Megace

Package Leaflet: Information for the Patient

MEGACE, 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 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Megace and what is it used for

The active substance of the medicine, megestrol acetate, is a synthetic progestagen for oral administration 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 due to cancer or acquired immunodeficiency syndrome (AIDS).

2. Important information before taking Megace

When not to take Megace

• If you are allergic (hypersensitive) to megestrol acetate or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding.

Warnings and precautions

Before taking Megace, discuss it with your doctor.
Megace should be used with caution in patients who have had thrombophlebitis in the past.
In patients with diabetes, an increased need for insulin may occur.
Clinical and laboratory signs of mild adrenal suppression have been reported during or after treatment with Megace. In case of sudden discontinuation of the medicine, patients should be carefully monitored for symptoms such as hypotension, nausea, vomiting, dizziness, or weakness.

Children and adolescents

The safety and efficacy of Megace in children under 12 years of age have not been established.

Megace and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
No confirmed interactions between megestrol acetate and other concomitantly administered medicines are known.

Pregnancy and breastfeeding

Megace should not be given to pregnant or breastfeeding women.

Driving and using machines

The effect of Megace on the ability to drive and use machines is not known.

Megace contains sucrose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

Megace contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 20 ml dose, which means it is considered "sodium-free".

Megace contains ethanol (a component of lemon flavoring)

This medicine contains 9.8 mg of alcohol (ethanol) per 20 ml dose, which corresponds to 0.49 mg of ethanol per 1 ml of oral suspension. The amount of alcohol in a dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.

Megace contains sodium benzoate (E 211)

The medicine contains 40 mg of sodium benzoate per 20 ml dose, which corresponds to 2 mg per 1 ml of oral suspension.

3. How to take Megace

Take this medicine always as directed by your doctor. If you are unsure, ask your doctor.
The recommended dose is:

Adults and adolescents over 12 years of age.

Orally 10 to 20 ml (400 – 800 mg), once a day.
Treatment with the oral suspension should be continued for at least two months.
The dosage of Megace is determined individually by the doctor.

Elderly patients

There is not enough data from clinical studies of megestrol acetate in patients over 65 years of age to determine whether it works differently than in younger patients.
Based on clinical experience, no differences in its effects have been found between elderly and younger patients. Caution should be exercised when selecting a dose for elderly patients. Due to more frequent disorders of liver, kidney, or heart function, as well as concomitant diseases and the use of other medicines, treatment usually starts with doses from the lower end of the dosage range.

Patients with renal impairment

Megestrol acetate is mainly excreted by the kidneys. Therefore, the risk of toxic effects of this medicine may be higher in patients with impaired renal function. In elderly patients, the occurrence of impaired renal function is more likely, so caution should be exercised when determining the dose, and it may be useful to monitor renal function.

Use in children and adolescents

Megace is not recommended for use in children under 12 years of age.

Method of administration

Oral administration.
Before administration, the suspension should be shaken well.
The bottle should be shaken immediately before use.

Overdose of Megace

Consult a doctor.
If necessary, the doctor will administer appropriate supportive treatment.

Missed dose of Megace

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

Discontinuation of Megace

If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, Megace can cause side effects, although not everybody gets them.
Common side effects(occurring in no more than 1 in 10 patients):

• nausea, vomiting, diarrhea, bloating,
• rash,
• uterine bleeding,
• impotence (reduced sexual potency, erectile dysfunction),
• weakness, pain, swelling at the injection site.

Side effects of unknown frequency(cannot be estimated from available data):

• rapid tumor growth,
• adrenal insufficiency (symptoms: increasing weakness, loss of appetite, weight loss, nausea, vomiting, irritability),
• Cushing's syndrome, Cushing's syndrome (symptoms: obesity, moon face, stretch marks, hypertension, rapid fatigue),
• diabetes, impaired glucose tolerance, hyperglycemia (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, weakness of grip, lack of precision of movements), lethargy,
• circulatory failure,
• thrombophlebitis, pulmonary embolism (in some cases fatal), hypertension, hot flashes to the head,
• shortness of breath,
• constipation,
• hair loss,
• frequent urination.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 Megace

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "EXP". The expiry date refers to the last day of the month.
Store in a temperature below 25°C.
Shelf life after first opening the bottle – 24 days.
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 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 that is easily mixed during shaking.
A high-density polyethylene (HDPE) bottle containing 240 ml of suspension with a polypropylene (PP) cap with a child-resistant closure and a 35 ml measuring cup with a PP graduations every 2.5 ml, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +48 17 865 51 00

Manufacturer/Importer

Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Mysłowice
Poland

Date of last revision of the leaflet: