Fluconazole aflofarm

Package leaflet: information for the patient

Fluconazolum Aflofarm, 100 mg, hard capsules
Fluconazolum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

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 pack 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 and may also be used to prevent yeast 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 system 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 denture use;
• genital yeast infections – vaginal or penile infections;
• skin mycoses – e.g. athlete's foot, tinea of the trunk, groin, or nails.

Fluconazolum Aflofarm may also be used for:

• prevention of recurrent cryptococcal meningitis;
• prevention of recurrent mucosal yeast infections;
• prevention of recurrent vaginal yeast infections;
• prevention of 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 for:

• prevention of yeast infections (in patients with weakened or impaired immune systems);
• prevention of recurrent cryptococcal meningitis.

2. Important information before taking Fluconazolum Aflofarm

When not to take Fluconazolum Aflofarm:

• if the patient is allergic to fluconazole, to other antifungal medicines, or to 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 or terfenadine (antihistamine medicines 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 treatment with Fluconazolum Aflofarm, consult a doctor or
pharmacist if:

• the patient has impaired kidney or liver function;
• the patient has heart disease, including heart rhythm disorders;
• the patient has abnormal blood levels of potassium, calcium, or magnesium;
• the patient has severe skin reactions (itching, redness of the skin, difficulty breathing);
• the patient develops symptoms of "adrenal insufficiency", where the adrenal glands do not produce adequate amounts of 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 severe skin rash, 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 occurred in patients treated with Fluconazolum Aflofarm. If the patient experiences any of the symptoms of severe skin reactions described in section 4, treatment with Fluconazolum Aflofarm must be discontinued immediately and medical help should be sought without delay.

Fluconazolum Aflofarm and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient intends to take.

Inform the doctor immediately if the patient is taking:

• astemizole or terfenadine (antihistamines used in allergy treatment),
• 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 (anesthetic 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 aid sleep or for calming,
• carbamazepine, phenytoin (used to treat epilepsy),
• nifedipine, isradipine, amlodipine, felodipine, and losartan (used to treat hypertension),
• cyclosporine, everolimus, sirolimus, or tacrolimus (used to prevent transplant rejection),
• cyclophosphamide, vinca alkaloids (vincristine, vinblastine or similar medicines) used in treating 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,
• prednisolone (a steroid),
• zidovudine, also known as AZT, saquinavir (used in the treatment of HIV infection),
• chlorpropamide, glibenclamide, glipizide, or tolbutamide (antidiabetic medicines),
• theophylline (a medicine used in asthma),
• vitamin A (dietary supplement),
• ivacaftor (used to treat cystic fibrosis),
• amiodarone (used to treat heart rhythm disorders – "arrhythmias"),
• hydrochlorothiazide (a diuretic),
• citalopram, escitalopram (antidepressants), as fluconazole (an antifungal medicine), cimetidine, lansoprazole, 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 concentrations.

Taking Fluconazolum Aflofarm with food and drink
This medicine can be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 directed by a doctor.

If the patient becomes pregnant or suspects she may be pregnant while taking 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 malformations 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 doses of 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 be continued after a single dose of Fluconazolum Aflofarm of 200 mg or less. Breastfeeding should be avoided if the patient is taking multiple doses of Fluconazolum Aflofarm.

Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If dizziness or seizures occur, the patient should not drive or operate machinery.

Fluconazolum Aflofarm contains monohydrate lactose and sodium

Monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".

3. How to take Fluconazolum Aflofarm

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, consult
your doctor or pharmacist.
For doses that cannot be achieved with capsules of this strength, fluconazole medicines
in capsules of different strengths are available.
The capsule should be swallowed whole with a glass of water. It is best to take the capsules
at the same time each day. For children who cannot swallow the capsule and for young children,
in whom precise dosing according to body weight is necessary, fluconazole syrup is available.
Recommended dosages, depending on the type of infection, are listed below.
Adults

Adolescents aged 12 to 17 years
The dose prescribed by the physician should be administered (as in adults 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 aged 3 to 4 weeks
The same dose as above, but administered every other day. Maximum dose is 12 mg per kg body weight every 48 hours.

Children under 2 weeks of age
The same dose as above, administered every 3 days. Maximum dose is 12 mg per kg body weight every 72 hours.

Elderly patients
The usual adult dose is administered, unless the patient has renal function impairment.

Patients with renal impairment
The physician may adjust the dosage according to renal function.

Accidental overdose of Fluconazolum Aflofarm
Taking too many capsules at once may cause feeling unwell. Immediate contact should be made with the emergency department of the nearest hospital. Symptoms of overdose may include disturbances in hearing, vision, and sensation, as well as thinking about things that are not real (hallucinations and paranoid behavior). Symptomatic treatment may be indicated (supportive treatment to maintain vital functions and gastric lavage, if necessary).

Missed dose of Fluconazolum Aflofarm
Do not take a double dose to make up for a missed dose. If a dose has been missed, it should be taken as soon as remembered. However, if it is almost time for the next dose, the missed dose should be skipped and not taken.

If there are any further doubts regarding the use of this medicine, consult a physician 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 adverse reaction occurs, consult a doctor or pharmacist.
This also applies to adverse reactions not listed in this leaflet.
If the patient experiences any of the following symptoms, stop taking
Fluconazolum Aflofarm immediately and seek medical help without delay:

• sudden wheezing, difficulty breathing, or tightness in the chest;
• swelling of the eyelids, face, or lips;
• itching all over the body, redness of the skin, or red itchy rash;
• 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;
• nausea and 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):

• reduced number of red blood cells, causing paleness, weakness, and breathlessness;
• decreased 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):

• reduced number of white blood cells involved in the body's defence against infections, and of blood cells that help 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 cholesterol, blood lipids);
• decreased potassium levels in the blood;
• tremor;
• abnormalities in ECG, heart rhythm disturbances;
• liver failure;
• allergic reactions (sometimes severe), including widespread blistering rash and skin peeling;
• severe skin reactions, swelling of 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), and inflammation of internal organs.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Fluconazolum Aflofarm

Keep this medicine out of the sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
LOT - batch number
EXP - expiry date
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Fluconazolum Aflofarm contains

• The active substance is fluconazole. Each hard capsule contains 100 mg of fluconazole.
• The other ingredients are: lactose monohydrate, maize starch, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate; capsule shell (cap and body): titanium dioxide (E 171), sodium lauryl sulfate, gelatin, water; printing ink: shellac, yellow iron oxide (E 172).

What Fluconazolum Aflofarm looks like and contents of the pack
Fluconazolum Aflofarm, 100 mg: hard gelatin capsule size '2', length 17.80 ± 0.40 mm, with a body and cap that are white to almost white, printed with yellow markings: "100" on the body and "FL" on the cap.
The packaging consists of a PVC/PVDC-Aluminium blister pack placed in a cardboard box with a leaflet.
Pack sizes: 7, 14 or 30 capsules.
Not all pack sizes may be marketed.

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

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