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Fluconazole

Fluconazole belongs to a group of medicines called “antifungal”.It is used to treat infections caused by fungi and may also be used to stop you from Getting a candidal infection.


Generic Name

Fluconazole


Packing

1,10


Therapeutic Category

Antifungal


Storage

Do not store above 25°C. Store in the original package.


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adobe-pdf-logoPrescribing Information(SPC)


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Product Description

Product Overview


WHAT FLUCONAZOLE 150mg CAPSULES ARE AND WHAT THEY ARE USED FOR

Fluconazole belongs to a group of medicines called “antifungal”.

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 infection is 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 capsules to:
• stop cryptococcal meningitis from coming back
• stop mucosal thrush from coming back
• reduce recurrence of vaginal thrush
• 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 capsules 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

BEFORE YOU TAKE FLUCONAZOLE 150mg CAPSULES

If you have any doubts about whether you should take these capsules then discuss with your doctor before taking them.

Do not take Fluconazole 150mg capsules
• If you are allergic to any of the ingredients of Fluconazole 150mg capsules (listed in section 6 of leaflet)
• If you are allergic to any other medicines that you have taken to treat a fungal infection. The symptoms may include itching, reddening of the skin or difficulty in breathing
• If you are taking terfenadine or astemizole (an antihistamine for allergies)
• If you are taking cisapride (used for stomach upsets)
• If you are taking quinidine (used for heart disease).
• If you are taking pimozide (for treating a mental disorder (Schizophrenia).
• If you are taking erythromycin (an antibiotic for treating infections).

Take special care with Fluconazole 150mg capsules

Before taking Fluconazole 150mg capsules, tell your doctor if;

• you are suffering from liver or kidney problems
• you are suffering from heart disease, including heart rhythm problems
• you have abnormal levels of potassium, calcium or magnesium in your blood
• develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)

Taking 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) as these should not be taken with Fluconazole Capsules.
There are some other 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)
• 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

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those medicines obtained without a prescription.

Taking Fluconazole 150mg capsules with food and drink
You can take your medicine with or without a meal.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. You should not
Take Fluconazole capsules while you are pregnant or breast-feeding unless your doctor has told you
To.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Fluconazole 150mg capsules occasionally causes dizziness or seizures may occur which
Could affect your ability to drive or use machinery.

Important information about some of the ingredients
Fluconazole 150mg capsules contain a small amount of lactose monohydrate. If you have
Been told by your doctor that you have intolerance to some sugars, please contact your
doctor before taking this medicine.

HOW TO TAKE FLUCONAZOLE 150mg CAPSULES

Always take your medicine exactly as your doctor has told you.
You should 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 usual doses of this medicine for different infections are below:
Adults

Condition Dose
To treat cryptococcal meningitis 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 coming back 200 mg once daily until you are told to stop
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 caused by Candida 800 mg on the first day then 400 mg once daily until you are told to stop
To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth 200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop
To treat mucosal thrush – dose depends on where the infection is located 50 mg to 400 mg once daily for 7 to 30 days until you are told to stop
To stop mucosal infections affecting the lining of mouth, throat 100 mg to 200 mg once daily or 200 mg 3 times a 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 thrush 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 caused by Candida (if your immune system is weak and not working properly) 200 mg to 400 mg once daily while you are at risk of getting an infection

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 Dose
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 3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day)
Cryptococcal meningitis or internal fungal infections caused by Candida 6 mg to 12 mg per kg of body weight
To stop children from getting an infection caused by Candida (if their immune system is not working properly) 3 mg to 12 mg per kg of body weight

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 modify your dose, depending on your kidney function.

If you take more Fluconazole 150mg capsules than you should
Taking too many capsules at once may make you unwell. Contact your doctor or you’re 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 150mg capsules
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 almost time for your next dose, do not take the dose that you
missed.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, Fluconazole 150mg capsules 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 150mg capsules may affect your liver. The signs of liver problems include:
• tiredness

If any of these happen, stop taking Fluconazole 150mg capsules and tell your doctor immediately.

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 affect 1 to 10 users in 100 are listed below:

• headache
• stomach discomfort, diarrhoea, feeling sick, vomiting
• increases in blood tests of liver function
• rash

Uncommon side effects which affect 1 to 10 users 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

Rare side effects which affect 1 to 10 users in 10,000 are listed below:
• 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

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.

HOW TO STORE FLUCONAZOLE 150mg CAPSULES

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use your capsules after the expiry date stated on the label or carton.

Medicines should not be disposed of via waste water or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.

FURTHER INFORMATION

What Fluconazole 150mg Capsules contains

The active substance is Fluconazole.
The other ingredients are lactose monohydrate, maize starch, sodium lauryl sulphate,
colloidal anhydrous silica, magnesium stearate, titanium dioxide (El 71), patent blue V
(E 131) and gelatin.(see section 2 for Important information about some of the ingredients of
Fluconazole 150mg Capsules).

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