Package leaflet: Information for the patient

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

Keep this leaflet so that you can read it again if necessary.
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. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is MEGACE and what is it used for
Important information before taking MEGACE
How to take MEGACE
Possible side effects
How to store MEGACE
Contents of the pack and other information

1. What is MEGACE and what is it used for

The active substance in MEGACE, megestrol acetate, is a synthetic progestagen administered orally in the form of a suspension. It causes weight gain due to increased appetite.
MEGACE is indicated for the treatment of lack of appetite (anorexia) or weight loss resulting from neoplastic disease or acquired immunodeficiency syndrome (AIDS).

2. Important information before using Megace

When not to use Megace

If the patient is allergic (hypersensitive) to megestrol acetate 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 Megace, discuss this with your doctor.
Megace should be used with caution in patients who have previously experienced thrombophlebitis.
In patients with diabetes, an increased insulin requirement may occur.
Clinical and laboratory signs of mild adrenal suppression have been reported during or after discontinuation of Megace. If the drug is stopped abruptly, patients should be closely monitored for symptoms such as hypotension, nausea, vomiting, dizziness, or weakness.
Children and adolescents
The safety and efficacy of Megace have not been established in children under 12 years of age.
Megace with other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
There are no known confirmed interactions between megestrol acetate and other concomitantly administered medicines.
Pregnancy and breastfeeding
Megace must not be given to women who are pregnant or breastfeeding.
Driving and using machines
The effect of Megace on driving and operating machinery is unknown.
Megace contains sucrose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Megace contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 20 ml dose, meaning the medicine is considered "sodium-free".
Megace contains ethanol (ingredient of lemon flavouring essence)
This medicine contains 9.8 mg of alcohol (ethanol) per 20 ml dose, equivalent to 0.49 mg ethanol per 1 ml of oral suspension. The amount of alcohol in a dose of this medicine corresponds to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
Megace contains sodium benzoate (E 211)
The medicine contains 40 mg of sodium benzoate per 20 ml dose, equivalent to 2 mg per 1 ml of oral suspension.

3. How to use Megace

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor.
Recommended dosage:
Adults and adolescents above 12 years of age:
Oral administration of 10 to 20 ml (400 – 800 mg) once daily.
It is recommended to continue treatment with the oral suspension for at least two months.
Megace dosage is individually adjusted by the physician.
Elderly patients
There is insufficient clinical trial data on megestrol acetate in patients aged 65 years and older to determine whether it acts differently than in younger patients. Based on clinical experience, no differences in effects have been observed between elderly and younger patients. A cautious dosage selection is recommended in elderly patients. Due to the higher likelihood of impaired liver, kidney, or heart function, as well as concomitant diseases and use of other medications, treatment usually begins with doses at the lower end of the dosage range.
Patients with renal impairment
Megestrol acetate is primarily excreted by the kidneys. Therefore, the risk of toxic effects of this medicine may be greater in patients with impaired renal function. In elderly patients, deterioration of kidney function is more likely, so caution should be exercised when determining dosage, and monitoring of kidney function may be advisable.
Use in children and adolescents
Megace is not recommended for use in children under 12 years of age.
Method of administration
For oral use.
The suspension should be thoroughly mixed before administration.
Shake the bottle well immediately before use.
Overdose of Megace
Consult your doctor.
If necessary, the doctor will initiate appropriate supportive treatment.
Missed dose of Megace
Do not take a double dose to make up for a missed dose.
Stopping Megace
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions (occurring in less than 1 in 10 patients):

nausea, vomiting, diarrhoea, flatulence,
rash,
uterine bleeding,
impotence (reduced sexual function, erectile dysfunction),
fatigue, pain, swelling at the injection site.

Adverse reactions with unknown frequency (cannot be estimated from available data):

rapid tumour growth,
adrenal insufficiency (symptoms: increasing weakness, loss of appetite, weight loss, nausea, vomiting, irritability),
Cushing-like symptoms, Cushing's syndrome (symptoms: obesity, so-called moon face, striae, hypertension, rapid fatigue),
diabetes, impaired glucose tolerance, hyperglycaemia (excessively high blood sugar levels, symptoms: excessive thirst, dry mouth, weight loss, drowsiness), increased appetite,
mood changes,
carpal tunnel syndrome (symptoms: tingling in the wrist and fingers, weakened grip, lack of movement precision), lethargy,
circulatory failure,
thrombophlebitis, pulmonary embolism (in some cases resulting in death), hypertension, hot flushes,
dyspnoea,
constipation,
alopecia,
frequent urination.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
Tel.: + 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 the medicine Megace

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and bottle after "EXP". The expiry date refers to the last day of the specified month. The abbreviation "Lot" means batch number.
Store below 25°C.
Period of validity after first opening the bottle – 24 days.
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 Megace contains

The active substance is micronized megestrol acetate (1 ml of suspension contains 40 mg of megestrol acetate).
The other ingredients (excipients) are: citric acid, lemon flavoring (ethanol, water, artificial and natural flavors), polyethylene glycol 1450, polysorbate 80, sodium benzoate (E 211), sodium citrate, sucrose, xanthan gum, purified water.

What Megace looks like and contents of the pack
Megace is a white to creamy, milky suspension which readily mixes upon shaking.
HDPE polyethylene bottle containing 240 ml of suspension, with a PP screw cap with child-resistant closure, and a PP dosing spoon with 35 ml capacity marked in 2.5 ml increments, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00
Manufacturer/Importer
Bausch Health Poland sp. z o.o.
Kosztowska Street 21
41-409 Mysłowice
Poland