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Fluconazole-Claris

Fluconazole, Solution for Intravenous Infusion


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common queries about Fluconazole-Claris, solution for intravenous infusion. It does not contain all the available information. If you have any further queries or concerns about this medicine, talk to your doctor or pharmacist.

Keep this leaflet. You may need to refer to it again.

What Fluconazole-Claris is used for

Fluconazole-Claris is used to treat certain fungal and yeast infections. It belongs to a group of medicines known as azoles. It works by preventing the growth of the fungal and yeast organisms causing your infection. Your doctor may have prescribed Fluconazole-Claris for you for another reason.

Ask you doctor if you have any queries about why Fluconazole-Claris was prescribed for you.

Fluconazole-Claris is only available with a doctor’s prescription and is given as an injection by a doctor or nurse.

Fluconazole-Claris should not affect your ability to drive a car or operate machinery.

Before you are given this medicine

When it should not be given

You should not have this medicine if you are allergic to fluconazole or any similar related medicines such as miconazole, ketoconazole, itraconazole or clotrimazole or to any of the other ingredients used in this medicine (listed under the heading Other Ingredients).

Symptoms of allergic reactions 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.

If you are receiving doses of 400 mg or more per day of Fluconazole-Claris do not take terfenadine (a medicine used to treat allergies).

Do not take Fluconazole-Claris if you are taking cisapride (a medicine used to treat stomach problems).

Before you start receiving this medicine

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

Tell you doctor if you have any other health problems including any liver, heart or kidney problems.

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding. You and your doctor can then discuss the potential risks and benefits involved.

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

Some medicines and Fluconazole-Claris affect how each other work when taken at the same time. The amount you take may need to be changed. Medicines that may affect how Fluconazole-Claris works or FluconazoleClaris may affect how they work include:

  • Some medicines used to treat allergies
  • Some medicines used to treat diabetes e.g. glipizide, tolbutamide, glibenclamide
  • Some antibiotics and anti-viral medicines e.g. rifampicin, rifabutin, zidovudine
  • Some medicines used in problems with the immune system e.g. cyclosporin, tacrolimus
  • Warfarin (used to treat blood clots)
  • Phenytoin (used to treat epilepsy)
  • Theophylline (used to treat asthma)
  • Some benzodiazepines e.g. midazolam
  • Hydrochlorothiazide (used for treating fluid problems)
  • Contraceptive pills (birth control pills)

If you are taking a contraceptive pill and are given Fluconazole-Claris, talk to your doctor about additional forms of contraception as the effectiveness of the pill you are taking may be decreased.

Receiving this medicine

Fluconazole-Claris, solution for intravenous infusion, can only be given by a doctor or nurse.

It is usually infused slowly into a vein.

The dose you are given and the length of the treatment time will vary depending upon the type and severity of the infection, your body weight and kidney function.

If you suffer from HIV or have a weakened immune system and develop a rash while being given Fluconazole-Claris tell your doctor immediately as treatment with Fluconazole-Claris may need to be stopped.

You may be changed from the Infusion to an oral dose form as you start to get better.

Side effects

Tell you doctor or pharmacist as soon as possible if you do not feel well while being given Fluconazole-Claris. While the medicine helps most people with fungal and yeast infections, but it may have unwanted effects in some people. These are usually not serious but you may need medical attention for some side effects.

Ask your doctor of pharmacist if you have any queries or concerns.

Talk to your doctor or pharmacist if you are concerned about any of these common side effects:

  • Nausea or vomiting
  • Headache
  • Stomach pain, indigestion, diarrhoea
  • Acne.

These side effects are usually mild, do not last long and will stop by themselves.

You must tell your doctor as soon as possible if you notice any of the following:

  • Swelling of your face, lips or tongue which may cause difficulty swallowing or breathing
  • Asthma, wheezing or shortness of breath
  • Sudden or severe itching, skin rash, hives
  • Fainting, seizures or fits
  • Flaking of the skin
  • Jaundice (your eyes or skin show signs of going yellow)
  • Bleeding or bruising easier than normal or reddish or purple blotches under the skin
  • Signs of frequent or worrying infections e.g. fever, severe chills, sore throat or mouth ulcers
  • Fast or irregular heart beat

These side effects are rare but if they occur they can be serious and need urgent medical attention.

This is not a complete list of possible side effects. Others may also occur. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Overdose

Because Fluconazole-Claris, solution for intravenous infusion, can only be given by a health professional, overdose is unlikely to occur. Contact the Poisons Information Centre on 131126 if an overdose has occurred.

Storage

Store below 30 ºC. Do not refrigerate or freeze. Protect from light.

Description

Fluconazole-Claris is a clear, colourless solution containing 2 mg/mL fluconazole in 0.9% saline (sodium chloride dissolved in water for injection) solution.

AUST R 133463 Glass vial containing 100 mg fluconazole in 50 mL.

AUST R 133468 Glass vial containing 200 mg fluconazole in 100 mL

AUST R 133469 Glass vial containing 400 ng fluconazole in 200 mL

Other ingredients

Sodium chloride and water for injections. Hydrochloric acid may be used to adjust the product to the correct pH.

Australian Sponsor

Claris Lifesciences Australia Pty Ltd
Suite1, Level 1
127-133 Burwood Road
Burwood NSW 2134

Distributor

Australia:

AFT Pharmaceuticals Pty Ltd
PO Box 748
North Ryde
NSW 1670
Freephone 1800 238 742760

New Zealand:

AFT Pharmaceuticals Ltd Takapuna
Auckland 1309
Telephone: (09) 488 0232

Email: customer.service@aftpharm.com

Date of preparation: 13 August 2015

Published by MIMS June 2017

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