Fluconazole

• For fungal infections
• Also used to prevent fungal infections
• Capsules for oral use
• Not to be used while pregnant or breastfeeding

Fluconazole is an antifungal medicine. This medicine kills certain fungi and yeasts. Fluconazole is used to treat infections caused by fungi, including:

• Vaginal yeast infection (vaginal thrush).
• Fungal infections in the mouth, throat or food pipe (oesophagus).
• Fungal infection that infects the whole body (invasive candidiasis).

You might also be given Fluconazole capsules to stop you from getting an infection caused by fungi.

Fluconazole is available in capsule form. Swallow the capsule whole with a glass of water. This medicine can be taken with or without food.

Dosage

The dose you are prescribed will depend on your symptoms. Strength and administration frequency must be determined by a doctor. The general dosage guidelines for use are as follows:

To treat vaginal thrush:

• Adults: 150 mg, once daily in a single dose.
• Children: 6 mg per kg body weight daily in a single dose.

To treat fungal infection in the mouth or throat:

• Adults: 50-100 mg a day in a single dose for 7-14 days (or longer if your immune system is weak and not working properly).
• Children: 6 mg per kg of body weight on the first day, followed by 3 mg per kg of body weight daily in a single dose for 7-14 days.

To treat fungal infection in the oesophagus:

• Adults: 50- 200 mg a day.
• Children: 3-6 mg per kg body weight a day.

To treat invasive candidiasis:

• Adults: 400 mg on the first day, followed by 200 mg a day. If the condition does not improve, the dose may be increased to 400 mg a day.
• Children: 6-12 mg per kg of body weight a day. Length of treatment and dose depends on the severity of the infection and laboratory test results.

Please refer to the package leaflet for more information on dosage for other conditions and special patient groups.

Always complete the entire course.

Alcohol/driving

This medicine is unlikely to affect your ability to drive or operate machinery. In rare cases dizziness or drowsiness may occur. Do not drive or use machinery if you experience these side effects.

This medicine does not interact with alcohol.

If you use too much/forget to use/stop using Fluconazole

If you take more Fluconazole capsules than you were told to, consult your doctor or pharmacist.

If you forget to take a dose, you may take it as soon as you remember unless it is almost time for your next scheduled dose. Do not take a double dose to make up for the forgotten one.

Do not stop the treatment earlier than agreed without talking to your doctor. Always finish the entire course, even if you feel better. Stopping early could cause the infection to return.

Fluconazole is not suitable for everyone. Do not use this medicine if:

• You are allergic to Fluconazole or any of the other ingredients in the capsules (see section 'What Fluconazole contains’).
• You are allergic to similar medicines, so-called antifungal azoles.
• You are taking terfenadine or cisapride (for digestive problems).

When should this medicine be used with caution?

Talk to your doctor before taking Fluconazole if:

• You are allergic to any other medicines that you have taken to treat a fungal infection.
• You are suffering from liver problems. In rare cases, Fluconazole may cause toxic hepatitis (severe inflammation of the liver in reaction to certain substances). This usually disappears after you stop taking the medicine.
• You have symptoms that indicate a severe hypersensitivity reaction, including high fever, red skin patches, joint pain and/or eye infection (Stevens-Johnson syndrome). These reactions have been reported in very rare cases during treatment with Fluconazole.
• You have symptoms that indicate a severe hypersensitivity reaction with skin problems, such as blisters, scaling skin and fever (toxic epidermal necrolysis). These reactions have been reported in very rare cases during treatment with Fluconazole. AIDS patients may develop severe skin reactions.

Pregnancy and breastfeeding

Fluconazole is not suitable for use during pregnancy and while breastfeeding. Ask your doctor or pharmacist for advice before taking this medicine.

Other medicines and Fluconazole

Some medicines can interact with Fluconazole which can significantly alter their effects. Tell your doctor if you are taking any of these medicines:

• Medicines that thin the blood to prevent blood clots.
• Benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety.
• Sulfonylureas (antidiabetic medicines).
• Hydrochlorothiazide (diuretic medicine).
• Phenytoin (used to treat epilepsy).
• Rifampicin (antibiotic).
• Ciclosporin (immunosuppressant used to prevent organ rejection after organ transplants).
• Theophylline (used to treat asthma).
• Cisapride (for digestive problems). Do not take this medicine in combination with Fluconazole:
• Rifabutin (antibiotic).
• Tacrolimus (used to prevent organ rejection after organ transplants).
• Zidovudine (anti-viral medicine).
• Tranquillizers, sleep medicines and/or muscle relaxants.
• Astemizole (antihistamine).

For more information on interactions, see the package leaflet. Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Medicines can cause side effects, although some people may not experience any. Side effects that are known to be associated with Fluconazole include:

Common (may affect more than 1 in 100 people but less than 1 in 10 people):

• Headache.
• Gastrointestinal symptoms (nausea, vomiting, diarrhoea, stomach pain, bloating, acid reflux, flatulence).
• Skin rash with redness or red patches.

Uncommon (may affect more than 1 in 1,000 people but less than 1 in 100 people):

• Dizziness.
• Changes in taste sensations.
• Skin rash, with symptoms such as severe itching and/or bumps.
• Itching.

Rare (may affect more than 1 in 10,000 people but less than 1 in 1,000 people):

• Haematological abnormalities, such as lower than normal white blood cells or blood platelets.
• High cholesterol or raised levels of triglycerides in the blood.
• Low levels of potassium in the blood.
• Fits/convulsions.
• Liver problems, such as jaundice, decreased liver function, elevated liver enzymes or bilirubin elevations in the blood.
• Hair loss.
• Severe allergic reactions (see section ‘When should this medicine be used with caution’).

For more information on the side effects of Fluconazole, see the package leaflet. Consult a doctor if you experience severe side effects. This includes any possible side effects not listed in this leaflet.

The active substance in Fluconazole Actavis is fluconazole (50 mg, 100 mg, 150 mg and 200 mg per capsule, respectively).

The other ingredients are:

• Fluconazole Actavis 50 mg and 100 mg: gelatin, lactose, magnesium stearate, maize starch, sodium laurylsulfate, anhydrous colloidal silicon dioxide, titanium dioxide (E171), indigo carmine FD&C blue no. 2 (E132).
• Fluconazole Actavis 150 mg: gelatin, lactose, magnesium stearate, maize starch, sodium laurylsulfate, anhydrous colloidal silicon dioxide, titanium dioxide (E171).
• Fluconazole Actavis 200 mg: gelatin, lactose, magnesium stearate, maize starch, sodium laurylsulfate, anhydrous colloidal silicon dioxide, titanium dioxide (E171), indigo carmine FD&C blue no. 2 (E132), ponceau 4R (colourant).
• Capsule ink: shellac, black iron oxide (E172), propylene glycol (E1520).

Read the package leaflet before use.