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•    tiredness, general feeling of being unwell, fever.

Rare: may affect up to 1 in 1,000 people

•    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.

r5 How to store Fluconazole

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in April 2016

PL 00289/0399 and 0402

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 Fluconazole after the expiry date that is stated on the outer packaging. 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.

©Contents of the pack and other information

What Fluconazole capsules contain:

•    The active ingredient is fluconazole 50 mg or 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 mg capsules: titanium dioxide (E171) and brilliant blue (E133)

•    200 mg capsules: titanium dioxide (E171), azorubine (E122) and brilliant blue (E133).

What Fluconazole capsules look like and contents of the pack:

•    Fluconazole 50 mg are hard gelatin capsules filled with white to yellowish white homogeneous powder, with a light blue opaque cap and white opaque body.

•    Fluconazole 200 mg are hard gelatin capsules filled with white to yellowish white homogeneous powder, with a purple opaque cap and white opaque body.

•    The 50 and 200 mg capsules are available in pack sizes of 7, 10, 20, 30, 50, and 100 capsules.

Not all pack sizes may be marketed.

TTWil

TEVA UK LIMITED    320 x 323

Fluconazole 50 mg and 200 mg capsules

Package leaflet: Information for the user

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. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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.

©

What you need to know before you take Fluconazole

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

OWhat 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 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.

Do not take Fluconazole:

•    if you are allergic to Fluconazole or any of the other ingredients of this medicine (listed in section 6)..

•    if you are allergic to any other medicines you have taken to treat fungal infections.

•    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 uneven heartbeats 'arrhythmias')

Warnings and precautions

Talk to your doctor or pharmacist before

taking Fluconazole

•    if you have kidney or liver 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).

•    if you 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

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) amiodarone (used for treating uneven heartbeats 'arrhythmias') as these should not be taken with Fluconazole (see "Do not take Fluconazole").

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)

•    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)

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•    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 (Non-Steroidal 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').

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

Fluconazole with food and drink

You can take your medicine with or without a meal.

Pregnancy and breast-feeding and fertility

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.

You should not take Fluconazole while you are pregnant or breast-feeding unless your doctor has told you to.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines

When driving vehicles or using machines, it should be taken into account that occasionally dizziness or fits may occur.

Fluconazole contains Lactose and E122 (Azorubine)

•    This medicine contains a small amount of lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.

•    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.

T3 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 recommended doses of this medicine for different infections are below:

Adults