FLUCOFAST 100 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Flucofast, 50 mg, hard capsules
3. Flucofast, 100 mg, hard capsules
4. Flucofast, 150 mg, hard capsules
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack
5. What Flucofast is and what it is used for
   1. Adults
   2. Children and adolescents (from birth to 17 years)
6. Before you take Flucofast
   1. Do not take Flucofast
   2. Warnings and precautions
   3. Flucofast with other medicines
   4. Pregnancy and breast-feeding
   5. Driving and using machines
   6. Flucofast 50 mg contains lactose monohydrate and sodium
   7. Flucofast 100 mg contains sunset yellow FCF (E 110), lactose monohydrate and sodium
   8. Flucofast 150 mg contains lactose monohydrate and sodium
7. How to take Flucofast
   1. For doses that cannot be achieved with the available strengths, other strengths of this medicine are available.
   2. Adults
   3. Adolescents (12 to 17 years)
   4. Children (up to 11 years)
   5. Dosing in children under 4 weeks of age
   6. Elderly patients
   7. Patients with kidney problems
   8. Method of administration
   9. Overdose
   10. Missed dose
8. Possible side effects
   1. If you experience any of the following symptoms, stop taking Flucofast and seek medical help immediately:
   3. Other side effects
   4. Reporting of side effects
9. How to store Flucofast
10. Contents of the pack and other information
    1. What Flucofast contains
    2. What Flucofast looks like and contents of the pack
    3. Marketing Authorisation Holder
    4. Manufacturer
    5. Date of last revision of the leaflet

Package Leaflet: Information for the Patient

Flucofast, 50 mg, hard capsules

Flucofast, 100 mg, hard capsules

Flucofast, 150 mg, hard capsules

Fluconazole

Read all of this leaflet carefully before 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.

Contents of the pack

• 1. What Flucofast is and what it is used for
• 2. Before you take Flucofast
• 3. How to take Flucofast
• 4. Possible side effects
• 5. How to store Flucofast
• 6. Contents of the pack and other information

1. What Flucofast is and what it is used for

Flucofast belongs to a group of medicines called antifungals. The active substance is fluconazole.
Flucofast is used to treat infections caused by fungi and can also be used to prevent fungal infections.
The most common cause of fungal infections is a type of fungus called Candida.

Adults

Your doctor may prescribe Flucofast for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain,
• Coccidioidomycosis - a disease of the lungs,
• Candida infections found in the blood, internal organs (such as the heart, lungs) or urinary tract,
• Mucosal thrush (candidiasis) - infection of the membranes of the mouth, throat and denture-related stomatitis,
• Vaginal candidiasis (vaginitis) - infection of the vagina,
• Fungal skin infections - such as athlete's foot (tinea pedis), tinea corporis, tinea cruris and nail infections.

Flucofast can also be used to prevent:

• relapse of cryptococcal meningitis,
• relapse of mucosal candidiasis,
• relapse of vaginal candidiasis,
• fungal infections in patients with a weakened immune system.

Children and adolescents (from birth to 17 years)

Your doctor may prescribe Flucofast for the following fungal infections:

• Mucosal candidiasis (oropharyngeal candidiasis) - infection of the mouth and throat,
• Candida infections found in the blood, internal organs (such as the heart, lungs) or urinary tract,
• Cryptococcal meningitis - a fungal infection of the brain.

Flucofast can also be used to prevent:

• fungal infections in patients with a weakened immune system,
• relapse of cryptocococcal meningitis.

2. Before you take Flucofast

Do not take Flucofast

• if you are allergic to fluconazole, to other medicines you have taken to treat fungal infections or to any of the other ingredients of this medicine (listed in section 6); symptoms may include itching, redness of the skin or difficulty breathing,
• if you are taking astemizole, terfenadine (antihistamine medicines used to treat allergies),
• if you are taking cisapride (used to treat stomach disorders),
• if you are taking pimozide (used to treat certain psychiatric disorders),
• if you are taking quinidine (used to treat irregular heartbeat),
• if you are taking erythromycin (an antibiotic used to treat bacterial infections).

