Canesten 500mg Soft Vaginal Capsule

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Clotrimazole

Dostupno od:

Bayer Limited

ATC koda:

G01AF; G01AF02

INN (International ime):

Clotrimazole

Doziranje:

500 milligram(s)

Farmaceutski oblik:

Vaginal capsule, soft

Tip recepta:

Product not subject to medical prescription

Područje terapije:

Imidazole derivatives; clotrimazole

Status autorizacije:

Not marketed

Datum autorizacije:

2014-12-12

Uputa o lijeku

BCH22024
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANESTEN
®
500MG SOFT VAGINAL CAPSULE
Clotrimazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor, pharmacist or nurse have
told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1. What Canesten Soft Vaginal Capsule is and what it is used for
2. What you need to know before you use Canesten Soft Vaginal Capsule
3. How to use Canesten Soft Vaginal Capsule
4. Possible side effects
5. How to store Canesten Soft Vaginal Capsule
6. Contents of the pack and other information
1. WHAT CANESTEN
®
SOFT VAGINAL CAPSULE IS AND WHAT IT IS USED FOR
Canesten Soft Vaginal Capsule is a single application for the
treatment of vaginal thrush. It is inserted
into the vagina for treatment at the site of infection.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR
DOCTOR AS HAVING VAGINAL
THRUSH.
The active substance in Canesten Soft Vaginal Capsule is clotrimazole.
Clotrimazole belongs to a group
of medicines called azoles and is an antifungal agent which fights the
cause of infections such as vaginal
thrush.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN
® SOFT VAGINAL
CAPSULE
DO NOT USE CANESTEN
®
SOFT VAGINAL CAPSULE:
•
If you are allergic to clotrimazole or any of the other ingredients of
Canesten Soft Vaginal Capsule
(
_listed in Section 6_
).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING CANESTEN
® SOFT VAGINAL CAPSULE IF:
•
You are unsure whether you have thrush or this is the first time you
have had these symptoms.
•
You have had mo

Svojstava lijeka

Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten 500mg Soft Vaginal Capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft vaginal capsule contains 500mg Clotrimazole.
Excipients with known effect: Soya oil
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Vaginal capsule, soft
Yellow teardrop-shaped soft capsule
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesten Soft Vaginal Capsules are recommended for the treatment of
candidal vaginitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
One 500mg soft vaginal capsule should be inserted at night before
going to bed. A second treatment may be carried out if
necessary.
Patients should be advised to consult their physician if the symptoms
have not been relieved within one week of using
Canesten Soft Vaginal Capsule. Canesten Soft Vaginal Capsules can be
used again if the candidal infection returns after 7 days.
However, if the candidal infection recurs more than twice within six
months, patients should be advised to consult their
physician.
_Paediatric population_
Not for use in children under 16.
Method of administration
The soft vaginal capsule should be inserted as high as possible into
the vagina, using the applicator provided. This is best
achieved when lying back with legs bent up.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Medical advice should be sought if this is the first time the patient
has experienced symptoms of candidal vaginitis.
Before using Canesten Soft Vaginal Capsule, medical advice must be
sought if any of the
following are applicable:
Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 2 of 6
- more than two infections of candidal vaginitis in the last 6 months.
- previous history of sexually transmitted disease or exposure to
partner with sexually transmitted disea