Fluconazole aflofarm

Package leaflet: information for the patient

Fluconazolum Aflofarm, 5 mg/ml, syrup
Fluconazolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• 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. The medicine may harm another person, 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 of the leaflet

1. What Fluconazolum Aflofarm is and what it is 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 package and other information

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

Fluconazolum Aflofarm belongs to a group of antifungal medicines. The active substance is
fluconazole.
Fluconazolum Aflofarm is used to treat infections caused by pathogenic fungi. It may also be used to prevent Candida infections. The most common cause of fungal infections are yeasts of the genus known in Latin as Candida.
Indications for use
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 mouth sores associated with wearing dental prostheses;
• 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.

Fluconazolum Aflofarm may also be used to:

• prevent recurrence of cryptococcal meningitis;
• prevent recurrence of mucosal yeast infections;
• prevent recurrence of vaginal yeast infections;
• 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.

Fluconazolum Aflofarm may also be used to:

• prevent yeast infections (in patients with a weakened or poorly functioning immune system);
• prevent recurrence of cryptococcal meningitis.

2. Important information before taking Fluconazolum Aflofarm

When not to take Fluconazolum Aflofarm:

• if the patient is allergic to fluconazole or other antifungal medicines, or to any of the other ingredients of this medicine (listed in section 6). Symptoms may include itching, skin redness or breathing difficulties;
• if the patient is taking astemizole, terfenadine (antihistamines 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
Before starting to take Fluconazolum Aflofarm, consult a doctor or pharmacist if:

• the patient has kidney or liver function disorders;
• the patient has heart disease, including heart rhythm disorders;
• the patient has abnormal blood levels of potassium, calcium or magnesium;
• the patient experiences severe skin reactions (itching, skin redness, breathing difficulties);
• if the patient has ever experienced severe skin rash or skin peeling, blisters and/or oral ulcers after taking Fluconazolum Aflofarm;
• if the fungal infection does not resolve, alternative antifungal treatment may be necessary.

Severe skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in patients treated with Fluconazolum Aflofarm. If any of the symptoms of severe skin reactions described in section 4 occur, the patient must stop taking Fluconazolum Aflofarm immediately and seek medical help without delay.
Fluconazolum Aflofarm should not be used to treat tinea capitis (fungal infection of the scalp).

Fluconazolum Aflofarm and other medicines
Tell the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Inform the doctor immediately if the patient is taking:

• astemizole, terfenadine (antihistamines used for 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 these should not be used together with Fluconazolum Aflofarm (see section "When not to take Fluconazolum Aflofarm").

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

• rifampicin or rifabutin (antibiotics used to treat infections);
• alfentanil, fentanyl (anaesthetic medicines);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• warfarin or similar medicines (medicines that reduce blood clotting, preventing blood clots);
• benzodiazepines (midazolam, triazolam or similar medicines) used to help 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 similar medicines) used to treat cancer;
• halofantrine (used to treat malaria);
• atorvastatin, simvastatin and fluvastatin or similar medicines (statins used to lower cholesterol levels);
• methadone (a painkiller);
• 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 to treat HIV infection);
• chlorpropamide, glibenclamide, glipizide or tolbutamide (antidiabetic medicines);
• theophylline (a medicine used for asthma);
• vitamin A (dietary supplement);
• citalopram, escitalopram (antidepressants), as fluconazole (an antifungal medicine), and cimetidine, lansoprazole and omeprazole (medicines used to treat peptic ulcer disease), fluvoxamine (an antidepressant), and ticlopidine (a medicine used to reduce the risk of heart attack) may increase their blood levels.

Fluconazolum Aflofarm with food and drink
This medicine can be taken during or independently of meals.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, 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 during treatment with 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 abnormalities in the newborn. Cases of infants born with congenital malformations of the skull, ears, femur and elbow bones have been reported in mothers treated for coccidioidomycosis with high-dose fluconazole (400–800 mg daily) for at least three months. The causal relationship between fluconazole use and these cases is not fully established.

Driving and operating machinery
This medicine may affect the ability to drive or operate machinery. 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 certain sugars, they should consult a doctor before taking this medicine.

Glycerol
The medicine contains 829.9 mg of glycerol in each 1 ml of syrup.
Glycerol may cause headache, gastrointestinal disturbances and diarrhoea.

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 whites of the 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 table salt) in 150 ml of syrup. This corresponds to 66.7% of the maximum recommended daily dietary sodium intake for adults.

Propylene glycol
The medicine contains 5.72 mg of propylene glycol in each 1 ml of syrup, equivalent to 5.72 mg/ml.
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.

3. How to take Fluconazolum Aflofarm

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
Method of administration
This is an oral medicine.
A measuring device or oral syringe is included in the package to facilitate dosing.
After each use, the dosing device should be washed and dried.
Administration of the medicine using an oral syringe:

• draw the appropriate volume of medicine from the bottle;
• place the tip of the syringe in the mouth and slowly press the plunger, carefully administering the syrup to avoid choking.

The medicine should preferably be taken at the same time each day.
Dosage
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 physician (as in adult patients or as in 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.

Dosage in children from 0 to 4 weeks of age
Children from 3 to 4 weeks of age
The same dose as above, but administered every other day. The maximum dose is 12 mg per kg
b.w. every 48 hours.
Children under 2 weeks of age
The same dose as above, administered every 3 days. The maximum dose is 12 mg per kg b.w.,
given every 72 hours.
Sometimes the doctor may recommend a different dosage. The medicine should always be used according to
the doctor's instructions. In case of doubt, consult a doctor or pharmacist.
Elderly patients
The usual adult dose is administered, unless the patient has renal impairment.
Patients with renal impairment
The doctor may recommend adjusting the dosage depending on kidney function.
Taking more than the recommended dose of Fluconazolum Aflofarm
Taking too high a dose of the medicine at once may cause feeling unwell. You should contact immediately
the emergency department of the nearest hospital. Symptoms of overdose may include disturbances of hearing,
vision and sensation, thinking about unreal things (hallucinations and paranoid behavior). Symptomatic treatment
(supportive treatment maintaining vital functions and gastric lavage, if necessary) may be indicated.
Missing a dose of Fluconazolum Aflofarm
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 the next dose, do not take the missed dose.
If you have any further doubts concerning 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 will experience them.
Allergic reactions may occur in some patients, although severe allergic reactions are rare.
If any of the following symptoms occur in a patient, treatment with Fluconazolum Aflofarm must be discontinued and immediate medical help sought:

• 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 (itchy red bumps on the skin);
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue);
• widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Fluconazolum Aflofarm may affect the liver. Liver-related symptoms include:

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

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

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

Uncommon (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 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 (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 discolouration, possibly due to reduced platelet count or changes in other blood cells;
• changes in blood biochemical parameters (elevated blood cholesterol and lipid levels);
• low blood potassium levels, 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 symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Fluconazolum Aflofarm

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in the refrigerator, do not freeze.
Keep 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 stated month.
Shelf life after first opening the bottle: 2 months.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Fluconazolum Aflofarm contains

• The active substance 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 flavour (containing a mixture of flavouring substances and solvent, 3-cis-hexenol, vanillin, propylene glycol-1,2), purified water.

What Fluconazolum Aflofarm looks like and contents of the pack
Fluconazolum Aflofarm is a colourless to pale yellow syrup with a raspberry odour.
The packaging contains:

• a bottle made of brown glass type III, containing 150 ml of syrup, closed with an aluminium cap, with an attached measuring spoon made of LDPE or an oral dosing syringe made of LDPE, packed in a cardboard box.

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