PATIENT INFORMATION LEAFLET

Fluconazole 50, 100, 150, 200mg Capsules

(Fluconazole)

□ WHAT FLUCONAZOLE IS AND WHAT IT IS USED FOR

Fluconazole belongs to a group of medicines called "antifungals”.

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 infection is 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

□ WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCONAZOLE

Do not take Fluconazole:

■    If you are allergic (hypersensitive) to fluconazole, to azoles or any of the other ingredients of this medicine (see Section 6 "Contents of the pack and other information”)

■    If you are taking any of the following medicines (see "Other medicines and Fluconazole”):

o cisapride, (used for stomach upsets) o astemizole, terfenadine, (antihistamine medicines for allergies)

o pimozide, (used to treat mental illness) o quinidine, (used to treat heart arrhythmia) o erythromycin, (an antibiotic for treating infections)

Warnings and precautions

Talk to your doctor before taking Fluconazole:

■    If you have a fungal infection of the scalp (called 'tinea capitis')

■    If you have liver problems

If your liver values deteriorate during fluconazole treatment (symptoms include: feeling and/or being sick [nausea, vomiting], abdominal pain, weakness, weight loss and yellowing of the skin or whites of the eyes), your doctor should monitor you carefully and discontinue the therapy as soon as signs indicating liver damage occur. The alterations are usually reversible.

■    If you suffer from heart disease, including heart rhythm problems

■    If you have abnormal levels of potassium, calcium or magnesium in your blood (electrolyte disorders should be corrected prior to fluconazole treatment).

■    If you develop sever skin reactions (itching, reddening of the skin or difficulty in breathing) during fluconazole treatment, the therapy with Fluconazole should discontinued or carefully monitored by the doctor.

■    If your kidney function is severely impaired, the dose must be reduced accordingly (see also section 3 "How to take Fluconazole")

■    If you have a serious disease such as AIDS or cancer as your haematology, liver, kidney or other biochemical function test results may be abnormal

■    If you are under 16 (Fluconazole should only be used in children under 16 years of age if no other alternative treatment is available)

■    If you are older than 65 years of age. The dosage should be adjusted in patients with impaired kidney function, (see Section 3 "How to take Fluconazole”).

Other medicines and Fluconazole

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Fluconazole must not be taken concomitantly with the following medicines: o cisapride, (used for stomach upsets) o astemizole, terfenadine, (antihistamine medicines for allergies)

o pimozide, (used to treat mental illness) o quinidine, (used to treat heart arrhythmia) o erythromycin, (an antibiotic for treating infections)

treatment with:

■    Hydrochlorothiazide, used to treat fluid retention and high blood pressure

■    Rifampicin, used to treat tuberculosis

The effect of the following medicines may be influenced by concomitant fluconazole use:

■    Alfentanil, an anaesthetic

■    Amitriptyline, nortriptyline, used to treat depression

■    Amphotericin B, Itraconazole, used to treat fungal infections

■    Medicines used to thin the blood (anticoagulants) such as warfarin

■    Benzodiazepines such as midazolam and triazolam, used to help you sleep or for anxiety

■    Nifedipine, isradipine, nicardipine, amlodipine, verapamil felodipine, losartan, used to treat high blood pressure

■    Carbamazepine, phenytoin, used to treat epilepsy

■    Cyclosporin, tacrolimus, sirolimus, everolimus,(immunosuppressants), used to reduce the body's immunity when receiving organ transplant

■    Cyclophosphamide, vinca alkaloids, such as vincristine and vinblastine, used to treat cancer

■    Didanosine, saquinavir or zidovudine used to treat HIV infection

■    Halofantrine (a medicine used to treat malaria)

■    Fentanyl or methadon, used to treat pain

■    Medicines used to lower high cholesterol levels such as atorvastatin, simvastatin and fluvastatin. Concomitant use can increases the risk of alterations in skeletal muscles.

■    Celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac, (Non-steroidal anti-inflammatory drugs [NSAIDs]), used to treat pain and fever

■    Oral contraceptives

■    Phenytoin, used to treat epilepsy

■    Prednisone, a cortisone

■    Rifabutin, used to treat tuberculosis

■    Medicines for diabetes such as chlorpropamide, glibenclamide, glipizide, tolbutamide

■    Theophylline, used to treat asthma

■    Trimetrexate, an anticancer medicine

■    Vitamin A (nutritional supplement)

Taking Fluconazole with food and drink

No significant influence is known.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

If you are pregnant or think you may be pregnant, you should not take fluconazole, unless your doctor thinks the benefits outweigh the possible risks.

