FLUCONAZOLE 100MG CAPSULES

Active substance: FLUCONAZOLE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fluconazole
Fluconazole
Fluconazole
Fluconazole

50mg Capsules
100mg Capsules
150mg Capsules
200mg Capsules

fluconazole
Read all of this leaflet carefully before you start taking
this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
If any of the side effects gets serious, or if you notice any

side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Fluconazole Capsules are and what they are used for
2. Before you take Fluconazole Capsules
3. How to take Fluconazole Capsules
4. Possible side effects
5. How to store Fluconazole Capsules
6. Further information



Internal (systemic) fungal infections caused by Candida,
e.g. infections of the blood stream, urinary tract or other
body organs.
• Internal (systemic) fungal infections caused by
Cryptococcus, e.g. cryptococcal meningitis and infections
of other sites such as the lungs and skin.
• Genital Candida infections like vaginal thrush or candidal
balanitis (inflammation of the end of the penis and/or
foreskin).
You may also be given Fluconazole to:
• Stop you from getting a fungal infection (if your immune
system is not working properly).
• Stop an infection caused by Cryptococcus from coming
back (in AIDS patients).

2 Before you take Fluconazole Capsules
Do not take Fluconazole Capsules



if you are allergic (hypersensitive) to fluconazole, or
another drug from the same group of antifungal drugs,or
any of the other ingredients of Fluconazole Capsules
• if you are taking another drug called terfenadine (an
antihistamine) or cisapride (a drug used to treat acid
reflux, indigestion or decreased gastric motility)
If any of the above apply to you and you have not already
discussed this with your doctor or pharmacist, you should
do so as soon as possible and before taking Fluconazole
Capsules.

Take special care with Fluconazole Capsules







if you suffer from liver problems
if you suffer from kidney problems
if you suffer from heart problems
if you have imbalances in the salt levels in your blood
if you have AIDS
Fluconazole is one of a group of medicines called
antifungal agents.
If you have any of these conditions and you have not already
Fluconazole is used to treat infections caused by fungi/yeasts. discussed this with your doctor or pharmacist, you should do
so as soon as possible and before taking Fluconazole Capsules.
The most common cause of fungal infections is yeast called
Candida.
Taking other medicines
You may be given Fluconazole to treat fungal infections
Please tell your doctor or pharmacist if you are taking any of
such as:
the following medicines:
• Thrush of the mouth or throat (mucosal infections).
• terfenadine or astemizole (types of antihistamines)
• Skin infections (e.g. athlete’s foot, ringworm).

1 What Fluconazole Capsules are and
what they are used for

• rifampicin or rifabutin (types of antibiotics, often used
for the treatment of tuberculosis)
• hydrochlorothiazide (a type of diuretic or ‘water tablet’)
• any drugs which thin the blood (known as anticoagulants
e.g. warfarin)
• any medicines to help you sleep (such as benzodiazepines
e.g. midazolam)
• any medicines to treat diabetes (known as sulphonylureas
e.g. chlorpropamide, glibenclamide, gliplizide or
tolbutamide)
• phenytoin (used to treat epilepsy)
• an oral contraceptive (the ‘Pill’)
• ciclosporin or tacrolimus (drugs which suppress the
immune system, which are commonly used following
organ transplants)
• theophylline (a drug used to treat asthma)
• zidovudine (AZT), nevirapine, ritanovir, tipranavir,
saquinavir (antiviral drugs, used to treat HIV)
• cisapride (a drug used to treat acid reflux, indigestion or
decreased gastric motility)
• drugs used to treat psychosis (e.g. pimozide, quetiapine,
sertindole)
• ergot alkaloids (drugs used to treat migraine)
• drugs used to control levels of fat in your blood
(lipid-regulating drugs)
• calcium channel antagonists
• antimalarial drugs such as artemether and lumefantrine
• ivabradine
• bosentan
• quinidine
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.

