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ASPEN FLUCONAZOLE injection

fluconazole


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about ASPEN FLUCONAZOLE 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 risks of you being given ASPEN FLUCONAZOLE injection against the benefits they expect it will have for you.

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

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

What ASPEN FLUCONAZOLE injection is used for

ASPEN FLUCONAZOLE contains fluconazole as the active ingredient and is used to treat certain fungal and yeast infections.

It belongs to a group of medicines called azole antibiotics.

It works by preventing the growth of the fungal and yeast organisms causing your infection.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another purpose.

This medicine is available only with a doctor’s prescription.

There is no evidence that it is addictive.

Before you are given it

When you must not be given it

You must not be given ASPEN FLUCONAZOLE injection if you have an allergy to:

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

Symptoms of an allergic reaction may include

  • shortness of breath,
  • wheezing or difficulty breathing;
  • swelling of the face, lips, tongue or other parts of the body;
  • rash, itching or hives on the skin.

You must not be given this medicine if you are taking other medicines called cisapride or terfenadine. Tell your doctor if you are taking cisapride or terfenadine.

You must not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

  • liver, heart or kidney problems
  • AIDS
  • cancer
  • currently on a sodium or fluid restricted diet.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell them before you are given ASPEN FLUCONAZOLE injection.

Taking other medicines

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

Some medicines may be affected by ASPEN FLUCONAZOLE or may affect how well it works. You may need to take different amounts of your medicine or you may need to take different medicines. These include:

  • cisapride
  • terfenadine
  • some medicines used to treat allergies
  • some medicines for diabetes such as glipizide or glibenclamide
  • some antibiotics and antiviral drugs such as rifampicin, rifabutin or zidovudine
  • some drugs used in problems with the immune system, such as cyclosporin or tacrolimus
  • warfarin (used to stop blood clots)
  • phenytoin (used to treat epilepsy)
  • theophylline (used to treat asthma)
  • short acting benzodiazepines such as midazolam
  • hydrochlorothiazide (used for treating fluid problems).

Your doctor has more information on medicines to be careful with or avoid while being given this medicine.

How it is given

How much is given

Your doctor will decide what dose you will receive depending on the type of infection, any pre-existing conditions and your response to the treatment.

If you are elderly or have reduced kidney function, your doctor may prescribe a lower dose.

How it is given

ASPEN FLUCONAZOLE injection will be given to you under the supervision of a doctor.

It is administered intravenously via a ‘drip’ line into a vein.

If you receive too much (overdose)

Because ASPEN FLUCONAZOLE injection is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

However, if you think you may have been given too much of this medicine, tell your doctor immediately or contact the Poisons Information Centre on 131 126 for advice.

While you are receiving it

Things you must do

Tell any other doctor, dentist or pharmacist that you are being given ASPEN FLUCONAZOLE injection, especially if you are about to be started on any new medicines.

If you are going to have surgery, tell the surgeon or anaesthetist that you are being given this medicine. It may affect other medicines used during surgery.

Tell your doctor immediately if you become pregnant while you are being given this medicine.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things to be careful of

If you suffer from HIV or have a weakened immune system and develop a rash while being given ASPEN FLUCONAZOLE injection, tell your doctor immediately. If this rash worsens, ASPEN FLUCONAZOLE injection may need to be stopped.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are being treated with ASPEN FLUCONAZOLE injection. This medicine helps most people with fungal and yeast infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Ask your doctor to answer any questions you may have.

Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:

  • nausea, vomiting
  • headache
  • dizziness
  • stomach pain, indigestion, diarrhoea
  • acne
  • rash.

The above list includes the more common side effects of your medicine. They are usually mild and short-lived.

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

  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • asthma, wheezing, shortness of breath
  • sudden or severe itching, skin rash, hives
  • blisters and bleeding in the lips, eyes, mouth, nose and genitals
  • fainting, seizures or fits
  • jaundice, a yellowing of the skin or eyes
  • bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
  • frequent infections such as fever, severe chills, sore throat or mouth ulcers
  • unusual hair loss or thinning
  • fast or irregular heart beat.

These are serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor, nurse or pharmacist anything else that is making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet. Other side effects not listed above may also occur in some people.

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

After using it

Storage

ASPEN FLUCONAZOLE injection will be stored in the pharmacy or on the ward. It is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

Product description

What it looks like

ASPEN FLUCONAZOLE injection is a clear, colourless sterile solution in an infusion bag.

Available in packs of 10 infusion bags.

Ingredients

Active ingredient:
Each 100 mL infusion bag contains 200 mg of fluconazole, equating to a strength of 2 mg/mL fluconazole.

Inactive ingredients:

  • sodium chloride
  • water for injections.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

Australian Registration Number:
AUST R 128728

This leaflet was prepared in
February 2012.

Published by MIMS September 2013

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