This medicine is available without prescription. However, you still need to use Canesten Thrush Oral Capsule carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve in 7 days.
• If you have any unusual effects after using this product, tell your doctor or pharmacist.

1. What is Canesten Thrush Oral Capsule and what is it used for?
2. Before you use Canesten Thrush Oral Capsule
3. How to use Canesten Thrush Oral Capsule
4. Possible side effects
5. How to store Canesten Thrush Oral Capsule
6. Further information

• If you are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Canesten Thrush Oral Capsule (see Section 6. Further Information).
• If you are taking astemizole or terfenadine (antihistamine medicines for allergies), cisapride (used for stomach upsets), pimozide (used for treating mental problems), quinidine (used for treating heart arrhythmia), erythromycin (an antibiotic for treating infections).

Women:

If you have any of the following symptoms do not use Canesten Thrush Oral Capsule and see your doctor as soon as possible:

• Irregular vaginal bleeding.
• Abnormal vaginal bleeding or a blood-stained discharge.
• Ulcers, blisters or sores of the vagina or vulva.
• Lower abdominal pain.
• Pain or difficulty in passing urine.
• Fever or chills.
• Feeling sick or vomiting.
• Diarrhoea.
• A foul smelling discharge from the vagina.

This is because Canesten Thrush Oral Capsule may not be the right treatment for you.

Men:

Do not use Canesten Thrush Oral Capsule without talking to your doctor first if:

• Your sexual partner does not have thrush.
• You have sores, ulcers or blisters on your penis.
• You have an abnormal discharge from your penis.
• Your penis has started to smell.
• You have pain or difficulty in passing urine.

This is because Canesten Thrush Oral Capsule may not be the right treatment for you.

• You are unsure whether you have thrush or this is the first time you have had these symptoms.
• You have had more than two infections of thrush in the last six months.
• You or your partner have ever had a sexually transmitted disease.
• You are aged under 16 or over 60.
• You have ever had an allergic reaction to fluconazole or any other vaginal antifungal products.
• You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Canesten Thrush Oral Capsule.
  Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Canesten Thrush Oral Capsules treatment. Stop using Canesten Thrush Oral Capsule and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
• You have had any disease or illness affecting the liver or kidneys, or have had any unexplained jaundice.
• You have heart problems, including heart rhythm problems.
• You suffer from any other chronic disease or illness.
• The fungal infection does not improve, as alternative antifungal therapy may be needed.

The capsule contains lactose monohydrate, so if you have an intolerance to some sugars contact your doctor before taking this medicinal product.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not use Canesten Thrush Oral Capsule if you are taking astemizole, terfenadine, cisapride, pimozide, quinidine or erythromycin.

Inform your doctor if you are taking: Anticoagulants (to prevent blood clots), Sulphonylureas (to control diabetes), Hydrochlorothiazide (to treat fluid retention and high blood pressure), Benzodiazepines (tranquilisers), Phenytoin or Carbamazepine (to control epilepsy), Rifampicin or Rifabutin (antibiotics), Ciclosporin, Sirolimus,

Tacrolimus or Tofacitinib (to reduce the immune response), Theophylline (to control asthma), Zidovudine or Saquinavir (to treat HIV infection), Losartan (to reduce blood pressure), Alfentanil, Fentanyl or Methadone (to treat pain), Halofantrine (for treating malaria), Amiodarone (to control irregular heartbeats, 'arrhythmias'), Amitriptyline or Nortriptyline (anti-depressants), Ivacaftor (for treating cystic fibrosis), Statins like Simvastatin, Atorvastatin or Fluvastatin (for reducing high cholesterol levels), Non-steroidal Anti-inflammatory Drugs like Ibuprofen, Celecoxib, Diclofenac, Meloxicam or Naproxen, Olaparib (to treat ovarian cancer), Ibrutinib (used for treating blood cancer), Tolvaptan (used for treating low levels of sodium in your blood), Lemborexant (used to treat insomnia), Lurasidone (used to treat schizophrenia), Abrocitinib (used to treat atopic dermatitis, also known as atopic eczema).

Canesten Thrush Oral Capsule should be swallowed whole with a glass of water. It can be taken with or without food. There is no known interaction with alcohol or nicotine.

You should not take Canesten Thrush Oral Capsule if you are pregnant, think you may be pregnant, are trying to become pregnant or breastfeeding, unless your doctor has told you so. If you are planning to become pregnant, it is recommended to wait a week after a single dose of fluconazole before becoming pregnant.

Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage.

Fluconazole taken during the first trimester may increase the risk of a baby being born with birth defects affecting the heart, bones and/or muscles.

Canesten Thrush Oral Capsule may cause dizziness.

If dizziness occurs after taking your capsule, you should not drive or use machines.

If more than one capsule is taken, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.

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.

• The active substance is fluconazole at a strength of 150mg.
• The other ingredients are colloidal silicon dioxide, lactose monohydrate, magnesium stearate, maize starch and sodium lauryl sulphate. The capsule shell contains brilliant blue FCF (E133), titanium dioxide (E171) and gelatine.
  The printing ink contains shellac, black iron oxide (E172) and propylene glycol. See Section 2 ‘Important information about some of the ingredients’ for lactose monohydrate advice.

Each pack contains a single light blue capsule with ‘Canesten^®’ printed on it in black between two black lines.