Apo-flutam

Package Leaflet: Information for the Patient

Apo-Flutam, 250 mg, coated tablets
Flutamidum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Apo-Flutam and what is it used for

Flutamide, the active substance of the medicine, is an oral, non-steroidal and non-hormonal androgen antagonist used in the treatment of prostate cancer with metastases. Cancer develops due to excessive growth of prostate cells, which is accelerated by androgens.
Flutamide inhibits the transport and/or binding of dihydrotestosterone in the nuclei of prostate tissue cells. As a result, the growth and division of prostate cells are inhibited.
The medicine shows the greatest therapeutic efficacy when used in combination with luteinizing hormone-releasing hormone (LHRH) agonists, e.g. leuprorelin acetate, and in patients who have not been previously treated with hormones.
Flutamide is not effective in the treatment of other hormone-dependent tumors, such as breast cancer or benign prostatic hyperplasia.
Apo-Flutam is indicated:

• in the treatment of prostate cancer (stage D) with metastases, in combination with LHRH agonists, e.g. leuprorelin acetate. To achieve the best efficacy in adjunctive treatment, both medicines should be taken at the same time (see section 3);
• in adjunctive treatment after orchiectomy to achieve total androgen blockade;
• before and during radiotherapy in patients with massive, locally advanced prostate cancer (stages B and C), in combination with LHRH agonists.

2. Important information before taking Apo-Flutam

When not to take Apo-Flutam

Warnings and precautions

Before taking Apo-Flutam, discuss with your doctor or pharmacist:

In patients with renal impairment, it is not necessary to reduce the dose of flutamide.
Warning!: During the use of the medicine, the color of the urine may change to amber or yellow-green, which is caused by the presence of flutamide and its metabolites in the urine.

Apo-Flutam and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No interactions have been found between flutamide and leuprorelin acetate.
In patients taking warfarin for a long time, flutamide may enhance the anticoagulant effect of warfarin and prolong blood clotting time. Your doctor may recommend a prothrombin time test and a reduction in the dose of the anticoagulant medicine.
Apo-Flutam and leuprorelin acetate should be taken at the same time and according to the recommended dosing schedule. Do not stop taking flutamide without consulting your doctor.
Apo-Flutam may affect the action of certain medicines used to treat arrhythmias (e.g. quinidine, procainamide, amiodarone, and sotalol) or may increase the risk of arrhythmias if taken with certain other medicines [e.g. methadone (used to reduce pain and as part of drug detoxification), moxifloxacin (an antibiotic), antipsychotic medicines used to treat severe mental disorders].

Apo-Flutam with food and drink

Flutamide is rapidly and completely absorbed from the gastrointestinal tract. Apo-Flutam can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Flutamide is indicated only in men. However, its use in women has been described.
Well-controlled studies have not been conducted in pregnant women. It is likely that flutamide may harm the fetus. Apo-Flutam should not be used in pregnant women.
Breastfeeding
There are no data from well-controlled clinical studies on the use of flutamide in breastfeeding women. Flutamide may pass into breast milk. Due to the risk of side effects in infants, women taking Apo-Flutam (as described in medical literature) should stop breastfeeding.

Driving and using machines

Some patients may experience side effects such as drowsiness, disorientation, fatigue, dizziness, or blurred vision. In such cases, do not drive or operate machinery.

Apo-Flutam contains lactose monohydrate

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

Apo-Flutam contains sodium

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

3. How to take Apo-Flutam

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Recommended dose
In the treatment of prostate cancer (stage D) in combination with LHRH agonists and in adjunctive treatment after orchiectomy:250 mg (1 coated tablet) three times a day, every 8 hours.
If Apo-Flutam is to be used in combination with an LHRH agonist, flutamide treatment should be started 3 days before taking the LHRH agonist.
In patients with massive, locally advanced prostate cancer (stages B and C):250 mg (1 coated tablet) three times a day, every 8 hours. Flutamide treatment should be started 3 days before taking the LHRH agonist.
Flutamide treatment starts 8 weeks before the start of radiotherapy. Flutamide treatment should be continued during radiotherapy.
Do not extend the treatment period without consulting your doctor.

What to do if you take more Apo-Flutam than you should

If you have taken more than the recommended dose, contact your doctor or pharmacist immediately.
Symptoms of overdose: decreased activity, slow breathing, lethargy, tearing, drowsiness, vomiting, methemoglobinemia, and even liver failure. The size of a single daily dose that would cause symptoms of overdose or life-threatening symptoms has not been established. If vomiting has not occurred spontaneously, it should be induced.
Hemodialysis is not effective in flutamide overdose.

What to do if you miss a dose of Apo-Flutam

Do not take a double dose to make up for a missed tablet. Continue with the prescribed treatment schedule.

What to do if you stop taking Apo-Flutam

Your doctor may recommend stopping flutamide treatment if jaundice or 2-3 times increased liver enzyme activity (without clinical symptoms) occurs. Usually, after reducing the dose or discontinuing flutamide, liver function returns to normal.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you experience any of the following symptoms:
Very common side effects(may affect more than 1 in 10 people):

• nausea, vomiting, diarrhea, decreased appetite;
• fatigue, muscle pain.

Common side effects(may affect up to 1 in 10 people):

• hypertension;
• drowsiness, disorientation, depression, anxiety, nervousness;
• respiratory disorders;
• gynecomastia (breast enlargement);
• other gastrointestinal disorders;
• edema;
• hemolytic or macrocytic anemia, decreased white blood cell count, thrombocytopenia, methemoglobinemia (abnormal hemoglobin formation).

Uncommon side effects(may affect up to 1 in 100 people):

• hepatitis, jaundice, cholestatic jaundice, hepatic encephalopathy, liver necrosis (reversible after discontinuation of the medicine).

Rare side effects(may affect up to 1 in 1000 people):

• myocardial infarction;
• pulmonary embolism;
• insomnia, fatigue, headache, dizziness, weakness, malaise, blurred vision;
• breast tenderness, sometimes with galactorrhea, decreased semen volume;
• increased appetite, dyspepsia, constipation;
• hematuria;
• in long-term treatment: pruritus, purpura, herpes zoster, increased thirst, lymphedema, lupus-like syndrome.

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

• changes in ECG recording (QT interval prolongation);
• cases of patient death due to severe liver damage caused by flutamide intolerance; hypersensitivity to light, rash, ulceration, blistering rash, skin necrosis.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Apo-Flutam

Keep the medicine out of the sight and reach of children.
Do not use Apo-Flutam after the expiry date stated on the packaging after "Expiry date:". The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Apo-Flutam contains

• The active substance of the medicine is flutamide. Each coated tablet contains 250 mg of flutamide.
• Other ingredients are:
• tablet core:magnesium stearate, silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose.
• tablet coating:hypromellose 2910 E5, hydroxypropylcellulose 470 CPS, macrogol 3350, titanium dioxide (E 171), carnauba wax.

What Apo-Flutam looks like and contents of the pack

White or almost white, round, biconvex coated tablet with a score and embossed with "FLUT" above "250" on one side and "APL" on the other side.
The pack contains: 30, 60, 90, or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lok.27
01-909 Warsaw
Poland
Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta

Date of last revision of the leaflet: