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TEVA FLUCONAZOLE 150 MG CAPSULES

Active substance(s): FLUCONAZOLE

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Package leaflet: Information for the user
Teva Fluconazole 50 mg, 100 mg, 150 mg and 200 mg Capsules
(fluconazole)
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1. What Fluconazole is and what it is used for
2. What you need to know before you take Fluconazole
3. How to take Fluconazole
4. Possible side effects
5. How to store Fluconazole
6. Contents of the pack and other information

1. What Fluconazole is and what it is used for
Fluconazole is one of a group of medicines called "antifungals". The active substance is
fluconazole.
Fluconazole is used to treat infections caused by fungi and may also be used to stop you from
getting a candidal infection. The most common cause of fungal infections is a yeast called Candida.
Adults
You might be given this medicine by your doctor to treat the following types of fungal infections:
 Cryptococcal meningitis – a fungal infection in the brain
 Coccidioidomycosis – a disease of the bronchopulmonary system
 Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs)
or urinary tract
 Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth
 Genital thrush – infection of the vagina or penis
 Skin infections - e.g. athlete's foot, ringworm, jock itch, nail infection
You might also be given Fluconazole to:
 stop cryptococcal meningitis from coming back
 stop mucosal trush from coming back
 reduce recurrence of vaginal trush
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stop you from getting an infection caused by Candida (if your immune system is weak and
not working properly)
Children and adolescents (0 to 17 years old)
You might be given this medicine by your doctor to treat the following types of fungal infections:
 Mucosal thrush - infection affecting the lining of the mouth, throat
 Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs)
or urinary tract
 Cryptococcal meningitis – a fungal infection in the brain
You might also be given Fluconazole to:
 stop you from getting an infection caused by Candida (if your immune system is weak and
not working properly).
 stop cryptococcal meningitis from coming back
2. What you need to know before you take Fluconazole
Do not take Fluconazole:
 If you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or
to any of the other ingredients of this medicine(listed in section 6). The symptoms may include
itching, reddening of the skin or difficulty in breathing.
 If you are taking astemizole, terfenadine (antihistamine medicines for allergies)
 If you are taking cisapride (used for stomach upsets)
 If you are taking pimozide (used for treating mental illness)
 If you are taking quinidine (used for treating heart arrhythmia)
 If you are taking erythromycin (an antibiotic for treating infections)
 If you are taking amiodarone (used for treating heart problems)
Warnings and precautions

Talk to your doctor or pharmacist before taking Fluconazole
 If you have liver or kidney problems
 If you suffer from heart disease, including heart rhythm problems
 If you have abnormal levels of potassium, calcium or magnesium in your blood.
 If you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing).
Other medicines and Fluconazole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Tell your doctor immediately if you are taking astemizole, terfenadine (an antihistamine for treating
allergies) or cisapride (used for stomach upsets) or pimozide (used for treating mental illness) or
quinidine (used for treating heart arrhythmia) or erythromycin (an antibiotic for treating infections)
or amiodarone (used for treating heart problems) as these should not be taken with Fluconazole (see
section: “Do not take Fluconazole if you”).
There are some medicines that may interact with fluconazole. Make sure your doctor knows if you
are taking any of the following medicines:
 rifampicin or rifabutin (antibiotics for infections)
 alfentanil, fentanyl (used as anaesthetic)
 amitriptyline, nortriptyline (used as anti-depressant)
 amphotericin B, voriconazole (anti-fungal)
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medicines that thin the blood to prevent blood clots (warfarin or similar medicines)
benzodiazepines (midazolam, triazolam or similar medicines) used to help you sleep or for
anxiety
carbamazepine, phenytoin (used for treating fits)
nifedipine, isradipine, amlodipine felodipine and losartan (for hypertension- high blood
pressure)
ciclosporin, everolimus , sirolimus or tacrolimus (to prevent transplant rejection)
cyclosphosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used for
treating cancer
halofantrine (used for treating malaria)
statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high
cholesterol levels
methadone (used for pain)
celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (NonSteroidal Anti-Inflammatory Drugs (NSAID))
oral contraceptives
prednisone (steroid)
zidovudine, also known as AZT; saquinavir (used in HIV-infected patients)
medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide
theophylline (used to control asthma)
vitamin A (nutritional supplement)
hydrochlorothiazide (a ‘water pill’)

Fluconazole with food and drink
You can take your medicine with or without a meal.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
When driving vehicles or using machines, it should be taken into account that occasionally
dizziness or fits may occur.
Fluconazole capsules contains Lactose and Azorubine (E122)
 Fluconazole capsules contain a small amount of lactose (milk 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.
 The 200 mg capsules also contain E122 (Azorubine), which can cause an allergic-type reaction,
including asthma. This reaction is more common in those people who are allergic to aspirin.
3. How to take Fluconazole
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the capsule whole with a glass of water. It is best to take your capsules at the same time
each day.
The capsules may be taken with or without a meal.
The usual doses of this medicine for different infections are below:
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Adults
Condition
To treat cryptococcal meningitis

Dose
400 mg on the first day then 200 mg to 400 mg once
daily for 6 to 8 weeks or longer if needed. Sometimes
doses are increased up to 800 mg
To stop cryptococcal meningitis from 200 mg once daily until you are told to stop
coming back
To treat coccidioidomycosis
200 mg to 400 mg once daily from 11 months for up
to 24 months or longer if needed. Sometimes doses
are increased up to 800 mg
To treat internal fungal infections 800 mg on the first day then 400 mg once daily until
caused by Candida
you are told to stop
To treat mucosal infections affecting the 200 mg to 400 mg on the first day then 100 mg to 200
lining of mouth, throat and denture sore mg until you are told to stop
mouth
To treat mucosal thrush – dose depends 50 mg to 400 mg once daily for 7 to 30 days until you
on where the infection is located
are told to stop
To stop mucosal infections affecting the 100 mg to 200 mg once daily, or 200 mg 3 times a
lining of mouth, throat
week, while you are at risk of getting an infection
To treat genital thrush
150 mg as a single dose
To reduce recurrence of vaginal trush
150 mg every third day for a total of 3 doses (day 1, 4
and 7) and then once a week for 6 months while you
are at risk of getting an infection
To treat fungal skin and nail infections
Depending on the site of the infection 50 mg once
daily, 150 mg once weekly, 300 to 400 mg once
weekly for 1 to 4 weeks (Athlete’s foot may be up to 6
weeks, for nail infection treatment until infected nail
is replaced)
To stop you from getting an infection 200 mg to 400 mg once daily while you are at risk of
caused by Candida (if your immune getting an infection
system is weak and not working
properly)

Use in children and adolescents
Adolescents from 12 to 17 years old
Follow the dose prescribed by your doctor (either adults or children posology).
Children to 11 years old
The maximum dose for children is 400 mg daily.
The dose will be based on the child’s weight in kilograms.
Condition
Mucosal thrush and throat infections caused by
Candida – dose and duration depends on the
severity of the infection and on where the
infection is located
Cryptococcal meningitis or internal fungal
infections caused by Candida
To stop children from getting an infection caused
by Candida (if their immune system is not
working properly)

Daily dose
3 mg per kg of body weight (6 mg per kg of
body weight might be given on the first day)

6 mg to 12 mg per kg of body weight
3 mg to 12 mg per kg of body weight

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Use in children 0 to 4 weeks of age
Use in children of 3 to 4 weeks of age:
The same dose as above but given once every 2 days. The maximum dose is 12 mg per kg of body
weight every 48 hours.
Use in children less than 2 weeks old:
The same dose as above but given once every 3 days. The maximum dose is 12 mg per kg of body
weight every 72 hours.
Doctors sometimes prescribe different doses to these. Always take your medicine exactly as your
doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Elderly
The usual adult dose should be given unless you have kidney problems.
Patients with kidney problems
Your doctor may change your dose, depending on your kidney function.
If you take more Fluconazole than you should:
Taking too many capsules at once may make you unwell. Contact your doctor or your nearest
hospital casualty department at once. The symptoms of a possible overdose may include hearing,
seeing, feeling and thinking things that are not real (hallucination and paranoid behaviour).
Symptomatic treatment (with supportive measures and gastric lavage if necessary) may be adequate.
If you forget to take Fluconazole:
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as
soon as you remember. If it is nearly time to take the next dose, do not take the dose that you
missed.
If you stop taking Fluconazole