Warnings and precautions

Before taking Flucofast, tell your doctor or pharmacist if:

• you have kidney or liver problems,
• you have heart problems, including heart rhythm disorders,
• you have abnormal levels of potassium, calcium or magnesium in your blood,
• you have had a previous allergic reaction to fluconazole or other antifungal medicines,
• you have ever had a severe skin reaction to fluconazole or other antifungal medicines,
• you develop signs of adrenal insufficiency (when your adrenal glands do not produce enough steroid hormones), such as chronic fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain,
• your fungal infection does not improve or gets worse, you may need to take a different antifungal medicine.

Flucofast can cause severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of the symptoms of severe skin reactions described in section 4, stop taking Flucofast and seek medical help immediately.

Flucofast with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including those you have bought without a prescription.
You must tell your doctor if you are taking any of the following medicines:
astemizole, terfenadine (antihistamine medicines used to treat allergies),
cisapride (used to treat stomach disorders),
pimozide (used to treat certain psychiatric disorders),
quinidine (used to treat irregular heartbeat),
erythromycin (an antibiotic used to treat bacterial infections),
as these medicines should not be taken with Flucofast (see section “Do not take Flucofast”).
There are other medicines that may interact with Flucofast.
If you are taking any of the following medicines, tell your doctor:

• rifampicin, rifabutin, azithromycin (antibiotics used to treat bacterial infections),
• alfentanil, fentanyl (anaesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• blood thinning medicines (such as warfarin) to prevent blood clots,
• benzodiazepines (such as midazolam, triazolam) used to help you sleep or to calm you,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat high blood pressure),
• cyclosporin, everolimus, sirolimus or tacrolimus (to prevent rejection of transplanted organs),
• cyclophosphamide, vincristine (used to treat cancer),
• halofantrine (used to treat malaria),
• statins (such as atorvastatin, simvastatin and fluvastatin) used to lower cholesterol,
• methadone (used to treat pain),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines),
• oral contraceptives,
• prednisone (steroid),
• zidovudine, also known as AZT; saquinavir (used to treat HIV),
• medicines for diabetes, such as chlorpropamide, glibenclamide, glipizide or tolbutamide,
• theophylline (used to treat asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• hydrochlorothiazide (diuretic),
• amiodarone (used to treat irregular heartbeat).

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 or pharmacist for advice before taking this medicine.
If you are planning to become pregnant, it is recommended that you wait for one week after taking a single dose of fluconazole before trying to become pregnant. If you are taking fluconazole for longer periods, you should discuss with your doctor the need for effective contraception during treatment and for one week after the end of treatment.
Do not take fluconazole if you are pregnant, think you may be pregnant or are trying for a baby, unless your doctor has told you to. If you become pregnant or think you may be pregnant while taking fluconazole, or within one week after taking a dose, tell your doctor immediately.
Fluconazole taken during the first or second trimester of pregnancy may increase the risk of miscarriage. Fluconazole taken during the first trimester of pregnancy may increase the risk of birth defects such as heart, bone or muscle defects.
There have been reports of birth defects in babies born to women treated with high doses of fluconazole (400-800 mg per day) for a long time (more than 3 months) for a condition called coccidioidomycosis. The link between fluconazole use and these defects is not clear.
Do not take Flucofast if you are breast-feeding, unless your doctor has told you to. Breast-feeding can continue after a single dose of Flucofast up to 200 mg. Do not breast-feed if you are taking more than one dose of Flucofast.

Driving and using machines

When driving or using machines, you should be aware that occasionally dizziness or fits (seizures) may occur.

Flucofast 50 mg contains lactose monohydrate and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sodium in this medicinal product is less than 1 mmol (23 mg) per capsule, which is considered to be essentially sodium-free.

Flucofast 100 mg contains sunset yellow FCF (E 110), lactose monohydrate and sodium

This medicinal product may cause allergic reactions.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sodium in this medicinal product is less than 1 mmol (23 mg) per capsule, which is considered to be essentially sodium-free.

Flucofast 150 mg contains lactose monohydrate and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The amount of sodium in this medicinal product is less than 1 mmol (23 mg) per capsule, which is considered to be essentially sodium-free.

3. How to take Flucofast

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the capsule whole with a glass of water. The capsules are best taken at the same time each day.
For children who cannot swallow the capsules and for small children who require precise dosing based on body weight, a fluconazole syrup is available.
The recommended dose depends on the type of infection, as described below.

For doses that cannot be achieved with the available strengths, other strengths of this medicine are available.

Adults

Adolescents (12 to 17 years)

The dose will be the same as for adults or children.

