Fluconazole polfarmex

Package leaflet: Information for the patient

Fluconazole Polfarmex, 50 mg/10 mL, syrup
Fluconazolum
Please read the entire leaflet carefully before using 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 questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Fluconazole Polfarmex is and what it is used for

Fluconazole Polfarmex belongs to a group of medicines called antifungal agents. The active substance is
fluconazole.
Fluconazole Polfarmex 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 belonging to a genus called in Latin 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 denture-related stomatitis,
• genital yeast infections – vaginal or penile infections,
• skin fungal infections – e.g. athlete's foot, body ringworm, groin infection (tinea cruris), nail infections (onychomycosis).

Fluconazole Polfarmex may also be used for:

• prevention of recurrent cryptococcal meningitis,
• prevention of recurrent mucosal Candida infections,
• prevention of recurrent vaginal Candida infections,
• prevention of yeast infections (in patients with weakened or impaired immune system).

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.

Fluconazole Polfarmex may also be used for:

• prevention of yeast infections (in patients with weakened or impaired immune system),
• prevention of recurrent cryptococcal meningitis.

2. Important information before using Fluconazole Polfarmex

When not to use Fluconazole Polfarmex:

• if the patient is allergic to the active substance, to other medicines used in the treatment of fungal infections, 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 or terfenadine (antihistamine medicines used to treat 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
Tell the doctor if:

• the patient has impaired kidney or liver function,
• the patient has heart diseases, 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).

Fluconazole Polfarmex and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to 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 used together with Fluconazole Polfarmex (see section "When not to use Fluconazole Polfarmex").
There are also other medicines that may interact with Fluconazole Polfarmex.
If the patient is taking any of the following medicines, they should ensure the doctor is informed:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anaesthetic medicines),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),
• medicines that reduce blood clotting and prevent blood clots (warfarin or similar medicines),
• benzodiazepines (midazolam, triazolam or other similar medicines) used to aid sleep or for calming,
• 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 other similar medicines) used in the treatment of cancer,
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin and fluvastatin or other similar medicines) used to lower cholesterol levels,
• methadone (a pain-relieving medicine),
• celecoxib, flurbiprofen, naproxen, ibuprofen, lornoxicam, meloxicam, diclofenac (non-steroidal anti-inflammatory drugs - 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 in asthma),
• vitamin A (dietary supplement).

Fluconazole Polfarmex with food and drink
This medicine can be taken during or independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor 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 during treatment with this medicine or within one week after the last dose, she should contact her 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 congenital heart, bone, and/or muscle malformations in the newborn.
Cases of infants born with congenital malformations of the skull, ears, and femur or elbow bones have been reported in mothers treated for coccidioidomycosis with high-dose fluconazole (400–800 mg daily) for at least three months. The relationship between fluconazole use and these cases is not fully established.
Breastfeeding
The medicine passes into human milk, reaching concentrations lower than in serum. Breastfeeding may continue after a standard single dose of 200 mg or less. Breastfeeding is not recommended after multiple doses of fluconazole or after administration of a high dose.

Driving and using machines
When driving or operating machinery, consider that dizziness or seizures may occasionally occur.

Fluconazole Polfarmex contains sorbitol (E 420), sucrose, sodium benzoate (E 211), sodium, glycerol, propylene glycol (E 1520), citral (component of liquid strawberry flavour).

Sorbitol
The medicine contains 3.5 g of sorbitol (E 420) in 10 mL of syrup. Sorbitol in doses of 10 g or more may have a mild laxative effect. Calorific value: 2.6 kcal/g of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot metabolize fructose, the patient should consult a doctor before taking this medicine or giving it to a child.

Sucrose
10 mL of syrup contains 4 g of sucrose. This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sodium benzoate (E 211)
The medicine contains 20 mg of sodium benzoate (E 211) in every 10 mL of syrup. Benzoic acid salts may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 10 mL, meaning it is considered "sodium-free".

Glycerol
The medicine contains 0.68 g of glycerol in 10 mL of syrup.
The medicine may cause headache, gastrointestinal disturbances, and diarrhoea.

Propylene glycol (E 1520)
10 mL of syrup contains 164.8 mg of propylene glycol (E 1520).
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.
Before administering the medicine to a child under 5 years of age, consult a doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.
Women who are pregnant or breastfeeding should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.

Citral
Component of liquid strawberry flavour.

3. How to use Fluconazole Polfarmex

This medicine should always be taken as directed by a doctor. If in doubt, consult a doctor or pharmacist.
It is best to take the medicine at the same time each day.
The usual recommended dosage, depending on the type of infection, is given below.
Adults

Adolescents aged 12 to 17 years
Administer the dose prescribed by the doctor (as in adult patients or as in children).
Children aged 28 days to 11 years
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 newborns (from 0 to 4 weeks of life)
Newborns 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.
Newborns 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.
Sometimes the physician may recommend a different dosage. The medicine should always be used according to the physician's instructions. In case of doubts, consult a physician or pharmacist.
Elderly patients
The usual adult dose is administered, unless the patient has impaired kidney function.
Patients with impaired kidney function
The physician may recommend adjusting the dosage depending on kidney function.
Overdose of Fluconazole Polfarmex
Taking too high a dose at once may cause malaise. Seek immediate medical attention at the nearest hospital emergency department. Symptoms of overdose may include disturbances in hearing, vision, and sensation, thinking about unreal things (hallucinations and paranoid behaviors). Symptomatic treatment may be necessary (supportive treatment to maintain vital functions and gastric lavage, if required).
Missed dose of Fluconazole Polfarmex
Do not take a double dose to make up for a missed dose. If a dose has been missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time.
If there are any further doubts regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any of the following symptoms occur, inform 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, itchy blisters, skin rash,
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue).

Fluconazole Polfarmex may affect the liver. Liver-related symptoms include:

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

If any of the above symptoms occur, stop taking Fluconazole Polfarmex and contact your doctor immediately.
Other adverse reactions
Additionally, if any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Common adverse reactions (in 1 to 10 out of 100 patients):

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

Uncommon adverse reactions (in 1 to 10 out of 1,000 patients):

• decreased number of red blood cells causing paleness, weakness and breathlessness,
• loss of appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (sensation of spinning), sensory disturbances, most commonly tingling, pricking 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 adverse reactions (in 1 to 10 out of 10,000 patients):

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

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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 this medicine.

5. How to store the medicine Fluconazole Polfarmex

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
Protect from light.
After first opening the container, the medicine should be used within 6 months.
Do not use this medicine after the expiry date stated on the carton and bottle after:
"Expiry date" or "EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect
the environment.

6. Contents of the pack and other information

What Fluconazole Polfarmex contains

• The active substance is fluconazole. 10 mL of syrup contains 50 mg of fluconazole.
• The other ingredients are: sucrose, sorbitol liquid, non-crystallizing (E 420), glycerol (E 422), propylene glycol (E 1520), hydrochloric acid, diluted, sodium benzoate (E 211), strawberry flavor, liquid (containing among others propylene glycol (E 1520), citral), purified water.

What Fluconazole Polfarmex looks like and contents of the pack
Brown soda-lime glass bottles or plastic bottles with a capacity of 150 mL,
in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]