If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A few people develop allergic reactions although serious allergic reactions are rare. If you get any
of the following symptoms, tell your doctor immediately.
 Sudden wheezing, difficulty in breathing or tightness in the chest
 Swelling of eyelids, face or lips
 Itching all over the body reddening of the skin or itchy red spots
 Skin rash
 Severe skin reactions such as a rash that causes blistering (this can affect the mouth and
tongue).
Fluconazole may affect your liver. The signs of liver problems include:
 Tiredness
 Loss of appetite
 Vomiting
 Yellowing of your skin or the whites of your eyes (jaundice)
 If any of these happen, stop taking Fluconazole Capsules and tell your doctor immediately.
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Other side effects:
Additionally, if any of the following side effects gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
Common side-effects which may affect up to 1 to 10 people in 100 are listed below):
 Headache
 Rash
 Stomach discomfort, feeling sick, vomiting, diarrhoea
 Increases in blood tests of liver function.
Uncommon side effects which may affect up to 1 to 10 people in 1,000 are listed below:
 Reduction in red blood cells which can make skin pale and cause weakness or breathlessness
 Decreased appetite
 Inability to sleep, feeling drowsy
 Fit, dizziness, sensation of spinning, tingling, pricking or numbness, changes in sense of taste,
 Constipation, difficult digestion, wind, dry mouth
 Muscle pain
 Liver damage and yellowing of the skin and eyes (jaundice)
 Wheals, blistering (hives), itching, increased sweating
 Tiredness, general feeling of being unwell, fever
Rare side effects which may affect up to1 to 10 people in 10,000 are listed below:
 Lower than normal white blood cells that help defend against infections and blood cells that
help to stop bleeding
 Red or purple discoloration of the skin which may be caused by low platelet count, other blood
cell changes
 Blood chemistry changes (high blood levels of cholesterol, fats)
 Low blood potassium
 Shaking
 Abnormal electrocardiogram (ECG), change in heart rate or rhythm
 Liver failure
 Allergic reactions (sometimes severe), including widespread blistering rash and skin peeling,
severe skin reactions, swelling of the lips or face
 Hair loss

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V*. By reporting side effects you can help provide more information on the
safety of this medicine.
5. How to store Fluconazole
Keep this medicine out of the sight and reach of children.
Do not store above 30C. Do not transfer the capsules to another container.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry
date refers to the last day of that month.

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fluconazole contains:
 The active substance is fluconazole 50 mg, 100 mg, 150 mg and 200 mg.
 The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, sodium
laurilsulfate and magnesium stearate. The capsule shell contains gelatin and the following
colours:
 50, 100 and 150 mg capsules: titanium dioxide (E171) and brilliant blue (E133)
 200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue (E133).

What Fluconazole look like and contents of the pack:
 Fluconazole 50 mg are hard gelatine capsules with a light blue opaque cap and white opaque
body.
 Fluconazole 100 mg are hard gelatine capsules with a blue opaque cap and white opaque body.
 Fluconazole 150 mg are hard gelatine capsules with a light blue opaque cap and light blue
opaque body.
 Fluconazole 200 mg are hard gelatine capsules with a purple opaque cap and white opaque
body.
 The 50 mg capsules are available in pack sizes * of 1, 7, 10, 20, 28, 30, 50, 100 and 500
capsules.
 The 100 mg capsules are available in pack sizes* of 7, 10, 28, 30, 50 (1x50), 60 and 100
capsules.
 The 150 mg capsules are available in pack sizes* of 1, 2, 4 and 12 capsules.
 The 200 mg capsules are available in pack sizes* of 1, 4, 7, 10, 12, 20, 30, 50 and 100 capsules.
Marketing Authorisation Holder and Manufacturer
To be completed nationally

This leaflet was last revised in: October 2015

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THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.1 pil-eu-50mg-100mg-150mg-200mg clean

APPROVALS
Signed by
Sneha Patel

REG0170866

Meaning of Signature
Regulatory Affairs Approval

Version 0.4

Approved

Server Date
27-Oct-2015 10:00:02 AM

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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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