If you are of child-bearing age and could become pregnant you should not take fluconazole unless you are using adequate contraception.

Breast-feeding

Fluconazole is pass into breast milk. Breast-feeding can be continued after single use of a standard 200mg dose of fluconazole or less. Breast-feeding is not recommended after repeated use or after high-dose Fluconazole.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines.

However dizziness or seizures may occur. If affected, do not drive or use machinery.

Fluconazole contains lactose

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

Fluconazole 200 mg Capsule contains colouring agent ponceau 4R, which may cause allergic reactions.

HOW TO TAKE FLUCONAZOLE

Always take Fluconazole exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

■    These capsules should be swallowed whole (unchewed) with a glass of water

■    The capsules can be taken before or after meal.

The recommended dose is:

Adults

■    To treat internal Fungal infections caused by Candida

400 mg on the first day then 200 mg once daily until you are told to stop.

If required, the dose may be increased to 400 mg once daily.

Your doctor will decide the duration of administration. It is recommended that treatment is continued until the laboratory tests exclude the fungal infection.

■    To treat Cryptococcal meningitis

400 mg on the first day then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if needed.

■    To stop Cryptococcal meningitis from coming back

100 mg to 200 mg once daily until you are told to stop.

■    To treat Candida pathogens in urine

50 mg once daily. In severe cases, the dose may be increased to100 mg once daily for 14-30 days.

■    To treat Fungal infections of superficial mucosae Recurrent fungal infections of mouth and throat:

50 mg once daily. In severe cases, especially in cases of recurrence, the dose may be increased to 100 mg once daily for 7-14 days

In case of severely suppressed immune system, the duration of treatment may be prolonged.

Recurrent infection of the foodpipe (oesophagus) :

50 mg once daily. In severe cases, especially in cases of recurrence, the dose may be increased to 100 mg once daily for 14-30 days.

Chronic-infections in patients with dentures:

50 mg once daily for 14-days. In addition, dental hygiene should be ensured and local disinfectant measures carried out.

Mucosae infection of the upper respiratory tract without lung involvement:

50 mg once daily. In severe cases of the disorder, the dose may be increased to 100 mg, once daily for 14-30 days.

Prophylaxis of candidiasis:

In patients with malignancies during chemotherapy or radiotherapy and in patients with a suppressed immune system (e.g. in AIDS or chemotherapy). o 50 mg once daily to prevent candidiasis in patients with a suppressed immune system. o In patients during chemotherapy or radiotherapy if systemic candidiasis is to be expected e.g. due to severe or prolonged reduction in the number of neutrophilic white blood cells, administration of 400 mg once daily is advisable.

Administration of fluconazole should be initiated 2-3 days prior to the anticipated onset of this cell reduction and continued a further 7 days after the neutrophil number has increased to more than 1000 cells per pl.

■    To treat Fungal infections of the skin:

Fungal infections of the body and lower legs, Pityriasis versicolor:

50 mg once daily or 150 mg once weekly for 2-4 weeks.

Athlete's foot infection:

50 mg once daily up to 6 weeks.

■    Vaginal fungal infections

150 mg as a single dose.

Use in Older people

The usual adult dose should be given unless you have kidney problems.

Use in children and adolescent

Fluconazole should not be used in children under 16 years of age unless no therapeutic alternative is available, as efficacy and safety have not been sufficiently demonstrated. The following doses per kg body weight are recommended for children:

■    To treat Mucosal candidiasis:

6 mg per kg once on the first day then 3 mg per kg daily

■    To treat Systemic candidal and cryptococcal infections:

Recommended dose: 6-12 mg per kg daily, depending on the severity of the infection.

■    Prophylaxis of candidal infections in children with a reduced number of white blood cells:

Recommended dose: 3-12 mg fluconazole per kg daily, depending on the extent and duration of neutropenia (see dose in adults).

In children with impaired kidney function, the dose should be adjusted according to the guidelines for adults (see below), depending on the degree of kidney function impairment.

Adults and children with impaired kidney function

Dosage adjustment is not required for single dose administration.

If several doses of fluconazole are administered " patients with impaired kidney function should receive an initial dose of 50-400 mg fluconazole once on the first day.

Thereafter, your doctor should adjust the dosage for the relevant indication according to your creatinine clearance.

If you take more Fluconazole than you should

If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.

If you forget to take Fluconazole

Take it 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.

If you stop taking Fluconazole

In order to avoid persistence or recurrence of fungal infections, you keep taking Fluconazole for as long as your doctor has told you to. Do not stop taking Fluconazole just because you feel better.

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.

Serious life-threatening effects:

Seek medical advice immediately if you develop the

following symptoms:

■    Difficulty in breathing or dizziness (anaphylaxis)

■    Itching all over the body, reddening of the skin, itchy red spots, skin rash

■    Swelling of the face or throat (angioedema)

■    Blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome or toxic epidermal necrolysis)

■    Irregular heart beat (Torsade de pointes or QT prolongation)

■ decreased appetite

■    insomnia, sleepiness

■    fits

■    tingling or numbness in the hands or feet

■    dizziness

■    altered sense of taste

■    feeling of dizziness or "spinning”

■    loss of appetite, constipation, indigestion, flatulence, dry mouth

■    congestion of bile liquid

■    yellowing of the skin or whites of the eyes caused by liver or blood problems (jaundice)

■    increase in total bilirubin

■    itching, skin eruptions and itchy rash

■    increased sweating

■    muscle pains

■    exhaustion, malaise, weakness, fever

Rare side effects (may affect up to 1 in 1000 people)

■    blood count alterations such as reduction in number of white blood cells and blood platelets reduction in the number of white blood cells, which can increase the risk of infections

■    reduction in blood platelets, which increases risk of bleeding or bruising

■    increased level of cholesterol in blood

■    increased level of triglycerides in blood

■    low blood levels of potassium which can cause muscle weakness, twitching or abnormal heart rhythm (hypokalaemia)

■    shaking (tremor)

■    liver cell destruction

■    liver failure

■    inflammation of the liver

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 internet 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

■    Keep this medicine out of the sight and reach of children.

■    Do not use this medicine after the expiry date which is stated on the carton/blister after "EXP”.

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

■    Do not store above 25 °C.

■    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 to protect the environment.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Fluconazole contains:

Each 50 mg hard capsule contains 50 mg of active ingredient Fluconazole

Each 100 mg hard capsule contains 100 mg of active ingredient Fluconazole

Each 150 mg hard capsule contains 150 mg of active ingredient Fluconazole

Each 200 mg hard capsule contains 200 mg of active ingredient Fluconazole

The other ingredients are lactose monohydrate, gelatin, maize starch, magnesium stearate, sodium laurel sulphate, colloidal silicon dioxide, titanium dioxide (E 171).

Fluconazole 50, 100, 200 mg Capsules also contains: indigo carmine (E 132)

Fluconazole 200 mg Capsules also contains: ponceau 4R (E 124) printing ink: shellac, black iron oxide (E 172), propylene glycol.

What Fluconazole looks like and contents of the pack

Fluconazole 50 mg capsules: hard gelatine capsules, turquoise cap, white body with the imprint FC50, containing a white odourless powder.

Fluconazole 100 mg capsules: hard gelatine capsules, blue cap, white body with the imprint FC100, containing a white odourless powder.

Fluconazole 150 mg capsules: hard gelatine capsules, white cap, white body with the imprint FC150, containing a white odourless powder.

Fluconazole 200 mg capsules: hard gelatine capsules, purple cap, white body with the imprint FC200, containing a white odourless powder.

Fluconazole is available in:

Fluconazole is available in packs of:

50 mg: 1,3, 7, 10, 14, 20, 28, 30, 42, 50 or 100 capsules. 100 mg:1,7, 10, 14, 20, 30, 50 or 100 capsules.

150 mg: 1 or 2 capsules.

200 mg: 7, 10, 14, 20, 30, 50 or 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St Neots Cambridgeshire PE198ET UK

Manufacturer

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben Germany

Product Licence Numbers:

Fluconazole 50mg Capsules: PL 11311/0471 Fluconazole 100mg Capsules: PL 11311/0472 Fluconazole 150mg Capsules: PL 11311/0473 Fluconazole 200mg Capsules: PL 11311/0474

This leaflet was last revised in April 2015

Common side effects (may affect up to 1 in 10 people)

■    feeling or being sick

■    abdominal pain, diarrhoea

■    increase in certain liver values

■    skin rash

■    headache

Uncommon side effects (may affect up to 1 in 100 people)

■ reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (anaemia)

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