Canesten Duopak

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Clotrimazole; Clotrimazole

Dostopno od:

Bayer Limited

Koda artikla:

G01AF; G01AF02

INN (mednarodno ime):

Clotrimazole; Clotrimazole

Odmerek:

100mg/1 percent weight/weight

Farmacevtska oblika:

Cream + pessary

Tip zastaranja:

Product not subject to medical prescription

Terapevtsko območje:

Imidazole derivatives; clotrimazole

Status dovoljenje:

Not marketed

Datum dovoljenje:

1977-04-01

Navodilo za uporabo

BCH22024
PACKAGE LEAFLET: INFORMATION FOR THE USER
CANESTEN® DUOPAK
clotrimazole
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your pharmacist has 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 contact a doctor if your symptoms worsen or do not improve in
7 days.
WHAT IS IN THIS LEAFLET
1. What is Canesten Duopak and what is it used for?
2.
What you need to know b
efore you use Canesten Duopak
3. How to use Canesten Duopak
4. Possible side effects
5. How to store Canesten Duopak
6. Contents of the pack and other information
1. WHAT IS CANESTEN
®
DUOPAK AND WHAT IS IT USED FOR?
Canesten Duopak is a complete treatment for vaginal thrush because it
treats both the internal
cause and external symptoms.
ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR
DOCTOR AS HAVING
VAGINAL THRUSH.
The active substance in Canesten Duopak 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.
Some women suffer from recurrent attacks of thrush. To reduce the
frequency of these attacks,
the sexual partner’s penis can be treated with this cream to prevent
reinfection, even if they have
no symptoms of thrush.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN
®
DUOPAK
DO NOT USE CANESTEN
®
DUOPAK:
•
If you are allergic (hypersensitive) to clotrimazole or any of the
other ingredients, including
cetostearyl alcohol or benzyl alcohol, of Canesten Duopak (listed in
Section 6).
•
During your period as it may be less effective.
WARNINGS AND PRECAUTIONS:
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE USING CANESTEN
®
DUOPAK IF:
You a

Lastnosti izdelka

Health Products Regulatory Authority
05 December 2022
CRN00D655
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Canesten Duopak
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains Clotrimazole 100mg.
Each gram of cream contains 10mg clotrimazole (equivalent to 1% w/w).
Excipients with known effect:
Cetostearyl alcohol 100mg in each gram of cream
Benzyl alcohol 20mg in each gram of cream
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pessaries and cream
White biconvex, oblong pessaries with the name “Bayer” engraved on
one side and the letters “P3” on the other.
A white oil-in-water type cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Canesten 100mg pessaries are recommended for the treatment of candidal
vaginitis.
The cream is recommended for associated vulvitis and treatment of the
sexual partner to prevent re-infection.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Canesten 100mg Pessaries should be inserted intravaginally, as high as
possible, using the applicator supplied.
The cream is for topical application to the vulva and surrounding
area.
ADULTS AND CHILDREN OF 12 YEARS OF AGE AND OLDER:
Insert one pessary daily, preferably at night, before going to bed,
for six consecutive days. Alternatively, two pessaries can be
inserted for three consecutive days. The cream should be applied two
or three times daily.
If symptoms persist for more than 7 days the patient may have a
medical condition that requires treatment by a doctor.
The treatment can be repeated if necessary, however, recurrent
infections may indicate an underlying medical cause. Patient
should seek medical advice if symptoms return within 2 months.
Canesten pessaries need moisture in the vagina in order to dissolve
completely, otherwise undissolved pieces of the pessary
might crumble out of the vagina. Pieces of undissolved pessary may be
noticed by women who experience vaginal dryness. To
help prevent this it is important that the pessary is inserted as
deeply as po