Canesten Combi contains a Canesten 1 Pessary 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 Combi.

CANESTEN 1 PESSARY

CANESTEN 1% CREAM

The pessary contains 500 mg of the active ingredient Clotrimazole BP. The other ingredients are lactose microcrystalline cellulose, lactic acid, maize starch povidone, calcium lactate, magnesium stearate, silicon dioxide and poly (o-hydroxypropyl-o-methyl) cellulose.

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 one 500 mg pessary with an applicator and 20 g of 1% cream.

The Canesten 1 pessary and 1% cream are also available separately. The pessary comes in a single dose pack and the cream comes in tubes of 20 g and 50g.

Canesten 1 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, Pharmaceutical Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA.

Manufacturer: Bayer AG, Leverkusen, Germany.

The pessary should be used to treat vaginal thrush.

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.

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).

Do not use the pessary 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 pessary 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 the Canesten 1 Pessary may not be the right treatment for you.

If you are pregnant or are planning a family, tell your doctor or pharmacist before using Canesten Combi. 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 pessary, 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.

This carton contains one Canesten 1 Pessary held inside a foil blister pack, an applicator for insertion of the pessary into the vagina and a tube of Canesten 1% cream. This is a full course of treatment.

If Canesten Combi 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:

The applicator should be used to insert the pessary into the vagina before going to sleep at night.

Remove the applicator from the packaging. Pull out plunger A until it stops. Remove the 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 1 cm).

Carefully put the applicator as deeply as is comfortable in the vagina (this is easiest when lying on your back with your knees bent up) (Diagram 2).

Holding the applicator in place, slowly press the plunger until it stops so that the pessary is deposited into the vagina (Diagram 3).

Remove the applicator. Dispose of the applicator in a safe place, out of the reach of children. The applicator cannot be flushed down the toilet.

For the treatment of vulvitis, the cream should be thinly and evenly applied to the area around the entrance of the vagina, 2-3 times a day and rubbed in.