Fluconazolum Aflofarm

Leaflet accompanying the packaging: patient information

Fluconazolum Aflofarm, 200 mg, hard capsules

Fluconazolum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 and 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 taking this medicine for the following fungal infections:

• Cryptococcal meningitis - a fungal infection of the brain;
• Coccidioidomycosis - a disease of the respiratory system;
• Infections caused by Candida yeast 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 associated with 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;
• prevent relapses of yeast infections of the mucous membranes;
• prevent relapses of yeast infections of the vagina;
• 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 taking 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 detected in the blood, internal organs (e.g. heart, lungs) or urinary tract;
• Cryptococcal meningitis - a fungal infection of the brain.

Fluconazolum Aflofarm can also be used to:

• prevent yeast infections (if the patient's immune system is weak and not functioning properly);
• 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, other antifungal medicines, 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 (antihistamines used to treat allergies);
• if the patient is taking cisapride (for stomach disorders);
• if the patient is taking pimozide (for mental disorders);
• if the patient is taking quinidine (for 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 develops symptoms of "adrenal insufficiency", when the adrenal glands do not produce enough certain steroid hormones, such as cortisol (chronic or prolonged fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain);
• -if 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.

Patient taking Fluconazolum Aflofarm have experienced 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 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 (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),

because 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, prevent blood clots),
• benzodiazepines (midazolam, triazolam or other similar medicines) that facilitate sleep or calmness,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat high blood pressure),
• cyclosporine, everolimus, sirolimus, or tacrolimus (prevent transplant rejection),
• 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 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 to treat HIV infection),
• chlorpropamide, glibenclamide, glipizide, or tolbutamide (antidiabetic medicines),
• theophylline (a medicine used to treat asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders - "arrhythmia"),
• hydrochlorothiazide (a diuretic),
• 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.

Taking 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 proper 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 recommends it.
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.

• Taking fluconazole in the first or second trimester of pregnancy may increase the risk of miscarriage.
• Taking fluconazole in the first trimester of pregnancy may increase the risk of birth defects of the heart, bones, and/or muscles.

There have been reports of children with birth defects of the skull, ears, and femur and humerus 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 taking a single dose of Fluconazolum Aflofarm of 200 mg or less. Breastfeeding should not be continued if the patient is taking multiple doses of Fluconazolum Aflofarm.

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 lactose monohydrate and sodium

Lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Fluconazolum Aflofarm

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

For doses that cannot be obtained using capsules of this strength, medicines containing fluconazole in capsules of other strengths are available.

The capsule should be swallowed whole, with a glass of water. Capsules are best taken at the same time every day. For children who cannot swallow the capsule and for young children, for whom precise dosing based on body weight is necessary, fluconazole is available in a syrup form.
The recommended dosing, 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 for children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Dosing 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 every 72 hours.

Elderly patients

The usual dose for adults is given, unless the patient has kidney function disorders.

Patients with kidney function disorders

The doctor may recommend changing the dose, depending on kidney function.

Taking more than the recommended dose of Fluconazolum Aflofarm

Taking too many capsules at once can 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 behavior). 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 remembered. If it is almost time for the next dose, the missed dose should not be taken.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Fluconazolum Aflofarm 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 side effects, they should consult their doctor or pharmacist.
This includes any side effects not listed in this leaflet.

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 hypersensitivity syndrome).

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

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

Other side effects may occur

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

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

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

• decreased red blood cell count, causing pallor, weakness, and shortness of breath;
• decreased 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):

• 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 biochemical parameters (high cholesterol, lipid levels in the blood);
• decreased potassium levels in the blood;
• tremors;
• ECG disorders, heart rhythm disorders;
• liver failure;
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling;
• severe skin reactions, swelling of the lips or face;
• hair loss.

Frequency not known(frequency cannot be estimated from available data):

• drug reaction with eosinophilia and systemic symptoms (DRESS). Characterized by skin rash, fever, swollen lymph nodes, increased white blood cell count (eosinophilia), inflammation of internal organs.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they 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 181 C, 02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Fluconazolum Aflofarm

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
The medicine should not be taken after the expiry date stated on the packaging and blister. The expiry date refers to the last day of the month.
Lot - batch number
EXP - expiry date
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. Each hard capsule contains 200 mg of fluconazole.
• Other ingredients are: lactose monohydrate, corn starch, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate; capsule shell and body: titanium dioxide (E 171), sodium lauryl sulfate, gelatin, water; ink: shellac, iron oxide yellow (E 172).

What Fluconazolum Aflofarm looks like and what the packaging contains

Fluconazolum Aflofarm, 200 mg: a hard gelatin capsule, size ‘0’, 21.40 ± 0.40 mm long, with a white to almost white body and cap, marked with yellow ink: "200" on the body and "FL" on the cap.
The packaging is a PVC/PVDC-Aluminum blister pack, placed in a cardboard box with a leaflet.
The packaging contains: 7 capsules.

Marketing authorization holder

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

Manufacturer/Importer

APL Swift Services (Malta) Ltd,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000,
Malta
Generis Farmacȇutica, S.A.
Rua João de Deus, n.o 19, Venda Nova,
2700-487 Amadora,
Portugal

Date of last revision of the leaflet: