK is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless you still need to use CANESTEN
®
DUOPAK carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Do not share CANESTEN
®
DUOPAK 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
® DUOPAK CONTAINS: VAGINAL TABLET
The active ingredient is: Clotrimazole 500 mg.
The
other
ingredients
are:
Calcium
lactate
pentahydrate,
cellulose
microcrystalline,
crospovidone,
hypromellose 15 cP, lactic acid, lactose monohydrate, magnesium
stearate, maize starch, silica colloidal
anhydrous.
CREAM
The active ingredient is: Clotrimazole 10 mg/g
The other ingredients are: Benzyl alcohol 2 %, cetostearyl alcohol,
cetyl palmitate, octyldodecanol, polysorbate
60, sorbitan stearate, purified water.
Page 2 of 7
WHAT CANESTEN
® DUOPAK IS USED FOR:
Vaginal Tablet is used for the relief of vaginal itching, burning and
discharge associated with vaginal yeast
infections.
Cream is used for candida infections of the labia and adjacent areas
as well as inflammation of the glans and
prepuce of the sexual partner.
BEFORE YOU USE CANESTEN
® DUOPAK:
DO NOT USE CANESTEN
® DUOPAK:

If you are hypersensitive (allergic) to clotrimazole or any of the
other ingredients of CANESTEN
®
DUOPAK.

If you are under 12 years of age.

If you are having your menstrual period.
TAKE SPECIAL CARE WITH CANESTEN
® DUOPAK:

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 a doctor.

Avoid vaginal intercou

Prekės savybės

Page 1 of 7
_PROFESSIONAL INFORMATION _
_HUMAN MEDICINE _
_The under-mentioned information with regard to this medicine shall
appear on the _
_package insert. The information shall be presented in the format
stipulated, provided _
_that the Council may authorise any deviation from such information or
such format _
_(refer to Regulation 9 of the Act). _
1
Scheduling status
2
Proprietary Name and Dosage Form
3
Composition
4
Category and Class
5
Pharmacological Action
Pharmacokinetic properties
Pharmacodynamic properties
6
Indications
7
Contraindications
8
Warnings and Special Precautions
9
Interactions
10
Human Reproduction
Pregnancy
Lactation
11
Dosage and Directions for Use
12
Side effects
13
Known Symptoms of Over-dosage and Particulars of its Treatment
14
Identification
15
Presentation
16
Storage Instructions
17
Registration Number
18
Name and Business Address of the Holder of the Certificate of
Registration
19
Date of publication of the Professional Information
Page 2 of 7
SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM: CANESTEN
® DUOPAK
Vaginal Tablet and Cream
COMPOSITION:
VAGINAL TABLET CONTAINS:
ACTIVE INGREDIENT: Clotrimazole 500 mg
INACTIVE
INGREDIENTS:
Calcium
lactate
pentahydrate,
cellulose
microcrystalline,
crospovidone,
hypromellose 15 cP, lactic acid, lactose monohydrate, magnesium
stearate, maize starch, silica
colloidal anhydrous.
10 G CREAM CONTAINS:
ACTIVE INGREDIENT: Clotrimazole 100 mg
INACTIVE
INGREDIENTS:
Benzyl
alcohol
2
%
m/m
(as
preservative),
cetostearyl
alcohol,
cetyl
palmitate, octyldodecanol, polysorbate 60, sorbitan stearate, 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 and functional impairment of the fungal
cytoplasmic membrane.

Clotrimazole has a broad antimycotic spectrum of action in vitro and
in vivo, which includes
dermatophytes, yeasts and moulds.
S1
Page 3 of 7
PHARMACOKINETIC P