Fluconazole-Teva

Fluconazole.

Each capsule contains either 50 or 150 mg of fluconazole.
Excipients/Inactive Ingredients: Lactose, maize starch, colloidal anhydrous silica, sodium laurilsulfate and magnesium stearate.
The capsule shell contains gelatin and the following colours: titanium dioxide (E171) and brilliant blue (E133).

Fluconazole belongs to a group of drugs called antifungal agents which can be used to treat or prevent a range of fungal infections.

Fluconazole-Teva is used to treat fungal infections of the mouth, throat, skin, genitals, urinary tract (bladder and kidneys) and internal organs. This may also be prescribed to prevent getting a fungal infection, or repeated infections, if the immune system is not working properly (e.g. following chemotherapy, radiotherapy, or in AIDS patients).

Adults: Genital infections e.g. vaginitis (inflammation of the vagina) or balanitis (inflammation of the glans penis): 150 mg as a single dose.
Mucosal infections of the mouth and oropharynx: 50 - 100 mg once daily for 7 - 14 days.
Infections of other mucous membranes: 50 - 100 once daily for 14 - 30 days.
Fungal skin infections: 50 mg once daily for 2 - 4 weeks. Athlete's foot: up to 6 weeks treatment.
Internal fungal infections (caused by Candida) e.g. infections of the bloodstream, urinary tract or other body organs: 400 mg on the first day, then 200 - 400 mg once daily.
Internal fungal infections (caused by Cryptococcus) e.g. cryptococcal meningitis and infections of other areas such as the skin and lungs: 400 mg on the first day, then 200 - 400 mg once daily for 6-8 weeks.
To prevent a fungal infection: 50 - 400 mg once daily while patient is at risk of getting an infection.
To prevent a cryptococcal infection from returning: 100 - 200 mg once daily until advised by the doctor to stop.
Children (6 to 15 years old): Mucosal infections: 3 mg/kg once daily.
Internal fungal infections caused by Candida or Cryptococcus: 6 - 12 mg/kg once daily.
Prevention of fungal infections: 3 - 12 mg/kg once daily while there is a risk of getting an infection.
The maximum daily dose in children should not exceed 400 mg.
Fluconazole is not recommended for treating genital Candida infections in children under 16 years old.
The elderly: The usual adult dose, unless there are kidney problems.
Kidney problems: Depending on the kidney function, the doctor may modify the dose.
Do not stop treatment early, even if the patient starts to feel better, because the original infection may still be present and recur if treatment is stopped. Take the full course.
Method of administration: The capsules should be swallowed with a drink of water.
The capsules may be taken with or without meal.
If patient forgets to take Fluconazole-Teva: If patient forgets to take a capsule, take one as soon as remembered, unless it is nearly time to take the next one.
Never take two doses together. Take the remaining doses at the correct time.

If the patient (or someone else) swallows a lot of the capsules all together, or if a child has accidentally swallowed any of the capsules, contact the nearest hospital casualty department or the doctor immediately.

Do not take Fluconazole-Teva if: sensitive to fluconazole or related 'azole' medicines e.g. ketoconazole, miconazole; sensitive to any of the other ingredients in the medicine, listed in Description; patient is taking terfenadine (an antihistamine) or cisapride (used for stomach upsets).

Advise patient to consult a doctor if he/she has kidney problems.

Do not take Fluconazole-Teva if patient is pregnant, trying to become pregnant or breast-feeding. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed in-utero to high dose maternal fluconazole (400-800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.

Like all medicines, Fluconazole-Teva can have side effects.
If the patient experiences the following, stop taking Fluconazole-Teva and tell the doctor immediately or go to the casualty department at the nearest hospital: difficulty breathing; swelling of the lips, face and neck.
These are very serious but rare side effects. The patient may need urgent medical attention or hospitalization.
The most common side effects are: headache; rash; stomach pain; diarrhoea; wind; nausea.
The following have also been reported but may not be directly due to Fluconazole: seizures; hair loss; skin reactions including Stevens-Johnson syndrome (blisters/bleeding of the lips, eyes, nose, mouth and genitals) and toxic epidermal necrolysis (severe blistering rash); abnormalities in blood, urine, liver function or other biochemical test results.
Other reported side effects are: liver toxicity; indigestion/heartburn; vomiting; dizziness; itching all over the body; jaundice (yellowing of the skin and whites of the eyes); abnormalities in taste.
If patient has these or any side effects not mentioned, please tell the doctor or pharmacist.

Tell the doctor if patient is taking any of the following: rifampicin or rifabutin (antibiotics); hydrochlorothiazide (used to remove excess water from the body and help reduce blood pressure); warfarin or coumarin anticoagulant drugs (used to prevent blood clots); benzodiazepines (used to treat anxiety and to help patient sleep) e.g. diazepam or midazolam; oral sulphonylureas (used to control diabetes) e.g. glibenclamide, chlorpropamide, glipizide or tolbutamide; phenytoin (used to control epilepsy); cyclosporin or tacrolimus (used to reduce the effect of the immune system e.g. to prevent the rejection of an organ transplant or graft); theophylline (used to increase the air flow to the lungs and improve breathing); zidovudine (used in HIV-positive patients); astemizole (an antihistamine); any other medicines.

Do not transfer the capsules to another container. Return all unused medicines to the pharmacist for safe disposal.

Antifungals

J02AC01 - fluconazole ; Belongs to the class of triazole and tetrazole derivatives. Used in the systemic treatment of mycotic infections.

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