Megalia

Package Leaflet: Information for the Patient

MEGALIA, 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.
In case of any doubts, consult a doctor or pharmacist.
This medicine has been prescribed to you by a doctor. 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 Megalia and what is it used for

2. Important information before taking Megalia

3. How to take Megalia

4. Possible side effects

5. How to store Megalia

6. Contents of the pack and other information

1. WHAT IS MEGALIA AND WHAT IS IT USED FOR

The active substance of Megalia is megestrol acetate, a synthetic progestagen.
Megalia is indicated for the treatment of loss of appetite (anorexia) or weight loss due to cancer or acquired immunodeficiency syndrome (AIDS). The medicine is administered in the form of an oral suspension.

2. IMPORTANT INFORMATION BEFORE TAKING MEGALIA

Follow all the doctor's instructions.

When not to take Megalia

if you are allergic to megestrol acetate or any of the other ingredients of the medicine (listed in section 6),
if you are pregnant or breastfeeding.

Warnings and precautions

Before starting treatment with Megalia, discuss it with your doctor, pharmacist, or nurse.
Be particularly careful when taking Megalia
in patients who have had thrombophlebitis in the past,
in patients with diabetes - may increase insulin requirements.
Clinical and laboratory signs of mild adrenal suppression have been reported during and after treatment with megestrol acetate. In case of sudden discontinuation of the medicine, the patient should be closely monitored, especially for symptoms such as hypotension, nausea, vomiting, dizziness, or weakness.

Use in patients with renal and/or hepatic impairment

Before taking Megalia, inform your doctor if you have any liver or kidney problems.

Use in the elderly

Megalia can be used in the elderly.

Children and adolescents

The efficacy and safety of Megalia in children and adolescents have not been established.

Megalia and other medicines

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

Pregnancy, breastfeeding, and fertility

Before taking any medicine, consult a doctor.
The medicine is contraindicated during pregnancy and breastfeeding.
In case of pregnancy or suspected pregnancy, inform your doctor.
In case of breastfeeding, consult a doctor.

Driving and using machines

There are no data on the effect of megestrol acetate on the ability to drive and use machines.
Megalia contains liquid maltitol(sweetener). If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. HOW TO TAKE MEGALIA

Always take Megalia exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Method of administration

Before administration, shake the suspension well.
The usual dose is:
Adults:400 - 800 mg, (10 to 20 ml) orally.
Treatment with Megalia should be continued for at least two months.

Elderly patients

There is not enough data from clinical studies of megestrol acetate in patients aged 65 and over to determine whether they respond differently to the medicine than younger patients. Based on clinical experience, no differences in the effect of the medicine have been observed between elderly and younger patients. The dose should be chosen carefully in the elderly. Due to more frequent liver, kidney, or heart function disorders, as well as concomitant diseases and the use of other medicines, treatment usually starts with doses from the lower end of the dose range.
Megestrol acetate is mainly excreted by the kidneys. Therefore, the risk of toxic effects of the medicine may be higher in patients with impaired renal function. Since the occurrence of impaired renal function is more likely in the elderly, caution should be exercised when determining the dose, and monitoring of renal function may be useful.

Use in children and adolescents

Megalia is not recommended for use in children.

How long to take Megalia

Treatment with Megalia should be continued for at least two months.

Taking more Megalia than prescribed

Studies of the effects of taking high doses of the medicine (1,600 mg per day for 6 months) did not show any severe side effects.
In case of overdose, symptomatic treatment should be used.

Missing a dose of Megalia

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking the medicine, consult a doctor.
or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Megalia can cause side effects, although not everybody gets them.
Common side effects(occurring in 1 to 10 patients out of 100):
nausea, vomiting, diarrhea, bloating, rash;
vaginal bleeding;
impotence (reduced sexual potency, erectile dysfunction);
weakness, pain, swelling at the injection site.
Side effects with unknown frequency(which cannot be estimated from available data):
rapid tumor growth;
adrenal insufficiency (symptoms: increasing weakness, loss of appetite, weight loss, nausea, vomiting, irritability);
symptoms similar to 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;
shortness of breath;
constipation;
hair loss;
frequent urination;
weight gain.
The main side effects observed in patients treated with megestrol acetate, especially in high doses, are weight gain, which is not usually associated with water retention in the body, but is the result of increased appetite and consumption of larger amounts of food.
This effect is the basis for the use of megestrol acetate in patients with anorexia or weight loss.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone and fax number of the Department} e-mail: [email protected]
By reporting side effects, you can help provide more information on the safety of the medicine.

5. HOW TO STORE MEGALIA

Keep the medicine out of the sight and reach of children.
Do not use after the expiry date stated on the packaging. The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the given month.
Store below 25°C.
Use within 24 days after opening.
Do not throw away medicines 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 Megalia contains

The active substance of Megalia is megestrol acetate.
It is available in the form of an oral suspension.
The other ingredients are: carbomer, macrogol glycerol hydroxystearate, sodium hydroxide (10%), citric acid monohydrate, sodium citrate, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, liquid maltitol, sodium saccharin, lemon flavor, purified water.

What Megalia looks like and contents of the pack

Megalia is available in polyethylene bottles with a screw cap and a measuring cup in a cardboard box. The bottle contains 240 ml of suspension.

Marketing authorization holder and manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: [email protected]

Date of last revision of the leaflet: