Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Clotrimazole may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
CANESTEN® 500mg PESSARY
Unless directed otherwise by your doctor, the pessary should be inserted as high as possible into the vagina, preferably before going to sleep at night for convenient and comfortable treatment. Wash your hands before handling the applicator and the foil blister pack and again afterwards when you have used the applicator. 1. Image 1 shows all the components included 1 in the Canesten 500mg Pessary pack.
B AY E R
Canesten
Pessary
Applicator Plunger
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2. BEFORE YOU USE CANESTEN® 500mg PESSARY
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Canesten 500mg Pessary is a full course of treatment for vaginal thrush (candidiasis). It is inserted into the vagina for treatment at the site of infection. The active substance in Canesten 500mg Pessary 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.
Remove the applicator from the packaging and pull out the plunger (with the red lock attached) from the applicator.
Red Lock
2. Remove the pessary from the foil blister pack and place into the open end of the applicator with the curved edge of the pessary facing down. Push the plunger and lock into the applicator until you feel a click. 3. Once you have felt the click, remove the lock from the plunger.
Do not use Canesten® 500mg Pessary: • •
If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten 500mg Pessary (see Section 6. Further Information). During your period as it may be less effective.
Special precautions:
As with other pessaries, 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 breastfeeding: Canesten 500mg Pessary can be used in pregnancy and breastfeeding. If you are pregnant, breastfeeding or trying for a baby, tell your doctor or midwife before using Canesten 500mg Pessary. If you have informed your doctor or midwife, follow his/her instructions carefully. To treat internal thrush, your doctor may recommend that you use the pessary without the help of an applicator.
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4. Carefully insert the applicator as deep as is comfortable into the vagina (this is easiest when lying on your back with your knees bent up) up to the patterned grip zone. Hold the applicator at the patterned grip zone. Carefully push the plunger all the way until it stops to dispense the vaginal pessary.
5. 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. As the pessary dissolves in the vagina, it may be helpful to wear a panty liner. It may leave a white chalky residue after using the pessary, which does not mean that the treatment has not worked. However, if you notice pieces of undissolved pessary, 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.
Canesten® 500mg Pessary is for use in the vagina only:
Do not put the pessary in your mouth or swallow it. If the pessary is swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.
Like all medicines, Canesten 500mg Pessary can cause side effects, although not everybody gets them. As with all medicines, some people may be allergic to the pessary. 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:
CANESTEN® 500mg PESSARY
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use Canesten 500mg Pessary after the expiry date which is stated at one end of the carton and on the foil blister strip of the pessary. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. The applicator is made of recyclable materials.
Further information about vaginal thrush:
Vaginal thrush (candidiasis) is a common infection that most women suffer from at some time in their lives and is not caused by lack of personal hygiene. Thrush is caused by a yeast (fungus) called Candida which lives harmlessly in the vagina and other parts of the body, without you even noticing it. However, the natural balance that keeps Candida under control can be upset by many factors such as hormonal changes (menstruation, contraceptive pill, pregnancy, menopause), poor health, antibiotics, perfumed soaps, bath additives and tight clothing. If the natural pH balance is altered, the level of yeast increases and can develop into a thrush infection causing any of the following symptoms: persistent burning and/or itching around the vagina and vulva, redness, swelling and soreness of the tissues of the vagina and vulva and a whitish, odourless discharge from the vagina. Not everybody who has thrush has all these symptoms; you may have only one of them.
How to avoid future recurrences:
3 Wear cotton knickers and loose clothing. 3 Wash daily. 3 After going to the toilet, wipe yourself from the front to back as a thrush infection may be transferred from the bowel. 3 Change your sanitary protection regularly. 7 Try to avoid wearing tights, nylon knickers and close fitting jeans. 7 Try to avoid washing with perfumed soaps or using vaginal deodorants. 7 Do not wash or rub yourself hard with sponges or flannels and avoid hot baths with strong perfumed oils. If you are still worried or have any questions about the symptoms or the treatment of thrush, do not hesitate to ask your doctor or pharmacist for advice. For UK residents only: if you have any questions or would like more information, call our Canesten Advice Line on 0845 758 5030. Calls charged at local rate. This leaflet was last revised in February 2023. Canesten is a registered trademark of Bayer AG, Germany.
