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PACKAGE LEAFLET: INFORMATION FOR THE USER

_FLUCONAZOLE 150 mg CAPSULE_

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.

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

•    You must talk to doctor if you do not feel better or if you feel worse after few days.

What is in this leaflet:

1.    What Fluconazole Capsule is and what it is used for

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

3.    How to take Fluconazole Capsule

4.    Possible side effects

5.    How to store Fluconazole Capsule

6.    Contents of the pack and other information.

1.    What Fluconazole Capsule is and what it is used for

The name of your medicine is Fluconazole 150mg Capsule. Fluconazole Capsule is a full course of treatment for thrush.

Only use this product if you have been previously diagnosed by your doctor as having thrush.

The active substance in Fluconazole Capsule is fluconazole. Fluconazole belongs to a group of medicines called azoles and is an antifungal agent which fights the cause of infections such as thrush.

2.    What you need to know before you take Fluconazole

Capsule

Do not take Fluconazole Capsule 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 Capsule. 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)

-    are taking ergot derivatives (ergotamine used for migraine)

-    are taking amiodarone (used for rhythm disorders)

Warnings and Precautions

Do not take Fluconazole Capsule without consulting your doctor if:

•    you are aged under 16 or over 60 years.

•    you have had thrush more than twice in the last six months

•    you have had any disease or illness affecting the liver or kidneys, or have had any unexplained jaundice.

•    you have heart diseases, including heart rhythm problems, or low levels of potassium, magnesium or calcium in your blood

•    you suffer from any other chronic diseases or illness.

•    you or your partner have been exposed to a sexually transmitted disease

•    you are unsure whether you have thrush or this is the first time you have had these symptoms.

Men:

Do not use Fluconazole Capsule without talking to your doctor first if:

•    your sexual partner does not have thrush

•    you have pain or difficulty on passing urine

•    you have an abnormal discharge from your penis

•    you have sores, ulcers or blisters on your penis.

•    your penis has started to smell

Women

If you have any of the following symptoms do not use Fluconazole Capsule and see your doctor as soon as possible:

•    Irregular vaginal bleeding.

•    Abnormal vaginal bleeding or a blood-stained discharge.

•    Ulcers, blisters or sores of the vagina or vulva.

•    Lower abdominal pain.

•    Pain or difficulty in passing urine.

•    Fever or chills.

•    Feeling sick or vomiting.

•    Diarrhoea.

•    A foul smelling discharge from the vagina.

This is because Fluconazole Capsule may not be the right treatment for you.

Other medicines and Fluconazole Capsule

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 Capsule (see section-2: ”Do not take Fluconazole Capsule 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:

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

•    Anti-arrhythmics (to control irregular heart beats)

•    amiodarone (used for rhythm disorders)

•    Astemizole (antihistamine)

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

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

•    vitamin A (nutritional supplement)

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

•    Carbamazepine, Phenobarbital or phenytoin (used to control epilepsy)

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

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

•    amphotericin B, voriconazole, ketoconazole (anti-fungal)

•    halofantrine (used for treating malaria)

•    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 as anti-depressant)

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

•    Saquinavir or zidovudine also known as AZT (used in HIV infected patients)

•    ivacaftor (used for treating cystic fibrosis)

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

taken any other medicines, including medicines obtained without a

prescription.

Fluconazole Capsule with food, drink and alcohol

•    You can take your medicine with or without a meal. Fluconazole Capsule should be swallowed whole with a glass of water.

•    There is no known interaction with alcohol.

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 this Capsule 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 led to dizziness or fits to occur and could affect your ability to drive or use machinery.

Fluconazole Capsule contains 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 Insert Same size artwork 340 mm x 140 mm Front

Fluconazole Capsule contains Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216)

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

3. How to take Fluconazole Capsule

If Fluconazole Capsule have been prescribed for you by your doctor, follow any instructions he/she may have given you. If you purchased this product without a prescription, follow these directions closely: The full course of treatment consists of a single Fluconazole Capsule. The capsule is to treat thrush at the site of infection and should be swallowed whole with a glass of water (with or without food). The symptoms of thrush should disappear within two days of treatment. If no improvement is seen after seven days, you must tell your doctor. If the infection returns after seven days another capsule may be taken but if you have more than two infections within six months you should see your doctor.

If you take more Fluconazole Capsule than you should:

If more than one capsule is taken, tell your doctor straight away or contact the Accident and Emergency Department of your nearest hospital.

4. Possible Side Effects

Like all medicines, Fluconazole 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 swallowing, breathing or tightness in chest

•    Swelling of eyelids, face, lips, throat or tongue

•    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.

The following undesirable effects have been observed and reported during the treatment of fluconazole with the following frequencies. Common: may affect up to 1 in 10 people

-    headache

-    Abdominal Pain

-    Diarrhoea

-    Nausea

-    Vomiting

-    Rash

Uncommon: may affect up to 1 in 100 people

-    Insomnia

-    Somnolence (feeling sleepy)

-    Dizziness

-    Seizures

-    Altered sense of taste

-    Vertigo

-    decreased appetite

-    Liver damage and yellowing of skin and eyes, dark urine or pale stools

-    Myalgia (muscle pain)

-    Fatigue, malaise

-    Feeling of weakness (asthenia)

-    Tingling or numbness in the hands or feet (paraesthesia)

-    Itching (pruritis)

-    Skin rash which is red and itchy (urticaria)

-    Cold and Flu

-    Dyspepsia (stomach discomfort), constipation, wind, dry mouth

-    Increased sweating

-    Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia).

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

-    Serious allergic reaction which causes difficulty in breathing or dizziness

-    Lower than normal white blood cells (leukopenia)

-    Serious allergic reaction which causes swelling of the face or throat (Angioedema)

-    Serious blistering of skin, mouth, eyes and genitals

-    Irregular heart beat

-    Tremor

-    Red or purple discoloration of the skin which may be caused by low platelet count (thrombocytopenia), other blood cell changes, lowernumber of neutrophils (neutropenia) causing frequent infections.

-    High blood levels of cholesterol, fats and salt

-    Liver damage

-    Hair loss (Alopecia)

-    Low blood potassium 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 Capsule

•    Keep out of the reach and sight of children.

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

•    Do not use fluconazole after the expiry date (exp.) which is stated on the pack. The expiry date refers to the last day of the 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 Capsule contains:

•    The active substance is Fluconazole

•    The other ingredients are: lactose anhydrous, maize starch, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate.

•    The capsule shell contains gelatin, titanium dioxide (E171), patent blue (E131), methylparahydroxy benzoate (E218) and propylparahydroxy benzoate (E216).

What Fluconazole Capsule looks like and contents of the pack. Fluconazole 150mg Capsule is white to off white powder filled in Blue/ blue coloured hard gelatin Capsule of size '1'.

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    150mg Capsule; PL 17907/0055

This leaflet was last revised in November 2015

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.

V6 27-10-2015 D0

Fluconazole Insert Same size artwork 340 mm x 140 mm Back