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contains the active ingredient fluconazole

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about FLUCONAZOLE AN.

It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you taking FLUCONAZOLE AN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, talk to your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What FLUCONAZOLE AN is used for

FLUCONAZOLE AN is used to treat a fungal infection known as vaginal thrush.

Vaginal candidiasis, an infection caused by a yeast-like fungus Candida, is commonly referred to as “vaginal thrush”.

How FLUCONAZOLE AN works

FLUCONAZOLE AN contains fluconazole, which belongs to a group of medicines called azole antifungals. This group of antifungal medicines work by preventing the growth of the fungi causing your infection.

You may have been recommended FLUCONAZOLE AN for another reason. Ask your doctor or pharmacist if you have any questions about why FLUCONAZOLE AN has been prescribed for you.

FLUCONAZOLE AN is a “Pharmacist Only Medicine”. It is available without a doctor’s prescription but your pharmacist’s advice is required.

FLUCONAZOLE AN is not recommended for use in children under 18 years of age, except under doctor advice.

There is no evidence that FLUCONAZOLE AN is addictive.

What is vaginal thrush?

Candida is one of the many organisms that live in the vagina and its growth is normally balanced by your body’s natural defence mechanism known as the ‘immune system’. However, when this natural balancing is upset, Candida can multiply in the vagina to cause the symptoms of thrush.

Common symptoms of vaginal thrush include:

  • itching, burning or soreness around the vagina
  • curdled – ‘cottage cheese’ – like whitish discharge
  • swelling or irritation of the infected area.

How to avoid thrush in the future

  • avoid wearing synthetic underwear
  • wear loose-fitting cotton briefs, stockings
  • wash the area regularly, but do not wash and dry yourself harshly
  • avoid vaginal deodorants, perfumed soaps and bath additives.

Ask your doctor or pharmacist for more information for things you can do to avoid thrush in the future.

Before you take FLUCONAZOLE AN

When you must not take it

Do not take FLUCONAZOLE AN if you are allergic to:

  • medicines containing fluconazole
  • medicines related to fluconazole such as miconazole, ketoconazole, clotrimazole or itraconazole
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, wheezing or shortness of breath.

If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

Do not take this medicine if you are taking any of the following medicines:

  • cisapride (Prepulsid), a medicine used to treat stomach problems
  • astemizole, an antihistamine
  • erythromycin, an antibiotic
  • quinidine, a medicine used to treat heart problems
  • pimozide, a medicine used to treat certain mental and emotional conditions
  • voriconazole, an antifungal medicine.

Combining fluconazole with these medicines may cause serious side effects, such as an abnormal heart rhythm.

Do not take FLUCONAZOLE AN if you are pregnant or plan to become pregnant unless you have discussed the risks and benefits involved. Fluconazole may affect your developing baby if you take it during pregnancy.

Do not take FLUCONAZOLE AN if you are breastfeeding or wish to breastfeed. Use of FLUCONAZOLE AN while breastfeeding is not recommended as fluconazole may pass into breast milk.

Do not take FLUCONAZOLE AN if the expiry date (Exp.) printed on the pack has passed.

Do not take FLUCONAZOLE AN if the packaging is torn or shows signs of tampering.

Before you start to take it

Tell your doctor if you:

  • are allergic to any other medicines, foods, dyes or preservatives
  • have lactose or galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption (this product contains lactose).

Tell your doctor if you have, or have had, any medical conditions, especially the following:

  • abnormal or irregular vaginal bleeding or blood stained discharge
  • vulvar or vaginal sores, ulcers or blisters
  • lower abdominal pain or burning when passing urine
  • any liver problems
  • any kidney problems
  • any heart problems.

Tell your doctor if you are planning to have an operation. Some medicines used during anaesthetics may interact with fluconazole. Your doctor may want to take special care if you have any of these conditions.

If you have not told your doctor about any of the above, tell them before you start taking FLUCONAZOLE AN.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may be affected by FLUCONAZOLE AN, or may affect how well it works.

Medicines not to be taken with FLUCONAZOLE AN:

  • cisapride (Prepulsid) – used to treat stomach problems
  • astemizole, an antihistamine
  • quinidine, used to treat heart problems
  • erythromycin, an antibiotic
  • quinidine, a medicine used to treat heart problems
  • pimozide, a medicine used to treat certain mental and emotional conditions
  • voriconazole, an antifungal medicine

Medicines that should be taken with care with FLUCONAZOLE AN include:

  • terfenadine, an antihistamine
  • some medicines used to treat diabetes, such as:
    – glipizide, chlorpropamide, tolbutamide, glibenclamide, glimepiride or gliclazide
    – pioglitazone (Actos), rosiglitazone (Avandia)
  • some antibiotics and antiviral drugs such as erythromycin, amphotericin B, rifampicinrifabutin, zidovudine or saquinavir
  • some medicines used in problems with the immune system, such as cyclosporine, tacrolimus or sirolimus
  • cyclophosphamide, used to treat cancer and autoimmune disease
  • vincristine and vinblastine, used to treat cancer
  • vitamin A
  • antidepressants such as amitriptyline and nortriptyline
  • warfarin or ticlopidine, (used to stop blood clots)
  • phenytoin and carbamazepine (used to treat epilepsy)
  • theophylline (used to treat asthma)
  • medicines used during anaesthetics such as alfentanyl, midazolam and fentanyl (also used for pain)
  • other benzodiazepines, such as triazolam (Halcion)
  • hydrochlorothiazide (Dithiazide), used for treating fluid problems and high blood pressure
  • medicines used to treat high blood pressure (e.g losartan, amlodipine and felodipine)
  • medicines used to treat high cholesterol (e.g. simvastatin, fluvastatin, atorvastatin)
  • methadone, used for pain relief and as a heroin replacement
  • celecoxib, used for treating arthritis and pain
  • halofantrine, used to treat malaria
  • prednisone, a type of corticosteroid
  • the contraceptive pill (birth control pill).

Talk to your doctor or pharmacist about the need for an additional method of contraception while taking fluconazole.

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking FLUCONAZOLE AN.

How to take FLUCONAZOLE AN

Follow all directions given to you by your doctor and pharmacist carefully. Their instructions may be different to the information in this leaflet.

How to take FLUCONAZOLE AN

Swallow the capsule whole with a glass of water.

The capsule can be taken at any time of the day, with or without food.

For vaginal thrush in adults, only a single dose (1 capsule) is needed.

If you take too much FLUCONAZOLE AN (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much FLUCONAZOLE AN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking FLUCONAZOLE AN

Things you must do

Before starting any new medicine, tell your doctor or pharmacist that you are taking FLUCONAZOLE AN.

Tell your doctor if you are pregnant or planning to become pregnant (use effective contraception and if you become pregnant, tell your doctor immediately.

Tell your doctor that you are breastfeeding.

If the symptoms of your infection do not improve after 3 days, or if they become worse, tell your doctor or pharmacist.

Things you must not do

Do not use FLUCONAZOLE AN to treat any other conditions unless your doctor tells you to.

Do not give FLUCONAZOLE AN to anyone else, even if they have the same condition as you.

Things to be careful of

Tell your doctor or pharmacist immediately if you develop a rash soon after taking this medicine. People with AIDS or a weak immune system may be more prone to serious side effects of the skin.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FLUCONAZOLE AN. Like all other medicines, FLUCONAZOLE AN may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

These are the more common side effects.

Tell your doctor as soon as possible if you notice any of the following:

  • skin reactions, rash
  • unusual muscle stiffness causing poor control of movement
  • frequent infections, such as fever, severe chills, sore throat or mouth ulcers
  • bleeding or bruising more easily than normal
  • passing more urine than normal, kidney pain (pain on the sides of the body)
  • symptoms of liver disease, such as yellowing of the skin or eyes – also called jaundice; dark urine, pale stools; loss of appetite; unusual tiredness.

Most of these side effects are rare.

If you experience any of the following, stop taking your medicines and contact your doctor immediately or go to Accident and Emergency at the nearest hospital:

  • fast, slow or irregular heart beat or palpitations and/or fainting.
  • severe blisters and bleeding of the lips, eyes, mouth, nose and genitals.
  • a severe rash with skin peeling, fever, chills and aching muscles.

Most of these side effects are rare, but serious.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

Allergic reactions

If you think you are having an allergic reaction to fluconazole, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

  • cough, shortness of breath, wheezing or difficulty breathing
  • swelling of the face, lips, tongue, throat or other parts of the body
  • rash, itching or hives on the skin
  • fainting
  • hayfever-like symptoms.

After using FLUCONAZOLE AN

Storage

Keep FLUCONAZOLE AN where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Keep your medicine in the blister pack until it is time to take it. If you take the capsules out of the pack they may not keep well.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store FLUCONAZOLE AN or any other medicine in the bathroom or near a sink. Do not leave FLUCONAZOLE AN in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking FLUCONAZOLE AN, or your medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Product description

What it looks like

FLUCONAZOLE AN is a blue hard capsule.

Each pack contains 1 capsule.

Ingredients

The active ingredient in FLUCONAZOLE AN is fluconazole.

Each FLUCONAZOLE AN capsule contains 150 mg of fluconazole.

The capsules also contain:

  • lactose anhydrous
  • magnesium stearate
  • methyl hydroxybenzoate
  • patent blue V
  • propyl hydroxybenzoate
  • colloidal anhydrous silica
  • sodium lauryl sulphate
  • pregelatinised maize starch
  • titanium dioxide
  • gelatin
  • purified water.

The capsules do not contain gluten, sucrose, tartrazine or any other azo dyes.

Supplier

Amneal Pharmaceuticals Pty Ltd
12 River Street
South Yarra VIC 3141
Australia

Australian Registration Numbers:
FLUCONAZOLE AN – AUST R 167038

Date of preparation:
July 2014.

Published by MIMS January 2015

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