Taking Fluconazole Capsules with food and drink
The capsules should always be taken with plenty of water.
They can be taken with or without food.

Pregnancy and breast-feeding
Fluconazole should not be used in pregnancy or in women of
childbearing potential unless adequate contraception is used.
Breast-feeding is not recommended whilst using fluconazole.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines
Fluconazole Capsules are unlikely to affect your ability to
drive or use machinery, however, when driving or operating
machines it should be taken into account that occasionally
dizziness or seizures may occur.
Important information about some of the ingredients of
Fluconazole Capsules
Fluconazole Capsules contain lactose monohydrate, a type
of sugar. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before
taking this medicinal product.

3 How to take Fluconazole Capsules
Always take Fluconazole Capsules exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
The capsules should always be taken with plenty of water.
They can be taken with or without food.
Your dose will be dependent on the type and severity of your
infection, your age, weight and kidney function. Your doctor
will choose the best dose for you.

Adults
The usual dose for the treatment of genital thrush is one
150mg single dose.
To treat mucosal thrush of the mouth or throat, the usual
dose is 50mg-100mg once daily for up to 14 days. In other
types of mucosal thrush, this may be continued for up to 30
days. If you have oral thrush associated with the use of
dentures, you may be given a local antiseptic to use at the
same time.
To treat fungal skin infections (e.g. athlete’s foot, ringworm),
the usual dose is 50mg once daily for up to 6 weeks.
For systemic (invasive) infections, the usual dose is
400mg on the first day, followed by 200mg – 400mg daily.
In cryptococcal infections, this may be continued for up to
8 weeks.
To prevent fungal infections in patients with poor immune
systems, the usual dose is 50-400mg once daily, depending
on the risk of infection. To prevent cryptococcal infections
coming back in AIDS patients, a usual dose of 100-200mg
daily may be given indefinitely.

• Aching muscles (myalgia)
• Hair loss (alopecia)
• Severe skin disorders or itching (e.g. Stevens-Johnson
Syndrome)
• Indigestion (dyspepsia)
Kidney problems
• Sickness (vomiting)
• Swelling of the face, lips, mouth or throat (angioedema)
Your doctor will decide what dose to give you depending on
• Changes to your sense of taste
your kidney function.
• Feeling tired and weak (asthenia) or generally unwell
Children
(malaise)
• Fever
The capsules formulation may be unsuitable for children
4 Possible side effects
• Increased sweating
under 5-6 years of age.
Like all medicines, Fluconazole Capsules can cause side
• Dry mouth
Children over 4 weeks of age
effects, although not everybody gets them.
• Sleeplessness (insomnia) or drowsiness (somnolence)
Your doctor will calculate an appropriate dose based on
If any of the following symptoms occur soon after taking
• Change in heart rate or rhythm
body weight. The usual dose for mucosal infections is
your capsules, stop taking the capsules and tell your doctor • Liver disease. Your liver may stop working properly, or,
3mg/kg body weight daily. A dose of 6mg/kg may be given
immediately. This kind of reaction is rare and may mean you
damage or death (necrosis) of liver cells may occur.
on the first day. For internal infections and cryptococcal
are suffering from an allergic reaction (anaphylaxis) to the
You may experience a yellowing of the skin and/or eyes
infections, the usual dose is 6-12mg/kg daily, depending on capsules:
(jaundice).
the severity of the infection. To prevent fungal infections in
• Severe rash, itching, a lumpy skin rash (‘hives’) or fever
If any of the side effects gets serious, or if you notice any
patients with poor immune systems, a dose of 3-12mg/kg
• Sudden wheeziness or tightness of the chest
side effects not listed in this leaflet, please tell your doctor
should be given daily, depending on the risk of infection.
• Swelling of the eyelids, face, lips or blood vessels in
or pharmacist.
A maximum dosage of 400mg daily should not be exceeded
the skin
in children.
The most common side effects, which may occur, are
5 How to store Fluconazole Capsules
It is very important that you follow your doctor’s instructions listed below:
as to how many Fluconazole Capsules to take, how often to
Keep out of the reach and sight of children. Do not store
• Headache
take them and for how long you should continue to take
above 25°C. Store in the original package.
• Rash
your capsules.
Do not use Fluconazole Capsules after the expiry date which
• Stomach pain or discomfort
Fluconazole capsules are not suitable for all dosages
is stated on the carton after expiry date. The expiry date
• Diarrhoea
described in this leaflet. Other products containing
refers to the last day of that month.
• Flatulence (wind)
fluconazole are available for this.
• Nausea (feeling sick)
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
If you take more Fluconazole Capsules than you should These side effects are usually mild. However, if you suffer
medicines no longer required. These measures will help to
from any of these and they are severe or prolonged, please
It is important to stick to the dose on the label of your
protect the environment.
inform your doctor or pharmacist.
medicine. If you or someone else swallows several of these
capsules all together, contact your doctor, pharmacist or
Other possible side effects, which may occur, include:
hospital emergency department immediately. Always take
6 Further information
• Abnormalities in blood, liver or kidney function, or other
any capsules left over with you and also the box, as this will
biochemical tests (especially if you have a serious
What Fluconazole Capsules contain
allow easier identification of the capsules.
underlying disease such as AIDS or cancer)
• The active substance is fluconazole. Each capsule
• Increase in your cholesterol and/or lipids and decrease in
If you forget to take Fluconazole Capsules
contains either 50mg, 100mg, 150mg, or 200mg
potassium levels. Your doctor may want to monitor you.
If you forget to take a dose, take it as soon as you remember.
fluconazole.
• Dizziness, vertigo
Do not take a double dose to make up for a forgotten dose if
• The other ingredients are lactose monohydrate, maize
• Seizures or convulsions (fits)
it is almost time for your next dose.
starch, sodium laurilsulfate, colloidal anhydrous silica
• Pins and needles (paraesthesia)
and magnesium stearate.
• Shaking (tremor)

