Fluconazole polfarmex

Package leaflet: Information for the patient

Fluconazole Polfarmex, 50 mg, tablets
Fluconazole Polfarmex, 100 mg, tablets
Fluconazole Polfarmex, 150 mg, tablets
Fluconazole Polfarmex, 200 mg, tablets
Fluconazole
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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. This medicine may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Fluconazole Polfarmex is and what it is used for
2. Important information before taking Fluconazole Polfarmex
3. How to take Fluconazole Polfarmex
4. Possible side effects
5. How to store Fluconazole Polfarmex
6. Contents of the pack and other information

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

Fluconazole Polfarmex belongs to a group of antifungal medicines. The active substance is
fluconazole.
Fluconazole Polfarmex is used to treat infections caused by pathogenic fungi and can also be used to prevent Candida infections. The most common cause of fungal infections are yeasts of the genus known in Latin as Candida.
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 denture-related stomatitis;
• genital yeast infections – infections of the vagina or penis;
• skin fungal infections – e.g. athlete’s foot, tinea of the trunk, groin, or nails.

Fluconazole Polfarmex 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 3 to 17 years)
Your doctor may prescribe this medicine for the treatment of 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.

Fluconazole Polfarmex 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 using Fluconazole Polfarmex

When not to use Fluconazole Polfarmex:

• if the patient is allergic to the active substance, to other medicines used in the treatment of fungal infections, or to any of the other ingredients of this medicine (listed in section 6); symptoms may include itching, skin redness, or difficulty breathing;
• if the patient is taking astemizole, 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
Tell your doctor if:

• the patient has impaired kidney or liver function;
• the patient has heart conditions, including heart rhythm disorders;
• the patient has abnormal blood levels of potassium, calcium, or magnesium;
• the patient experiences severe skin reactions (itching, skin redness, difficulty breathing).

Fluconazole Polfarmex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Tell your doctor immediately if the patient is taking astemizole, terfenadine (antihistamines used for allergies), cisapride (used for stomach disorders), pimozide (used for mental disorders), quinidine (used for heart rhythm disorders), or erythromycin (an antibiotic used to treat infections), because these should not be used together with Fluconazole Polfarmex (see section "When not to use Fluconazole Polfarmex").
There are also other medicines that may interact with Fluconazole Polfarmex.
If the patient is taking any of the following medicines, ensure that the doctor is informed:

• rifampicin or rifabutin (antibiotics used to treat infections);
• alfentanil, fentanyl (anesthetic medicines);
• amitriptyline, nortriptyline (antidepressants);
• amphotericin B, voriconazole (antifungal medicines);
• medicines that reduce blood clotting and prevent blood clots (warfarin or similar medicines);
• 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 in the treatment of cancer;
• halofantrine (used to treat malaria);
• statins (atorvastatin, simvastatin, fluvastatin or similar medicines) 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 HIV patients);
• antidiabetic medicines such as chlorpropamide, glyburide, glipizide, or tolbutamide;
• theophylline (used in asthma);
• vitamin A (dietary supplement).

Fluconazole Polfarmex with food and drink
This medicine can be taken during meals or independently of 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 her doctor 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 your 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 malformations of the heart, bones, and/or muscles.
Cases of children born with congenital malformations of the skull, ears, and femur or 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 relationship between fluconazole use and these cases is not fully established.
Breastfeeding
The medicine passes into human milk, reaching concentrations lower than in serum. Breastfeeding may be continued after administration of a standard single dose of 200 mg or less. Breastfeeding is not recommended after multiple doses of fluconazole or after administration of a high dose.
Driving and operating machinery
When driving or operating machinery, consider that dizziness or seizures may occur occasionally.
Fluconazole Polfarmex contains lactose monohydrate and sodium
Lactose monohydrate
Fluconazole 50 mg contains 0.084 g of lactose monohydrate per tablet.
Fluconazole 100 mg contains 0.08 g of lactose monohydrate per tablet.
Fluconazole 150 mg contains 0.12 g of lactose monohydrate per tablet.
Fluconazole 200 mg contains 0.16 g of lactose monohydrate per tablet.
This should be considered in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Fluconazole Polfarmex

This medicine should always be taken exactly as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
The tablet should be swallowed whole, with a glass of water. Tablets are best taken
daily at the same time. For children who cannot swallow tablets and for young children,
in whom precise dosing according to body weight is necessary, fluconazole syrup is available on the market.
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 doctor (as in adult patients or as in children).
Children aged 3 to 11 years
The maximum dose in children is 400 mg per day.
The dose will be determined based on the child's body weight in kilograms.

Elderly patients
The usual adult dose should be used, unless the patient has impaired renal function.

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

Taking more Fluconazole Polfarmex than prescribed
Taking too many tablets 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 unreal things (hallucinations and paranoid behavior). Symptomatic treatment may be necessary (supportive treatment to maintain vital functions and gastric lavage, if required).

Missed dose of Fluconazole Polfarmex
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. If it is almost time for the next dose, the missed dose should not be taken.

If you have any further questions about 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; however, severe allergic reactions are rare. If any of the following symptoms occur, inform your doctor 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, skin rash;
• severe skin reactions, such as blistering rash (may also affect the mouth and tongue).

Fluconazole Polfarmex may affect the liver. Liver-related symptoms include:

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

If any of the above symptoms occur, stop taking Fluconazole Polfarmex and contact your doctor immediately.
Other adverse reactions
Furthermore, if any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

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

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

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

• decreased 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, pricking or numbness, taste alterations;
• 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 adverse reactions (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 purpuric skin discolorations, 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 disorders;
• liver failure;
• allergic reactions (sometimes severe), including extensive blistering rash, skin peeling, severe skin reactions, swelling of the lips or face;
• hair loss.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your 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 181C
02-222 Warsaw
Phone: +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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fluconazole Polfarmex

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton, blister, or container after "EXP". 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. This will help protect the environment.

6. Contents of the packaging and other information

What Fluconazole Polfarmex contains

• The active substance is fluconazole. Each tablet contains 50 mg, 100 mg, 150 mg or 200 mg of fluconazole.
• The other ingredients are: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A), povidone, magnesium stearate.

What Fluconazole Polfarmex looks like and contents of the pack
Fluconazole Polfarmex is available as uncoated tablets.
50 mg, 100 mg and 150 mg tablets are white or off-white, round, biconvex tablets.
200 mg tablets are white or off-white, elongated tablets.
50 mg tablets – pack contains 3, 7 or 14 tablets.
100 mg tablets – pack contains 7 or 28 tablets.
150 mg tablets – pack contains 1 or 3 tablets.
200 mg tablets – pack contains 7 or 14 tablets.
Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: + 48 24 357 44 44
Fax: + 48 24 357 45 45
e-mail: [email protected]