Flucofast

Leaflet attached to the packaging: patient information

Flucofast, 200 mg, hard capsules

Fluconazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Flucofast and what is it used for
• 2. Important information before taking 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 is Flucofast and what is it used for

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

Adults

Your doctor may prescribe this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain,
• Coccidioidomycosis - a disease of the respiratory system,
• Infections caused by Candida yeast detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• Fungal infections (thrush) of the mucous membranes - infection of the mucous membrane of the mouth, throat and mouth sores associated with the use of dental prostheses,
• Fungal infections of the genital organs - infections of the vagina or penis,
• Skin fungi - e.g. athlete's foot, body fungus, groin fungus, nail fungus.

Flucofast can also be used to:

• prevent relapses of cryptococcal meningitis,
• prevent relapses of fungal infections of the mucous membranes,
• prevent relapses of vaginal yeast infections,
• prevent yeast infections (in patients with a weakened immune system).

Children and adolescents (from 0 to 17 years old)

Your doctor may prescribe this medicine to treat the following fungal infections:

• Fungal infections (thrush) of the mucous membranes - infections of the mucous membrane of the mouth or throat,
• Infections caused by Candida yeast detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• Cryptococcal meningitis - a fungal infection of the brain.

Flucofast can also be used to:

• prevent yeast infections (if the patient's immune system is weak and not functioning properly),
• prevent relapses of cryptococcal meningitis.

2. Important information before taking Flucofast

When not to take Flucofast

Warnings and precautions

Before taking Flucofast, discuss with your doctor or pharmacist if:

• you have kidney or liver function disorders,
• you have heart disease, including heart rhythm disorders,
• you have detected disturbances in potassium, calcium or magnesium levels in your blood,
• you have severe skin reactions (itching, redness of the skin, difficulty breathing),
• you have ever had a severe skin rash or skin peeling after taking Flucofast,
• you develop symptoms of "adrenal insufficiency", when the adrenal glands do not produce enough certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),

In patients treated with Flucofast, there have been cases of 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 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or plan to take.
You must immediatelytell your doctor about taking astemizole, terfenadine (antihistamines used to treat allergies), cisapride (used to treat stomach disorders), pimozide (used to treat mental disorders), quinidine (used to treat heart rhythm disorders) or erythromycin (an antibiotic used to treat infections), as they should not be taken with Flucofast (see "When not to take Flucofast").
There are also other medicines that may interact with Flucofast.
If you are taking any of the following medicines, make sure your doctor knows about it:

• rifampicin, rifabutin, azithromycin (antibiotics used to treat infections),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• blood thinners, preventing blood clots (warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam or other similar medicines) that help you fall asleep or calm down,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat high blood pressure),
• cyclosporin, everolimus, sirolimus or tacrolimus (preventing transplant rejection),
• cyclophosphamide, vincristine (used to treat cancer),
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin and fluvastatin or other similar medicines) used to lower cholesterol levels,
• methadone (a pain reliever),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory medicines - NSAIDs),
• oral contraceptives,
• prednisone (a steroid),
• zidovudine, also known as AZT; saquinavir (used in HIV patients),
• antidiabetic medicines, such as chlorpropamide, glibenclamide, glipizide or tolbutamide,
• theophylline (used to treat asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• hydrochlorothiazide (a diuretic),
• amiodarone (used to treat heart rhythm disorders).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 plan to become pregnant, it is recommended that after taking a single dose of fluconazole, and before becoming pregnant, you wait a week. In case of longer treatment cycles with fluconazole, you should discuss with your doctor the need for proper contraception during treatment and for a week after the last dose.
If you are pregnant, think you may be pregnant or are trying to become pregnant, do not take fluconazole unless your doctor has told you to. If you become pregnant or think you may be pregnant while taking this medicine or within a week of taking the last dose, tell your doctor.
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 of the heart, bones and/or muscles.
There have been cases of children with birth defects of the skull, ears and thigh and forearm bones, born to mothers treated for coccidioidomycosis with high doses of fluconazole (400-800 mg per day) for at least 3 months. The relationship between fluconazole use and these cases is unclear.
Do not take Flucofast if you are breastfeeding, unless your doctor has told you to. Breastfeeding can continue after taking a single dose of Flucofast of 200 mg or less. Do not breastfeed if you are taking multiple doses of Flucofast.

