Flucofast

Package leaflet: Information for the patient

Flucofast, 50 mg, hard capsules
Flucofast, 100 mg, hard capsules
Flucofast, 150 mg, hard capsules
Fluconazole
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

1. What Flucofast is and what it is 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 Flucofast is and what it is used for

Flucofast belongs to a group of antifungal medicines. The active substance is fluconazole.
Flucofast is used to treat infections caused by disease-causing fungi and can also be used to prevent Candida infections. The most common cause of fungal infections are yeasts of the genus Candida.
Adults
Your doctor may prescribe this medicine for the following fungal infections:

• Cryptococcal meningitis – a fungal infection of the brain,
• Coccidioidomycosis – a respiratory disease,
• Infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract,
• Mucosal yeast infections (thrush) – infection of the mucous membranes of the mouth, throat, and oral lesions associated with denture use,
• Genital yeast infections – infections of the vagina or penis,
• Skin fungal infections – e.g. athlete's foot, fungal infections of the trunk, groin, or nails.

Flucofast may also be used:

• To prevent recurrence of cryptococcal meningitis,
• To prevent recurrence of mucosal yeast infections,
• To prevent recurrence of vaginal yeast infections,
• To prevent yeast infections in patients with weakened or impaired immune systems.

Children and adolescents (aged 0 to 17 years)
Your doctor may prescribe this medicine to treat the following fungal infections:

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

Flucofast may also be used:

• To prevent yeast infections (in patients with weakened or impaired immune systems),
• To prevent recurrence of cryptococcal meningitis.

2. Important information before using Flucofast

When not to use Flucofast

• if the patient is allergic to fluconazole, to other azole compounds, or to any of the other ingredients of this medicine (listed in section 6); symptoms may include itching, skin redness, or difficulty breathing,
• if the patient is taking astemizole, terfenadine (antihistamines used in the treatment of allergies),
• if the patient is taking cisapride (used to treat stomach disorders),
• if the patient is taking pimozide (used to treat mental disorders),
• if the patient is taking quinidine (used to treat heart rhythm disorders),
• if the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Before starting treatment with Flucofast, consult a doctor or pharmacist if:

• the patient has impaired kidney or liver function,
• the patient has heart conditions, including heart rhythm disorders,
• the patient has abnormal blood levels of potassium, calcium, or magnesium,
• the patient experiences severe skin reactions (itching, skin redness, difficulty breathing),
• the patient has previously experienced severe skin rash or skin peeling, blisters, and/or oral ulcers after taking Flucofast,
• the patient develops symptoms of "adrenal insufficiency," where the adrenal glands do not produce sufficient amounts of certain steroid hormones such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain),
• fungal infection does not resolve, which may require alternative antifungal treatment.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred in patients treated with Flucofast. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Flucofast must be discontinued immediately and medical help should be sought without delay.

Flucofast and other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use.

Immediately inform the doctor if the patient is taking astemizole, terfenadine (antihistamines used for allergies), cisapride (used for stomach disorders), pimozide (used for mental disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), as these should not be taken together with Flucofast (see section "When not to use Flucofast").

There are also other medicines that may interact with Flucofast.
If the patient is taking any of the following medicines, ensure the doctor is informed:

• rifampicin, rifabutin, azithromycin (antibiotics for treating infections),
• alfentanil, fentanyl (anaesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• anticoagulants (medicines that reduce blood clotting and prevent blood clots, such as warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam, or similar medicines) used to aid sleep or for calming effects,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine, or similar medicines) used in the treatment of cancer,
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin, and fluvastatin or similar medicines) used to reduce cholesterol levels,
• methadone (a pain-relieving medicine),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - NSAIDs),
• oral contraceptives,
• prednisone (a steroid),
• zidovudine, also known as AZT; saquinavir (used in HIV patients),
• antidiabetic medicines such as chlorpropamide, glyburide, glipizide, or tolbutamide,
• theophylline (used in 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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

If the patient plans to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception. For longer treatment courses with fluconazole, discuss with the doctor the need for appropriate contraception during treatment and for one week after the last dose.

If the patient is pregnant, suspects she may be pregnant, or is trying to conceive, she should not take fluconazole unless otherwise advised by a doctor. If the patient becomes pregnant or suspects she may be pregnant while taking this medicine or within one week after the last dose, she should contact her 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 congenital heart, bone, and/or muscle malformations in the newborn.

Cases of infants born with congenital malformations of the skull, ears, and femur and humerus bones have been reported in mothers treated with high-dose fluconazole (400–800 mg daily) for at least 3 months due to coccidioidomycosis. The causal relationship between fluconazole use and these cases is not fully established.

Flucofast should not be used in breastfeeding women unless otherwise advised by a doctor. Breastfeeding may continue after a single dose of Flucofast of 200 mg or less. Breastfeeding should be avoided if the patient is taking multiple doses of Flucofast.

Driving and operating machinery
When driving or operating machinery, bear in mind that dizziness or seizures may occur occasionally.

Flucofast 50 mg contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

Flucofast 100 mg contains sunset yellow (E 110), lactose monohydrate, and sodium
This medicine may cause allergic reactions.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

Flucofast 150 mg contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Flucofast

This medicine should always be taken as directed by a physician. If in doubt, consult a doctor or pharmacist.
The capsule should be swallowed whole with a glass of water. It is best to take the capsules at the same time each day. For children who cannot swallow the capsule and for young children requiring precise dosing according to body weight, fluconazole syrup is available on the market.
The recommended dosage, depending on the type of infection, is given below.
For doses that cannot be achieved using capsules of this strength, other strengths of this medicine are available on the market.
Adults

Adolescents aged 12 to 17 years
Administer the dose prescribed by the doctor (as for adult patients or as for children).
Children up to 11 years of age
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 of age
Children aged 3 to 4 weeks
The same dose as above, but administered 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, administered every 3 days. The maximum dose is 12 mg/kg body weight every 72 hours.
Elderly patients
The dose usually administered to adults is given, unless the patient has impaired kidney function.
Patients with impaired kidney function
The physician may adjust the dosage depending on kidney function.
Method of administration
The medicine may be taken independently of meals.
Use of a higher than recommended dose of Flucofast
Taking too many capsules at once may cause malaise. Immediate contact should be made with the emergency department of the nearest hospital. Symptoms of overdose may include hearing, vision and sensory disturbances, thinking about things that are not true (hallucinations and paranoid behavior). Symptomatic treatment may be indicated (supportive treatment to maintain vital functions and gastric lavage, if necessary).
Missed dose of Flucofast
Do not take a double dose to make up for a missed dose. If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some patients may experience allergic reactions, although severe allergic reactions are rare.
If any of the following symptoms occur, you should 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,
• skin rash,
• severe skin reactions such as blistering rash (may also affect the mouth and tongue).

If any of the following symptoms occur, treatment with Flucofast should be discontinued and immediate medical help sought:

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

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

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

Flucofast may affect the adrenal cortex and the levels of steroid hormones produced. Symptoms of adrenal cortex disorders include:

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

If any of the above symptoms occur, treatment with Flucofast should be discontinued and medical advice should be sought immediately.

Other adverse reactions

Common (occur in up to 1 in 10 patients)

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

Uncommon (occur in up to 1 in 100 patients)

• decrease in red blood cells causing paleness, weakness and breathlessness,
• loss of appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly as tingling, prickling or numbness, taste changes,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, urticaria, itching, increased sweating,
• feeling of fatigue, malaise, fever.

Rare (occur in up to 1 in 1,000 patients)

• decrease in white blood cells involved in the body's defence against infections and in blood cells helping to stop bleeding,
• red or purple skin discolouration, possibly due to reduced platelet count or changes in other blood cells,
• changes in blood biochemical parameters (elevated cholesterol, blood lipids),
• decreased blood potassium levels,
• tremor,
• abnormalities in ECG, heart rhythm disorders,
• liver failure,
• allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of lips or face,
• hair loss.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Flucofast

Keep in the original packaging to protect from light.
Do not store above 25°C.
Keep the medicine 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 indicated.
The marking on the packaging: after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Flucofast contains

• The active substance is fluconazole. Each capsule contains 50 mg, 100 mg, or 150 mg of fluconazole, respectively.
• Other components
  Contents of the capsule: monohydrate lactose, corn starch, colloidal anhydrous silica, magnesium stearate, sodium lauryl sulfate.
  Capsule shell composition:
  Flucofast 50 mg and 150 mg: gelatin, titanium dioxide (E 171).
  Flucofast 100 mg: gelatin, titanium dioxide (E 171), sunset yellow (E 110), patent blue (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-colored cap and base, without imprint; size number 3.
Pack contains 7 or 14 capsules.
Flucofast, 100 mg
Hard capsules containing white granules, with a white cap and amethyst-colored base; size number 2.
Pack contains 7 or 28 capsules.
Flucofast, 150 mg
Hard capsules containing white granules, with an opaque cream-colored cap and base, without imprint; size number 1.
Pack contains 1 or 3 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
POLPHARMA Pharmaceutical Works S.A.
Pelplińska 19, 83-200 Starogard Gdański, Poland
Tel. +48 22 364 61 01

Manufacturer
POLPHARMA Pharmaceutical Works S.A.
Medana Branch in Sieradz
Władysława Łokietka 10, 98-200 Sieradz, Poland
POLPHARMA Pharmaceutical Works S.A.
Production Branch in Nowa Dęba
Metalowca 2, 39-460 Nowa Dęba, Poland