S1411 LEAFLET Canesten 20140606

PACKAGE LEAFLET: INFORMATION FOR THE USER CANESTEN VAGINAL TABLETS 100mg CLOTRIMAZOLE VAGINAL TABLETS 100mg (clotrimazole)

Your medicine is known with either of the above names but will be referred to as Canesten throughout the following leaflet.

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Canesten carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve in 7 days.

•    If you have any unusual effects after using this product, tell your doctor or pharmacist.

In this leaflet

1.    What is Canesten and what is it used for?

2.    Before you use Canesten

3.    How to use Canesten

4.    Possible side effects

5.    How to store Canesten

6.    Further information

1. WHAT IS CANESTEN AND WHAT IS IT USED FOR ?

Canesten is indicated 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 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. BEFORE YOU USE CANESTEN

Do not use Canesten:

•    If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten (see Section 6. Further Information).

•    During your period as it may be less effective.

Before using Canesten, you should see your doctor if:

•    If you are unsure whether you have thrush or this is the first time you have had these symptoms.

•    You have had more than two infections of thrush in the last six months.

•    You or your partner have ever had a sexually transmitted disease.

•    You are aged under 16 or over 60.

•    You have ever had an allergic reaction to Canesten or any other vaginal antifungal products.

•    You have any of the following symptoms:

•    Irregular vaginal bleeding.

•    Abnormal vaginal bleeding or a blood-stained discharge.

•    Ulcers, blisters or sores 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 may not be the right treatment for you.

Special precautions:

As with other tablets, this product may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms. Consequently, you should use alternative precautions for at least five days after using this product.

Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.

Avoid vaginal intercourse while you have thrush and during use of this product because your partner could become infected.

Using other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Inform your doctor if you are taking tacrolimus or sirolimus (used to reduce the immune response to prevent rejection after an organ transplant).

Pregnancy and breast-feeding:

If you are pregnant, breast-feeding or trying for a baby, tell your doctor or midwife before using Canesten. If you have informed your doctor or midwife already, follow his/her instructions carefully.

To treat internal thrush, your doctor may recommend that you use the pessary without the help of an applicator.

3. HOW TO USE CANESTEN

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

The applicator should be used to insert the tablet as high as possible into the vagina, preferably before going to sleep on six consecutive nights for convenient and comfortable treatment. Alternatively, two tablets may be inserted into the vagina before going to sleep on three consecutive nights.

Wash your hands before removing the foil from the blister pack and again afterwards when you have used the applicator.

1. Remove the applicator from the packaging. Pull out the plunger A until it stops. Remove the tablet from the foil blister pack and place firmly into the applicator B.

2. To fit the tablet into the applicator, the holder of the applicator needs to be squeezed lightly at both sides. The tablet fits tightly into the applicator and needs to be squeezed into the holder to about 1cm.

3. Carefully put the applicator as deep as is comfortable into the vagina (this is easiest when lying on your back with your knees bent up). Holding the applicator in place, slowly press the plunger until it stops so that the tablet is deposited into the vagina.

4.    Remove the applicator. After use, remove plunger A completely by pulling it out of the applicator B. Then wash it in warm (not boiling) soapy water, rinse and dry carefully.

5.    After completing the treatment, dispose of the applicator in a safe place, out of the reach of children. The applicator cannot be flushed down the toilet.

Since the tablet dissolves in the vagina, it may be helpful to wear a panty liner because it is quite common to notice a white chalky residue after using the tablet. This does not mean that the treatment has not worked. However, if you notice pieces of undissolved tablet, speak to your doctor or a pharmacist, as the treatment may not have worked properly.

The symptoms of thrush should disappear within three days of treatment. If no improvement is seen after seven days you must tell your doctor. If the infection returns after seven days you may use one further treatment, but if you have more than two infections within six months you should see your doctor.

Canesten is for use in the vagina only:

Do not put the tablet in your mouth or swallow it.

If the tablet is swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.

If you forget to use Canesten:

Canesten should be used for six consecutive nights if one tablet is used, or three consecutive nights if two tablets are used. However, if you forget to insert a tablet, follow the advice given below:

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, see your doctor.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Canesten can cause side effects, although not everybody gets them.

As with all medicines, some people may be allergic to the tablet. If you are allergic, a reaction will occur soon after you have used the medicine. If you experience an allergic reaction or the redness, burning, pain, itching or swelling get worse, stop using this product and tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital. Signs of an allergic reaction may include:

•    Rash.

•    Swallowing or breathing problems.

•    Swelling of your lips, face, throat or tongue.

•    Weakness, feeling dizzy or faint.

•    Nausea.

After you use the tablet you might experience:

•    Itching, rash, swelling, redness, discomfort, burning, irritation, vaginal peeling or bleeding.

•    Pain in the abdomen or pelvic area.

If you experience any of the above effects or react badly to the tablet in any other way not listed in this leaflet, tell your doctor or pharmacist immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CANESTEN

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    This product should be stored in the original carton. Do not store above 25°C.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    If your doctor tells you to stop using the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

•    If the Canesten become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. FURTHER INFORMATION

What Canesten contains

•    Each tablet contains 100mg of the active ingredient clotrimazole micronised.

•    Canesten Vaginal Tablets also contain the following: lactose monohydrate, maize starch, lactic acid, microcrystalline cellulose, magnesium stearate, hypromellose, anhydrous colloidal silica, crospovidone and calcium lactate pentahydrate.

What Canesten looks like and contents of the pack

Canesten tablets are large rectangular white tablets with a rounded end marked ‘P3' on one side and ‘Bayer' on the other.

Canesten tablets are available as blister packs of 6 tablets together with an applicator.

Product Licence holder

Procured from within the EU and repackaged by the Parallel Import Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1 DX.

Manufacturer

This product is manufactured by

•    Bayer Schering Pharma AG, Leverkusen, Germany. or

•    Bayer Pharma AG, Leverkusen,Germany.

| POM | PL No. 19488/1411

Leaflet revision date: 06 June 2014

Canesten is a registered trade mark of Bayer AG, Germany.

S1411 LEAFLET Canesten 20140606