Package leaflet: Information for the patient

Fluconazole Hasco
5 mg/mL, syrup
Fluconazolum
Please read carefully the entire leaflet before use, as it contains
important information for the patient.

Keep this leaflet, so 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 give it to others. The medicine may harm another person, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Fluconazole Hasco is and what it is used for
Important information before taking Fluconazole Hasco
How to take Fluconazole Hasco
Possible side effects
How to store Fluconazole Hasco
Contents of the pack and other information

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

Fluconazole Hasco is an antifungal medicine. The active substance is fluconazole, which inhibits
the formation of a key component of the cell wall of pathogenic fungi and disrupts its
normal function.
Fluconazole Hasco is used in the treatment of infections caused by pathogenic fungi, and may also be used
for the prevention of candidiasis. The most common cause of fungal infections are
yeasts of the genus known in Latin as Candida.
Adults
Your doctor may recommend using Fluconazole Hasco for the following fungal infections:

cryptococcal meningitis (fungal infection of the brain),
coccidioidomycosis (a respiratory system disease),
infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract,
mucosal yeast infections (thrush) of the mucous membranes (oral cavity, throat, and denture-related stomatitis),
genital yeast infections (infections of the vagina or penis),
skin fungal infections, e.g. athlete's foot, body ringworm, groin ringworm, nail fungal infections.

Additionally, your doctor may recommend using Fluconazole Hasco for:

preventing recurrence of cryptococcal meningitis,
preventing recurrence of mucosal, throat, and oesophageal yeast infections in HIV-infected patients at increased risk of recurrence,
preventing recurrence of vaginal yeast infections (4 or more episodes per year),
preventing yeast infections (in patients with weakened or impaired immune systems).

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Children and adolescents (aged 0 to 17 years)
Your doctor may recommend using Fluconazole Hasco to treat the following fungal infections:

mucosal yeast infections (thrush) of the oral cavity or throat,
infections caused by Candida yeasts detected in the blood, internal organs (e.g. heart, lungs), or urinary tract,
cryptococcal meningitis (fungal infection of the brain).

Additionally, your doctor may recommend using Fluconazole Hasco for:

preventing yeast infections (in patients with a weakened or impaired immune system),
preventing recurrence of cryptococcal meningitis in children at high risk of recurrence.

2. Information before using Fluconazole Hasco

When not to use Fluconazole Hasco

If the patient is allergic to the active substance – fluconazole, to other azole derivatives, or to any of the other ingredients of this medicine listed in section 6. Symptoms of allergy may include: itching, skin redness, or difficulty breathing.
If the patient is taking medicines containing:
astemizole or terfenadine (used in the treatment of allergies),
cisapride (used in the treatment of stomach motility disorders),
pimozide (used in the treatment of psychiatric disorders),
quinidine (used in the treatment of cardiac arrhythmias),
erythromycin (an antibiotic used to treat infections).

Warnings and precautions
Inform your doctor if:

the patient has impaired kidney or liver function,
the patient has heart disease, including cardiac arrhythmias,
the patient has blood electrolyte imbalances (abnormal levels of potassium, calcium, or magnesium),
the patient experiences severe skin reactions (itching, skin redness, difficulty breathing),
the patient has previously experienced severe skin rash or skin peeling, blisters, and/or oral mucosal ulcers after taking Fluconazole Hasco,
if fungal infection does not improve, 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 Fluconazole Hasco. If any of the symptoms of severe skin reactions described in section 4 occur, the patient must stop taking Fluconazole Hasco immediately and seek urgent medical attention.

Exercise special caution when using Fluconazole Hasco
Special caution is required, particularly in patients with serious conditions such as AIDS or malignancies, and in those with impaired liver function. To minimize the risk of liver dysfunction, regular monitoring of liver function is necessary. If symptoms of liver failure occur, the doctor will decide to discontinue fluconazole treatment.

Rarely, during fluconazole treatment, skin reactions have been observed (such as Stevens-Johnson syndrome – a variant of erythema multiforme, and toxic epidermal necrolysis – Lyell’s syndrome). Patients with AIDS are more susceptible to skin reactions during therapy with various drugs.

If a skin rash develops 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 infection, fluconazole therapy may be continued provided the patient is closely monitored.

If the patient develops blistering skin lesions or erythema multiforme, the doctor will decide to discontinue fluconazole.

