Consumer Medicine Information
FLUCONAZOLE
Fluconazole 50mg, 100mg*, 150mg & 200mg Capsules
What is in this leaflet
This leaflet answers some common questions about Fluconazole capsules. 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 using Fluconazole capsules against the benefits it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Fluconazole is used for and how it works
Your Fluconazole capsules contain fluconazole. It belongs to a group of medicines known as antifungals.
Fluconazole is used to treat certain fungal and yeast infections. It works by preventing the growth of the fungal and yeast organisms causing your infection.
Your doctor may have prescribed Fluconazole for another reason. Ask your doctor if you have any questions about why Fluconazole has been prescribed for you.
There is no evidence that Fluconazole is addictive.
Fluconazole is only available with a doctor's prescription.
Before you take Fluconazole
When you must not take it
Do not take Fluconazole if you have an allergy to the following:
- 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.
If you are taking cisapride (a medicine used to treat stomach problems), do not take this medicine.
Talk to your doctor or pharmacist if you are not sure whether you should take this medicine.
Before you start taking 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, 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 take Fluconazole.
Taking other medicines
If you are taking any other medicines, including any you get without a prescription from a pharmacy, supermarket or health food shop, tell your pharmacist or doctor.
Medicines that may interfere with Fluconazole include:
- cisapride (used to treat stomach problems)
- some medicines used to treat allergies such as terfenadine or astemizole
- some medicines for diabetes such as glipizide, tolbutamide 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)
- some benzodiazepines such as midazolam or triazolam
- hydrochlorothiazide (used for treating fluid problems)
- the contraceptive pill (birth control pill).
These medicines may be affected by Fluconazole or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
This medicine may decrease the effectiveness of some birth control pills. Talk to your pharmacist or doctor about the need for an additional method of contraception while taking Fluconazole.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Fluconazole.
How to take Fluconazole
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 Fluconazole. It usually ranges from 50mg to 150mg once daily.
Children
The dose for a child will depend on body weight and usually ranges from 3mg to 12mg per kilogram of body weight. In very young children (below 4 weeks of age), Fluconazole 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
Swallow the capsules whole with a glass of water.
When to take it
Try to take your medicine at about the same time each day. It does not matter if you take this medicine before or after food.
Taking it at the same time each day will have the best effect. It will also help you to remember when to take it.
How long to take it
Continue taking Fluconazole until you finish the pack or bottle or until your doctor recommends. The length of time you take Fluconazole 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 Fluconazole 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 your capsules as you would normally.
Do not take a double dose to make up for the dose that you missed.
While you are taking it
Things you must do
Tell your doctor if the symptoms of your infection do not improve within a few days, or if they become worse.
If you are a woman of child-bearing age, you should avoid becoming pregnant while taking Fluconazole. Tell your doctor immediately if you do become pregnant while taking Fluconazole.
If you are about to be started on any new medicine, remind your doctor or pharmacist that you are taking Fluconazole.
Tell all doctors, dentists and pharmacists who treat you that you are taking Fluconazole.
Things you must not do
Do not stop taking Fluconazole 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 Fluconazole to anyone else, even if they have the same condition as you.
Do not use Fluconazole 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, Fluconazole 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 Fluconazole, tell your doctor immediately. If this rash worsens, Fluconazole may need to be stopped.
This medicine is not expected to affect your ability to drive a car or operate machinery.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Fluconazole.
All medicines can have some unwanted effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
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.
These are the more common side effects of Fluconazole. They are usually mild and short-lived.
Tell your doctor as immediately 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.
These side effects are usually rare but can be serious and need urgent medical attention.
The list of side effects mentioned above is not complete. If you should suffer from any of these side effects or any other undesired effect, please tell your doctor or pharmacist.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
If you take too much (overdose)
Immediately contact your doctor or the National Poisons Information Centre (0800 POISON or 0800 764 766) or go to the Emergency department at your nearest hospital, if you think you that you may have taken too much, or if anyone else has taken Fluconazole by mistake. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Take the pack of Fluconazole with you if you can.
Keep telephone numbers for these places handy.
Storage conditions
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 your Fluconazole capsules in a cool, dry place where the temperature stays below 25°C. Avoid exposure to heat and moisture. Keep out of the reach of children.
Do not store Fluconazole, or any other medicine in the bathroom or near a sink.
Disposal
If your doctor tells you to stop taking Fluconazole, or it has passed its expiry date, ask your pharmacist what to do with any that are left over.
Product description
What it looks like
Fluconazole capsules come in four strengths:
- Fluconazole 50mg - hard gelatin, opaque white/dark blue capsule marked "FC 50" and "G" in black
- Fluconazole 100mg* - hard gelatin, opaque white/blue capsule marked " FC 100" and "G" in black
- Fluconazole 150mg - hard gelatin, opaque white capsule marked "FC 150" and "G" in black
- Fluconazole 200mg - hard gelatin, opaque white/blue capsule marked "FC 200" and "G" in black.
Ingredients
Active ingredient
The active ingredient in Fluconazole capsules is fluconazole.
- Each Fluconazole 50mg capsule contains 50mg of fluconazole
- Each Fluconazole 100mg* capsule contains 100mg of fluconazole
- Each Fluconazole 150mg capsule contains 150mg of fluconazole
- Each Fluconazole 200mg capsule contains 200mg of fluconazole
* Not currently available in New Zealand
Other ingredients
Each capsule also contains: lactose, pregelatinised starch or maize (corn) starch, sodium lauryl sulphate, colloidal hydrated silica, magnesium stearate, gelatin and titanium dioxide (E171), patent blue V (E131) (50mg, 100mg and 200mg capsules only), and erythrosine (E127) (50mg capsules only).
If you want to know more
Should you have any questions regarding this product, please contact your doctor or pharmacist.
Who supplies this medicine
Distributed in New Zealand by:
Pacific Pharmaceuticals Ltd,
P O Box 11183
Ellerslie,
Auckland.
Telephone: (09) 579 2792
Date of information
16 November 2006
(Based on datasheet dated17 October 2006)