Flutamide egis

Package leaflet: Information for the patient

Flutamid EGIS, 250 mg, tablets
Flutamidum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• 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. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Flutamid EGIS is and what it is used for

Flutamid EGIS belongs to a group of non-steroidal drugs known as antiandrogens. It blocks the action of testosterone in the body. Administration of flutamide in combination with other drugs that reduce testosterone levels is one of the treatment methods for prostate cancer. The drug causes a reduction in the size and firmness of the tumour, reduction or regression of metastases, especially to the bones, and relief or reduction of bone pain. As a result of flutamide treatment, remission may occur – complete or partial disappearance or alleviation of disease symptoms.

Flutamid EGIS is used in the treatment of advanced prostate cancer when suppression of testosterone action is indicated. It is also used in combination with drugs called luteinizing hormone-releasing hormone (LHRH) agonists in the treatment of localized prostate cancer (stage B2 or T2b), and in the treatment of advanced prostate cancer with tumour extension beyond the capsule (stage C or T3–T4), without metastases or with involvement of nearby lymph nodes. It is also used as an adjunctive treatment in patients previously treated with LHRH agonists, in patients after orchidectomy, and in patients who responded poorly or poorly tolerated hormonal therapy.

Flutamide is rapidly and completely absorbed from the gastrointestinal tract. It is metabolized relatively quickly and excreted by the kidneys in the form of metabolites in urine.

2. Important information before using Flutamid EGIS

When not to take Flutamid EGIS
If the patient is allergic to flutamide or any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Before starting treatment with Flutamid EGIS, discuss this with your doctor or pharmacist.
Long-term treatment with flutamide should only be prescribed after careful assessment of the individual benefits of treatment compared to the risk of adverse effects.
Exercise particular caution when using flutamide in patients with hepatic impairment. Flutamide may be hepatotoxic. Liver damage may result in symptoms such as: changes in aminotransferase activity, cholestatic jaundice, liver cirrhosis. If any symptoms of liver failure occur (e.g. itching, darker urine, chronic loss of appetite, pain under the right rib cage, flu-like symptoms), contact your doctor immediately. If jaundice occurs or aminotransferase activity increases two- to threefold without clinical symptoms, treatment with flutamide should be discontinued. Symptoms of liver failure usually resolve after discontinuation of the drug.
Do not stop taking the medicine if you feel better and your symptoms have subsided. Discontinuation of treatment may only occur after consultation with your doctor.
In all patients undergoing long-term treatment, liver function should be monitored periodically (i.e. measurement of serum AspAT and AlAT aminotransferase activity).
Additionally, concentrations of bilirubin, creatinine, estradiol, and testosterone may increase. In severe cases, this may lead to an increased risk of chest pain and heart failure. Therefore, caution should be exercised when using flutamide in the presence of cardiovascular disease. Flutamide may exacerbate oedema and swelling around the ankles in susceptible patients.
Caution is advised when using flutamide in patients with impaired renal function.
During treatment, contraceptive measures should be used.
In men chronically treated with flutamide without prior pharmacological or surgical castration, regular sperm count examinations should be performed.
Inform your treating physician:
if the patient has heart or vascular diseases, such as arrhythmia (irregular heartbeat), or is being treated for such conditions. During treatment with Flutamid EGIS, the risk of cardiac rhythm disturbances may increase.

Flutamid EGIS and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Flutamid EGIS is usually used concomitantly with a medicine from the group of luteinizing hormone-releasing hormone agonists. It is very important that both medicines are taken strictly according to the doctor's instructions. This treatment may cause hot flushes and reduced sexual function. The increased estradiol levels during flutamide treatment may increase the patient's susceptibility to thrombosis with embolism.
Flutamide enhances the anticoagulant effect of warfarin. If both medicines are used concomitantly, medical consultation is recommended, along with monitoring of prothrombin time and possible adjustment of dosage.
Avoid using other potentially hepatotoxic medicines.
Increased serum AspAT and AlAT activity has been observed during long-term treatment or in cases of severe liver damage.
Cases of increased theophylline plasma concentration have been observed in patients treated concomitantly with theophylline and flutamide.
Flutamid EGIS may interact with certain medicines used to treat cardiac arrhythmias (such as quinidine, procainamide, amiodarone, or sotalol) or may increase the risk of arrhythmias when used concomitantly with medicines such as methadone (used for pain relief and as part of detoxification therapy in addicts), moxifloxacin (an antibiotic), or antipsychotics used in serious psychiatric disorders.

Taking Flutamid EGIS with food and alcohol
Food does not affect the bioavailability of flutamide. Patients should avoid alcohol.

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.
This medicine is intended for use in men. If used in pregnant women, it may adversely affect the development of male fetuses due to inhibition of the male hormone, testosterone. Breastfeeding women should not breastfeed if they use this medicine.

Driving and operating machinery
No studies have been conducted with flutamide assessing its effect on the ability to drive vehicles or operate machinery. However, in some patients, adverse effects such as drowsiness, disorientation, fatigue, dizziness, or blurred vision may occur. Do not drive or operate machinery if these symptoms occur.

Flutamid EGIS contains monohydrate lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Flutamid Egis

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts,
consult your doctor or pharmacist. The dosage is determined by the doctor.
The recommended dose is 1 tablet every 8 hours. Treatment with Flutamid Egis in combination with an LHRH agonist
should be started 3 days before administration of the LHRH agonist and 8 weeks before the start of
radiotherapy, and continued during radiotherapy, usually for approximately 8 weeks. The total
duration of treatment in this case will be about 16 weeks.
Do not change the amount or timing of the medicine without consulting your doctor. Increasing
the dose may lead to the occurrence or worsening of adverse effects.
If vomiting occurs after taking Flutamid Egis, consult your doctor, who will decide on further treatment.

Dosing in patients with hepatic impairment
In cases where long-term administration of Flutamid Egis is indicated in patients with
liver dysfunction, the benefits of treatment should be individually assessed against the risk of
adverse effects.

Dosing in patients with renal impairment
There is no need to adjust the dosage of the medicine in patients with impaired kidney function.

Duration of treatment
The recommended dose is one 250 mg tablet three times daily. The duration of treatment is determined by the doctor.

Use of a higher than recommended dose of Flutamid Egis
If a higher than recommended dose is taken by the patient or accidentally by another person,
seek immediate advice from a doctor or pharmacist. If possible, induce vomiting.

Missed dose of Flutamid Egis
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose,
skip the missed dose and continue treatment according to the prescribed dosing schedule. Do not take a double dose to make up for a missed dose.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
In case of any further doubts concerning 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.

Monotherapy

Very common adverse reactions (may affect more than 1 in 10 patients): gynaecomastia, which may be accompanied by breast tenderness and galactorrhea. These symptoms resolve after discontinuation of the medicine or after dose reduction.
Flutamide may exacerbate cardiac and circulatory disorders; however, this effect is considerably weaker than that of diethylstilboestrol.

Common adverse reactions (may affect up to 1 in 10 patients): diarrhoea, nausea, vomiting, increased appetite, insomnia, feeling of fatigue, transient disturbances in liver function and hepatitis.

Uncommon adverse reactions (may affect up to 1 in 1000 patients): decreased libido, gastrointestinal disorders (loss of appetite, abdominal pain, heartburn, constipation), oedema, subcutaneous haemorrhages, herpes zoster, itching, lupus-like syndrome, headache, dizziness, weakness, malaise, visual disturbances, increased thirst, chest pain, feeling of anxiety, depression, lymph node swelling, hot flushes, occlusion of a major pulmonary artery (pulmonary embolism).

During long-term treatment, disturbances in spermatogenesis (reduced sperm count) have been observed.

Very rare adverse reactions (may affect up to 1 in 10,000 patients): cough, photosensitivity.

There have also been two reports of malignant breast cancer in men receiving flutamide.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data): changes in ECG findings (QT interval prolongation).

Combination therapy

Very common adverse reactions (may affect more than 1 in 10 patients): during combination treatment with flutamide and an LHRH agonist: hot flushes, decreased libido, impotence, diarrhoea, nausea and vomiting. These symptoms, except diarrhoea, occur with similar frequency during treatment with an LHRH agonist alone.

Common adverse reactions (may affect up to 1 in 10 patients): disturbances in liver function.

Uncommon adverse reactions (may affect up to 1 in 100 patients): hepatitis, gynaecomastia.

Rare adverse reactions (may affect up to 1 in 1000 patients): anaemia, leukopenia, thrombocytopenia, gastrointestinal disorders, loss of appetite, hypertension, neuromuscular disorders (muscle pain, joint pain), liver failure, jaundice, urinary and genital disorders, disorders of the central nervous system (numbness, somnolence, depression, disorientation, anxiety, irritability), rash, gynaecomastia, oedema, injection site irritation.

Very rare adverse reactions (may affect up to 1 in 10,000 patients):
Since flutamide was introduced to the world markets, haemolytic anaemia (anaemia caused by accelerated breakdown of red blood cells due to their abnormal structure or external factors) and macrocytic anaemia (a disorder in maturation of blood cells), methaemoglobinaemia (associated with formation of abnormal haemoglobin, resulting in inability to bind oxygen and thus transport oxygen molecules), sulfhaemoglobinaemia (a rare blood disorder occurring when a sulfur atom is incorporated into the haemoglobin molecule, rendering blood unable to transport oxygen), hyperglycaemia (excessively high blood sugar levels), worsening of diabetes, respiratory disorders (pulmonary symptoms such as dyspnoea), photosensitivity, erythema, ulceration, bullous rash, epidermal necrolysis have been reported.

Other symptoms reported include: congestive jaundice, hepatic encephalopathy (a neurological syndrome involving impaired functioning of the central nervous system due to toxin accumulation resulting from liver damage caused by certain medicines, toxic substances, acute infections during other liver diseases, gastrointestinal bleeding, viruses (viral hepatitis) or alcohol), hepatocellular necrosis, cases of death following hepatotoxicity, amber or greenish-yellow discoloration of urine.

The above adverse reactions resolved after discontinuation of the medicine.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Occlusion of a blood vessel by a blood clot (thromboembolic disease).

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 authorisation holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Flutamid Egis

Keep this 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 stated month.
Store below 25°C. Protect from light.
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. Contents of the packaging and other information

What Flutamid EGIS contains
The active substance is flutamide.
Each tablet contains 250 mg of flutamide.

• Other ingredients: potato starch, monohydrate lactose, microcrystalline cellulose, polyvinylpyrrolidone, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silicon dioxide.

What Flutamid EGIS looks like and contents of the pack
Appearance: light yellow, round, smooth, biconvex tablets without spots or damage.
Packaging: aluminum/PCW foil blisters in a cardboard box.
Pack contains 100 tablets (5 blisters with 20 tablets each).
Marketing Authorisation Holder
EGIS Pharmaceuticals PLC
Keresztúri út 30-38, 1106 Budapest,
Hungary
Manufacturer
EGIS Pharmaceuticals PLC
Bökényföldi út 118-120,
1165 Budapest,
Hungary
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Phone: +48 22 417 92 00