Megastril

Package Leaflet: Information for the Patient

MEGASTRIL, 40 mg/ml, Oral Suspension

Megestrol Acetate

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. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Megastril and what is it used for

The active substance of Megastril is megestrol acetate, which is a synthetic progestogen (a type of hormone).

Indications

Megastril is indicated for the treatment of loss of appetite (anorexia) or weight loss due to cancer or AIDS. Megastril is administered orally in the form of a suspension.

2. Important information before taking Megastril

When not to take Megastril

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding.

Warnings and precautions

Before taking Megastril, discuss it with your doctor or pharmacist.

• Megastril should be used with caution in patients who currently have or have had thromboembolic disorders.
• If the following symptoms occur after sudden withdrawal of the medicine: low blood pressure (hypotension), nausea, vomiting, dizziness, or weakness, the patient should contact their doctor.
• In patients with diabetes, an increased need for insulin may occur.
• During treatment with or after withdrawal of megestrol acetate, symptoms of mild adrenal insufficiency have been reported.
• Women of childbearing age should use effective contraceptive methods during treatment with Megastril. 1/4

Megastril 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.

Pregnancy and breastfeeding

Megastril should not be given to pregnant women. Megestrol acetate used during pregnancy may cause severe birth defects in children. Women of childbearing age must use effective contraception during treatment. Before starting treatment, inform your doctor that you are pregnant or plan to become pregnant. During treatment with Megastril, do not breastfeed, due to potential side effects that may occur in the newborn.

Driving and using machines

It is not known whether Megastril affects the ability to drive and use machines. Before taking the medicine, consult your doctor.

Megastril contains sucrose

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

Megastril contains sodium benzoate

The medicine contains 2 mg of sodium benzoate per milliliter of suspension.

Megastril contains sodium

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

3. How to take Megastril

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The medicine is taken orally. Before administration, the suspension should be shaken well. The recommended dose is 400 mg to 800 mg once a day. It is recommended to continue treatment for at least 2 months.

Use in children

Megastril is not recommended for use in children.

Overdose of Megastril

No cases of overdose have been reported. If you have taken more than the recommended dose, contact your doctor immediately.

Missed dose of Megastril

Do not take a double dose to make up for a missed dose.

Stopping treatment with Megastril

If you have any further questions about the use of this medicine, ask your doctor or pharmacist. 2/4

4. Possible side effects

Like all medicines, Megastril can cause side effects, although not everybody gets them. The following side effects have been observed during treatment with the medicine:

• high blood pressure (hypertension), heart muscle disease (cardiomyopathy), palpitations;
• thromboembolic disorders, pulmonary embolism;
• diarrhea, nausea, bloating, vomiting, constipation, dry mouth, liver enlargement, indigestion;
• mood changes, weakness, insomnia, neuropathy, confusion, seizures, tingling (paresthesia), coma, depression, headache;
• intermenstrual bleeding, decreased libido, urinary tract infections, proteinuria, incontinence;
• moon face (cushingoid features), high blood sugar levels (hyperglycemia), high calcium levels in the blood (hypercalcemia), edema;
• shortness of breath, cough, pneumonia, pharyngitis;
• anemia, decreased white blood cell count (leukopenia);
• rash, hair loss, herpes, itching, sweating, urticaria;
• nerve compression in the wrist (carpal tunnel syndrome);
• vision disturbances;
• pain, thrush (candidiasis), tumors, heat strokes.

In patients with advanced non-hormone-dependent cancer who received megestrol acetate for loss of appetite and weight loss, the following side effects usually occurred:

• shortness of breath, nausea, edema, pain, coma, and diarrhea. Rarely, during long-term administration of megestrol acetate, urticaria was observed. Thromboembolic disorders, such as thrombophlebitis and pulmonary embolism (in some cases leading to death), have also been reported.

In patients with AIDS taking megestrol acetate, the following side effects have been reported:

• diarrhea, impotence, rash, bloating, weakness, and pain. Constipation and frequent urination have been reported in patients who received high doses of megestrol acetate.

In patients who have stopped taking the medicine, symptoms of mild adrenal insufficiency have been reported.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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 this medicine. 3/4

5. How to store Megastril

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Store in the original package. Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month stated. Shelf life after first opening: 2 years. Medicines should 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 pack and other information

What Megastril contains

• The active substance is megestrol acetate. 1 ml of oral suspension contains 40 mg of megestrol acetate.
• The other ingredients (excipients) are: sucrose, xanthan gum, citric acid monohydrate, sodium benzoate (E 211), sodium citrate, lemon flavor (contains natural citral), macrogol 1500, polysorbate 80, purified water.

What Megastril looks like and contents of the pack

Megastril is a white oral suspension with a characteristic lemon flavor and sweet taste. The pack consists of an HDPE bottle with an HDPE or PP/PE cap with a tamper-evident seal and a PP measuring cup in a cardboard box. The bottle contains 240 ml of suspension.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A. 51-131 Wrocław, ul. Żmigrodzka 242 E. Information about the medicine tel. 22 742 00 22 e-mail: [email protected]

Date of last revision of the leaflet:

4/4