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 Combi 6. Further information
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3. Once you have felt the click, remove the lock from the plunger.
1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR? Canesten Combi Pessary & External Cream is a full course of treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms.
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Some women suffer from recurrent attacks of thrush. To reduce the frequency of these attacks, the sexual partner's penis can be treated with this cream to prevent re-infection, even if they have no symptoms of thrush. The active substance in Canesten Combi Pessary & External Cream 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® COMBI
Do not use Canesten Combi Pessary & External Cream:
Important information about some of the ingredients:
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.
the applicator. Dispose of the applicator in a safe place, out of the reach of 5. Remove 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.
The cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). It also contains 20mg benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions and mild local irritation.
However, if you notice pieces of undissolved pessary, speak to your doctor or a pharmacist, as the treatment may not have worked properly.
Special precautions:
Women:
As with other creams and 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).
The Cream: Before use, pierce the tube seal by inverting the cap over the end of the tube and press. To treat the itching and soreness of the vulva, the cream should be thinly and evenly applied to the area around the entrance of the vagina, 2 or 3 times a day and smoothed in gently. The symptoms of thrush should disappear within three days of treatment. If no improvement is seen after seven days you must tell your doctor. Treating your sexual partner: If your sexual partner is treated with this cream, the cream should be applied to the end of the penis 2 or 3 times a day for up to two weeks.
The pessary is for use in the vagina only. The cream is for external use only: Do not put the pessary or cream in your mouth or swallow them.
Pregnancy and breastfeeding:
If the pessary or cream are swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.
If you are pregnant, breastfeeding or trying for a baby, tell your doctor or midwife before using Canesten Combi Pessary & External Cream. If you have informed your doctor or midwife already, follow his/her instructions carefully.
4. POSSIBLE SIDE EFFECTS
Canesten Combi Pessary & External Cream can be used in pregnancy and breastfeeding.
To treat internal thrush, your doctor may recommend that you use the pessary without the help of an applicator.
Like all medicines, Canesten Combi Pessary & External Cream can cause side effects, although not everybody gets them.
3. HOW TO USE CANESTEN® COMBI
As with all medicines, some people may be allergic to the pessary or cream. 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:
Wash your hands before handling the applicator and the foil blister pack and again afterwards when you have used the applicator.
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The 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.
1. Image 1 shows all the components (apart from the cream) included in the Canesten Combi Pessary & External Cream pack.
B AYER
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Pessary
Applicator Plunger
Red Lock
Remove the applicator from the packaging and pull out the plunger (with the red lock attached) from the applicator.
Rash. Swallowing or breathing problems. Swelling of your lips, face, throat or tongue. Weakness, feeling dizzy or faint. Nausea.
After you use the pessary you might experience:
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE CANESTEN® COMBI Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not use the pessary or cream after the expiry date which is stated at one end of the carton, on the foil blister strip of the pessary and on the end of the tube of cream. 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.
6. FURTHER INFORMATION
What Canesten Combi Pessary & External Cream contains: Pessary:
Cream:
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 Combi Pessary & External Cream correctly, seek the advice of your doctor or pharmacist.
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:
✓ Wear cotton knickers and loose clothing. ✓ Wash daily. ✓ After going to the toilet, wipe yourself from the front to back as a thrush infection may be transferred from the bowel. ✓ Change your sanitary protection regularly. ✗ Try to avoid wearing tights, nylon knickers and close fitting jeans. ✗ Try to avoid washing with perfumed soaps or using vaginal deodorants. ✗ D o 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.
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Canesten Combi Pessary & External Cream 500mg / 2% w/w pessary & cream comes as cream 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 Combi Pessary & External Cream 500mg / 2% w/w pessary & cream is clotrimazole.
Medicines with the same active substance, strength and form include: Canesten Thrush Combi Pessary & External Cream 500mg / 2% w/w pessary & cream. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Canesten Combi Pessary & External Cream 500mg / 2% w/w pessary & cream, 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.
Canesten External Cream is indicated for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis.
Cream can also be used for treatment of the sexual partner's penis to prevent re-infection.
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.
The cream should be thinly applied to the vulva and surrounding area, two or three times daily and rubbed in gently.
Treatment with the cream should be continued until symptoms of the infection disappear. However, if after concomitant treatment of the vaginitis, the symptoms do not improve within seven days, the patient should consult a doctor.
If the cream is being used for treatment of the sexual partner's penis it should be applied two or three times daily for up to two weeks.
Children:
As the pessary is used with an applicator, paediatric usage is not recommended. There is no clinical experience in the use of Canesten External Cream in children.
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 Combi Pessary and External Cream, 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 Combi Pessary and External Cream should not be used if the patient has any of the following symptoms whereupon 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.
External cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). It also contains benzyl alcohol which may cause allergic reactions and mild local irritation.
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.
Canesten 500mg Pessary
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.
Canesten External Cream
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity
Vascular disorder: syncope, hypotension
Respiratory, thoracic and mediastinal disorders: dyspnea
Skin and subcutaneous tissue disorders: blister, dermatitis contact, erythema, paraesthesia, skin exfoliation, pruritus, rash, urticaria, stinging skin/burning sensation skin.
General disorders and administration site conditions: application site irritation, application site reaction, 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.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Canesten Combi Pessary & External Cream 500mg / 2% w/w pessary & cream. 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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