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® CREAM If Canesten Cream 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:
Canesten® Cream is for external use only:
Do not put the cream in your mouth or swallow it. If the cream is swallowed accidentally, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital. If you accidentally get cream in your eyes or mouth, wash immediately with water and contact your doctor.
If you forget to use Canesten® Cream:
Apply the cream as soon as possible and then continue the rest of your treatment as usual.
You can help the treatment to work if you follow these simple self-help tips: • • • • •
Although the infected area will itch, try not to scratch. Scratching will damage the surface of the skin and cause the infection to spread further. Keep the affected skin areas clean. Pay particular attention to drying the skin, but avoid excessive rubbing. Do not share towels, bath mats, etc. with other people as you could spread the infection to them. Always wash your hands after treating the infection to prevent it from spreading.
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This medicine is available without prescription. However, you still need to use Canesten Cream carefully to get the best results from it.
• • •
Remember to dry the skin between the toes thoroughly. Wash your socks, stockings and tights thoroughly in hot water to remove any shed skin or fungal spores. Change your footwear daily if possible.
Like all medicines, Canesten Cream can cause side effects, although not everybody gets them. As with all medicines, some people may be allergic to the cream. If you or your baby are allergic, a reaction will occur soon after you start using it. If you or your baby experience an allergic reaction, stop using Canesten Cream 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® CREAM 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 Canesten Cream after the expiry date which is stated at one end of the carton 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.
Remember: If you have any doubts about using Canesten® Cream correctly, seek the advice of your doctor or pharmacist.
Further information about fungal infections:
Fungal infections are very common and affect many people. Some of the most common fungal skin infections include athlete's foot, nappy rash, sweat rash and ringworm. There are two main types of fungal infection:
This leaflet was last revised in April 2021. Canesten is a registered trademark of Bayer AG, Germany.
6. FURTHER INFORMATION What Canesten® Cream contains: •
•
The active substance is clotrimazole at a strength of 1% w/w. The other ingredients are benzyl alcohol, polysorbate 60, sorbitan stearate, cetyl palmitate, cetostearyl alcohol, octyldodecanol and purified water. See Section 2 'Do not use' and 'Important information about some of the ingredients' for cetosteary and benzyl alcohol advice.
What Canesten® Cream looks like and contents of the pack:
Canesten Cream is available in tubes containing 20g and 50g of white cream. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Bayer plc, 400 South Oak Way, Reading, RG2 6AD, UK
Manufacturer:
GP Grenzach Produktions GmbH, 79639 Grenzach-Wyhlen, Germany.
89254779
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If you have athlete's foot:
Canesten 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 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 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.
For the treatment of:
(i) All dermatomycoses due to moulds and other fungi (e.g. Trichophyton species).
(ii) All dermatomycoses due to yeasts (Candida species).
(iii) Skin diseases showing secondary infection with these fungi.
(iv) Candidal nappy rash, vulvitis and balanitis.
There is no separate dosage schedule for the young or elderly.
The cream should be applied thinly 2-3 times daily and rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand. Treatment should be continued for at least one month for dermatophyte infections and at least two weeks for candidal infections.
If the feet are infected they should be washed and dried, especially between the toes, before applying the cream.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Do not use the cream to treat nail or scalp infections.
This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). The cream also contains benzyl alcohol which may cause allergic reactions and mild local irritation.
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
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.
Pregnancy:
There is a 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 topical 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.
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. If used topically on the nipple area, wash breasts before feeding child.
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.
Clotrimazole cream has no or negligible influence on the ability to drive or use machines.
As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible.
Immune system disorders: anaphylactic reaction, angioedema, hypersensitivity.
Vascular disorders: syncope, hypotension.
Respiratory, thoracic and mediastinal disorders: dyspnoea.
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 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, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or 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 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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