Flumicon

Package Leaflet: Information for the User

Flumycon, 5 mg/ml, syrup

Fluconazole

Read the package 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.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Flumycon and what is it used for

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

Adults

The doctor may recommend taking this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain,
• Coccidioidomycosis - a respiratory system disease,
• Candida yeast infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• Mucosal candidiasis (thrush) - infection of the mucous membrane of the mouth, throat, and mouth ulcers related to the use of dental prostheses,
• Genital candidiasis - vaginal or penis infections,
• Fungal skin infections - e.g. athlete's foot, body ringworm, groin ringworm, nail fungus.

Flumycon can also be used to:

• prevent relapses of cryptococcal meningitis,
• prevent relapses of mucosal candidiasis,
• prevent relapses of vaginal candidiasis,
• prevent yeast infections (in patients with a weakened immune system).

Children and adolescents (from 0 to 17 years old)

The doctor may recommend taking this medicine to treat the following fungal infections:

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

Flumycon 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 Flumycon

When not to take Flumycon

• If you are allergic (hypersensitive) to fluconazole, other antifungal medicines, or any of the other ingredients of Flumycon. Symptoms may include itching, skin redness, or difficulty breathing.
• If you are taking astemizole, terfenadine (antihistamines used to treat allergies).
• If you are taking cisapride (for stomach disorders).
• If you are taking pimozide (for mental disorders).
• If you are taking quinidine (for heart rhythm disorders).
• If you are taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions

Before taking Flumycon, discuss with your doctor:

• if you have kidney or liver function disorders,
• if you have heart disease, including heart rhythm disorders,
• if you have potassium, calcium, or magnesium level disorders in your blood,
• if you have severe skin reactions (itching, skin redness, difficulty breathing),
• if you have ever had a severe skin rash or skin peeling after taking Flumycon.
• if the fungal infection does not improve, another antifungal treatment may be necessary. Patients taking Flumycon have experienced severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If you experience any of the severe skin reactions described in section 4, stop taking Flumycon and seek medical attention immediately,

Flumycon and other medicines

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

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• blood thinners, anticoagulants (warfarin, coumarins, and indandione derivatives 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, hydrochlorothiazide, and losartan (used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection),
• cyclophosphamide, vincristine (used to treat cancer),
• halofantrine (used to treat malaria),
• amiodarone (used to treat heart rhythm disorders),
• statins (atorvastatin, simvastatin, and fluvastatin, and 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,
• prednisolone (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).

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, including those that are available without a prescription.

Flumycon with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, planning to become pregnant, or breastfeeding, tell your doctor.
If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, do not take Flumycon unless your doctor has told you to.
Fluconazole taken during the first trimester of pregnancy may increase the risk of miscarriage.
Fluconazole taken in low doses during the first trimester of pregnancy may slightly increase the risk of congenital malformations in the newborn.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

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

Flumycon contains sucrose

Flumycon contains sucrose (sugar).

• 1 ml of syrup contains 130 mg of sucrose.
• The product contains 20.8 g of sucrose in the maximum daily dose (800 mg). This should be taken into account in patients with diabetes.
• If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine.
• The medicine may be harmful to teeth if taken for more than 2 weeks.

Flumycon contains glycerol

Flumycon contains glycerol.

• 1 ml of syrup contains 820 mg of glycerol.
• After taking a dose of glycerol greater than 10 g (i.e. more than 12 ml of syrup), the medicine may cause headache, stomach upset, and diarrhea.

Flumycon contains propylene glycol

The medicine contains 0.7 mg of propylene glycol per 1 ml of syrup, which corresponds to 112 mg of propylene glycol in the maximum daily dose (800 mg).
Before administering the medicine to a child under 4 weeks of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Flumycon contains sodium

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

3. How to take Flumycon

This medicine should always be taken as directed by your doctor.If you are unsure, consult your doctor or pharmacist.
The recommended dosage, depending on the type of infection, is presented below.
The medicine is best taken once a day at the same time.
The dosage of Flumycon, depending on the type of infection, is presented below:

Adults

Use in children and adolescents

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.

Dosage in children from 0 to 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.
Sometimes the doctor may recommend a different dosage. The medicine should always be taken as directed by the doctor. If you are unsure, consult your doctor or pharmacist.

Elderly patients

The usual adult dose is given, unless the patient has kidney function disorders.

Patients with kidney function disorders

The doctor may recommend changing the dosage, depending on kidney function.

Taking more than the recommended dose of Flumycon

Taking too much medicine at once may cause discomfort. Consult the emergency department of the nearest hospital immediately. Symptoms of possible overdose may include hearing, vision, or 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 Flumycon

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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following symptoms, stop taking Flumycon and seek medical attention immediately

Flumycon and seek medical attention immediately:

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

Some patients may experience allergic reactions, however, 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, skin redness, or red or itchy blisters,
• skin rash,
• severe skin reactions, such as blistering rash (which may also affect the mouth and tongue).

Flumycon may affect the liver. Liver symptoms include:

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

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

Other side effects

Additionally, if any of the side effects worsen or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.
Frequentside effects (may occur in up to 1 in 10 patients):

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

Uncommon(may occur in up to 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, taste changes,
• 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(may occur in up to 1 in 1000 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 extensive 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 those not listed in this leaflet, 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 Flumycon

• Keep the medicine out of the sight and reach of children.
• Store in a temperature below 25°C.
• Do not use this medicine after the expiry date stated on the packaging after "Expiry Date (EXP)". The expiry date refers to the last day of the month. After the first opening, Flumycon can be used for a maximum of 30 days.

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 Flumycon contains

• The active substance is fluconazole.
• 1 ml of syrup contains 5 mg of fluconazole.
• Other ingredients are: glycerol, citric acid monohydrate, sodium citrate, sucrose, strawberry flavor, purified water.

What Flumycon looks like and what the pack contains

Flumycon is a colorless, clear liquid with a strawberry flavor.
It is available in a brown glass bottle, closed with an aluminum cap, containing 750 mg of fluconazole.
A measuring spoon with a scale of 1 ml, 2 ml, 3 ml, 4 ml, and 5 ml is attached to the bottle.
Pack size: 150 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53, 00-113 Warsaw
phone: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków

Date of last revision of the leaflet: