CANESTEN THRUSH DUO ORAL CAPSULE & EXTERNAL CREAM 150 MG / 2% W/W CAPSULE & CREAM - patient leaflet, side effects, dosage

2. before you use canesten® thrush duo®

Do not use Canesten® Thrush Duo®:

• 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).

Women:

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.

Men:

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.

Before using Canesten® Thrush Duo®, you should see your doctor if:

• 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.

Important information about some of the ingredients:

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.

Special precautions:

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.

Using other medicines:

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

3. HOW TO USE CANESTEN® THRUSH DUO®

If Canesten Thrush Duo 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:

The capsule is to treat thrush at the site of infection and should be swallowed whole with a glass of water (with or without food). The cream is to treat the itching and soreness of the vulva (vulvitis).

• Before use, pierce the tube seal by inverting the cap over the end of the tube and press.
• 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. It should be used until symptoms of the infections disappear.

The symptoms of thrush should disappear within two days of treatment. If no improvement is seen after seven days, you must tell your doctor. If the infection returns after seven days another capsule may be taken but if you have more than two infections within six months you should see your doctor.

Some women suffer from recurrent attacks of thrush. To reduce the frequency of these attacks, the sexual partner’s penis can be treated with this cream to prevent re-infection, even if they have no symptoms of thrush.

If your sexual partner is treated with this cream, the cream should be applied to the end of the penis 2 or 3 times a day for up to two weeks.

The 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 take more Canesten® Thrush Duo® than you should:

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

4.POSSIBLE SIDE EFFECTS

Like all medicines, Canesten Thrush Duo can cause side effects, although not everybody gets them.

As with all medicines, some people may be allergic to the capsule or the cream. If you are allergic, a reaction will occur soon after you have taken or 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:

• Rash.
• Swallowing or breathing problems.
• Swelling of your lips, face, throat or tongue.
• Weakness, feeling dizzy or faint.
• Nausea.

Capsule

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 ~ 1 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)).

Cream

,1 After you apply the cream you might experience:

• Itching, rash, blisters, burning, discomfort, swelling, redness, irritation, pins and needles or peeling of the skin.

Reporting of side effects

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: 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.

5.HOW TO STORE CANESTEN® THRUSH DUO®

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use Canesten Thrush Duo after the expiry date which is stated at one end of the carton, on the blister pack 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.

6.FURTHER INFORMATION

What Canesten® Thrush Duo® contains:

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.

What Canesten® Thrush Duo® looks like and contents of the pack:

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).