Canesten Thrush Duo Oral Capsule & External Cream 150mg & 2% w/w capsule and cream

This medicine is available without prescription. However, you still need to use Canesten Thrush Duo Oral & Cream 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 Duo and what is it used for?
2. Before you use Canesten Thrush Duo
3. How to use Canesten Thrush Duo
4. Possible side effects
5. How to store Canesten Thrush Duo
6. Further information

• If you are allergic (hypersensitive) to fluconazole, clotrimazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients, including lactose monohydrate, cetostearyl alcohol or benzyl alcohol, of Canesten Thrush Duo (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).

If you have any of the following symptoms do not use Canesten Thrush Duo 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 Duo may not be the right treatment for you.

Do not use Canesten Thrush Duo 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 Duo 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, clotrimazole 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 Duo.
  Serious skin reactions including drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Canesten Thrush Duo treatment. Stop using Canesten Thrush Duo 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 been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product.

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.

As with other creams, 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.

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 Duo 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).

The 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 Duo 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 Oral Capsule may cause dizziness. If dizziness occurs after taking your capsule, you should not drive or use machines.

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

If you experience any of the following, please contact your doctor or pharmacist immediately – you may need urgent medical attention:

• Severe condition with blistering and peeling of the skin, mouth, eyes or genitals.
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Liver disorders with symptoms such as yellowing of the skin or eyes, dark urine or pale stools.
• Seizures
• Change in heart rhythm or rate.

Additionally, if any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Common side effects (may affect up to 1 in 10 people) are:

• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash

Uncommon side effects (may affect up to 1 in 100 people) are:

• reduction in red blood cells which can make skin pale and cause weakness or breathlessness
• decreased appetite
• inability to sleep, feeling drowsy
• fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste
• constipation, indigestion, wind, dry mouth
• muscle pain
• wheals, blistering (hives), itching, increased sweating
• fatigue, general feeling of being unwell, fever

Rare side effects (may affect up to 1 in 1,000 people) are:

• lower than normal white blood cells that help defend against infections and red blood cells that help to stop bleeding, respectively causing recurrent infections like cold and flu and increased bleeding/blood thinning (if you cut yourself)
• red or purple discoloration of the skin which may be caused by low platelet count, other blood cell changes
• blood chemistry changes (high blood levels of cholesterol, fats)
• low blood potassium
• shaking
• hair loss

Frequency not known, but may occur (cannot be estimated from the available data):

• hypersensitivity reaction with skin rash, fever, swollen glands, increase in a type of white blood cell (eosinophilia) and inflammation of internal organs (liver, lungs, heart, kidneys and large intestine) (Drug Reaction or rash with Eosinophilia and Systemic Symptoms (DRESS)).

After you apply the cream you might experience:

• Itching, rash, blisters, burning, discomfort, swelling, redness, irritation or peeling of skin.

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 oral capsule:

• 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.

The cream:

• The active substance is clotrimazole at a strength of 2% 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 cetostearyl alcohol and benzyl alcohol advice.

Canesten Thrush Duo contains:

• A single light blue capsule with ‘Canesten^®’ printed on it in black between two black lines. To be taken orally.
• A tube containing 10g of white external cream (Canesten^® Thrush External Cream).