Elderly

If you stop taking Fluconazole Capsules

Your doctor will decide what dose to give you. This may be
lower than the usual adult dose depending on your kidney
function.

Even when you start to feel better it is important for you to
keep on taking your capsules for as long as your doctor tells
you. If you stop too soon, the infection may start up again.
Sometimes your doctor may want you to continue taking
your capsules to prevent your infection from coming back.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

The capsule shell contains:
50mg: titanium dioxide (E171), yellow iron oxide (E172),
indigo carmine (E132) and gelatin.
100mg and 150mg: titanium dioxide (E171), patent blue V
(E131) and gelatin.
200mg: titanium dioxide (E171) and gelatin.
The ink contains shellac glaze, black iron oxide (E172),
industrial methylated spirit 74 OP, n-butyl alcohol,
propylene glycol (E1520) and isopropyl alcohol.
What Fluconazole Capsules look like and contents of
the pack
50mg: green and white capsules with imprint FLUCO 50.
100mg: blue and white capsules with imprint FLUCO 100.
150mg: blue capsules with imprint FLUCO 150.
200mg: white capsules with imprint FLUCO 200.
Fluconazole Capsules are available in blister packs of:
50mg: 7, 14 or 28 capsules
100mg: 7, 10, 20 or 50 capsules
150mg: 1, 2 or 4 capsules
200mg: 7, 20 or 50 capsules.
Not all pack sizes maybe marketed.

Marketing Authorisation Holder
PLIVA Pharma Ltd, Vision House, Bedford Road, Petersfield,
Hampshire, GU32 3QB.

Manufacturer
PLIVA Krakow S.A., 80 Mogilska Str., 31 546 Krakow,
Poland.
PL 10622/0129
PL 10622/0130
PL 10622/0132
PL 10622/0133
This leaflet was last approved in
10/2008

Item code

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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