Flutamid Egis

Leaflet attached to the packaging: patient information

Flutamid EGIS, 250 mg, tablets

Flutamidum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Flutamid EGIS and what is it 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 packaging and other information

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

Flutamid EGIS belongs to a group of non-steroidal drugs known as anti-androgens. It blocks the action of testosterone in the body. The administration of flutamide in combination with other drugs that lower testosterone levels is one of the methods of treating prostate cancer. The drug causes a reduction in the size and density of the tumor, a reduction or disappearance of metastases, especially to the bones, and a disappearance or reduction of bone pain. As a result of treatment with flutamide, remission may occur - complete or partial disappearance or alleviation of disease symptoms. Flutamid EGIS is used to treat advanced prostate cancer when it is indicated to inhibit the action of testosterone. It is also used in combination with drugs called luteinizing hormone-releasing hormone (LHRH) agonists in the treatment of limited prostate cancer (stage B2 or T2b) and in the treatment of advanced prostate cancer with a tumor infiltrating outside the prostate capsule (stage C or T3-T4), without metastases or with involvement of nearby lymph nodes. It is also used as a supportive drug in patients who have previously been treated with an LHRH agonist, in patients after orchiectomy, and in patients who have responded poorly or have poorly tolerated hormonal treatment. Flutamide is rapidly and completely absorbed from the gastrointestinal tract. It is quite quickly metabolized. It is excreted by the kidneys, with urine, in the form of metabolites.

2. Important information before taking 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 to take Flutamid EGIS, you should discuss it with your doctor or pharmacist. Long-term treatment with flutamide can only be recommended after a thorough assessment of the individual benefits of treatment compared to the risk of side effects. Particular caution should be exercised when using flutamide in patients with liver failure. Flutamide may be hepatotoxic. As a result of liver damage, symptoms such as changes in aminotransferase activity, obstructive jaundice, liver cirrhosis may occur. In case of any symptoms of liver failure (e.g. itching, darker urine, chronic loss of appetite, pain under the right costal arch, flu-like symptoms), you should immediately contact your doctor. If jaundice or a 2-3-fold increase in aminotransferase activity occurs without clinical symptoms, treatment with flutamide should be discontinued. Symptoms of liver failure usually disappear after withdrawal of the drug. You should not stop taking the medicine in case of improvement and disappearance of symptoms. Withdrawal of the drug can only be done after consulting a doctor. In all patients treated for a long time, liver function (i.e. aminotransferase activity measurements in serum) should be periodically checked. Additionally, bilirubin, creatinine, estradiol, and testosterone levels 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 edema and swelling around the ankles in susceptible patients. Caution should be exercised 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, sperm count should be performed at regular intervals. You should inform your doctor: if you have heart or blood vessel diseases, such as arrhythmia or if you are being treated for such diseases. During the use of Flutamid EGIS, the risk of cardiac arrhythmias may increase.

Flutamid EGIS and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take. Flutamid EGIS is usually used in combination with a medicine from the group of luteinizing hormone-releasing hormone (LHRH) agonists. It is very important that both medicines are taken strictly according to the doctor's instructions. The treatment used may cause hot flashes and a decrease in sexual function. The increased level of estradiol during the use of flutamide may increase the patient's susceptibility to thromboembolism. Flutamide enhances the effect of anticoagulant treatment with warfarin. In case of concurrent use of both medicines, medical consultation and examination of prothrombin time and possible modification of the dose of the medicine are recommended. You should avoid using other potentially hepatotoxic medicines. During long-term treatment or severe liver damage, an increase in AspAT and AlAT activity in serum is observed. In patients treated with theophylline and flutamide, cases of increased theophylline levels in serum have been observed. Flutamid EGIS may interact with some medicines used to treat heart rhythm disorders (such as quinidine, procainamide, amiodarone, or sotalol) or increase the risk of arrhythmias during concurrent use with such medicines as methadone (used as an analgesic and as part of detoxification therapy in drug addicts), moxifloxacin (antibiotic), or antipsychotic drugs used in severe mental disorders.

Using 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 that she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. The drug is intended for use in men. In the case of use in pregnant women, it may harm the development of male fetuses due to the inhibition of the action of the male hormone, testosterone. Breastfeeding women should not breastfeed if they are taking the drug.

Driving vehicles and operating machines

No studies have been conducted with flutamide to assess its impact on the ability to drive vehicles and operate machines. However, some patients may experience side effects such as drowsiness, disorientation, fatigue, dizziness, and blurred vision. You should not drive vehicles or operate machines if these symptoms occur.

Flutamid EGIS contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine. The drug contains less than 1 mmol (23 mg) of sodium per tablet, which means that the drug is considered "sodium-free".

3. How to take Flutamid EGIS

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, you should consult a doctor or pharmacist. The dose is determined by the doctor. The recommended dose is 1 tablet every 8 hours. Treatment with Flutamid EGIS in combination with an LHRH agonist starts 3 days before the administration of the LHRH agonist and 8 weeks before the start of radiotherapy and continues during its duration, usually also for about 8 weeks. The total treatment duration in this case will be approximately 16 weeks. You should not change the amount and time of taking the medicine without consulting a doctor. Increasing the dose of the medicine may lead to the occurrence or intensification of side effects. If, after taking Flutamid EGIS, vomiting occurs, you should consult a doctor, who will decide on further treatment. Dosing in patients with liver failureIn the case of an indication for long-term administration of Flutamid EGIS in patients with liver failure, the benefits of treatment should be individually assessed compared to the risk of side effects. Dosing in patients with renal impairmentThere is no need to adjust the dose of the medicine in patients with impaired renal function. Duration of treatmentThe recommended dose is one 250 mg tablet three times a day. The duration of treatment is determined by the doctor.

