Fluconazole, clotrimazole (Canesten oral and cream duo)

How does it work?

Canesten oral and cream duo consists of Canesten oral capsule, which is a single dose oral treatment for vaginal thrush, and Canesten thrush cream, which is applied to the outside of the vagina (vulva and labia) to relieve the external symptoms of the infection. Both medicines can also be used to treat men who are suffering from thrush on the penis.

Canesten oral capsule contains the active ingredient fluconazole and Canesten thrush cream contains the active ingredient clotrimazole. Both these are antifungal medicines used to treat infections with fungi and yeasts.

Vaginal thrush is the common term for infections of the vagina with Candida species of fungi, in particular Candida albicans. This infection causes inflammation and discharge from the vagina. In men it causes soreness and redness of the penis, tightness of the foreskin, or a white, odourless discharge from the penis.

Clotrimazole and fluconazole both kill the Candida fungi causing the infection by interfering with their cell membranes. They work by stopping the fungi from producing a substance called ergosterol, which is an essential component of fungal cell membranes. The disruption in production of ergosterol causes holes to appear in the fungal cell membrane.

The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As clotrimazole and fluconazole cause holes to appear in the cell membranes, essential constituents of the fungal cells can leak out. This kills the fungi and treats the infection.

Canesten oral capsule should be swallowed whole with a glass of water, either with or without food.

Canesten thrush cream can be applied to the outside of the vagina (vulva and labia) and to the penis to help provide immediate relief from the external symptoms of the infection, such as itching, inflammation and soreness.

What is it used for?

  • Inflammation of the vagina (vaginitis) caused by infection with Candida albicans (also known as vaginal thrush).
  • Inflammation of the penis and/or foreskin (candidal balanitis) caused by infection with Candida albicans (also known as thrush).

Warning!

  • You should consult your doctor before using this medicine if you are not sure about the cause of your symptoms, if you or your partner have been exposed to a sexually transmitted disease, if you have had thrush more than twice in the last six months, if you are allergic to other antifungals or thrush treatments, or if you are aged under 16 or over 60 years of age.
  • Women should consult their doctor before taking this medicine if they are pregnant, suspect they could be pregnant or are breastfeeding, or if they have any of the following symptoms: abnormal or irregular vaginal bleeding, blood-stained or foul-smelling vaginal discharge, vulval or vaginal ulcers, blisters or sores, lower abdominal pain, pain passing urine, fever, chills, nausea, vomiting or diarrhoea.
  • Men should consult their doctor before taking this medicine if their sexual partner does not have vaginal thrush, or if they have penile sores, ulcers or blisters, an abnormal penile discharge, if their penis has started to smell, or if they have pain on passing urine.
  • Consult your doctor before taking the Canesten oral capsule if you suffer from kidney disease, liver disease, unexplained jaundice (yellowing of the eyes and skin) or any other chronic illness or disease, or if you are taking any other medicines, particularly those listed at the end of this factsheet.
  • Canesten thrush cream is for external use and must not to be taken by mouth.
  • Canesten thrush cream may damage latex (rubber) condoms and diaphragms (caps) and so make them ineffective at preventing pregnancy and STIs. You should use an alternative method of contraception for at least five days after using the thrush cream, or preferably avoid having sex until after the infection has cleared up. Remember that having sex while you still have the infection is likely to transmit the infection to your partner, who could then transfer it back to you.
  • If your sexual partner also has symptoms of thrush it is important that they are treated at the same time as you, to prevent you being re-infected.
  • You can keep using the thrush cream until the symptoms of the infection have cleared up, however, you should consult your doctor if your symptoms have not got better within a week of taking the Canesten oral capsule.

Canesten oral capsule should be used with caution in

  • Kidney disease
  • Liver disease.

Canesten oral capsule should not be used in

  • Children under 16 years of age
  • Allergy to azole antifungal medicines, eg itraconazole, ketoconazole
  • Pregnancy
  • Breastfeeding.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

  • The safety of Canesten oral capsule for use during pregnancy has not been established. It should not be taken by pregnant women.
  • The safety of Canesten thrush cream when used during pregnancy has not been specifically studied. However, it has been used by a large number of women during pregnancy without any apparant harmful effects. As with all medicines, you should consult your doctor before using this medicine during pregnancy.
  • Fluconazole passes into breast milk. As a result, Canesten oral capsule should not be taken by women who are breastfeeding. Seek medical advice from your doctor.
  • Since very little clotrimazole is absorbed into the bloodstream from the vagina, it is unlikely that any of the medicine will pass into breast milk from Canesten thrush cream. However, as with all medicines, you should seek medical advice from your doctor or pharmacist before using this medicine if you are breastfeeding.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Side effects associated with Canesten thrush cream:

  • Irritation in area of use
  • Burning sensation

Side effects associated with Canesten oral capsule:

  • Nausea
  • Abdominal discomfort
  • Diarrhoea
  • Excess gas in the stomach and intestines (flatulence)
  • Headache
  • Rash (you should not take Canesten oral capsule again if you get a rash after taking it).

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Canesten thrush cream is not known to affect other medicines.

If you are already taking any medicines, including herbal medicines and those bought without a prescription, you should check with your doctor or pharmacist before taking Canesten oral capsule. This is so they can check that the combination is safe.

You should not take Canesten oral capsule if you are taking any of the following medicines:

  • cisapride
  • terfenadine.

The following interactions can occur with longer courses of fluconazole. It is not clear if these interactions can happen with the single dose of fluconazole in Canesten oral capsule. If you are taking any of the medicines mentioned below you should check with your doctor or pharmacist before taking Canesten oral capsule.

The anti-blood-clotting effect of anticoagulants such as nicoumalone and warfarin may be enhanced by fluconazole. As this may increase the risk of bleeding, people taking an anticoagulant medicine should have their blood clotting time (INR) monitored if they also take fluconazole.

The antibiotic rifampicin (used for tuberculosis) lowers the blood level of fluconazole. Your doctor may need to prescribe you a larger than normal dose of fluconazole if you need both these medicines.

Fluconazole may increase the blood levels of the following medicines:

  • benzodiazepines, eg midazolam (this may cause increased drowsiness, and people taking both medicines may need a lower dose of benzodiazepine)
  • ciclosporin (monitoring of ciclosporin blood levels is recommended)
  • phenytoin (phenytoin blood levels should be monitored if you need both medicines; your doctor may need to reduce your phenytoin dose)
  • repaglinide
  • rifabutin
  • sulphonylureas used for diabetes, eg glibenclamide, glipizide (this does not usually affect blood sugar control, but may rarely cause hypoglycaemia in some people)
  • tacrolimus
  • theophylline
  • zidovudine (also known as AZT).

Other medicines containing the same active ingredients

Canesten thrush cream and Canesten oral capsule are also available as separate products.