370 LEAFLET Diflucan 20160419

PACKAGE LEAFLET: INFORMATION FOR THE USER DIFLUCAN CAPSULES 150mg FLUCONAZOLE CAPSULES 150mg (fluconazole)

Your medicine is known as the above names but will be referred to as Diflucan throughout the following leaflet.

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, pharmacist or nurse.

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

What is in this leaflet:

1.    What Diflucan is and what it is used for

2.    What you need to know before you take Diflucan

3.    How to take Diflucan

4.    Possible side effects

5.    How to store Diflucan

6.    Contents of the pack and other information

1. WHAT DIFLUCAN IS AND WHAT IT IS USED FOR

Diflucan is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Diflucan 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 Diflucan 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 Diflucan 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 DIFLUCAN

Do not take Diflucan

-    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)

Warnings and precautions

Talk to your doctor or pharmacist before taking Diflucan

-    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 Diflucan

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 Diflucan (see section: “Do not take Diflucan if you”).

There are some medicines that may interact with Diflucan. 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)

-    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)

-    ivacaftor (used for treating cystic fibrosis)

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Diflucan with food and drink

You can take your medicine with or without a meal.

Pregnancy, 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 Diflucan while you are pregnant unless your doctor has told you to.

You can continue breast-feeding after taking a single dose of Diflucan up to 200 mg.

You should not breast-feed if you are taking a repeated dose of Diflucan.

Driving and using machines

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

Diflucan contains lactose (milk sugar)

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.

3. HOW TO TAKE DIFLUCAN

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 recommended doses of this medicine for different infections are below:

Adults

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.

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 change your dose, depending on your kidney function.

If you take more Diflucan 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 Diflucan

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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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).

Diflucan 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 Diflucan 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

5. HOW TO STORE DIFLUCAN

•    Do not store the medicine above 30°C.

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not use after the expiry date printed on the carton label or blister.

•    If the capsule becomes discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will advise you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Diflucan contains

•    Each capsule contains 150mg of the active ingredient fluconazole.

•    Diflucan capsules also contain lactose, maize starch, colloidal silicon dioxide, magnesium stearate and sodium lauryl sulphate.

The capsule shell contains gelatin, titanium dioxide (E171) and patent blue V(E131). The black printing ink is composed of shellac, black iron oxide (E172), N-Butyl alcohol, dehydrated alcohol, purified water, propylene glycol, industrial methylated spirit, isopropyl alcohol, strong ammonia solution and potassium hydroxide.

What Diflucan looks like and contents of the pack

•    Diflucan capsules are turquoise blue and are marked Pfizer on one end and FLU-150 on the other, in black printing ink.

•    Diflucan Capsules comes in pack containing 1 capsule.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,

Wembley, Middlesex HA0 1DX.

Manufacturer

The capsules are made by

•    Pfizer SARL, BP 109, 37401 Amboise Cedex, France.

•    Pfizer, PGM, Zone Industrielle de Pocesur-Cisse, 37401 Amboise Cedex, France.

•    Fareva Amboise, zone industrielle, 29 route des industries, 37530 poce sur cisse, France.

|POM | PL: 08747/0370

Leaflet revision date: 19 April 2016

Diflucan is a registered trade mark of Pfizer Ltd, UK.

370 LEAFLET Diflucan 20160419