MEGASTRIL

Patient Information Leaflet

MEGASTRIL, 40 mg/ml, oral suspension
Megestrol acetate
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of Contents

1. What Megastril is and what it is 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 Megastril is and what it is used for

The active substance in Megastril is megestrol acetate, a synthetic progestagen
(a type of hormone).
Indications
Megastril is indicated for the treatment of lack of appetite (anorexia) or weight loss associated with cancer or acquired immunodeficiency syndrome (AIDS).
Megastril is administered orally as a suspension.

2. Important information before using Megastril

When not to use Megastril

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

Warnings and precautions
Before starting treatment with Megastril, discuss this with your doctor or pharmacist.

• Megastril should be used with caution in patients who currently have or have had thrombophlebitis in the past.
• If symptoms such as low blood pressure (hypotension), nausea, vomiting, dizziness, or weakness occur after abrupt discontinuation of the medicine, the patient should contact their doctor.
• In patients with diabetes, an increased insulin requirement may occur.
• Mild adrenal suppression has been reported during or after discontinuation of megestrol acetate.
• Women of childbearing age should use effective methods of contraception during treatment with Megastril. 1/4

Megastril and other medicines
Inform 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 take.

Pregnancy and breastfeeding
Megastril must not be given to women who are pregnant. Megestrol acetate used during pregnancy may cause severe congenital malformations in children. Women of childbearing age must use effective contraception during treatment. Before starting treatment, inform the doctor if the patient is pregnant or planning to become pregnant.
Breastfeeding must not be undertaken during treatment with Megastril due to potential adverse effects that may occur in the newborn.

Driving and operating machinery
It is unknown whether Megastril affects the ability to drive or operate machinery.
Consult your doctor before using this medicine.

Megastril contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

Megastril contains sodium benzoate
The medicine contains 2 mg of sodium benzoate in each millilitre of suspension.

Megastril contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium in each millilitre of suspension, meaning the medicine is considered "sodium-free".

3. How to use Megastril

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
This medicine is taken orally.
The suspension should be shaken well before administration.
The recommended dose is 400 mg to 800 mg once daily.
It is recommended to continue treatment for a period of at least 2 months.
Use in children
Megastril is not recommended for use in children.
Taking more Megastril than recommended
There have been no reported cases of overdose.
If you take more than the recommended dose, contact your doctor immediately.
Missing a dose of Megastril
Do not take a double dose to make up for a missed dose.
Stopping Megastril
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
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4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during treatment with this medicine:

• high blood pressure (hypertension), heart muscle disorders (cardiomyopathy), palpitations;
• venous thrombosis, pulmonary embolism;
• diarrhoea, nausea, bloating, vomiting, constipation, dry mouth, liver enlargement, dyspepsia;
• mood changes, weakness, insomnia, neuropathy, confusion, seizures, tingling sensations (paraesthesia), coma, depression, headache;
• intermenstrual bleeding, decreased libido, urinary tract infections, presence of protein in urine (proteinuria), urinary incontinence;
• moon-shaped, flushed face (Cushingoid appearance), increased blood sugar levels (hyperglycaemia), increased blood calcium levels (hypercalcaemia), oedema;
• shortness of breath, cough, pneumonia, sore throat;
• anaemia, decreased white blood cell count (leukopenia);
• rash, alopecia, herpes, itching, sweating, urticaria;
• nerve compression in the carpal tunnel (carpal tunnel syndrome);
• visual impairment;
• pain, fungal infection (candidiasis), sarcomas, hot flushes.

In patients with advanced hormone-independent tumours who received megestrol acetate due to loss of appetite and weight loss, the following adverse reactions were usually observed:

• shortness of breath, nausea, oedema, pain, coma, and diarrhoea. Rarely, urticaria occurred during long-term administration of megestrol acetate. Thromboinflammatory disorders have also been reported, such as venous thrombosis and pulmonary embolism (in some cases leading to death).

In AIDS patients receiving megestrol acetate, the following adverse reactions have been reported:

• diarrhoea, erectile difficulties (impotence), rash, bloating, weakness, and pain. Constipation and frequent urination have been reported in patients receiving high doses of megestrol acetate.

In patients who discontinued the medicine, symptoms of mild adrenal suppression have been reported.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 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 to provide more information on the safety of this medicine.
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5. How to store Megastril

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original tightly closed container.
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.
Storage period after first opening of the packaging: 2 years.
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 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, monohydrate citric acid, sodium benzoate (E 211), sodium citrate, lemon flavour (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 odour and sweet taste.
HDPE bottle with HDPE cap or PP/PE cap with polyethylene foam seal, child-resistant closure, and a PP measuring cup, packed in a cardboard box.
The bottle contains 240 ml of suspension.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel. 22 742 00 22
e-mail: [email protected]
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