Fluconazole Hasco

Leaflet attached to the packaging: patient information

Fluconazole Hasco

5 mg/mL, syrup

Fluconazolum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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.
• 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 Fluconazole Hasco and what is it used for
• 2. Important information before taking Fluconazole Hasco
• 3. How to take Fluconazole Hasco
• 4. Possible side effects
• 5. How to store Fluconazole Hasco
• 6. Package contents and other information

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

Fluconazole Hasco is an antifungal medicine. The active substance of the medicine is fluconazole, which inhibits the production of the main component of the fungal cell wall and disrupts its proper functioning.
Fluconazole Hasco is used to treat fungal infections, and it can also be used to prevent fungal infections.

Adults

The doctor may recommend taking Fluconazole Hasco for the following fungal infections:

• cryptococcal meningitis (fungal brain infection),
• coccidioidomycosis (respiratory system disease),
• Candida fungal infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• fungal infections of the mucous membranes (infection of the mouth, throat and mouth ulcers related to the use of dental prostheses),
• fungal infections of the genital organs (vaginal or penile infections),
• skin fungal infections, e.g. athlete's foot (so-called "athlete's foot"), fungal infections of the torso, groin, and fingernails.

In addition, the doctor may recommend taking Fluconazole Hasco to:

• prevent recurrence of cryptococcal meningitis,
• prevent recurrence of fungal infections of the mucous membranes, throat and esophagus in HIV-infected patients who are at increased risk of recurrence,
• prevent recurrence of vaginal fungal infections (4 or more infections per year),
• prevent fungal infections in patients with a weakened immune system.

Children and adolescents (from 0 to 17 years old)

The doctor may recommend taking Fluconazole Hasco to treat the following fungal infections:

• fungal infections of the mucous membranes (infection of the mouth or throat),
• Candida fungal infections detected in the blood, internal organs (e.g. heart, lungs) or urinary tract,
• cryptococcal meningitis (fungal brain infection).

In addition, the doctor may recommend taking Fluconazole Hasco to:

• prevent fungal infections if the patient's immune system is weak and not functioning properly,
• prevent recurrence of cryptococcal meningitis in children with a high risk of recurrence.

2. Important information before taking Fluconazole Hasco

When not to take Fluconazole Hasco

• If the patient is allergic to the active substance - fluconazole, or to other azole derivatives or any of the other ingredients of this medicine listed in section 6. Symptoms of an allergy may include: itching, skin redness or difficulty breathing.
• If the patient is taking medicines containing:
• astemizole or terfenadine (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).

Warnings and precautions

Tell your doctor 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, skin redness, difficulty breathing),
• the patient has ever experienced a severe skin rash or skin peeling after taking Fluconazole Hasco,
• if the fungal infection does not improve, other antifungal treatment may be necessary.

In patients treated with Fluconazole Hasco, 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 Fluconazole Hasco and seek medical help immediately.

Be careful when taking Fluconazole Hasco

Particular caution should be exercised, especially in patients suffering from serious diseases, such as AIDS or cancer, as well as in patients with liver function abnormalities. To minimize the risk of liver function disorders, regular monitoring of the liver is necessary. If symptoms of liver failure occur, the doctor will decide whether to discontinue fluconazole.
During fluconazole treatment, rare cases of skin changes (Stevens-Johnson syndrome - a variant of erythema multiforme and toxic epidermal necrolysis) have been observed. AIDS patients are more prone to skin reactions during therapy with various medicines.
If a rash occurs during treatment with fluconazole for superficial fungal infections, the doctor will recommend discontinuing fluconazole.
If a rash occurs during treatment with fluconazole for invasive systemic fungal infections, fluconazole treatment can be continued under regular monitoring of the patient's condition.
If the patient experiences blistering or erythema multiforme, the doctor will decide whether to discontinue fluconazole.
There have also been rare cases of anaphylaxis (see section 4. Possible side effects).
Fluconazole treatment can rarely lead to changes in the ECG record (so-called QT interval prolongation) or even to the occurrence of very serious heart rhythm disorders (so-called torsades de pointes). Fluconazole administration may contribute to the occurrence of arrhythmias in patients:

• with congenital or documented QT interval prolongation in the ECG record;
• with cardiomyopathy (especially in patients with heart failure);
• with sinus bradycardia;
• with other heart rhythm disorders;
• taking other medicines that prolong the QT interval in the ECG record;
• with electrolyte disorders (decreased potassium, magnesium, calcium levels in the blood).

Patients with kidney function disorders
In patients with renal failure, it is necessary to adjust the fluconazole dosage (see section 3. How to take Fluconazole Hasco).
Children
See section 3. How to take Fluconazole Hasco.

Fluconazole Hasco and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor immediately if you are taking medicines containing:

• astemizole or terfenadine (antihistamines 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 Fluconazole Hasco (see section When not to take Fluconazole Hasco).

Other medicines are known to interact with Fluconazole Hasco.
If you are taking any of the following medicines, make sure your doctor is informed:

• rifampicin or rifabutin (antibiotics used to treat infections),
• alfentanil, fentanyl (anesthetics),
• amitriptyline, nortriptyline (antidepressants),
• amphotericin B, voriconazole (antifungal medicines),

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• blood thinning medicines that prevent blood clots (warfarin or similar medicines),
• 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 (used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or other similar medicines) used to treat cancer,
• halofantrine (used to treat malaria),
• statins (atorvastatin, simvastatin and fluvastatin or 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).

Fluconazole Hasco with food and drink

The medicine can be taken with or without food. Eating food at the same time does not affect the absorption of fluconazole.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, do not take Fluconazole Hasco unless your doctor has told you to.
If you plan to become pregnant, it is recommended that you wait one week after taking a single dose of fluconazole before becoming pregnant.
In the case of longer treatment cycles with fluconazole, you should discuss the need for appropriate contraception during treatment and for one week after the last dose with your 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 birth defects of the heart, bones and/or muscles.
There have been cases of children born with congenital 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.
Breastfeeding can be continued after a standard single dose of 200 mg or less, but if you are taking multiple or high doses of fluconazole, breastfeeding is not recommended. Fluconazole passes into breast milk at concentrations lower than in blood.

Driving and using machines

Consider that dizziness or seizures may occur, and do not drive or operate machinery in such cases.

Fluconazole Hasco contains liquid maltitol

1 mL of Fluconazole Hasco syrup contains 723 mg of liquid maltitol. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine may have a mild laxative effect. The energy value is 2.3 kcal/g of maltitol.

Fluconazole Hasco contains propylene glycol (E 1520)

The medicine contains 60.797 mg of propylene glycol in 1 mL of syrup.
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.
Pregnant or breastfeeding women should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without a doctor's recommendation. The doctor may decide to perform additional tests on such patients.

Fluconazole Hasco contains sodium benzoate (E 211)

The medicine contains 1.808 mg of sodium benzoate in 1 mL of syrup. Benzoic acid salt may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

Fluconazole Hasco contains ethanol

This medicine contains 0.361 mg of ethanol in each mL of syrup. The amount of alcohol in 5 mL of syrup is equivalent to less than 1 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Fluconazole Hasco contains sodium

The medicine contains 0.356 mg of sodium (the main component of table salt) in 1 mL of syrup. This corresponds to 0.018% of the maximum recommended daily sodium intake in adults.

3. How to take Fluconazole Hasco

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine orally.
It is best to take the medicine at the same time every day.
General recommendations
Treatment should be continued until clinical symptoms disappear and mycological test results indicate the disappearance of fungal activity in the collected material. Inadequate dosing or too short a treatment period may expose the patient to the risk of infection recurrence. In patients with AIDS and cryptococcal meningitis, further maintenance treatment is usually necessary to prevent infection recurrence.
The recommended dosage of Fluconazole Hasco depends on the type of infection and is presented below.

Adults

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Adolescents from 12 to 17 years old

The maximum dose for adolescents is 80 mL of syrup (i.e. 400 mg of fluconazole) per day.
The dose should be taken as prescribed by the doctor (either as for adults or as for children).

Children from 28 days to 11 years old

The maximum dose for children is 80 mL of syrup (i.e. 400 mg of fluconazole) per day.
The dose is determined by the doctor based on the child's body weight in kilograms.

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Dosage for children from 0 to 4 weeks of age

Children from 3 to 4 weeks of age
The same dose as in the table above, but given every other day. The maximum dose is 12 mg per kilogram of body weight every 48 hours (i.e. 2.4 mL of syrup per kilogram of body weight every 48 hours).
Children under 2 weeks of age
The same dose as in the table above, but given every 3 days. The maximum dose is 12 mg per kilogram of body weight every 72 hours (i.e. 2.4 mL of syrup per kilogram of body weight every 72 hours).
A measuring spoon and cup are included with the packaging.

