FLUCONAZOLE 150 MG CAPSULES

Active substance: FLUCONAZOLE

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FLUCONAZOLE 50 mg, 100 mg, 150 mg
and 200 mg CAPSULES



benzodiazepines (used to treat anxiety and to
help you sleep) e.g. diazepam, carbamazepine
or midazolam
PACKAGE LEAFLET: INFORMATION
• oral sulphonylureas (used to control diabetes)
FOR THE USER
e.g. glibenclamide, chlorpropamide, glipizide
or tolbutamide
Read all of this leaflet carefully before you start
• phenytoin or carbamazepine (used to control
taking this medicine.
epilepsy)
• Keep this leaflet. You may need to read it again. • amitriptyline (used for depression)
• If you have further questions, ask your doctor
• cyclosporin, tacrolimus or sirolimus (used to
or your pharmacist.
reduce the effect of the immune system e.g. to
• This medicine has been prescribed for you. Do
prevent the rejection of an organ transplant or
not pass it on to others. It may harm them,
graft)
even if their symptoms are the same as yours. • theophylline (used to increase the air flow to
• If any of the side effects get serious, or if you
the lungs and improve breathing)
notice any side effects not listed in this leaflet, • alfentanil (used as an anaesthetic)
please tell your doctor or pharmacist.
• halofantrine (used to treat malaria)
• methadone (treatment of opioid drug addiction)
IN THIS LEAFLET:
• ‘statin’ medicines (used to lower lipid levels in
1. What Fluconazole is and what it is used for
your blood e.g. fluvastatin, atorvastatin,
2. Before you take Fluconazole
simvastatin and pravastatin)
3. How to take Fluconazole
• trimetrexate, didanosine or zidovudine (used
4. Possible side effects
to treat infections in HIV and AIDS patients)
5. How to store Fluconazole
• prednisone (a corticosteroid used for a wide
6. Further information
variety of disorders including rheumatism)
WHAT FLUCONAZOLE IS AND WHAT • celecoxib (used as a pain-killer)
1
• nifedipine, isradipine, nicardipine, amlodipine
IT IS USED FOR
or felodipine (used for angina)
• amphotericin (used to treat fungal infections)
Fluconazole belongs to a group of drugs called
• ‘combined’ oral contraceptives (e.g.
antifungal agents, which can be used to treat or
ethinyloestradiol or levonorgestrel).
prevent a range of fungal infections.
Please tell your doctor or pharmacist if you are
Fluconazole is used:
taking or have recently taken any other medicines,
• to treat infections of the mouth and throat
including medicines obtained without a
• to treat infections of the genitals
prescription.
• to treat infections of the skin, nail and foot
• to treat internal fungal infections caused by
Important information about some of the
Candida- e.g. to the lining of the heart, the
ingredients of Fluconazole
lungs, urinary tract (bladder and kidneys) and
• Patients who are intolerant to lactose should
internal organs
note that Fluconazole capsules contain a small
• to treat internal fungal infections caused by
amount of lactose. If you have been told by
Cryptococcal- e.g. cryptococcal meningitis
your doctor that you have an intolerance to
• to prevent you getting a fungal infection, or
some sugars, contact your doctor before taking
repeated infections, if your immune system is
this medicinal product.
not working properly (e.g. following
• The 200 mg capsules also contain E122
chemotherapy, bone marrow transplant,
(Azorubine), which can cause an allergic-type
radiotherapy, or in AIDS patients).
reaction, including asthma.
This reaction is more common in those people
BEFORE YOU TAKE FLUCONAZOLE
2
who are allergic to aspirin.
DO NOT take Fluconazole if you:
Pregnancy and Breast-feeding
• are allergic (hypersensitive) to fluconazole or
• Do not take Fluconazole if you are pregnant,
any other ingredients in this medicine
planning to become pregnant or are
• are sensitive to related “azole” medicines e.g.
breast-feeding
ketoconazole, miconazole
• Women of childbearing age should use
• are taking terfenadine or astemizole
adequate contraception if taking Fluconazole.
(antihistamines), cisapride (used for stomach
upsets), quinidine (a medicine that acts on the Driving and using machines
• Fluconazole may cause dizziness/fits. If you are
heart) or pimozide.
affected, do not drive or operate machinery.
Take special care with Fluconazole
Tell your doctor before you start to take this
3 HOW TO TAKE FLUCONAZOLE
medicine if you:
• have any problems with your heart particularly Always take Fluconazole exactly as your doctor
has told you. You should check with your doctor
affecting its normal rate or rhythm
or pharmacist if you are not sure.
• have heart muscle disease (cardiomyopathy)
The capsules should be swallowed preferably
which can cause shortness of breath or ankle
with a drink of water, either with or without a
swelling
• have any disease or illness affecting your liver meal.
The usual dosage instructions are given below:
or kidneys
• have been told by your doctor that you have
Adults
low levels of potassium, magnesium or calcium • Genital infections e.g. vaginitis (inflammation
in your blood
of the vagina)
• are under 16 years of age. Your doctor will
150 mg as a single dose.
decide whether treatment with Fluconazole is
• Mucosal infections of the mouth
right for you
50 mg once daily for 7-14 days. Your doctor
• are a woman of child bearing age.
may increase this to 100 mg.

Other important information
• While you are taking Fluconazole your doctor
may want to monitor you by doing heart,
blood, urine or liver tests.
• If you have a genital infection your doctor may •
wish to treat your sexual partner if they also
show symptoms of genital infection.
• Whilst taking Fluconazole AIDS patients are

likely to be prone to skin reactions.
Taking other medicines
DO NOT take Fluconazole if you are taking:
• terfenadine or astemizole (antihistamines)
• cisapride (used for stomach upsets)
• quinidine (a medicine that acts on the heart)
• pimozide.
Talk to your doctor if you are taking any of the
following:
• rifampicin or rifabutin (antibiotics)
• hydrochlorothiazide (used to remove excess
water from the body and help reduce blood
pressure)
• losartan (used to lower blood pressure)
• warfarin or coumarin (anticoagulant drugs,
used to prevent blood clots)






Mucosal infections of the throat or other
sites
50 mg once daily for 14-30 days. Your doctor
may increase this to 100 mg.
Infection of the nails
150 mg once a week for 3-6 months for
fingernails and 6-12 months for toenails, or
until the nail has totally regrown.
Fungal skin infections
50 mg once daily for 2-4 weeks. Athlete’s foot:
up to 6 weeks treatment.
Internal fungal infections caused by Candida
e.g. infections of the bloodstream, urinary
tract or other body organs
400 mg on the first day, then 200-400 mg once
daily.
Cryptococcal meningitis
400 mg on the first day, then 200-400 mg once
daily for 6-8 weeks.
To prevent a fungal infection in
immunocompromised patients (having weak
or impaired immune system)
50-400 mg once daily while you are at risk of
getting an infection.



To prevent cryptococcal meningitis from
returning
100-200 mg once daily until your doctor
tells you to stop.

Fluconazole should only be used in children and
adolescents under the age of 16 years if there are
no therapeutic alternatives then the dosage
recommended below should be used.
The maximum daily dose in children should not
exceed 400 mg.











spinning either up or down or from side to side
Itching all over the body
Loss of appetite, indigestion/heartburn
Constipation, wind
Muscle pain
Dry mouth, increased sweating
Difficulty sleeping, sleepiness
Jaundice, liver problems
Anaemia (reduction in red blood cells)
Taste disturbances.

Rare (affecting fewer than one person in 1,000 but
more than one person in 10,000):
• Life threatening irregular heart beat
• Blood disorder which may be characterised by
fever or chills, sore throat, ulcers in your
mouth or throat
• Liver failure, inflammation of the liver
• Unusual bleeding or unexplained bruising
• Increased fat or cholesterol levels in the blood
Children aged 3 – 4 weeks:
• The usual child dose but given every 2 days. A • Low blood potassium levels
• Hair loss.
maximum dose of 12 mg/kg every 2 days.
Children aged 4 weeks – 15 years:
• Mucosal infections
3 mg/kg once daily. An initial dose of 6 mg/kg
may be used on the first day.
• Internal fungal infections caused by Candida or
Cryptococcus
6-12 mg/kg once daily.

Children under 3 weeks of age:
• The usual child dose but given once every
3 days. A maximum dose of 12 mg/kg every
3 days.

Very rare (affecting fewer than one person in
10,000):
• Swelling of the face or throat
• Severe illness with blistering of the skin.

Fluconazole should not be used for treating genital
The following side effects have also been reported
Candida infections in children under 16 years old.
but may not be directly due to Fluconazole:
The capsules are not suitable for children who
• Nettle Rash.
cannot take oral medication.
Children are more likely to be prone to side
The Elderly
effects when using Fluconazole (particularly
The usual adult dose, unless you have kidney
irritability and anaemia).
problems.
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
Patients with Kidney Problems
please tell your doctor or pharmacist.
Depending on your kidney function, your doctor
may modify your dose.
If you take more Fluconazole than you should:
If you (or someone else) swallow a lot of the
capsules all together, or if you think a child has
accidentally swallowed any of the capsules,
contact your nearest hospital casualty department
or your doctor immediately. Please take this
leaflet, any remaining capsules and the container
with you to the hospital or doctor so that they
know which capsules were consumed.
If you forget to take Fluconazole:
If you forget to take a capsule, take one as soon
as you remember, unless it is nearly time to take
the next one. Do not take a double dose to make
up for a forgotten capsule. Take the remaining
doses at the correct time.

5 HOW TO STORE FLUCONAZOLE
Keep out of the reach and sight of children.
Do not store above 30°C. Do not transfer the
capsules to another container.
Do not use Fluconazole after the expiry date that
is stated on the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6 FURTHER INFORMATION

What Fluconazole capsules contain:
• The active substance is fluconazole 50 mg,
If you stop taking Fluconazole:
100 mg, 150 mg and 200 mg.
Do not stop treatment early, even if you start to
• Other ingredients are lactose monohydrate,
feel better, because the original infection may still
maize starch, colloidal anhydrous silica, sodium
be present and recur if treatment is stopped. Take
laurilsulfate and magnesium stearate. The
the full course.
capsule shell contains gelatin and the following
colours:
If you have any further questions on the use of
• 50, 100 and 150 mg capsules: titanium
this product, ask your doctor or pharmacist.
dioxide (E171) and brilliant blue (E133)
• 200 mg capsules: titanium dioxide (E171),
4 POSSIBLE SIDE EFFECTS
azorubine (E122) and brilliant blue (E133).
Like all medicines, Fluconazole can cause side
effects, although not everybody gets them.
What Fluconazole capsules look like and contents
of the pack:
Stop taking the capsules and tell your doctor
immediately or go to the casualty department at • Fluconazole 50 mg are hard gelatine capsules
with a light blue opaque cap and white opaque
your nearest hospital If the following happens:
body.
• an allergic reaction (swelling of the lips,
• Fluconazole 100 mg are hard gelatine capsules
face or neck leading to severe difficulty in
with a blue opaque cap and white opaque body.
breathing; skin rash or hives).
This is a very serious but rare side effect. You may • Fluconazole 150 mg are hard gelatine capsules
with a light blue opaque cap and light blue
need urgent medical attention or hospitalisation.
opaque body.
Tell your doctor immediately if you suffer from:
• Fluconazole 200 mg are hard gelatine capsules
• skin reactions including Stevens-Johnson
with a purple opaque cap and white opaque
Syndrome (blisters/bleeding of the lips, eyes,
body.
nose, mouth and genitals) and toxic epidermal • The 50 mg capsules are available in pack sizes
necrolysis (severe blistering rash)
of 1, 7, 10, 20, 28, 30, 50, 100 and 500 capsules.
• angioedema, a serious allergic reaction which • The 100 mg capsules are available in pack sizes
causes swelling of the face or throat.
of 7, 10, 28, 30, 50 (1x50), 60 and 100 capsules.
• The 150 mg capsules are available in pack sizes
The following side effects have been reported at
of 1, 2, 4 and 12 capsules.
the approximate frequencies shown:
• The 200 mg capsules are available in pack sizes
Common (affecting fewer than one person in 10
of 1, 4, 7, 10, 12, 20, 30, 50 and 100 capsules.
but more than one person in 100):
Marketing Authorisation Holder and Manufacturer
• Headache
The Marketing Authorisation holder and company
• Skin rash
responsible for manufacture is TEVA UK Limited,
• Stomach pain, nausea, vomiting, diarrhoea
Eastbourne, BN22 9AG England.
• Abnormalities in liver function test results.
Uncommon (affecting fewer than one person in
100 but more than one person in 1,000):
• Tiredness, lethargy
• General feeling of being unwell, fever
• Fits, dizziness, tremor
• Pins-and-needles or numbness
• A sensation that your surroundings are

This leaflet was last revised: November 2008.
PL 00289/0403-0406

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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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