Fluconazole 50mg Capsules

Document: leaflet MAH GENERIC_PL 21880-0134 change

Package Leaflet: Information for the User

Fluconazole 50mg Capsules

Read all of this leaflet carefully before you start taking this medicine:

- 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 symptoms are the same as yours.

In this leaflet I

1. What Fluconazole 50mg Capsules are and what they are used for

2. Before you take Fluconazole 50mg Capsules

3. How to take Fluconazole 50mg Capsules

4. Possible side effects

5. How to store Fluconazole 50mg Capsules

6. Further information

1. What Fluconazole 50mg Capsules are and what they are used for

Fluconazole is a type of antifungal medicine, which kills fungi or yeasts. Fluconazole 50mg Capsules are used to treat:

• genital thrush of the vagina or penis (genital candidiasis)

• mucosal thrush of the mouth or throat (including when caused by dentures)

• fungal skin infections (such as athlete’s foot, ringworm)

• systemic (internal) fungal infections (caused by Candida and present in the tissues of the abdomen, heart, lung or urinary tract or caused by Cryptococcus, such as cryptococcal meningitis or infections of the lungs or skin).

Fluconazole capsules may also be given to the sexual partners of people who are suffering with genital thrush and to prevent fungal infections (e.g. in patients whose immune systems are not working properly) or to prevent fungal infections coming back (e.g. in AIDS patients).

2. Before you take Fluconazole 50mg Capsules

Do not take Fluconazole 50mg Capsules if you:

• are allergic to fluconazole, other antifungals or to any of the other ingredients in the capsules (see Section 6)

• have serious liver or kidney problems

• are taking terfenadine or astemizole (antihistamines), cisapride (for stomach problems), primozide (for schizophrenia) or quinidine (for heart beat problems

• are pregnant or planning to become pregnant.

Check with your doctor before taking Fluconazole 50mg Capsules if you have:

• liver/kidney problems or a disease which may affect your liver

• heart disease including heart rhythm problems

• AIDS.

Taking other medicines

Tell your doctor if you are taking any of the following as th medicine works.

• azithromycin, erythromycin,rifampicin or rifabutin (types of antibiotics)

• oral contraceptives (the ‘Pill’)

• anticoagulants (to thin the blood) such as warfarin

• theophylline (used to treat asthma)

• zidovudine (AZT), nevirapine, ritonavir, tipranavir, saquinavir (used to treat HIV)

• phenytoin, carbamazepine (for epilepsy)

• reboxetine, amitriptyline (antidepressants)

• calcium channel blockers such as verapamil or diltiazen (for high blood pressure and angina)

• amphotericin B (antifungal medicine)

• halofantine (used to treat malaria)

• simvastatin, atorvastatin (used to control cholesterol)

• methadone (for treatment of heroin addiction)

Please tell your doctor or pharmacist if you are taking or obtained without a prescription and herbal products (such a

y may affect the way this medicine or the other

• hydrochlorothiazide, epterenone (diuretic or ‘water tablet¹)

• benzodiazepines (to help you sleep) such as midazolam

• medicines for diabetes (e.g. chlorpropamide, glibenclamide, glipizide or tolbutamide)

• ciclosporin, sirolimus or tacrolimus (to suppress the immune system, particularly after organ transplants).

• NSAIDs such as ibuprofen, naproxen, diclofenac, celecoxib, parecoxib (analgesic or ‘pain killers’)

• alfentanil, fentanyl (opioid analgesic/‘pain killer’)

• cyclophosphamide, vincristine, vinblastine

(cancer treatments)

• losartan (used to treat high blood pressure)

• prednisone (steroid to treat inflammatory diseases).

have recently taken any other medicine including those s S^t John’s Wort).

Pregnancy and breast-feeding

Do not take Fluconazole Capsules if you are pregnant or think you are pregnant. If you become pregnant whilst taking this medicine, tell your doctor as soon as possible. Fluconazole may pass into breast milk therefore its use during breastfeeding is not recommended.

Driving and using machines

This medicine may make you feel dizzy and can rarely cause seizures. If you are affected, do not drive or operate machinery.

Sugar intolerance

If a doctor has told you that you have an intolerance to some sugars, check with your doctor before taking the capsules, as they contain a sugar called lactose.

3. How to take Fluconazole 50mg Capsules

Always take Fluconazole capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Do not take more than the doctor has told you. Take the capsules with plenty of water. They can be taken with or without food.

