MEGACE 160 mg Coated Tablet

Зміст інструкції

1. Megace 160 mg tablets
   1. What is Megace and what is it used for
   2. What you need to know before taking Megace
2. Megace is eliminated from the body substantially by the kidneys, and the risk of reactions
   1. How to take Megace
   2. Possible side effects
   3. How to store Megace
   4. Contents of the pack and other information

Megace 160 mg tablets

megestrolo acetato

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Megace is and what it is used for
• 2. What you need to know before you take 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

Megace contains the active substance megestrol acetate, a substance that belongs to a
group of medicines called progestins.
This medicine is indicated for the following conditions:
palliative treatment (relieves symptoms but does not remove the cause) of breast cancer
(mammary carcinoma) or uterus cancer (endometrial carcinoma) in an advanced stage.
treatment of loss of appetite (anorexia) and weight loss secondary to
tumors (neoplasms) or AIDS, in patients of both sexes.

2. What you need to know before taking Megace

Do not take Megace

• if you are allergic to megestrol acetate or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

You must also not take Megace:

• for the prevention of recurrent abortion or as treatment for threatened abortion (see “Warnings and precautions”);
• as a diagnostic test for pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Megace.

Pay particular attention with Megace:

• if you have a breast or endometrial cancer that has recurred following previous treatment (recurrent) or a cancer that has spread to other parts of the body (metastatic),

because you must be carefully and regularly monitored by your doctor;

• if you have a history of inflammation of the superficial veins that has led to the formation of blood clots (thrombophlebitis);
• if you are elderly or have reduced kidney function, as the dose of the medicine may need to be adjusted and your kidney function must be monitored.

Megace is eliminated from the body substantially by the kidneys, and the risk of reactions

toxic to the medicine may be greater if you have reduced kidney function (see
“How to take Megace”).

Children
The safety and efficacy of the medicine in children have not been established.

Other medicines and Megace
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those available without a prescription.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
Do not take Megace during pregnancy and during breastfeeding.
If you are of childbearing potential, you should be informed of the potential risks to the fetus associated with the use of
the medicine. During treatment with Megace, it is necessary to adopt an effective
contraceptive method. If you discover you are pregnant, consult your doctor immediately.

Driving and using machines
Megace does not impair the ability to drive vehicles or use machines.

Megace contains lactose
If your doctor has diagnosed an intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Megace

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

The recommended doses are:
Breast cancer: 1 tablet (160 mg) per day.
Endometrial cancer: 1-2 tablets (160-320 mg) per day.
Anorexia and cachexia (weight loss): 2 to 5 tablets (400-800 mg) per day,
administered as a single dose.
Your doctor may prescribe taking this medicine together with other anticancer medicines.
Megace should generally be taken for at least two months to evaluate its effects for the purpose of
efficacy.

Use in children
The safety and efficacy of this medicine in children have not been established.

Use in elderly patients
If you are an elderly person, your doctor should choose the dosage with caution, usually
starting from the minimum recommended dose. When choosing the dosage, your doctor will consider whether you have problems with the liver, kidneys or heart, or if you suffer from other diseases or
if you are undergoing concomitant treatment with other medicines.

If you take more Megace than you should
In case of accidental ingestion/taking of an excessive dose of Megace, immediately inform
your doctor or go to the nearest hospital.
Signs and symptoms of overdose may include diarrhea, nausea, abdominal pain,
shortness of breath, cough, unsteady gait, apathy and chest pain.
Since there are no specific antidotes, in case of overdose you will be given
symptomatic treatment.

If you forget to take Megace
If you miss a dose, take it as soon as possible. However, if it is almost time to take the next
dose, skip the missed dose. Do not take a double dose to make up for the
forgotten dose.

If you stop taking Megace
Do not stop taking Megace unless your doctor tells you to do so.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With Megace, the following side effects may occur:

• weight gain in patients treated for cancer, especially if high dosages are taken (weight gain has been associated with increased appetite, fat and cell mass, and is usually not associated with fluid retention)
• thromboembolic events including thrombophlebitis (inflammation of the vein following the formation of a blood clot) and pulmonary embolism (obstruction of a blood vessel leading blood from the heart to the lungs), potentially fatal
• nausea, vomiting
• swelling (edema)
• uterine bleeding
• difficulty breathing (dyspnea)
• pain
• heart failure (inability of the heart to pump sufficient blood through the body)
• increased blood pressure (hypertension)
• hot flashes
• mood changes
• “moon face” (cushingoid appearance)
• tumor growth (with or without increased calcium levels in the blood)
• increased blood sugar levels (hyperglycemia)
• hair and hair loss (alopecia)
• carpal tunnel syndrome (a nerve disease characterized by pain and numbness in the hand and fingers)
• diarrhea
• lethargy
• rash (skin eruption)
• impotence
• gas in the intestine (flatulence)
• asthenia (decreased muscle strength)
• constipation
• increased frequency of urination (following high doses)
• abnormalities of a system of hormone glands that regulate various functions of the body (hypothalamic-adrenal axis) including glucose intolerance, non-pre-existing diabetes or worsening of a previous diabetic condition with reduced glucose tolerance, Cushing's syndrome (excess production of cortisol)
• adrenal insufficiency, adrenal suppression syndrome (insufficient production of hormones by the adrenal glands), during or immediately after discontinuation of treatment

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects
you can help provide more information on the safety of this
medicine.

5. How to store Megace

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after
“Exp.”. The expiry date refers to the last day of that month. The expiry date
refers to the product in intact packaging, correctly stored.
Store at a temperature below 25°C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Megace contains

• The active ingredient is megestrol acetate. Each tablet contains 160 mg of megestrol acetate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethyl starch, povidone, colloidal silicon dioxide, magnesium stearate.

Description of the appearance of Megace and contents of the pack
Megace is presented as tablets.
3 blisters each containing 10 tablets of 160 mg.

Marketing Authorisation Holder
Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3
Ireland

Manufacturer
AndersonBrecon (UK) Ltd
Pharos House, Wye Valley Business Park
Hay-on-Wye, Hereford
United Kingdom