Using a higher dose of Flutamid EGIS than recommended

In case of taking a higher dose of the medicine than recommended by the patient or accidentally by another person, you should immediately consult a doctor or pharmacist. If possible, induce vomiting.

Missing a dose of Flutamid EGIS

In case of missing a dose, you should take it as soon as possible. However, if it is close to the time of taking the next dose, you should skip the missed dose and continue treatment according to the adopted dosing schedule. You should not take a double dose to make up for the missed dose. If you feel that the effect of the medicine is too strong or too weak, you should consult a doctor. In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Monotherapy Very common side effects(may occur in more than 1 in 10 patients): gynecomastia, which may be accompanied by breast pain and galactorrhea. These symptoms disappear after withdrawal of the medicine or after reducing the dose. Flutamide may exacerbate heart and circulatory disorders, but this effect is much weaker than that of diethylstilbestrol. Common side effects(may occur in up to 1 in 10 patients): diarrhea, nausea, vomiting, increased appetite, insomnia, feeling of fatigue, transient liver function disorders, and hepatitis. Rare side effects(may occur in up to 1 in 1000 patients): decreased libido, gastrointestinal disorders (loss of appetite, abdominal pain, heartburn, constipation), edema, subcutaneous bleeding, shingles, itching, lupus-like syndrome, headache, dizziness, weakness, malaise, vision disorders, increased thirst, chest pain, feeling of anxiety, depression, lymph node swelling, hot flashes, and thrombophlebitis. During long-term treatment, spermatogenesis disorders (decreased sperm count) have been observed. Very rare side effects(may occur in up to 1 in 10,000 patients): cough, sensitivity to sunlight. Two cases of malignant breast cancer have also been reported in men taking flutamide. Side effects with unknown frequency(cannot be estimated from the available data): changes in the ECG record (QT interval prolongation). Combination therapy Very common side effects(may occur in more than 1 in 10 patients): during combination treatment with flutamide and LHRH agonist: hot flashes, decreased libido, impotence, diarrhea, nausea, and vomiting. These symptoms, except for diarrhea, occur with similar frequency during treatment with LHRH agonist alone. Common side effects(may occur in up to 1 in 10 patients): liver function disorders. Uncommon side effects(may occur in up to 1 in 100 patients): hepatitis, gynecomastia. Rare side effects(may occur in up to 1 in 1000 patients): anemia, leukopenia, thrombocytopenia, gastrointestinal disorders, loss of appetite, hypertension, neurological and muscular disorders (muscle pain, joint pain), liver failure, jaundice, disorders of the genitourinary system, central nervous system disorders (numbness, drowsiness, depression, disorientation, anxiety, irritability), rash, gynecomastia, edema, irritation at the injection site. Very rare side effects(may occur in up to 1 in 10,000 patients): Hemolytic anemia (anemia caused by faster breakdown of red blood cells due to their incorrect structure or external factors) and macrocytic anemia (disorder of blood cell maturation), methemoglobinemia (associated with the formation of abnormal hemoglobin, which makes it impossible to bind oxygen and thus transport oxygen molecules), sulfhemoglobinemia (a rare blood disease that occurs when a sulfur atom is incorporated into the hemoglobin molecule, making the blood unable to transport oxygen), hyperglycemia (too high blood sugar levels), exacerbation of diabetes, respiratory disorders (pulmonary symptoms such as shortness of breath), hypersensitivity to sunlight, erythema, ulcers, vesicular rash. Other symptoms such as obstructive jaundice, hepatic encephalopathy (a neurological syndrome characterized by impaired central nervous system function due to the action of toxins in the system due to liver damage caused by certain medicines, toxic substances, acute infections during other liver diseases, bleeding into the digestive tract, viruses (viral hepatitis) or alcohol), and liver cell necrosis have also been reported. These side effects usually disappear after withdrawal of the medicine. Side effects with unknown frequency(cannot be estimated from the available data): Closure of a vessel by a blood clot (thromboembolic disease).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Flutamid EGIS

The medicine should be stored in a place invisible and inaccessible to children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Store in a temperature below 25°C. Protect from light. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Flutamid EGIS contains

The active substance of the medicine is flutamide. Each tablet contains 250 mg of flutamide.

• Other ingredients are: potato starch, lactose monohydrate, microcrystalline cellulose, povidone, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica.

What Flutamid EGIS looks like and what the packaging contains

Appearance: light yellow, round, smooth, biconvex tablets without spots and damage. Packaging: blisters of aluminum/PCW, in a cardboard box. The packaging contains 100 tablets (5 blisters of 20 tablets each).

Marketing authorization holder

EGIS Pharmaceuticals PLC, 1106 Budapest, Keresztúri út 30-38, Hungary

Manufacturer

EGIS Pharmaceuticals PLC, Bökényföldi út 118-120, 1165 Budapest, Hungary. For more detailed information about this medicine, you should contact the local representative of the marketing authorization holder: EGIS Polska Sp. z o.o., ul. Komitetu Obrony Robotników 45D, 02-146 Warsaw, phone: +48 22 417 92 00.

Date of last revision of the leaflet: 28.07.2021