Children over 4 weeks of age Mucosal infections: The recommended dose is 3mg/kg bodyweight daily. A dose of 6mg/kg may be given on the first day.

Internal infections and cryptococcal infections:

The recommended dose is 6-12mg/kg daily, depending on the severity of the infection.

To prevent fungal infections: A dose of 3-12mg/kg should be given daily, depending on the risk of infection. A maximum dose of 400mg daily should not be exceeded in children.

Children under 4 weeks of age

In the first two weeks of life, the recommended dose for older children should be followed, but given every 72 hours. In weeks three and four, the same dose should be given every 48 hours.

A maximum dose of 12mg/kg every 72 hours should not be exceeded during the first two weeks of life. A maximum dose of 12mg/kg every 48 hours should not be exceeded during weeks three and four.

Adults

Genital thrush: The usual dose is one 150mg single dose.

Mucosal thrush of the mouth or throat: Usual dose is 50mg-100mg once daily for up to 14 days. For other types of mucosal thrush, this may be continued for up to 30 days. If you have oral thrush due to the use of dentures, you may be given a local antiseptic to use at the same time.

Fungal skin infections: Recommended dose is 50mg once daily for up to 6 weeks.

Systemic (invasive) infections: The usual dose is 400mg on the first day, followed by 200—400mg daily. In cryptococcal infections, this may be continued for up to 8 weeks Prevention of fungal infections: 50-400mg once daily, depending on the risk of infection. To prevent cryptococcal infections coming back in AIDS patients, 100-50mg daily may be given indefinitely.

Elderly and patients with kidney/liver problems Your doctor will decide what dose to give you. This may be lower than the usual adult dose depending on your kidney function.

Duration of treatment

Keep on taking your capsules for as long as your doctor tells you, even if you start to feel better. If you stop too soon, the infection may start up again. Sometimes your doctor may want you to continue taking the capsules to prevent your infection from coming back.

If you take more Fluconazole capsules than you should

If you or someone else swallows several of these capsules together, contact a doctor or the nearest casualty department at once. Take this leaflet or some capsules with you so the doctor will know what you have taken. Symptoms of overdose may include hallucinations (seeing things or hearing voices that don’t exist) and/or extreme fear that others are trying to harm you.

If you forget to take a dose

Take the next dose as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines Fluconazole can cause side effects, although not everybody gets them.

If you suffer from any of the following rare symptoms, stop taking this medicine and tell your doctor at once.

• unexpected skin reactions such as severe rashes, peeling, sore or blistering skin, mouth, eyes and/or genitals (severe skin reactions are more likely in AIDS patients).

• symptoms of liver problems such as yellowing of the skin and whites of the eyes (hepatitis), persistent nausea (feeling sick), tiredness, vomiting (being sick) dark coloured urine, light coloured stools and abdominal (tummy) pain.

• a severe allergic reaction such as Swelling of the eyelids, face, lips, or tongue, blood vessels in the skin, difficulty swallowing or breathing.

• bruising and unusual bleeding which can be due to a change in the number of certain blood cells.

• changes in heart rhythm.

The following side effects have also been reported.

Common

• headache, rash, stomach pain or discomfort, flatulence (wind), diarrhoea, nausea (feeling sick).

Other side effects

• dizziness,vertigo seizures (fits), hair loss, indigestion, vomiting (being sick), changes to your sense of taste, muscle pain (myalgia), fatigue, fever, high blood levels of cholesterol and blood fats, low levels of potassium in the blood.

If any of these side effects become severe or prolonged or if you notice any effects not listed, tell your doctor.

5. How to store

Keep out of the reach and sight of children. There are no special storage requirements. Do not use after the expiry

date stated on the package, which refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask you pharmacist to dispose of medicine no longer required. These measures will help protect the environment.

6. Further information

What is in your capsules

The ingredient which makes the capsule work is fluconazole. Other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, colloidal anhydrous silica, magnesium stearate and sodium laurilsulfate. The capsule shell contains titanium dioxide (E171), quinoline yellow (E104), yellow iron oxide (E172), patent blue V (E131) and gelatin. What your capsules look like

Fluconazole 50mg capsules are green and white and are available in blister packs of seven capsules.

Marketing authorisation holder and manufacturer

Medreich PLC, 9 Royal Parade, Kew Gardens, Surrey , TW9 3QD.