NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
DIFLUCAN®
Fluconazole (flu-con-a-zole)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Diflucan.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 taking Diflucan against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What Diflucan is used for
Diflucan capsules (for adults) and oral suspension (for children) are used to treat certain fungal and yeast infections.
Diflucan 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 Diflucan has been prescribed for you.
Your doctor may have prescribed Diflucan for another reason.
Diflucan is available only with a doctor’s prescription.
This medicine is not addictive.
Before you take Diflucan
When you must not take it
Do not take Diflucan if you have an allergy to:
any medicine containing 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.
Do not take DIFLUCAN if you are taking any of the following medicines:
terfenadine or astemizole (a medicine used to treat allergy)
cisapride (a medicine used to treat stomach problems)
erythromycin (a medicine used to treat infections)
pimozide (a medicine used to treat mental illness)
quinidine (a medicine used to treat irregular heartbeat).
Do not take this medicine if the expiry date (EXP) printed on the packaging has passed or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have any other health problems, including:
any liver problems
any heart problems
any kidney problems.
Tell your doctor if you are pregnant or if you plan to become pregnant or are breastfeeding.
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 start taking Diflucan.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines should not be taken with DIFLUCAN.These include:
terfenadine or astemizole (a medicine used to treat allergy)
cisapride (a medicine used to treat stomach problems)
erythromycin (a medicine used to treat infections)
pimozide (a medicine used to treat mental illness)
quinidine (a medicine used to treat irregular heartbeat).
Some medicines and Diflucan may interfere with each other.These include:
some medicines for diabetes such as glipizide, tolbutamide or glibenclamide
some antibiotics, antiviral and antifungal drugs such as rifampicin, rifabutin, zidovudine, amphotericin B, azithromycin, saquinavir or voriconazole
some drugs used for heart problems, such as amiodarone or verapamil
some drugs used in problems with the immune system, such as ciclosporin, tacrolimus, sirolimus or tofacitinib
some medicines used to lower cholesterol, such as atorvastatin, simvastatin or fluvastatin
cyclophosphamide, vincristine, vinblastine, olaparib or ibrutinib (used to treat certain types of cancers)
tolvaptan (used to treat low levels of sodium in your blood or for kidney problems)
halofantrine (used to treat malaria)
warfarin (used to stop blood clots)
phenytoin (used to treat epilepsy)
prednisone (used to treat inflammation or suppress the immune system)
theophylline (used to treat asthma)
some benzodiazepines such as midazolam
hydrochlorothiazide (used for treating fluid problems)
the contraceptive pill (birth control pill)
carbamazepine (used in the treatment of epilepsy and bipolar disorder)
NSAIDS such as naproxen, diclofenac and celecoxib
Vitamin A
opioid pain killers such as alfentanil, fentanyl and methadone
losartan (used for treating high blood pressure)
antidepressants such as amitriptyline and nortriptyline.
These medicines and some others may be affected by Diflucan or may affect how well it works.You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Diflucan.
How to take Diflucan
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box or bottle, ask your doctor or pharmacist for help.
How much to take
Adults
The dose will depend on your infection and how you respond to Diflucan.It usually ranges from 50 mg to 400 mg once daily.
Children
The dose for a child will depend on body weight and usually ranges from 3 mg to 12 mg per kilogram of body weight.In very young children (below 4 weeks of age), Diflucan is usually given every second or third day.
However, depending on how serious the infection is, and how you react to the medicine, your doctor may ask you to take a different dose.
How to take it
Capsules:
Swallow the capsules whole with water.
Oral Suspension:
Shake the bottle well and accurately measure the dose with a medicine measure.Only take it by mouth.
When to take it
Try to take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect.It will also help you to remember when to take it.
It does not matter if you take this medicine before or after food.
How long to take it
Continue taking Diflucan until you finish the pack or bottle or until your doctor recommends.
The length of time you take Diflucan will depend on the sort of infection you have.
Patients with a weakened immune system or those with difficult infections may need long-term treatment to prevent the infection from returning.
Do not stop taking your Diflucan because you are feeling better.
If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, take it as soon as you remember, then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you take too much (overdose)
Immediately telephone your doctor or the National Poisons Information Centre (telephone Australia 13 11 26; New Zealand 0800 POISON or 0800 764 766) for advice if you think you or anyone else may have taken too much Diflucan.
Do this even if there are no signs of discomfort or poisoning.You may need urgent medical attention.
While you are taking it
Things you must do
If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.
If you are a woman of child-bearing age, you should avoid becoming pregnant while taking Diflucan.
If you do become pregnant while taking Diflucan, tell your doctor immediately.
If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking Diflucan.
Tell any other doctors, dentists and pharmacists who treat you that you are taking Diflucan.
Things you must not do
Do not stop taking Diflucan or lower the dosage without checking with your doctor.
If you do not complete the full course prescribed by your doctor, all of the organisms causing your infection may not be killed.These organisms may continue to grow and multiply so that your infection may not clear completely or may return.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not use Diflucan to treat any other medical complaints unless your doctor tells you to.
Things to be careful of
Be sure to follow your doctor’s advice if regular checks on your liver are recommended.
In rare cases, Diflucan may affect the liver and may need to be stopped.
If you suffer from HIV or have a weakened immune system and develop a rash while taking Diflucan, tell your doctor immediately.
If this rash worsens, Diflucan may need to be stopped.
Be careful when driving vehicles or operating machinery as occasional dizziness or seizures may occur.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Diflucan.
This medicine helps most people with fungal and yeast infections, but it may have a few unwanted effects in some 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 or pharmacist to answer any questions you may have.
Do not be alarmed by the following list of side effects.You may not experience any of them.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
nausea or feeling sick, vomiting
headache
stomach pain, indigestion, diarrhoea
acne.
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
fainting, seizures or fits
flaking of the skin
yellowing of the skin or eyes, also called jaundice
bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
signs of frequent or worrying infections such as fever, severe chills, sore throat or mouth ulcers
fast or irregular heart beat
increased sweating.
These side effects are usually rare but can be serious and need urgent medical attention.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
This is not a complete list of all possible side effects.Others may also occur in some people and there may be some side effects not yet known.
After using Diflucan
Storage
Keep your medicine in its original pack until it is time to take it.
If you take it out of the pack it may not keep well.
Keep Diflucan capsules and oral suspension in a cool, dry place where the temperature stays below 30°C.
Do not store your medicine in the bathroom or near a sink.Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep your medicine where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking this medicine, or it has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Discard any oral suspension left over after 14 days.
Product description
What it looks like
Diflucan capsules come in the following strengths:
Diflucan 50 mg – light turquoise blue/white, marked FLU-50 and Pfizer
Diflucan 100 mg – standard blue/white and marked FLU-100 and Pfizer
Diflucan 200 mg – purple/white and marked FLU-200 and Pfizer.
Diflucan oral suspension is a white/off-white, orange flavoured suspension in bottles of 35 mL.
Ingredients
Active ingredients
Diflucan 50 mg – 50 mg fluconazole / capsule
Diflucan 100 mg – 100 mg fluconazole / capsule
Diflucan 200 mg – 200 mg fluconazole / capsule
Diflucan oral suspension – 35 mL bottle containing 50mg fluconazole /5mL
Other ingredients
Capsules (50 mg, 100 mg and 200 mg capsules):
gelatin, lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate, titanium dioxide, (50 and 100 mg capsules only), patent blue V (50 and 100 mg capsules only).The 100 mg and 200 mg capsules also contain erythrosine; the 200 mg capsules also contain indigo carmine.
Oral Suspension:
sucrose, colloidal anhydrous silica, xanthan gum, sodium citrate dihydrate, citric acid, sodium benzoate, titanium dioxide, natural orange flavour.
Supplier
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
www.pfizer.com.au
Australian Registration Numbers:
Diflucan 50 mg; AUST R 48399
Diflucan 100 mg; AUST R 48401
Diflucan 200 mg; AUST R 48397
Diflucan oral suspension 50 mg per
5 mL; AUST R 59089
Date of preparation
This leaflet was prepared in
October 2020.
® = Registered Trademark
© Pfizer Australia Pty Ltd
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