FLUCONAZOLE THRUSH TREATMENT

Active substance: FLUCONAZOLE

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FLUCONAZOLE 50 mg CAPSULES
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may want to read it again. • If you have further questions,
please ask your doctor or pharmacist. • This medicine has been prescribed for
you personally. Do not give it to anyone else. It may harm them, even if their
symptoms are the same as yours.
YOUR MEDICINE
There are four strengths of Fluconazole Capsules available. Each capsule contains
either 50 mg, 100 mg, 150 mg or 200 mg of the active ingredient fluconazole.
The capsules also contain lactose, maize starch, colloidal silicon dioxide,
magnesium stearate and sodium laurilsulfate. The capsule shells contain
titanium dioxide (E171) and gelatin. The printing ink contains shellac, purified
water, potassium hydroxide, propylene glycol and black iron oxide (E172). The 50
mg capsule shell also contains Acid red 18 colour and patent blue V (E131). The
100 mg, 150 mg and 200 mg capsules also contain patent blue V (E131). The 50
mg strength capsules are white and dark blue with 'FC 50' and 'G' printed on
them. The 100 mg strength capsules are white and blue with 'FC 100' and 'G'
printed on them. The 150 mg strength capsules are all white with 'FC 150' and 'G'
printed on them. The 200 mg strength capsules are white and blue with 'FC 200'
and 'G' printed on them. Fluconazole 50 mg, 100 mg, 150 mg and 200 mg
Capsules come in blister packs of 7 capsules. Fluconazole 150 mg Capsule also
comes in a blister pack of 1 capsule.
Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close,
Potters Bar, Hertfordshire, EN6 1TL.
WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR
Your medicine is in the form of a capsule containing Fluconazole. Fluconazole
belongs to a group of medicines called antifungals used to treat fungal
infections. Fluconazole can be taken to treat any of the following infections:
• vaginal 'thrush' in women or balanitis (inflammation of the end of the
penis) in men, caused by Candida
• 'thrush' of the mouth or throat, caused by Candida
• skin infections eg. athlete's foot, ringworm
• candidal infections in the body eg. in the blood stream, lungs, urinary tract
• infections in the body caused by Cryptococcus eg. cryptococcal meningitis.
Fluconazole Capsules can also be taken if you have a weak immune system:
• to stop you getting a fungal infection eg. after transplant surgery, or
• to stop an infection caused by Cryptococcus, from coming back.
If you are not sure why you are taking this medicine, check with your doctor.
BEFORE YOU TAKE FLUCONAZOLE CAPSULES
Do not take this medicine if:
• you have taken Fluconazole or a similar antifungal medicine before and
suffered an unusual or allergic reaction to it
• you are already taking Terfenadine (an antihistamine) or Cisapride (used
for stomach problems)
• you think you may be allergic to any of the capsule ingredients such as lactose or
you know you have an inherited problem coping with lactose or galactose.
Tell your doctor or pharmacist before taking this medicine if:
• you are pregnant or breast-feeding
• you are already taking any of the following medicines:
» anticoagulants eg. Warfarin, used to thin the blood
» Rifampicin or Rifabutin (antibiotics)
» diuretics (or 'water' tablets) eg. Hydrochlorothiazide
» a benzodiazepine eg. Midazolam
» antidiabetic medicine eg. Chlorpropamide, Glibenclamide, Glipizide, Tolbutamide
» Phenytoin (antiepileptic medicine)
» Ciclosporin or Tacrolimus (immunosuppressants)
» Theophylline (asthma medicine)
» Zidovudine or AZT (antiviral medicine)
» Astemizole (an antihistamine).
HOW TO TAKE YOUR FLUCONAZOLE CAPSULES
Fluconazole Capsules should only be taken by mouth. Swallow the capsules with
a glass of water. Always read the label on the carton and follow your doctor's
instructions. The usual doses of Fluconazole used to treat the specific infections
are listed below.

ADULTS
'Thrush' (Candida) of the genital area: Three Fluconazole 50 mg Capsules (150
mg) as a single dose.
'Thrush' (Candida) of the mouth or throat: One Fluconazole 50 mg Capsule once a
day for 7-14 days. Treatment is usually for no longer than 14 days. For more
severe Candida infections of the throat, lungs or if found in the urine, one or two
50 mg capsules may be given once daily for up to 30 days.
Skin infections caused by Candida: One Fluconazole 50 mg capsule once a day
for between 2 to 4 weeks. Treatment of athlete's foot may last for up to 6 weeks.
Infections in the body eg. bloodstream, caused by Candida: Two Fluconazole 200
mg capsules on the first day of treatment followed by one Fluconazole 200 mg
capsule daily. Your doctor may decide to increase the dose to two 200 mg
capsules every day. How long you need to take your capsules will depend on
how severe the infection is.
Infections in the body caused by Cryptococcus eg. Cryptococcal meningitis: Two
Fluconazole 200 mg capsules on the first day, followed by one Fluconazole 200
mg capsule once daily. If necessary, your doctor may increase this dose to two
200 mg capsules every day. Treatment usually lasts between 6 to 8 weeks.
To stop you from getting a fungal infection: The dose will depend on the risk of
getting an infection. The usual dose is between 50 mg and 400 mg of
Fluconazole once daily for the time the patient is at risk.
To prevent a cryptococcal infection coming back: 100 mg to 200 mg Fluconazole
once daily.
CHILDREN
The maximum dose in children is 400 mg of Fluconazole daily. The dose of
Fluconazole will depend on the age of the child (see below). Fluconazole
Capsules should not be given to children under 16 years to treat genital
infections caused by Candida.
Over 4 weeks old - To treat 'thrush' in the mouth or throat: 3 mg/kg of
bodyweight daily.
To treat a fungal infection in the body caused by Candida or Cryptococcus: 6-12
mg/kg of body weight daily.
To prevent a fungal infection in a child with a weak immune system: 3-12 mg/kg
of bodyweight daily.
2 to 4 weeks old - Same dose as older children but given once every 2 days.
Maximum dose is 12 mg/kg every 2 days.
Under 2 weeks old - Same dose as children over 4 weeks but given every 3 days.
Maximum dose is 12 mg/kg every 3 days.
Patients with kidney problems - If you have kidney problems, your doctor may
give you a lower dose than stated above.
If you forget to take the dose, take it as soon as you remember, unless it is nearly
time for your next dose. Never take two doses at the same time. If you take too
much of your medicine contact your doctor or nearest casualty department
immediately.
POSSIBLE SIDE EFFECTS
Most people have no side effects while taking Fluconazole. The most common
side effects which are usually mild, include headache, skin rash, stomach pain,
diarrhoea, wind, indigestion, feeling or being sick.
Stop taking this medicine and go to your nearest casualty department if you
suffer from swelling of the lips, tongue or face or have difficulty breathing. This is
a very rare allergic reaction. If you notice any of the following side effects, tell
your doctor: • fits, dizziness • itchy skin or severe skin reactions • hair loss
• unusual bruising or bleeding of the skin, sore throat with fever, looking pale
• yellowing of the skin or whites of the eyes or liver problems. Fluconazole may
also cause changes in fat or cholesterol blood levels or taste changes. If you
notice any side effects not mentioned in this leaflet, please tell your
pharmacist or doctor.
STORING YOUR MEDICINE
• Keep Fluconazole Capsules out of the reach and sight of children. • Store in the
original packaging. Do not take this medicine after the expiry date shown on
the carton. On the carton label you will find the letters 'Exp' followed by some
numbers. These numbers are the date when the medicine is no longer fit for use.

Date of leaflet preparation: November 2009

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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