Elderly patients

If kidney function is not impaired (the so-called creatinine clearance value exceeds 50 mL/min), it is not necessary to modify the fluconazole dosage in elderly patients.

Patients with kidney function disorders

A single dose of fluconazole in patients with renal failure does not require dose adjustment.
Patients (including children and adolescents) with kidney function disorders should be given a dose on the first day according to the indications and age, but subsequent daily doses should be adjusted by the doctor based on the creatinine clearance value.

Taking a higher dose of Fluconazole Hasco than recommended

In case of taking a higher dose of Fluconazole Hasco than recommended or accidental ingestion of the medicine by another person, contact a doctor or pharmacist immediately. Take the medicine packaging and leaflet with you to show the doctor, who will decide on further action depending on the dose taken and symptoms of overdose.
Symptoms of fluconazole overdose may include: hearing, vision or sensation disorders, thinking about untrue things (hallucinations and paranoid behavior).
Usually, the doctor will administer symptomatic treatment (if necessary, supported by gastric lavage) and forced diuresis. A 3-hour hemodialysis session reduces the concentration of the medicine in the blood by 50%.

Missing a dose of Fluconazole Hasco

Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible. If it is almost time for the next dose, do not take the missed dose.

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 you experience any of the following symptoms, stop taking Fluconazole Hasco and seek medical help immediately:

• sudden shortness of breath, difficulty breathing or chest tightness,
• swelling of the eyelids, face or lips,
• itching all over the body, skin redness or red, itchy blisters,

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

Fluconazole Hasco may affect the liver, so the following symptoms may occur during treatment:

• fatigue,
• loss of appetite,
• nausea and vomiting,
• yellowing of the skin or whites of the eyes (jaundice).

If you experience any of these symptoms, stop taking Fluconazole Hasco and contact your doctor immediately.

Other side effects

Frequent side effects(in 1 to 10 out of 100 patients):

• headache,
• abdominal pain, diarrhea, nausea, vomiting,
• increased values of some laboratory test results - so-called liver function tests,
• skin rash.

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

• decreased red blood cell count, which can cause pallor, weakness and shortness of breath,
• decreased appetite,
• insomnia, drowsiness,
• seizures, dizziness, balance disorders (feeling of spinning), sensation disorders, usually in the form of tingling, numbness or prickling, changes in taste,
• constipation, indigestion, bloating, dry mouth,
• muscle pain,
• liver damage and yellowing of the skin and eyes (jaundice),
• blisters, hives, itching, increased sweating,
• fatigue, malaise, fever.

Rare side effects(in 1 to 10 out of 10,000 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 biochemistry parameters (high cholesterol, lipid levels in the blood),
• decreased potassium levels in the blood,
• tremors,
• heart rhythm disorders visible in the ECG record,
• liver failure,
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling, severe skin reactions, swelling of the lips or face,
• anaphylactic reaction (a life-threatening hypersensitivity reaction with symptoms such as itching, hives, difficulty breathing, low blood pressure, rapid heartbeat),
• 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: 22 49 21 301
Fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Fluconazole Hasco

Store in a temperature below 25°C. Store in the original packaging.
Shelf life after opening the bottle: 3 months.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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. Package contents and other information

What Fluconazole Hasco contains

• The active substance of the medicine is fluconazole. One milliliter of syrup contains 5 mg of fluconazole.
• Other ingredients are: liquid maltitol, propylene glycol (E 1520), sodium benzoate (E 211), citric acid monohydrate, sodium saccharin, strawberry flavor AR0012/F (contains propylene glycol and ethanol), purified water.

What Fluconazole Hasco looks like and what the packaging contains

Fluconazole Hasco is a clear, colorless syrup with a strawberry flavor.
The medicine packaging is a brown glass bottle.
One packaging contains 150 mL of syrup.
A measuring spoon and cup are included with the packaging.

Marketing authorization holder and manufacturer

Hasco-Lek Pharmaceutical Company S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicine information
phone: 22 742 00 22
e-mail: [email protected]
Date of last update of the leaflet:02/2024
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