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Package leaflet: Information for the user

Fluconazole 50 mg capsules, hard Fluconazole 100 mg capsules, hard Fluconazole 150 mg capsules, hard Fluconazole 200 mg capsules, hard

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 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 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 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

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

-    are taking astemizole, terfenadine (antihistamine medicines for allergies)

-    are taking cisapride (used for stomach upsets)

- are taking pimozide (used for treating mental illness)

- are taking quinidine (used for treating heart arrhythmia)

-    are taking erythromycin (an antibiotic for treating infections)

Warnings and precautions

Talk to your doctor or pharmacist before using Fluconazole 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 severe 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

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) 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)

-    medicines that thin the blood to prevent blood clots (warfarin, indanedione 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)

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

-    hydrochlorothiazide (used to treat fluid retention)

Fluconazole with food and drink and alcohol

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.

Driving and using machines

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

Fluconazole capsule contains lactose monohydrate, a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Fluconazole capsules

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.

Instructions to remove the capsule from blister pocket:

Pushing the capsule pocket in its middle portion may cause deformation/ breakage of capsule as shown in Fig. A. In order to avoid such damage remove the capsule by pushing the capsule pocket at its edge as shown in Fig. B.

Fig. A    Fig. B

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.

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 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 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 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 may affect up to 1 in 10 people are listed below:

•    headache

•    stomach discomfort, diarrhoea, feeling sick, vomiting

•    increases in blood tests of liver function

•    rash

Uncommon side effects which may affect up to 1 in 100 people 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 to 1 in 1,000 people 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

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.

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 Yellow Card Scheme. Website: 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

Keep out of the sight and reach of children.

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.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Fluconazole contains

•    The active substance is fluconazole.

•    Each capsule contains 50 mg/ 100 mg/ 150 mg or 200 mg fluconazole.

•    The other ingredients are lactose monohydrate, maize starch, sodium lauril sulfate, colloidal anhydrous silica and magnesium stearate.

The capsule shell contains titanium dioxide (E171), sodium lauril sulfate and gelatin.

The printing ink contains shellac, propylene glycol, yellow iron oxide.

What Fluconazole looks like and contents of the pack Fluconazole 50 mg Capsules

Size '4' hard gelatin capsule filled with white to off-white powder and imprinted with 'E' on white to off-white opaque cap and '95' on white to off-white opaque body with yellow ink.

Fluconazole 100 mg Capsules

Size '2' hard gelatin capsule filled with white to off-white powder and imprinted with 'E' on white to off-white opaque cap and '96' on white to off-white opaque body with yellow ink.

Fluconazole 150 mg Capsules

Size '1' hard gelatin capsule filled with white to off-white powder and imprinted with 'E' on white to off-white opaque cap and '97' on white to off-white opaque body with yellow ink.

Fluconazole 200 mg Capsules

Size '0' hard gelatin capsule filled with white to off-white powder and imprinted with 'E' on white to off-white opaque cap and '98' on white to off-white opaque body with yellow ink.

Fluconazole capsules are available in Clear PVC/PVpC-Aluminium blister

Fluconazole 50 mg/100 mg/150 mg/200 mg: 1,2, 3, 4, 5, 6, 7, 10, 14, 20, 21, 28, 30, 50, 60, 90, 100 capsules

HDPE Bottle

Fluconazole 50 mg/100 mg: 30 and 1000 capsules Fluconazole 200 mg: 30 and 500 capsules Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road, South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited HF 26, Hal Far Industrial Estate, Hal Far Brizubbugia BBG 3000 Malta

This medicinal product is authorised in the Member States of the EEA

under the following names:

Austria:    Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg

Hartkapseln

Czech Republic: Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg tvrde tobolky

Denmark:    Fluconazol “Aurobindo”

Germany:    Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200mg

Hartkapseln

Greece:    Fluconazole Aurobindo 50 mg/ 100 mg/ 150 mg Ka^iaKia,

aKAripa

Hungary:    Fluconazol Aurobindo    150 mg kemeny kapszula

Ireland:    Fluconazole Aurobindo 50 mg/ 150 mg/ 200 mg capsules,

hard

Italy:    Fluconazolo Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg

capsule rigide

Netherlands:    Fluconazol Aurobindo 50 mg/ 150 mg/ 200 mg, capsules

Poland:    Fluconazole Aurobindo

Portugal:    Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg

capsulas duras

Romania:    Fluconazol Aurobindo    50    mg/ 100    mg/ 150 mg capsule

Spain:    Fluconazol Aurobindo    50    mg/ 100    mg/ 150 mg/ 200 mg

capsulas duras

Sweden:    Fluconazol Aurobindo 50 mg/ 100 mg/ 150 mg/ 200 mg

kapslar, harda

United Kingdom: Fluconazole 50 mg/ 100 mg/ 150 mg/ 200 mg capsules, hard

This leaflet was last approved in 06/2016.

CL