Consumer medicine information

Fluconazole Hexal®

Fluconazole Hexal Injection

Consumer Medicine Information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Fluconazole Hexal Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you being given Fluconazole Hexal Injection against the benefits it is expected to have for you.

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

Keep this leaflet with the medicine. You may want to read it again.

WHAT FLUCONAZOLE HEXAL INJECTION IS USED FOR

The name of your medicine is Fluconazole Hexal Injection. It contains the active ingredient fluconazole.

Fluconazole Hexal Injection is used to treat certain types of fungal or yeast infection.

Your doctor may have prescribed Fluconazole Hexal Injection for another reason. Ask your doctor if you have any questions about why Fluconazole Hexal Injection was prescribed for you.

How Fluconazole Hexal Injection works

Fluconazole Hexal Injection belongs to a group of medicines called bis-triazole antibiotics.

It works by stopping the growth of organisms (fungus or yeast) which cause infections.

There is no evidence that Fluconazole Hexal Injection is addictive.

BEFORE YOU ARE GIVEN FLUCONAZOLE HEXAL INJECTION

When you must not be given Fluconazole Hexal injection

You should not be given Fluconazole Hexal Injection if:

  • You are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description.
  • It is past its expiry date or the packaging appears to have been tampered with.
  • You are pregnant or breastfeeding, unless permitted by your doctor.
  • You are taking cisapride, a medicine used to treat stomach problems.
  • You are taking terfenadine, a medicine used to treat allergies, the dose of Fluconazole Hexal should not exceed 400mg a day.
  • You are taking doses of 400mg or more a day of Fluconazole or related azole compounds.

Before you are given Fluconazole Hexal Injection

Tell your doctor if you have allergies to:

  • Any other medicines, especially if they are in the same drug class as fluconazole.
  • Any other substances, including foods, preservatives or dyes.

Tell your doctor if you plan on becoming pregnant or will be breastfeeding while you are being given Fluconazole Hexal Injection.

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

  • Kidney problems.
  • Liver problems.
  • Heart problems.

Taking other medicines

Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

In particular, tell your doctor if you take any of the following:

  • Terfenadine and astemizole, medicines used to control allergies.
  • Cisapride, a medicine used to treat stomach problems.
  • Warfarin, a medicine used to thin the blood.
  • Phenytoin, a medicine used to control epilepsy.
  • Carbamazepine, a medicine to control seizures and other nerve functions in the body.
  • Theophylline, a medicine used to treat asthma.
  • Medicines used for sedation, such as midazolam.
  • Hydrochlorothiazide, used as a fluid tablet or to treat high blood pressure.
  • Birth control pills.
  • Medicines used to control the immune system such as cyclosporin and tacrolimus.
  • Some antiviral and antibiotic medicines including rifampicin, rifabutin and zidovudine.
  • Medicines used to treat diabetes such as glipizide, tolbutamide and glibenclamide.

These medicines may be affected by Fluconazole Hexal Injection, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.

HOW FLUCONAZOLE HEXAL INJECTION IS GIVEN

The dose of Fluconazole Hexal Injection you will receive depends on your medical condition, the severity of infection and other factors such as your weight.

Fluconazole Hexal Injection is administered in a hospital as a continuous infusion into your veins. This medicine must only be given by a doctor or nurse.

If you are given too much

Fluconazole Hexal Injection is administered in a hospital, under the supervision of a doctor. Therefore it is unlikely that you will receive too much. However, you should tell your doctor or nurse immediately if you feel unwell while you are being given Fluconazole Hexal Injection. You may need urgent medical attention.

WHILE YOU ARE BEING GIVEN FLUCONAZOLE HEXAL INJECTION

Things you must do

  • Always follow your doctor’s instructions carefully.
  • Tell your doctor if you become pregnant while you are being given Fluconazole Hexal Injection.
  • If you are about to start taking a new medicine, tell your doctor and pharmacist that you are being given Fluconazole Hexal Injection.

SIDE EFFECTS

All medicines can have unwanted effects. Sometimes they are serious, most of the time they are not. Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Fluconazole Hexal Injection.

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

  • Acne.
  • Nausea, vomiting.
  • Stomach cramp, diarrhoea.
  • Headache.

These are the more common side effects of Fluconazole Hexal. Mostly, these are mild and short-lived. Fluconazole is generally well tolerated.

Tell your doctor immediately if you notice any of the following:

  • Skin reactions/ rash.
  • Bleeding or bruising more easily than normal.
  • Flaking of the skin.
  • Yellowing of the skin or eye, which may indicate hepatitis.
  • Worsening of your infection, with symptoms such as fever, severe chills.

These may be serious side effects of Fluconazole Hexal You may need urgent medical attention. Serious side effects are rare.

If any of the following happen, tell your doctor immediately, or go to Accident and Emergency at your nearest hospital:

  • Symptoms of a hypersensitivity reaction such as swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing.
  • Allergic reactions which can cause shortness of breath or difficulties breathing.
  • Fits or seizures.
  • Fast or irregular heartbeat.

These are very serious side effects. You may need urgent medical attention or hospitalisation. All of these side effects are very rare.

Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

AFTER USING FLUCONAZOLE HEXAL INJECTION

Storage

Fluconazole Hexal Injection should only be given to you in a hospital. It should be kept in the original packaging until immediately before use.

Fluconazole Hexal injection must be stored below 25°C. Do not refrigerate or freeze.

Disposal

Return any unused or out of date medicine to your pharmacist.

PRODUCT DESCRIPTION

What Fluconazole Hexal Injection looks like

Fluconazole Hexal Injection 2mg/mL is a clear colourless solution, free from visible particles. It is available as:

100mg of fluconazole in 50mL vials, in boxes of 1’s.

200mg of fluconazole in 100mL vials, in boxes of 1’s.

Ingredients

Active Ingredient
Each Fluconazole Hexal 100mg/50mL injection contains 100mg fluconazole.
Each Fluconazole Hexal 200mg/100mL injection contains 200mg fluconazole.

Inactive Ingredients
As well as the active ingredient, fluconazole, Fluconazole Hexal Injection also contain inactive ingredients. These are sodium chloride, hydrochloric acid and water for injection.

Supplier

Fluconazole Hexal is supplied in Australia by:
Sandoz Pty Ltd
Level 4, 100 Harris St
Pyrmont NSW 2009
Tel: 1800 634 500

This leaflet was revised in June 2008.

Australian Register Numbers

Fluconazole 100mg/50mL injection: AUST R 104301
Fluconazole 200mg/100mL injection: AUST R 104302

Published by MIMS November 2008