Rare cases of anaphylaxis have also been reported (see section 4. Possible side effects).

Fluconazole treatment may rarely lead to changes in the ECG (prolongation of the QT interval) or even to the development of serious cardiac arrhythmias (torsades de pointes). Administration of fluconazole may predispose to arrhythmias in patients:

with congenital or documented QT prolongation on ECG,
with cardiomyopathy (especially in patients with heart failure),
with sinus bradycardia,
with other cardiac rhythm disorders,
concurrently taking other drugs that prolong the QT interval on ECG,
with electrolyte imbalances (low blood potassium, magnesium, or calcium levels).

Patients with renal impairment
In patients with renal impairment, appropriate dose adjustment of fluconazole is required (see section 3. How to use Fluconazole Hasco).

Children
See section 3. How to use Fluconazole Hasco.

Fluconazole Hasco and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

You must immediately inform your doctor if the patient is taking medicines containing:

astemizole or terfenadine (antihistamines used in allergy),
cisapride (used for gastric motility disorders),
pimozide (used for psychiatric disorders),
quinidine (used for cardiac arrhythmias),
erythromycin (an antibiotic used to treat infections), as these should not be used together with Fluconazole Hasco (see section When not to use Fluconazole Hasco).

Other medicines are known to interact with Fluconazole Hasco.
If the patient is taking any of the following medicines, ensure the doctor is informed:

rifampicin or rifabutin (antibiotics used to treat infections),
alfentanil, fentanyl (analgesic/anaesthetic agents),
amitriptyline, nortriptyline (antidepressants),
amphotericin B, voriconazole (antifungal agents),
anticoagulants (warfarin or similar agents) used to prevent blood clots,
benzodiazepines (midazolam, triazolam or similar agents) used to aid sleep or for sedation,
carbamazepine, phenytoin (used in the treatment of epilepsy),
nifedipine, isradipine, amlodipine, felodipine, losartan (used in the treatment of hypertension),
cyclosporine, everolimus, sirolimus, or tacrolimus (immunosuppressants used to prevent transplant rejection),
cyclophosphamide, vinca alkaloids (vincristine, winblastine or similar agents) used in the treatment of cancer,
halofantrine (used in the treatment of malaria),
statins (atorvastatin, simvastatin, fluvastatin or similar agents) used to lower cholesterol levels,
methadone (analgesic),
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 agents such as chlorpropamide, glyburide, glipizide, or tolbutamide,
theophylline (used in asthma),
vitamin A (dietary supplement).

Fluconazole Hasco with food and drink
The medicine can be taken during or independently of meals. Concomitant food intake does not affect the absorption of fluconazole.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should not take Fluconazole Hasco unless otherwise advised by a doctor.

If the patient is planning to become pregnant, it is recommended to wait one week after taking a single dose of fluconazole before attempting conception.

For prolonged courses of fluconazole treatment, discuss with the doctor the need for appropriate contraception during treatment and for one week after the last dose.

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 malformations of the heart, bones, and/or muscles.

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 causal relationship between fluconazole use and these cases is not fully established.

Breastfeeding may continue after a standard single dose of 200 mg or less. However, if the patient is taking multiple or high doses of fluconazole, breastfeeding is not recommended. Fluconazole passes into human milk, reaching concentrations lower than those in blood.

Driving and operating machinery
Consider that dizziness or seizures may occur; therefore, driving or operating machinery should be avoided.

Fluconazole Hasco contains liquid maltitol
1 mL of Fluconazole Hasco syrup contains 723 mg of liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

The medicine may have a mild laxative effect. Calorific value: 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 medical advice. The doctor may decide to perform additional monitoring 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 monitoring in 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 salts 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 is unlikely to cause 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 intake of sodium in the adult diet.

3. How to use Fluconazole Hasco

This medicine should always be used as directed by the physician. In case of doubt, consult your
physician or pharmacist.
The medicine is administered orally.
It is best to take the medicine at the same time each day.
General instructions
Treatment should be continued until clinical symptoms have resolved and mycological test results
indicate absence of yeast activity in the collected specimen. Inadequate dosing or treatment duration
too short may expose the patient to recurrence of infection. In patients with AIDS and cryptococcal
meningitis, prolonged maintenance therapy is usually required to prevent recurrence of infection.
Dosage of Fluconazole Hasco usually recommended depending on the type of infection is given below.
Adults

Indication	Dosage
Treatment of cryptococcal meningitis	80 mL of syrup (i.e. 400 mg of fluconazole) on the first day, followed by 40 to 80 mL of syrup (i.e. 200 to 400 mg of fluconazole) once daily, depending on physician's recommendation, for 6 to 8 weeks, or longer if necessary. Sometimes the dose may be increased to 160 mL of syrup (i.e. 800 mg of fluconazole) per day.
Prevention of recurrence of cryptococcal meningitis	40 mL of syrup (i.e. 200 mg of fluconazole) once daily until the physician recommends discontinuation of treatment.

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of the brain
Treatment of coccidioidomycosis	40 to 80 mL of syrup (i.e. 200 to 400 mg of fluconazole) once daily for a period of 11 to 24 months, or longer if necessary. Sometimes the dose may be increased to 160 mL of syrup (i.e. 800 mg of fluconazole) per day.
Treatment of systemic Candida infections	160 mL of syrup (i.e. 800 mg of fluconazole) on the first day, then 80 mL of syrup (i.e. 400 mg of fluconazole) once daily until your doctor advises stopping treatment.
Treatment of fungal infections of the oral mucosa, throat and denture-related stomatitis	40 to 80 mL of syrup (i.e. 200 to 400 mg of fluconazole) on the first day, then 20 to 40 mL of syrup (i.e. 100 to 200 mg of fluconazole) until your doctor advises stopping treatment.
Fungal (yeast) mucosal infections – dosage depends on location	10 to 80 mL of syrup (i.e. 50 to 400 mg of fluconazole) once daily for 7 to 30 days, or until your doctor advises stopping treatment.
Prevention of mucosal infections of the mouth, throat and oesophagus in HIV-infected patients at increased risk of recurrence	20 to 40 mL of syrup (i.e. 100 to 200 mg of fluconazole) once daily, or 40 mL of syrup (i.e. 200 mg of fluconazole) three times a week, in patients at increased risk of recurrent infection.
Treatment of genital yeast infections	A single dose of 30 mL of syrup (i.e. 150 mg of fluconazole).
Prevention of recurrent vaginal yeast infections	30 mL of syrup (i.e. 150 mg of fluconazole) every third day, for a total of 3 doses (on days 1, 4 and 7), then once weekly for 6 months (in patients at increased risk of recurrent infection).
Treatment of fungal skin and nail infections	Depending on the site of infection: 10 mL of syrup (i.e. 50 mg of fluconazole) once daily, 30 mL of syrup (i.e. 150 mg of fluconazole) once weekly, or 60 to 80 mL of syrup (i.e. 300 to 400 mg of fluconazole) once weekly for 1 to 4 weeks. In cases of athlete’s foot, treatment may be required for up to 6 weeks; in nail infections, treatment should continue until the infected nail is completely replaced by a new, uninfected one.
Prevention of yeast infections (in patients with weakened or impaired immune systems)	40 to 80 mL of syrup (i.e. 200 to 400 mg of fluconazole) once daily, in patients at increased risk of recurrent infection.

Adolescents aged 12 to 17 years
The maximum dose for adolescents is 80 mL of syrup (i.e. 400 mg of fluconazole) per day.
The dose prescribed by the physician should be administered (either as for adult patients or as for children).

Children aged 28 days to 11 years
The maximum dose for children is 80 mL of syrup (i.e. 400 mg of fluconazole) per day.
The physician determines the dose based on the child's body weight (bw) in kilograms.

Indication	Daily dose
Yeast infections of the mucous membranes of the oral cavity and pharynx – dose and duration of treatment depend on the severity and site of infection	3 mg of fluconazole per kg body weight (i.e. 0.6 mL of syrup per kg body weight). On the first day, a dose of 6 mg per kg body weight (i.e. 1.2 mL of syrup per kg body weight) may be administered.
Cryptococcal meningitis or systemic yeast infections	6 to 12 mg of fluconazole per kg body weight (i.e. 1.2 to 2.4 mL of syrup per kg body weight)
Maintenance treatment to prevent relapses	6 mg of fluconazole per kg body weight

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Cryptococcal meningitis in children at high risk of relapse	(i.e. 1.2 mL of syrup per kg body weight)
Prevention of Candida infections in children (if the immune system is not functioning properly)	3 to 12 mg of fluconazole per kg body weight (i.e. 0.6 to 2.4 mL of syrup per kg body weight)

Dosage in children from 0 to 4 weeks of age
Children aged 3 to 4 weeks
The same dose as in the table above, but administered every other day. The maximum dose is 12 mg per kg of body weight every 48 hours (i.e. 2.4 mL of syrup per kg of body weight every 48 hours).
Children under 2 weeks of age
The same dose as in the table above, but administered every 3 days. The maximum dose is 12 mg per kg of body weight every 72 hours (i.e. 2.4 mL of syrup per kg of body weight every 72 hours).
A measuring spoon and measuring device are included in the package.
Elderly patients
If renal excretory function is not impaired (creatinine clearance value exceeds 50 mL/min), dosage adjustment of fluconazole is not necessary in elderly patients.
Patients with renal impairment
A single dose of fluconazole in patients with renal insufficiency does not require dosage adjustment. In patients (including children and adolescents) with impaired renal function, the initial dose on day one should be as indicated above according to indication and age; however, subsequent daily doses should be adjusted by the physician according to the creatinine clearance value.
Administration of a higher than recommended dose of Fluconazole Hasco
If an overdose of Fluconazole Hasco is taken or if the medicine is accidentally ingested by another person, contact a physician or pharmacist immediately. Bring the medicine package and the patient information leaflet to show the doctor, who will decide on further management based on the amount ingested and symptoms of overdose.
Symptoms of fluconazole overdose may include disturbances in hearing, vision, and sensation, as well as false beliefs (hallucinations and paranoid behavior).
Usually, the physician will administer symptomatic treatment (if necessary, supported by gastric lavage) and so-called forced diuresis. Three-hour hemodialysis reduces drug concentration in serum by 50%.
Missed dose of Fluconazole Hasco
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible. If the time for the next dose is approaching, skip the missed dose and take the next dose at the regular scheduled time.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Allergic reactions may occur in some patients, but severe allergic reactions are rare.
If the patient experiences any of the symptoms listed below, treatment with Fluconazole Hasco must be stopped immediately and medical help must be sought without delay:

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 (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 liver function, therefore during treatment the following may occur:

feeling of fatigue,
loss of appetite,
vomiting,
yellowing of the skin or whites of the eyes (so-called jaundice).

If any of the above symptoms occur, treatment with Fluconazole Hasco must be stopped and a doctor must be contacted immediately.

Other side effects

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

headache,
abdominal pain, diarrhoea, nausea, vomiting,
increased values of certain laboratory test results – so-called liver function tests,
rash.

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

decrease in the 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 sensation,
muscle pain,
liver damage and yellowing of the skin and eyes (so-called jaundice),
blisters, urticaria, itching, increased sweating,
feeling of fatigue, malaise, fever.

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

decrease in the number of white blood cells involved in the body's defence against infections (so-called leukopenia) and blood cells helping to stop bleeding (so-called thrombocytopenia),
red or purple skin discolouration, which may result from a reduced number of platelets or changes in other blood cells,
changes in blood biochemical parameters (elevated cholesterol levels, elevated plasma lipid levels),
decreased blood potassium levels,
tremor,
abnormalities visible on ECG, heart rhythm disorders,
liver failure,
allergic reactions (sometimes severe), including widespread blistering rash, skin peeling, severe skin reactions, swelling of lips or face,
anaphylactic reaction (a potentially life-threatening hypersensitivity reaction with symptoms such as itching, urticaria, breathing difficulty, drop in blood pressure, rapid heartbeat),
hair loss.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of 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
Side effects may also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Fluconazole Hasco

Store below 25°C. Keep in the original packaging.
Shelf life after first opening the bottle: 3 months.
Keep this medicine out of 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package contents and other information

What Fluconazole Hasco contains

The active substance is fluconazole. One millilitre of syrup contains 5 mg of fluconazole.
The other ingredients are: liquid maltitol, propylene glycol (E 1520), sodium benzoate (E 211), monohydrate citric acid, sodium saccharin, strawberry flavour AR0012/F (containing propylene glycol and ethanol), purified water.

What Fluconazole Hasco looks like and contents of the pack
Fluconazole Hasco is a clear, colourless syrup with a strawberry odour.
The medicine comes in a brown glass bottle.
One pack contains 150 mL of syrup.
An oral dosing spoon and a measuring cup are included in the pack.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine Information
Tel.: 22 742 00 22
E-mail: [email protected]
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Fluconazole hasco