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 COMBI
The Internal Cream: The cream 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 removing the foil from the blister pack and again afterwards when you have used the applicator. 1. Remove the applicator from the packaging. Keeping the cap in place, insert the tip of plunger A into the applicator B (approximately 1cm).
2. Twist and pull to remove the cap C. Be careful not to press the plunger in any further before you have inserted the applicator into the vagina. This will avoid wasting any cream.
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 pre-measured dose of cream is deposited into the vagina.
Do not use the creams after the expiry date which is stated at one end of the carton, on the end of the tube of cream, on the applicator and on the applicator foil wrapping. 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.
6.FURTHER INFORMATION
4. 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. The cream is deposited in the vagina, but it is quite common to notice a slight discharge after using the cream and therefore it may be helpful to wear a panty liner. This does not mean that the treatment has not worked. The External 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 (vulvitis), 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. 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.
The internal cream is for use in the vagina only and the external cream is for external use only: Do not put the creams in your mouth or swallow them. If the creams are swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.
Like all medicines, Canesten Thrush Combi Internal & External Creams can cause side effects, although not everybody gets them. As with all medicines, some people may be allergic to the creams. 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 COMBI
Keep this medicine out of the sight and reach of children. Do not store above 25°C.
What Canesten® Thrush Combi Internal & External Creams contains: Applicator of internal cream:
Canesten Thrush Combi Internal & External Creams 10% w/w / 2% w/w vaginal cream & cream comes as cream. 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 Combi Internal & External Creams 10% w/w / 2% w/w vaginal cream & cream is clotrimazole.
Medicines with the same active substance, strength and form include: Boots Antifungal Cream, Boots Thrush 1% w/w Cream, Canesten 10% w/w Vaginal Cream. In total there are 7 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Canesten Thrush Combi Internal & External Creams 10% w/w / 2% w/w vaginal cream & 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.
The internal cream is recommended for the treatment of candidal vaginitis.
The external cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis.
These products should only be used if candidal vulvovaginitis (thrush) was previously diagnosed by a doctor.
Adults
The internal cream should be administered intravaginally using the applicator supplied. The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night.
The external cream should be thinly applied to the vulva and surrounding area, two or three times daily and rubbed in gently.
Treatment with the external 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 physician.
Children
Not for use in children under 16.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Do not use to treat nail or scalp infections.
These products contain cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). They also contain benzyl alcohol which may cause allergic reactions and mild local irritation.
Before using Canesten Thrush Combi Internal & External Creams 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 a 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
The creams 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 be avoided due to the risk of the cream 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.
If no improvement in symptoms is seen after 7 days the patient should consult their doctor.
Laboratory tests have suggested that 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 treatment should be carried out with clotrimazole pessary, since these can 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.
Canesten Internal Cream
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 Cream
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.
Ask anything about Canesten Thrush Combi Internal & External Creams 10% w/w / 2% w/w vaginal cream & 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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