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® THRUSH PESSARY If Canesten Thrush Pessary 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 pessary 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 in the Canesten Thrush 500mg Pessary pack.
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2. BEFORE YOU USE CANESTEN® THRUSH PESSARY • •
B AY E R
Do not use Canesten Thrush Pessary:
If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten Thrush Pessary (see Section 6. Further Information). During your period as it may be less effective.
Pessary
Before using Canesten Thrush Pessary, you should see your doctor if:
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.
Y ER
Special precautions:
2 BA
You are unsure whether you have thrush or this is the first time you have had these symptoms.
Applicator Plunger
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4
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.
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.
Canesten Thrush 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 Thrush 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® THRUSH PESSARY
6. FURTHER INFORMATION
What Canesten Thrush Pessary contains:
Canesten is a registered trademark of Bayer AG, Germany.
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use Canesten Thrush 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.
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Canesten Thrush Pessary 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 Thrush Pessary 500mg pessary is clotrimazole.
Medicines with the same active substance, strength and form include: Canesten 500mg Pessary. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Canesten Thrush Pessary 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 Pessaries are recommended 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: Not for use in children under 16.
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 Pessary. Canesten 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 Thrush Pessary 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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