Children (up to 11 years)

The maximum dose is 400 mg per day.
The dose will be based on the child’s weight in kilograms.

Dosing in children under 4 weeks of age

Children from 3 to 4 weeks of age
The same dose as above, but given every other day. The maximum dose is 12 mg/kg body weight every 48 hours.
Children under 2 weeks of age
The same dose as above, given every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.

Elderly patients

The usual dose for adults is given, unless you have kidney problems.

Patients with kidney problems

Your doctor may prescribe a different dose, depending on your kidney function.

Method of administration

The medicine can be taken with or without food.

Overdose

Taking too many capsules at once may cause discomfort. Contact the emergency department of your nearest hospital immediately. Symptoms of overdose may include hearing, vision or feeling disturbances, and hallucinations or paranoid behaviour. Treatment may include supportive therapy (life-supporting measures and stomach lavage if necessary).

Missed dose

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 missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Flucofast can cause side effects, although not everybody gets them.
Some patients may experience allergic reactions, but severe allergic reactions are rare. If you experience any of the following symptoms, tell your doctor immediately:

• sudden wheezing, difficulty breathing or tightness in the chest,
• swelling of the eyelids, face or lips,
• itching all over the body, redness of the skin or red or itchy lumps,
• rash,
• severe skin reactions, including blistering of the skin (this can also affect the mouth and tongue).

If you experience any of the following symptoms, stop taking Flucofast and seek medical help immediately:

• widespread rash, high fever and enlarged lymph nodes (DRESS or hypersensitivity syndrome).

Flucofast can affect the liver. Symptoms of liver problems include:

• feeling tired,
• loss of appetite,
• vomiting,
• yellowing of the skin or the whites of the eyes (jaundice).

Flucofast can affect the adrenal glands and the production of steroid hormones. Symptoms of adrenal insufficiency include:

• feeling tired,
• muscle weakness,
• loss of appetite,
• weight loss,
• abdominal pain.

If you experience any of these symptoms, stop taking Flucofast and contact your doctor immediately.

Other side effects

Common(may affect up to 1 in 10 people)

• headache,
• abdominal pain, diarrhoea, nausea, vomiting,
• increased values in liver function tests,
• rash.

Uncommon(may affect up to 1 in 100 people)

• reduced number of red blood cells, which can cause pale skin, weakness and breathlessness,
• reduced appetite,
• insomnia, drowsiness,
• seizures, dizziness, disturbances in balance (feeling of spinning), disturbances in sensation, usually in the form of tingling, prickling or numbness, changes in taste,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, hives, itching, increased sweating,
• feeling tired, feeling unwell, fever.

Rare(may affect up to 1 in 1,000 people)

• reduced number of white blood cells, which can increase the risk of infection, or platelets, which can increase the risk of bleeding,
• red or purple discoloration of the skin, which can be caused by a reduced number of platelets or changes in other blood cells,
• changes in blood biochemistry (high cholesterol or lipid levels),
• reduced potassium levels in the blood,
• tremors,
• abnormal ECG, irregular heartbeat,
• liver failure,
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the mouth or face,
• hair loss.

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.
Side effects can be reported to the national reporting system via the Medicines Information Department, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flucofast

Keep the blister in the outer carton in order to protect from light.
Do not store above 25°C.
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 and blister after EXP. The expiry date refers to the last day of that month.
The packaging is marked with EXP (expiry date) and Lot/LOT (batch number).
Medicines should not be disposed of via 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 Flucofast contains

• The active substance is fluconazole. Each capsule contains 50 mg, 100 mg or 150 mg of fluconazole.
• The other ingredients are lactose monohydrate, maize starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide (E 171). Flucofast 100 mg also contains sunset yellow FCF (E 110), patent blue V (E 131), erythrosine (E 127).

What Flucofast looks like and contents of the pack

Flucofast 50 mg
Hard capsules, containing white granules, with an opaque cream-coloured body and cap, without imprint; size 3.
Pack contains 7 or 14 capsules.
Flucofast 100 mg
Hard capsules, containing white granules, with a white body and an amethyst cap; size 2.
Pack contains 7 or 28 capsules.
Flucofast 150 mg
Hard capsules, containing white granules, with an opaque cream-coloured body and cap, without imprint; size 1.
Pack contains 1 or 3 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Division in Sieradz
Władysława Łokietka 10, 98-200 Sieradz
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba

Date of last revision of the leaflet