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PACKAGE LEAFLET: INFORMATION FOR THE USER_

FLUCONAZOLE 50MG CAPSULES _FLUCONAZOLE 200MG CAPSULES_

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 any 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 Capsules are and what they are used for

2.    What you need to know before you take Fluconazole Capsules

3.    How to take Fluconazole Capsules

4.    Possible side effects

5.    How to Store Fluconazole Capsules

6.    Contents of the pack and other information

1. What Fluconazole Capsules are and what they are used for

The name of your medicine is Fluconazole 50mg or 200mg Capsules and the active ingredient is Fluconazole. Fluconazole is one of a group of medicines called "antifungals”.

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 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 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 Capsules Do not take Fluconazole if you:

•    are allergic (hypersensitive) to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of Fluconazole capsules. The symptoms may include itching, reddening of the skin or difficulty in breathing

•    are taking terfenadine or astemizole (an antihistamine for allergies)

•    are taking cisapride (used for stomach upsets)

•    are taking pimozide (for treating mental illness)

•    are taking quinidine (used for irregular heart beats)

•    are taking erythromycin (an antibiotic for treating infections)

Warnings and Precautions

Talk to your doctor or pharmacist before taking Fluconazole capsules.

Tell your doctor if you:

-    have liver or kidney problems

-    suffer from heart disease, including heart rhythm problems

-    have abnormal levels of potassium, calcium or magnesium in your blood

-    develop skin reactions (itching, reddening of the skin or difficulty in breathing

-    develop signs of 'adrenal insufficiency' where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)

Other medicines and Fluconazole Capsules

Tell your doctor, immediately if you are taking Terfenadine or astemizole (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 (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:

•    hydrochlorothiazide or eplerenone (types of diuretic or "water tablet”)

•    warfarin, indanedione (or similar drugs) that thin the blood to prevent blood clots

•    nifedipine, isradipine, amlodipine, felodipine, nisoldipine and losartan (for hypertension-high blood pressure)

•    amiodarone (used for treating uneven heartbeats 'arrhythmias' )

•    medicines for diabetes such as chlorpropamide, glibenclamide, glipizide or tolbutamide

•    vitamin A (as a trans-retinoid acid used to treat acne)

•    Statins (atorvastatin, simvastatin and fluvastatin or similar medicines) used for reducing high cholesterol levels.

•    benzodiapines (midazolam, triazolam or similar medicines) used to help you sleep or for anxiety.

•    carbamazepine or phenytoin (used to control epilepsy)

•    medicines for treating infections (antibiotics) such as azithromycin, erythromycin, rifampicin or rifabutin

•    amphotericin B (used to treat fungal infections)

•    halofantrine (to treat malaria)

•    Ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)

•    oral contraceptives such as ethinyloestradiol, levonorgestrel, norethindrone

•    theophylline (used to control asthma)

•    alfentanil, fentanyl or methadone (for treating pain)

•    celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (Non-Steroidal Anti-Inflammatory Drugs (NSAID))

•    amitriptyline, nortriptyline (used to treat migraine)

•    cyclophosphamide, prednisone or vinca alkaloids (for treating some forms of leukaemia)

•    saquinavir or zidovudine, also known as AZT, nevirapine, ritanovir, tipranavir. (used in HIV infected patients)

•    bosentan (used to treat hypertension)

•    drugs used to treat migraine (such as ergot alkaloids e.g. ergotamine or methylsergide)

•    antimalarial drugs such as artemether and lumefantrine

•    ivabradine (used to treat angina)

•    voriconazole (an antifungal drug)

•    ivacaftor (used for treating cystic fibrosis)

Please tell your doctor or pharmacist if you are taking or have recently

taken or might take any other medicines.

Fluconazole Capsules with food, drink and alcohol

You can take your medicine with or without a meal

Pregnancy, breast-feeding and fertility

•    Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these capsules or are breast-feeding.

•    Always ask your doctor or pharmacist for advice before taking any other medicine.

Driving and using machines

•    Treatment with Fluconazole has occasionally lead to dizziness or fits to occur and could affect your ability to drive or use machinery.

Fluconazole Capsules contain Lactose

•    If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.

Fluconazole Capsules contain Methyl parahydroxybenzoate (E218)

and Propyl parahydroxybenzoate (E216)

•    E216 and E218 in this medicine might cause allergic reactions (possibly delayed)

3. How to take Fluconazole Capsules

•    Always take this medicine exactly as advised by your doctor.

•    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:

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Same size artwork 360 mm x 160 mm Front

Adolescents from 12 to 17 years old

Follow the dose prescribed by your doctor (either adults or children posology).

Children 4 weeks 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.

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.

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 capsules 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 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.

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 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 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 (may affect up to 1 in 10 people) are:

•    headache

•    stomach discomfort, diarrhoea, feeling sick, vomiting

•    increases in blood tests of liver function

•    rash

Uncommon side effects (may affect up to 1 in 100 people) are:

•    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 (may affect up to 1 in 1,000 people) are:

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to Store Fluconazole Capsules

•    Keep this medicine out of the sight and reach of children.

•    Containers: Do not store above 25⁰C. Keep the container tightly closed.

•    Blister packs: Do not store above 25⁰C. Store in the original package.

•    Do not use this medicine after the expiry date (exp.) which is stated on the pack. The expiry date refers to the last day of that month.

•    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 Capsules contain:

•    The active substance is Fluconazole

•    The other ingredients are: Lactose anhydrous, Maize starch, Colloidal anhydrous silica, Sodium lauryl sulfate, Magnesium stearate and the capsule shell contains Gelatin, Titanium dioxide (E171), Methylparahydroxy benzoate (E218) and Propylparahydroxy benzoate (E216). The 50mg capsules contains: Patent blue (E131). The 200mg capsules contains: Erythrosine (E127), Indigo carmine (E132).

What Fluconazole Capsules look like and contents of the pack

•    Fluconazole 50mg capsules are White to off white powder filled in Blue/White coloured hard gelatin capsules of size ”4”

•    Fluconazole 200mg capsules are White to off white powder filled in Purple/white coloured hard gelatin capsules of size ”0”

•    The capsules are supplied in blister packs containing 7 capsules and containers containing 500 capsules.

•    Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Name and address:    Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom.

Telephone:    0044 (0)1442 200922

Fax:    0044 (0)1442 873717

Email:    info@bristol-labs.co.uk

Fluconazole 50mg Capsules; PL 17907/0054 Fluconazole 200mg Capsules; PL 17907/0056 This leaflet was last revised in February 2016

To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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