Driving and using machines

When driving or operating machinery, consider that dizziness or seizures may occasionally occur.

Flucofast contains lactose monohydrate, orange yellow S (E 110) and sodium

The medicine may cause allergic reactions.
If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means that the medicine is considered "sodium-free".

3. How to take Flucofast

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the capsule whole with a glass of water. Capsules are best taken at the same time every day. For children who cannot swallow the capsule and for young children, for whom precise dosing based on body weight is necessary, fluconazole is available in syrup form.
Recommended dosing, depending on the type of infection, is shown below.

For doses that cannot be achieved with the help of capsules of this strength, other strengths of this medicine are available on the market.

Adults

Adolescents from 12 to 17 years old

The dose prescribed by the doctor should be taken (as for adult patients or as for children).

Children up to 11 years old

The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Dosing in children up to 4 weeks old

Children from 3 to 4 weeks old
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 old
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 adult dose is given, unless the patient has kidney function disorders.

Patients with kidney function disorders

The doctor may recommend a change in dosing, depending on kidney function.

Method of administration

The medicine can be taken regardless of meals.

Taking a higher dose of Flucofast than recommended

Taking too many capsules at once may cause discomfort. You should immediately contact the emergency department of the nearest hospital. Symptoms of possible overdose may include hearing, vision and sensation disorders, thinking about untrue things (hallucinations and paranoid behavior). Symptomatic treatment (life-supporting treatment and stomach lavage, if necessary) may be indicated.

Missing a dose of Flucofast

Do not take a double dose to make up for a missed dose. If you miss 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 about taking this medicine, 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 chest tightness,
• swelling of the eyelids, face or lips,
• itching all over the body, redness of the skin or red, itchy blisters,
• rash on the skin,
• severe skin reactions, such as a rash with blisters (may also affect the mouth and tongue).

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

Flucofast

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

Flucofast may affect the liver. Liver-related symptoms include:

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

Flucofast may affect the adrenal glands and the production of steroid hormones. Symptoms of adrenal disorders include:

• fatigue,
• muscle weakness,
• loss of appetite,
• weight loss,
• abdominal pain.

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

Other side effects

Common(occurring in no more than 1 in 10 patients)

• headache,
• abdominal pain, diarrhea, nausea, vomiting,
• increased liver function test values,
• rash.

Uncommon(occurring in no more than 1 in 100 patients)

• decreased red blood cell count, causing pallor, weakness and shortness of breath,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, most often in the form of tingling, numbness or prickling, 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, malaise, fever.

Rare(occurring in less than 1 in 1,000 patients)

• decreased white blood cell count and platelet count,
• red or purple skin discoloration, which may be a sign of decreased platelet count or changes in other blood cells,
• changes in blood biochemical parameters (high cholesterol, lipid levels in the blood),
• decreased potassium levels in the blood,
• tremors,
• ECG changes, heart rhythm disorders,
• liver failure,
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face,
• hair loss.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flucofast

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Flucofast contains

• The active substance of the medicine is fluconazole. Each capsule contains 200 mg of fluconazole.
• Other ingredients Capsule contents: lactose monohydrate, cornstarch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate. Capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E 127), patent blue (E 131), orange yellow S (E 110); cap: gelatin, titanium dioxide (E 171).

What Flucofast looks like and contents of the pack

Flucofast 200 mg are hard capsules, with an amethyst bottom and a white cap, size ‘0’.
The pack contains 7, 10, 12 or 14 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

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

Date of last revision of the leaflet: