Package leaflet: Information for the user

Fluconazol Takeda 50 mg, 100 mg, 150 mg and 200 mgHard Capsules

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 Fluconazol Takeda is and what it is used for

2. What you need to know before you take Fluconazol Takeda

3. How to take Fluconazol Takeda

4. Possible side effects

5. How to store Fluconazol Takeda

6. Contents of the pack and other information

Fluconazol Takeda is one of a group of medicines called “antifungals”. The active substance is fluconazole.

Fluconazol Takeda 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 Fluconazol Takeda 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)

Childrens 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 Fluconazol Takeda 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

Do not take Fluconazol Takeda:

• if you are allergic to fluconazole or 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

• if you are taking astemizole, terfenadine (antihistamine medicines for allergies)

• if you are taking cisapride (used for stomach upsets)

• if you are taking pimozide (used for treating mental illness)

• if you are taking quinidine (used for treating heart arrhythmia)

• if you are taking erythromycin (an antibiotic for treating infections)

Warnings and precautions

Talk to your doctor before taking Fluconazol Takeda:

• if you have liver or kidney problems

• if you suffer from heart disease, including heart rhythm problems

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

• if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing)

• if you 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 Fluconazol Takeda

Tell your doctor immediatelyif 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 amiodarone or erythromycin (an antibiotic for treating infections) as these should not be taken with Fluconazol Takeda (see section: “Do not take Fluconazol Takeda if you are taking any of the following medicines”).

There are some medicines that may interact with Fluconazol Takeda. Make sure your doctor knows if you are taking any of the following medicines:

• rifampicine 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)

• if you are taking amiodarone (used for treating uneven heartbeats)

• hydrochlorothiazide (used as a diuretic)

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

• ciclosporin, everolimus, sirolimus or tacrolimus (to prevent transplant rejection)

• cyclophosphamide, 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)

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

Fluconazol Takeda with food and drink

You can take your medicine with or without a meal.

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. You should not take Fluconazol Takeda while you are pregnant or breast-feeding unless your doctor has told you to.

Driving and using machines

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

Fluconazol Takeda contains lactose

This medicine contains a small amount of lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicine.

Fluconazol Takeda contains the colourant Sunset Yellow (E110)

Fluconazol Takeda 150 mg hard capsules contain Sunset Yellow (E 110), which may cause allergic reactions.

3. How to take Fluconazol Takeda

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Swallow the capsule whole with a glass of water. Itisbest to take your capsules at the same time each day.

The usual doses of this medicine for different infections are below:

Adults

Condition	Dose
To treat cryptococcal meningitis	400 mg on the first day then 200 mg to 400 mg once daily for 6 to8 weeks or longer if needed. Sometimes doses are increased up to 800 mg.
To stop cryptococcal meningitis from coming back	200 mg once daily until you are told to stop.
To treat coccidioidomycosis	200 mg to 400 mg once daily from 11 months for up to 24 months or longer if needed. Sometimes doses are increased up to 800 mg.
To treat internal fungal infections caused by Candida	800 mg on the first day then 400 mg once daily until you are told to stop.
To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth	200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop.
To treat mucosal thrush – dose depends on where the infection is located	50 mg to 400 mg once daily for 7 to 30 days until you are told to stop.
To stop mucosal infections affecting the lining of mouth, throat	100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection.
To treat genital thrush	150 mg as a single dose.
To reduce the recurrence of vaginal thrush	150 mg every third day for a total of 3 doses (day 1, 4 and 7) and then once a week for 6 months while you are at risk of getting an infection.
To treat fungal skin and nail infections	Depending on the site of infection 50 mg once daily, 150 mg once weekly, 300 mg to 400 mg once weekly for 1 to 4 weeks (Athlete’s foot may be up to 6 weeks, for nail infection treatment until infected nail is replaced).
To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly	200 mg to 400 mg once daily while you are at risk of getting an infection.

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.

Condition	Dose
Mucosal thrush and throat infections caused by Candida – dose and duration depends on the severity of the infection and on where the infection is located	3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day).
Cryptococcal meningitis or internal fungal infections caused by Candida	6 mg to 12 mg per kg of body weight.
To stop children from getting an infection caused by Candida (if their immune system is not working properly)	3 mg to 12 mg per kg of body weight.

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 Fluconazol Takeda 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 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 Fluconazol Takeda

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, Fluconazol Takeda can cause side effects, although not everybody gets them.

A few people developallergic 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 (that can affect the mouth and tongue).

Fluconazol Takeda 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 Fluconazol Takeda and tell your doctor immediately.

Other side effects:

Additionally, if any of the followingside effects gets serious, or if you notice anyside effects not listed in this leaflet, please tell your doctor or pharmacist.

Commonside effects may affect up to 1 in 10 people

• headache

• stomach discomfort, diarrhoea, feeling sick, vomiting

• increases in blood tests of liver function

• rash

Uncommonside effects may affect up to 1 in 100 people

• 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, prickling 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

Rareside effects may affect up to 1 in 1,000 people

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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Fluconazol Takeda

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. The expiry date refers to the last day of that 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 Fluconazol Takeda contains

The active substance is: fluconazole.

Fluconazol Takeda is available in 4 strengths: 50 mg, 100 mg 150 mg and 200 mg.

The other ingredients are lactose monohydrate (see section 2 of this leaflet), magnesium stearate (E 470b), cellulose microcrystalline (E 460), sodium lauryl sulphate, pregelatinised maize starch, waterfree colloidal silica.

Capsule shell: Gelatin and titanium dioxide (E 171).

Colourants:

50 mg: Yellow iron oxide(E 172), quinoline yellow (E 104), Patent Blue V (E 131).

100 mg: Yellow iron oxide(E 172)

150mg: Quinoline yellow (E 104), Sunset Yellow (E 110) (see section 2 of this leaflet).

What Fluconazol Takeda looks like and contents of the pack

Fluconazol Takeda hard capsules come in blister packs. The capsules are different colours so that you can tell the difference between the strengths as follows:

50 mg: Green/white capsules.

100 mg: Yellowish brown capsules.

150 mg: Yellow capsules.

200 mg: White capsules.

The blister packs contain either:

50 mg capsules: 1, 7, 10, 28, 30, 98, 98 (2 x 49 x 1) Unit Doseand 100 capsules.

100 mg capsules: 7, 14, 28 and 98 capsules.

150 mg capsules: 1, 2, 4, 6, 12 and 14 capsules.

200 mg capsules: 7, 28 and 98 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pharmathen S.A.

6 Dervenakion str.,

15351 Pallini, Attica,

Greece

Manufacturer:

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Greece

This leaflet was last revised in 2016-03-22