PLEASE READ THIS LEAFLET CAREFULLY

BEFORE USING CANESTEN DUOPAK

Canesten Duopak contains 6 Canesten 1OOmg Pessaries to treat the cause of thrush (vaginal candidiasis) and a tube of Canesten 1% cream to soothe and relieve the itching which is caused by thrush. This leaflet contains information on how to use these products. Please read it before using your Canesten Duopak

CANESTEN 100MG PESSARY

CANESTEN 1% CREAM

WHAT DO CANESTEN 100MG PESSARIES AND CANESTEN 1% CREAM CONTAIN?

Each pessary contains 100mg of the active ingredient Clotrimazole BP. The other ingredients are lactose, maize starch, adipic acid, sodium bicarbonate, magnesium stearate, stearic acid, silicon dioxide and polysorbate 80.

The cream contains 1% Clotrimazole BP. The other ingredients are benzyl alcohol, polysorbate 60, sorbitan stearate, cetyl esters wax, cetyl stearyl alcohol, 2-octyldodecanol and purified water.

The pack contains six 100mg pessaries with an applicator and 20g of 1% cream.

The Canesten 100 mg Pessaries and 1% cream are also available separately. The pessaries come in a box of six and the cream comes in tubes of 20g and 50 g.

Canesten 100 mg Pessaries and 1% cream contain clotrimazole. This is one of a group of medicines called imidazoles which are used to treat fungal infections such as thrush.

Product Licence holder:

Bayer plc Pharmaceuticals Division

Bayer House, Strawberry Hill

Newbury, Berkshire, RG14 1JA Manufacturer: Bayer AG

Leverkusen, Germany

WHEN SHOULD I USE CANESTEN 100MG

PESSARIES?

The pessaries should be used to treat vaginal thrush .

Vaginal thrush (candidiasis) is a common infection caused by a fungus which may live harmlessly in the vagina without you even noticing it. However, in certain circumstances it may develop into an infection in the vagina and the symptoms may spread to the surrounding area (the vulva).

The common symptoms of thrush are:

itching of the vagina and vulva

redness and swelling of the tissues of the vagina and vulva

soreness of the vagina

a white non-smelling discharge from the vagina

Not everybody who has thrush has all of these symptoms. You may have only one of them.

If this is the first time you have had these symptoms, talk to your doctor before using any treatment.

WHEN SHOULD I USE CANESTEN 1%

CREAM?

The cream should be used to soothe and relieve the irritation of the vulva (vulvitis) which is caused by thrush.

It can also be used for the treatment of irritation of the end of the penis (glans) which is caused by thrush. If the cream is used to treat your sexual partner at the same time as your own treatment, it can help

prevent re-infection and so reduce the frequency of your attacks of thrush.

Canesten 1% cream can also be used to treat fungal skin infections such as ringworm, athlete’s foot, fungal nappy rash and fungal infection of the breast fold (intertrigo).

WHEN SHOULD I NOT USE CANESTEN 100mg PESSARIES AND CANESTEN 1% CREAM?

Do not use the pessaries or cream if you have previously had an allergic reaction to the active ingredient clotrimazole. If you are unsure about this, ask your doctor or pharmacist.

See your doctor as soon as possible and do not use the pessaries if you have any of the following symptoms:

irregular vaginal bleeding

abnormal vaginal bleeding or a blood-stained discharge

ulcers, blisters, sores or pain of the vagina or vulva

lower abdominal pain

pain or difficulty in passing urine

fever or chills

feeling sick or vomiting

diarrhoea

a foul smelling discharge from the vagina

This is because Canesten 100mg Pessaries may not be the right treatment for you.

If you are unsure whether you have thrush, check with your doctor before using Canesten Duopak.

WHAT SPECIAL PRECAUTIONS SHOULD I

TAKE?

If you are pregnant or are planning a family, tell your doctor or pharmacist before using Canesten Duopak. If you have informed your doctor or pharmacist already, follow their instructions carefully.

During pregnancy, extra care should be taken when using the applicator.

Before using the pessaries, you should see your doctor if:

you have had more than two infections in the last six months

you or your partner have ever had a sexually transmitted disease

you are aged under 16 or over 60 years

you have ever had an allergic reaction to Canesten or any other anti-fungal products.

WHEN AND HOW DO I USE CANESTEN DUOPAK?

The carton contains six Canesten 100mg Pessaries held inside a foil blister pack, an applicator for insertion of the pessaries into the vagina and a tube of Canesten 1% cream. This is a full course of treatment. However, in the event that your symptoms persist upon completion of the course, see your doctor as he/she may recommend further treatment.

If Canesten Duopak has been prescribed for you by your doctor, follow any instructions he/she may have given you. If you have purchased this product without a prescription, follow these directions closely:

CANESTEN 100MG PESSARIES

The applicator should be used to insert a pessary into the vagina before going to sleep on six consecutive nights. Alternatively, two pessaries may be inserted into the vagina before going to sleep on three consecutive nights.

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Please follow the instructions below carefully:

Remove the applicator from the packaging. Pull out plunger A until it stops. Remove a pessary from the blister pack and place the pessary firmly into applicator B (Diagram 1). To fit the pessary into the applicator, the holder of the applicator needs to be squeezed lightly at either side. The pessary fits tightly into

the applicator and needs to be squeezed into the holder just far enough to be held in place during insertion (about 1cm).

When you remember, continue with your course of treatment. If you have forgotten for more than one day, your infection may not be fully treated, so if symptoms persist upon completion of this course, please arrange to see your doctor

If you forget to use the cream, apply it as soon as possible and then continue the rest of your treatment as usual.

WHAT SIDE-EFFECTS MAY I EXPERIENCE?

Rarely, Canesten 100 mg Pessaries may cause side-effects in some people. The side-effects are very similar to the symptoms of thrush. If the redness, burning, irritation or swelling get worse, stop using the pessaries and see your doctor as soon as possible.

As with all medicines, some people may be allergic to the Canesten Pessaries. Usually, if you are allergic to the pessaries, a reaction will occur soon after you start using it. An allergic reaction may appear as a rash, nausea, faintness or facial swelling. If you experience any of these effects, tell your doctor Immediately.

Canesten cream may also cause side-effects in some people. You may experience a mild burning or irritation immediately after applying the cream. If you find this intolerable, stop treatment and tell your doctor.

If, upon first use of Canesten cream you experience a rash and itching, tell your doctor immediately as you may be allergic to it.

If symptoms get worse or persist or you feel you are reacting badly to this medicine in any other way, speak to your doctor or pharmacist.

HOW SHOULD I STORE MY CANESTEN DUOPAK?

Canesten Duopak should be stored in the original carton in a cool, dry place, below 25ºC

Keep out of the reach of children

Do not use the pessaries or cream after their expiry date. This will be printed at one end of the carton, on the end of the tube of cream and on the foil blister strip of the pessaries. Wherever you see "EXP" this means "expiry date". For example, EXP 12/99 means that your pessaries must not be used after December 1999.

If you find that you still have this medicine after its expiry date, return it to your local pharmacist who will dispose of it properly.

Date of Preparation: March 1995

REMEMBER:

This medicine is for use by you and your sexual partner only. Do not give it to anyone else under any circumstances. If you have any doubts about using Canesten Duopak correctly, seek the advice of your doctor or pharmacist.

Product Licence Numbers:

Canesten 100mg Pessary 0010/0015R

Canesten 1% Cream 0010/001 6R

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