Fluconazole 150mg Capsules

Document: leaflet MAH GENERIC_PL 20395-0041 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Fluconazole 50mg, 150mg & 200mg Capsules

Fluconazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. WhatFluconazoleCapsulesareand 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. WhatFluconazoleCapsulesareand what they are used for

Fluconazole is one ofa group of medicines known as triazole antifungal agents. Fluconazole Capsules are used to treat infections caused by fungi / yeasts. Fluconazole may also be used to stop you getting a fungal infection. The most common cause offungal infections is a yeast called Candida.

You may be given this medicine by your doctor to treat fungal infections such as:

• Thrush ofthe mouth orthroat. Thrush is commonly caused by Candida.

• Skin infections e.g. athlete's foot, ringworm.

• Internal (systemic) fungal infections caused by Candida- e.g. infections of the blood stream, urinary tract or other body organs.

• Internal (systemic) fungal infections caused by Cryptococcus e.g. cryptococcal meningitis and infections ofother sites such as the lungs and skin.

• Genital Cand/da infections e.g. vaginal thrush or candidal balanitis (inflammation of the end of the penis and/or foreskin).

• You may also be given Fluconazole Capsules to:

• Stop you getting a fungal infection (if your immune system is not working properly).

• Prevent an infection caused by Cryptococcus from coming back (in AIDS patients).

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

Do not take Fluconazole Capsules

• If you have ever had an allergic reaction to any of the ingredients of Fluconazole Capsules (listed in section 6) or other medicines to treat a fungal infection. This may have been itching, reddening ofthe skin or difficulty breathing.

• If you are taking terfenadine or astemizole (antihistamines which are often used to treat symptoms of allergies such as runny nose, itchy eyes and sneezing), cisapride (used for stomach upsets) or sotalol (for heart rhythm disturbances) or amiodarone.

• If you are taking medicine(s) to control your heart rate or rhythm or If you are taking Erythromycin (an antibiotic for treating infections).

• If you have a slow heart rate or serious heart rhythm disturbance or heart failure. Also if you have ever been told that you have a long QT interval a type of heart rhythm disturbance that is found on ECG's (electrocardiogram used to record rhythms and electrical activity of the heart).

• If you suffer from low levels of potassium, calcium or magnesium in your blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking these tablets:

• If you have liver or kidney problems.

• If you have a serious ongoing illness such as AIDS, cancer or severe problems with your blood.

• If you have taken Fluconazole previously and have had problems with your liver.

• If you suffer from heart disease, including heart rhythm problems.

• If you have abnormal levels of potassium, calcium or magnesium in your blood?

Other medicines and Fluconazole Capsules

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

• Warfar/n or coamar/n drugs to prevent blood clots.

• Oral antidiabetics (sulphonylureas) e.g chlorpropamide, glibenclamide, glipizide or tolbutamide.

• Diuretics used to treat fluid retention and high blood pressure e.g hydrochlorothiazide

• Tranquillizers e.g Benzod/azep/nes

• Phenyfo/n used to control epilepsy.

• Antibiotics e.g rifampicin or rifabutin.

• C/c/ospodn, evero/Zmas, facro//mas or sirolimus used to affect the immune response.

• T/reop/ryffine used to control asthma.

• Asfem/zo/e orferfenad/ne antihistamines (antihistamines which are often used to treat symptoms ofallergies such as runny nose, itchy eyes and sneezing).

• D/daaos/ae, saquinavir or zidovudine also known as AZT used in HIV-infected patients.

• Cisapride an ulcer-healing drug.

• Oral contraceptives.

• Ergot alkaloids for migraine.

• HMG-CoA reductase inhibitors such as atorvastatin or fluvastatin used to lower blood cholesterol.

• Quinidine for heart rhythm disturbance.

• Calcium channel antagonists used to control angina and/or high blood pressure including nifedipine, isradipine, nicardipine, amlodipine and felodipine.

• Losarfan used to control high blood pressure.

• Tdmefrexafe to treat pneumonia.

• Predn/sone a steroid.

• Amitriptyline or nortriptyline, antidepressants.

• Celecoxib to treat arthritis.

• Amp/rofedc/n B used to treat fungal infections.

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

• Halofantrine (to treat malaria).

• Alfentanil, fentanyl or methadone (for treating pain).

• Non-steroidal anti inflammatory drugs (such as aspirin and ibuprofen) that are used to treat the pain and fever.

• Pimozide (to treat schizophrenia and chronic psychosis)

• Erythromycin (an antibiotic used for treating infection), azithromycin (antibiotics)

• Carbamazapine to treat epilepsy and bi polar disorder.

• Cyclophosphamide to treat lymphoma and some forms of leukemia.

• Endogenous steroids and vinka alkaloids.

• Quinidine used to treat abnormal heart rythmns

• Voriconazole used to treat fungal infections

• Ivacaftor (used for treating cystic fibrosis)

Fluconazole Capsules with food and drink

Swallow the capsules with a glass ofwater. You may take your medicine with or without a meal.

Pregnancy and Breast-feeding

Tell your doctor if you are, think you might be pregnant or planning to become pregnant or are breast-feeding.

You should not take Fluconazole capsules while you are pregnant or if you are breast feeding.

Driving and using machines

Fluconazole Capsules may occasionally cause dizziness or fits. If affected do not drive or operate machinery.

Fluconazole Capsules contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Fluconazole Capsules

Always take Fluconazole Capsules exactly as

your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Fluconazole Capsules should be taken by mouth. Swallow your capsules with a glass of water.

The usual oral dose:-Adults:

• Mucosal (the moist lining inside the mouth) infections of mouth: 50-100mg once daily for 7-14 days.

• Mucosal infections of throat, lungs and genital areas: 50-100mg once daily for 1430 days.

• Fungal skin infections: 50mg once daily for 2-4 weeks. Athlete's foot may need up to 6 week's treatment.

• Internal fungal infections caused by Candida: 400mg on the first day then 200400mg once daily.

• Internal fungal infections caused by Cryptococcus: 400mg on the first day then 200-400mg once daily for 6-8 weeks.

• To stop you from getting a fungal infection: 50-400mg once daily while you are at risk ofgetting an infection.

• To prevent a cryptococcal infection from coming back: 100-200mg once daily indefinitely.

• To treat a genital Candida infection:

150mg as a single oral dose.

Children:

The capsules are not intended for children who are unable to take oral medication.

Children offourweeks ofage and younger:

A maximum dosage of12mg/kg every 72 hours should not be exceeded in children in the first two weeks of life. For children between 3 and 4 weeks of life, 12mg/kg every 48 hours should not be exceeded.

4 weeks to 15years old:

• Mucosal infections: 3mg/kg once daily.

• Internal fungal infections caused by Candida orCryptococcus: 6-12mg/kg once daily.

• Prevention offungal infections: 3-12mg/kg once daily while at risk of getting an infection.

Children should not take more than 400mg daily.

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. The normal dose is usually given on the first day of treatment and then halfthe usual dose daily. People on dialysis are given the usual adult dose after each session.

Ifyou take more Fluconazole Capsules than you should

Taking too many capsules at once may make you feel unwell, if you take too many or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

Ifyou forget to take Fluconazole Capsules

Tryto take Fluconazole Capsules as prescribed. However, ifyou miss a dose wait until the next dose is due then continue as before. Do not take a double dose to make up for the forgotten one.

Ifyou stop taking Fluconazole Capsules

Do not stop taking Fluconazole Capsules without first discussing it with your doctor.

If you have any further questions on the use of Fluconazole Capsules ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. A few people develop allergic reactions to medicines. If you develop any of the following reactions, tell your doctor immediately.

• Sudden wheezing, difficulty in breathing, tightness in the chest.

• Swelling of the eyelids, face or lips.

• Skin lumps or red itchy spots.

• An itch all over your body.

• Severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue).

• If you are an AIDS patient you are more likely to get severe skin reactions to drugs including Fluconazole Capsules.

Uncommon (between 1 in100 and 1 in

1,000)

• Changes in the number of red blood cells (anaemia)

• Decreased appetite

• Sleep disturbances, feeling sleepy

• Fits (seizures)

• Dizziness, tingling in the hands and feet

• Changes in the sense of taste

• Spinning sensation (vertigo)

• Dry mouth, constipation, wind, indigestion

• Problems with the liver including yellowing of the eyes and skin

• Itching, skin rash, increased in sweating

• Muscle ache

• Tiredness, fatigue, weakness, fever

Rare (less than 1 in 1,000 patients)

• Changes in your blood. These will be picked up during a blood test

• High blood levels of cholesterol and fats. These will be picked up during a blood test

• Low levels of potassium in the blood. These will be picked up during a blood test

• Shaking (tremor)

• Changes in the heart rate or rhythm

• Liver failure, swelling of the liver (hepatitis), liver injury

• Hair loss

Common (between 1in10 and 1 in 100)

• Headache

• Abdominal pain, diarrhoea, feeling sick, being sick

• Increased in liver enzymes. These will be picked up during a blood test

• Rash

Reporting ofside effects

If you get any side effects, talk to your doctor or 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 out of the sight and reach of children.

Keep in the original packaging.

Do not use after the expiry date shown on the carton.

The expiry date refers to the last day of that month.

Medicines should not be disposed ofvia wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 50mg capsules contain 50mg fluconazole, 150mg capsules contain 150mg fluconazole and 200mg capsules contain 200mg fluconazole.

The other ingredients are colloidal silicon dioxide, lactose, magnesium stearate, maize starch, sodium lauryl sulphate and gelatin.

The colouring agents in the capsule shell are: 50mg capsules: titanium dioxide (E171), yellow iron oxide (E172) and indigo carmine (E132).

150mg capsules: titanium dioxide (E171) and Patent BlueV(E131).

200mg capsules: titanium dioxide (E171).

What Fluconazole Capsules look like and contents of the pack:

50mg capsules have a white body and green cap and are supplied in packs of 7 capsules. 150mg capsules have a blue body and cap and are supplied in packs of 1 capsule.

200mg capsules have a white body and cap and supplied in packs of 7 capsules.

Fluconazole Capsules are packed in PVC blister packs.

Marketing Authorisation Holderand Manufacturer

Relonchem Limited Cheshire House, Gorsey Lane Widnes, Cheshire, WA8 0RP, UK

PL 20395/0040 PL 20395/0041 PL 20395/0043

I POM I

This leaflet was last revised in October 2015.