6. FURTHER INFORMATION
What Canesten® 500mg Pessary contains: • •
The active substance is clotrimazole at a strength of 500mg. The other ingredients are lactose monohydrate, microcrystalline cellulose, lactic acid, maize starch, crospovidone, calcium lactate pentahydrate, magnesium stearate, colloidal anhydrous silica and hypromellose.
What Canesten® 500mg Pessary looks like and contents of the pack: Canesten 500mg Pessary contains a white pessary held inside a foil blister and an applicator for insertion of the pessary into the vagina.
Marketing Authorisation Holder:
Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK.
Manufacturer:
GP Grenzach Produktions GmbH, 79639 Grenzach-Wyhlen, Germany. Remember: This medicine has been prescribed for you. Do not give it to anyone else under any circumstances. If you have any doubts about using Canesten® 500mg Pessary correctly, seek the advice of your doctor or pharmacist.
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Canesten 500mg Pessary comes as pessary containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Canesten 500mg Pessary is clotrimazole.
Medicines with the same active substance, strength and form include: Canesten Thrush Pessary 500mg pessary. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Canesten 500mg Pessary, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Canesten 500mg Pessary is indicated for the treatment of candidal vaginitis.
The pessary should be inserted into the vagina, as high as possible, using the applicator provided.
Adults: One 500mg pessary should be inserted at night. Using the applicator provided, the pessary should be inserted as high as possible into the vagina. This is best achieved when lying back with legs bent up. A second treatment may be carried out if necessary.
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 high as possible into the vagina at bedtime.
Children: As the product is used with an applicator, paediatric usage is not recommended.
For instructions on handling and disposal see section 6.6.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
Before using Canesten Pessaries, medical advice must be sought if any of the following are applicable:
- 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 disease.
- pregnancy or suspected pregnancy.
- aged under 16 or over 60 years.
- known hypersensitivity to imidazoles or other vaginal antifungal products.
Canesten Pessaries should not be used if the patient has any of the following symptoms where upon medical advice should be sought:
- irregular vaginal bleeding.
- abnormal vaginal bleeding or a blood-stained discharge.
- vulval or vaginal ulcers, blisters or sores.
- lower abdominal pain or dysuria.
- any adverse events such as redness, irritation or swelling associated with the treatment.
- fever or chills.
- nausea or vomiting.
- diarrhoea.
- foul smelling vaginal discharge.
Treatment during the menstrual period should not be performed due to the risk of the pessary being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.
Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.
Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.
When used in pregnancy, the pessary should be inserted without using an applicator (see “Pregnancy”).
Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten 500mg Pessary. Canesten 500mg Pessary 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.
Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.
Concomitant treatment with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels and similarly with sirolimus. Patients should thus be closely monitored for signs and symptoms of tacrolimus or sirolimus overdosage, if necessary by determination of the respective plasma levels.
Pregnancy:
There are limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following vaginal treatment, harmful effects with respect to reproductive toxicity are not predicted.
Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
During pregnancy the pessary should be inserted without using an applicator.
Lactation:
There are no data on the excretion of clotrimazole into human milk. However, systemic absorption is minimal after administration and is unlikely to lead to systemic effects. Clotrimazole may be used during lactation.
Fertility:
No human studies of the effects of clotrimazole on fertility have been performed, however, animal studies have not demonstrated any effects of the drug on fertility.
The medication has no or negligible influence on the ability to drive or use machinery.
Frequency not known. As the listed undesirable effects are based on spontaneous reports, assigning accurate frequency of occurrence for each is not possible.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorder: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnea.
Gastrointestinal disorders: abdominal pain, nausea.
Skin and Subcutaneous Tissue Disorders: rash, urticaria, pruritus.
Reproductive system and breast disorders: vaginal exfoliation, vaginal discharge, vaginal haemorrhage, vulvovaginal discomfort, vulvovaginal erythema, vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal pain.
General disorders and administration site conditions: application site irritation, oedema, pain.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
No risk of acute intoxication is seen as it is unlikely to occur following a single vaginal or dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.
Ask anything about Canesten 500mg Pessary. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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