Fluconazolum Aflofarm

Leaflet attached to the packaging: patient information

Fluconazolum Aflofarm, 5 mg/ml, syrup

Fluconazolum

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Fluconazolum Aflofarm and what is it used for

Fluconazolum Aflofarm belongs to a group of antifungal medicines. The active substance of the medicine is flukonazol.
Fluconazolum Aflofarm is used to treat infections caused by pathogenic fungi. It can also be used to prevent yeast infections. The most common cause of fungal infections is yeast of the genus Candida.

Indications for use

Adults

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

• cryptococcal meningitis - fungal infection of the brain;
• coccidioidomycosis - a disease of the respiratory system;
• infections caused by Candida yeast and detected in the blood, internal organs (e.g. heart, lungs) or urinary tract;
• yeast infections (thrush) of the mucous membranes - infection of the mucous membrane of the mouth, throat and mouth sores related to the use of dental prostheses;
• yeast infections of the genital organs - infections of the vagina or penis;
• fungal skin infections - e.g. athlete's foot, fungal infections of the torso, groin, and nails.

Fluconazolum Aflofarm can also be used:

• to prevent relapses of cryptococcal meningitis;
• to prevent relapses of yeast infections of the mucous membranes;
• to prevent relapses of yeast infections of the vagina;
• to prevent yeast infections (in patients with a weakened and improperly functioning immune system).

Children and adolescents (from 0 to 17 years old)

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

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

Fluconazolum Aflofarm can also be used:

• to prevent yeast infections (if the patient's immune system is weak and does not function properly);
• to prevent relapses of cryptococcal meningitis.

2. Important information before taking Fluconazolum Aflofarm

When not to take Fluconazolum Aflofarm:

• if the patient is allergic to flukonazol and other medicines used to treat fungal infections or any of the other ingredients of this medicine (listed in section 6). Symptoms may include: itching, redness of the skin or difficulty breathing;
• if the patient is taking astemizole, terfenadine (antihistamine medicines used to treat allergies);
• if the patient is taking cisapride (for the treatment of stomach disorders);
• if the patient is taking pimozide (for the treatment of mental disorders);
• if the patient is taking quinidine (for the treatment of heart rhythm disorders);
• if the patient is taking erythromycin (an antibiotic used to treat infections).

Warnings and precautions

Before starting to take Fluconazolum Aflofarm, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney or liver function disorders;
• the patient has heart disease, including heart rhythm disorders;
• the patient has blood potassium, calcium or magnesium level disorders;
• the patient experiences severe skin reactions (itching, redness of the skin, difficulty breathing);
• the patient has ever experienced a severe skin rash or skin peeling after taking Fluconazolum Aflofarm;
• if the fungal infection does not improve, it may be necessary to use another antifungal treatment.

In patients treated with Fluconazolum Aflofarm, there have been cases of severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). If the patient experiences any of the severe skin reactions described in section 4, they should stop taking Fluconazolum Aflofarm and seek medical help immediately.
Fluconazolum Aflofarm should not be used to treat fungal infections of the scalp.

Fluconazolum Aflofarm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The patient should immediatelytell their doctor if they are taking:

• astemizole, terfenadine (antihistamine medicines used to treat allergies);
• cisapride (used to treat stomach disorders);
• pimozide (used to treat mental disorders);
• quinidine (used to treat heart rhythm disorders);
• erythromycin (an antibiotic used to treat infections), as they should not be taken with Fluconazolum Aflofarm (see "When not to take Fluconazolum Aflofarm").

The patient should inform their doctor if they are taking any of the following medicines:

• rifampicin or rifabutin (antibiotics used to treat infections);
• alfentanil, fentanyl (anesthetics);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• warfarin or similar medicines (medicines that reduce blood clotting and prevent blood clots);
• benzodiazepines (midazolam, triazolam or other similar medicines) that facilitate sleep or have a calming effect;
• carbamazepine, phenytoin (used to treat epilepsy);
• nifedipine, isradipine, amlodipine, felodipine and losartan (used to treat high blood pressure);
• cyclosporine, everolimus, sirolimus or tacrolimus (prevent rejection of transplants);
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or other similar medicines) used to treat cancer;
• halofantrine (used to treat malaria);
• atorvastatin, simvastatin and fluvastatin or other similar medicines (statins used to reduce 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 to treat HIV infection);
• chlorpropamide, glibenclamide, glipizide or tolbutamide (antidiabetic medicines);
• theophylline (a medicine used to treat asthma);
• vitamin A (dietary supplement);
• citalopram, escitalopram (antidepressants), as fluconazole (an antifungal medicine) and cimetidine, lansoprazole and omeprazole (medicines used to treat stomach ulcers), fluvoxamine (an antidepressant) and ticlopidine (a medicine used to reduce the risk of heart attack) may increase their levels in the blood.

Fluconazolum Aflofarm with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
If the patient plans to become pregnant, it is recommended that they wait for a week after taking a single dose of fluconazole before becoming pregnant.
In case of longer treatment cycles with fluconazole, the patient should discuss the need for appropriate contraception during treatment and for a week after the last dose with their doctor.
If the patient is pregnant, thinks they may be pregnant or is trying to become pregnant, they should not take fluconazole unless their doctor has told them to. If the patient becomes pregnant or thinks they may be pregnant while taking this medicine or within a week of taking the last dose, they should contact their doctor.

• -Fluconazole taken in the first or second trimester of pregnancy may increase the risk of miscarriage.
• -Fluconazole taken in 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/or 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.

Driving and using machines

The medicine may affect the ability to drive and use machines. If dizziness or seizures occur, the patient should not drive or operate machinery.

Fluconazolum Aflofarm contains sucrose, glycerol, sodium benzoate, sodium and propylene glycol

Sucrose

The medicine contains 134.4 mg of sucrose in each 1 ml of syrup.
This should be taken into account in patients with diabetes.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Glycerol

The medicine contains 829.9 mg of glycerol in each 1 ml of syrup.
Glycerol may cause headache, stomach upset and diarrhea.

Sodium benzoate

The medicine contains 0.74 mg of sodium benzoate in each 1 ml of syrup.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

Sodium

The medicine contains 0.2 mg of sodium in 1 ml of syrup.
The medicine contains 30 mg of sodium (the main component of common salt) in 150 ml of syrup. This corresponds to 66.7% of the maximum recommended daily intake of sodium in the diet for adults.

Propylene glycol

The medicine contains 5.72 mg of propylene glycol in each 1 ml of syrup, which corresponds to 5.72 mg/ml.
Before administering the medicine to a child under 4 weeks of age, the patient should consult their doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take Fluconazolum Aflofarm

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Method of administration

The medicine is for oral use.
A measuring cup or oral syringe is attached to the packaging to facilitate dosing.
After each use, the dosing device should be washed and dried.
Administration of the medicine using an oral syringe:

• take the appropriate volume of the medicine from the bottle;
• place the tip of the syringe in the mouth and, while slowly pressing the plunger, carefully administer the syrup to avoid choking.

The medicine is best taken at the same time every day.

Dosage

The recommended usual dosage, depending on the type of infection, is presented below.
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.

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 per kg of 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 per kg of body weight given every 72 hours.
Sometimes the doctor may recommend a different dosage. The medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Older patients
The usual dose for adults is taken, unless the patient has kidney function disorders.
Patients with kidney function disorders
The doctor may recommend changing the dosage depending on kidney function.

Taking a higher dose of Fluconazolum Aflofarm than recommended

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

Missing a dose of Fluconazolum Aflofarm

The patient should not take a double dose to make up for a missed dose. If a dose is missed, it should be taken as soon as possible. If it is almost time for the next dose, the missed dose should not be taken.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients may experience allergic reactions, but severe allergic reactions are rare.

If the patient experiences any of the following symptoms, they should stop taking Fluconazolum Aflofarm and seek medical help 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 (itchy, red bumps on the skin);
• severe skin reactions, such as a rash with blisters (may also affect the mouth and tongue);
• widespread rash, high fever and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Fluconazolum Aflofarm may affect the liver. Symptoms of liver disorders include:

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

Other side effects may occur

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

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

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

• reduced red blood cell count, causing paleness, weakness and shortness of breath;
• reduced 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, unwell, fever.

Rare(in 1 to 10 out of 10,000 patients):

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

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices and Biocides of the Office for Registration of Medicinal Products, Medical Devices and Biocides
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +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, more information can be collected on the safety of the medicine.

5. How to store Fluconazolum Aflofarm

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Do not store in the refrigerator, do not freeze.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 2 months.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Fluconazolum Aflofarm contains

• The active substance of the medicine is fluconazole. 1 ml of syrup contains 5 mg of fluconazole.
• The other ingredients are: sucrose, glycerol (E 422), citric acid (E 330), sodium citrate (E 331), sodium benzoate (E 211), raspberry flavor (containing a mixture of flavoring substances and solvent, 3-cis-hexenol, vanillin, propylene glycol-1, 2), purified water.

What Fluconazolum Aflofarm looks like and what the packaging contains

The medicine is a colorless to light yellow syrup with a raspberry flavor.
The packaging of the medicine is:

• a brown glass bottle type III, containing 150 ml of syrup, closed with an aluminum cap, with a measuring cup or oral syringe made of LDPE, in a cardboard box.

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Date of last revision of the leaflet: