Consumer Medicine Information
Diflucan™ One
Fluconazole (flu-con-a-zole)
Capsules 150 mg
What is in this leaflet
This leaflet answers some common questions about DIFLUCAN ONE. 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 pharmacist or doctor has weighed the risks of you taking DIFLUCAN ONE against the benefits expected 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 ONE is used for
DIFLUCAN ONE is used to treat vaginal thrush, a yeast infection of the vagina.
DIFLUCAN ONE belongs to a group of medicines called azole antibiotics.
When taken by mouth, DIFLUCAN ONE works by preventing the growth of the fungal organisms causing your infection.
Ask your doctor or pharmacist if you have any questions about why DIFLUCAN ONE has been recommended for you.
This medicine is not addictive.
This medicine is available only from a pharmacist (it is a Pharmacist Only Medicine, your pharmacist's advice is required).
What is vaginal thrush
Vaginal thrush is a fungal infection of the vagina caused by the yeast named Candida albicans.
When you have vaginal thrush you may have one or more of these common symptoms:
- vaginal itching
- vaginal soreness
- pain during intercourse
- a white, odourless, discharge from the vagina (like cottage cheese)
Rubbing and scratching can aggravate the soreness and itching. Also, the salt of urine can sting the sore tissue.
Tell your doctor or pharmacist if you are experiencing any of the following:
- abnormal or irregular vaginal bleeding or blood stained discharge
- vulval or vaginal sores, ulcers or blisters
- lower abdominal pain or burning when passing urine
These are not usually symptoms of vaginal thrush, and you may need your doctor's or pharmacist's advice the problems you are experiencing.
Things that may help you avoid thrush in the future
Wear cotton briefs, stockings and loose-fitting clothing rather than tight synthetic clothing.
Wash regularly but do not wash and dry yourself harshly.
Avoid perfumed soaps, bath additives and vaginal deodorants.
Before you take DIFLUCAN ONE
When you must not take it
Do not take DIFLUCAN ONE if you have an allergy to:
- any medicine containing fluconazole
- any other similar antifungals 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 ONE if you are taking cisapride (Prepulsid®) - a medicine used to treat stomach problems.
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 be taking DIFLUCAN ONE, talk to your doctor or pharmacist.
DIFLUCAN ONE is not recommended for children under 18 years of age, unless recommended by a doctor.
Safety and effectiveness in children under 18 years of age have not been established.
Before you start to take it
Tell your doctor or pharmacist if you are pregnant, suspect you are pregnant or are breastfeeding.
DIFLUCAN ONE is not recommended for use by pregnant or breastfeeding women.
DIFLUCAN ONE is not recommended for women who may be at risk of falling pregnant, unless contraception is being used.
Do not take DIFLUCAN ONE if you are pregnant, suspect you are pregnant or are breastfeeding.
Tell your doctor or pharmacist if you have any other health problems, including:
- any liver problems
- any heart problems.
- severe kidney problems
- if you have AIDS
Tell your doctor or pharmacist if you have previously developed a rash while taking fluconzole.
Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor or pharmacist if you have had thrush more than twice in the last 6 months.
If you have not told your doctor or pharmacist about any of the above, do so before you start taking DIFLUCAN ONE.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and DIFLUCAN ONE may interfere with each other. These include:
- some medicines for diabetes such as glimepiride, gliclazide, glipizide, pioglitazone, rosiglitazone or glibenclamide
- phenytoin (used to treat epilepsy)
- hydrochlorothiazide
- rifampicin or rifabutin
- tacrolimus
- zidovudine
- warfarin (used to stop blood clots)
Tell your doctor or pharmacist if you are taking warfarin as bleeding or bruising may occur.
Your doctor and pharmacist will have more information on medicines to be careful with or avoid while taking DIFLUCAN ONE.
How to take DIFLUCAN ONE
Follow all directions given to you by your pharmacist carefully. If you do not understand the instructions on the box ask your pharmacist for help.
How much to take
The complete DIFLUCAN ONE treatment for thrush is one 150mg capsule. Take only one capsule.
After taking the DIFLUCAN ONE capsule, the symptoms of thrush usually start to disappear in about one day.
How to take it
Swallow the capsule whole with water.
When to take it
DIFLUCAN ONE can be taken at any time of the day.
If does not matter if you take this medicine before or after food.
If you take too much (overdose)
Immediately telephone your doctor or the National Poisons Information Centre (0800 POISON or 0800 764 766) for advice or go to your nearest Accident and Emergency Centre if you think you or anyone else may have taken too much DIFLUCAN ONE. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking DIFLUCAN ONE
Things you must do
Tell your doctor, if the symptoms of your infection do not improve within 3 days, or if they become worse.
Things you must not do
Do not give your medicine to anyone else, even if they have the same condition / symptoms as you.
Do not use DIFLUCAN ONE to treat any other medical complaints unless your doctor tells you to.
Things to be careful of
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 after you have taken DIFLUCAN ONE.
This medicine helps most people with vaginal thrush, but it may have a few unwanted 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.
Do not be alarmed by the following list of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following symptoms and they worry you:
- nausea or feeling sick
- headache
- stomach pain
- indigestion
- diarrhoea
The above list includes the more common side effects of DIFLUCAN ONE. 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 swallowing or breathing
- asthma, wheezing, shortness of breath
- sudden or severe itching, skin rash, hives
- yellowing of the skin or eyes, also called jaundice
These side effects are usually rare but can be serious and need urgent medical attention.
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.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell, even if it is not on this list.
Ask your doctor orpharmacist if you don't understand anything on this list.
After using DIFLUCAN ONE
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 ONE capsules 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 1½ metres above the ground is a good place to store medicines.
Disposal
If this medicine has passed its expiry date, ask your pharmacist what to do with it.
Product Description
Availability
DIFLUCAN ONE tablets are available in one strength - 150 mg fluconazole per capsule. DIFLUCAN ONE is available in packs of one capsule.
What it looks like
DIFLUCAN ONE capsules are light turquoise blue, opaque capsules marked with FLU-150.
Ingredients
Active ingredient
Each capsule contains 150 mg fluconazole.
Other ingredients
Lactose, maize starch, silicon dioxide, magnesium stearate, sodium lauryl sulfate, the colours titanium dioxide and patent blue, and a gelatin capsule shell.
Supplier
DIFLUCAN ONE is supplied in New Zealand by:
Johnson & Johnson (New Zealand) Ltd.
PO Box 9222
Newmarket 1149
Auckland
Ph: 09 523 8700
Fax: 09 523 1646
This leaflet was prepared on 6 May 2008.
Ref: DIFLUCAN ONE Data Sheet dated 29 April 2008.