MEGESTIL 160 mg Tablets

Зміст інструкції

1. Megestil 160 mg tablets, 160 mg granules for oral suspension
   1. What is Megestil and what is it used for
   2. What you need to know before taking Megestil
   3. How to take Megestil
   4. Possible side effects
   5. How to store Megestil
   6. Contents of the pack and other information

Megestil 160 mg tablets, 160 mg granules for oral suspension

magestrolo 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 Megestil is and what it is used for
• 2. What you need to know before you take Megestil
• 3. How to take Megestil
• 4. Possible side effects
• 5. How to store Megestil
• 6. Contents of the pack and other information

1. What is Megestil and what is it used for

Megestil contains the active ingredient megestrol acetate, a substance capable of counteracting the activity of
estrogens (female sex hormones).
Megestil is used to alleviate the symptoms (but not to treat the cause):

• of advanced breast cancer;
• of advanced endometrial cancer (the tissue that lines the inside of the uterus);
• of loss of appetite (anorexia) and/or physical wasting (cachexia) due to any advanced cancer or AIDS.

2. What you need to know before taking Megestil

DO NOT take Megestil

• 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 suspect you may be (see section “Pregnancy and breastfeeding”);
• if you are breastfeeding with breast milk (see section “Pregnancy and breastfeeding”).

Megestil should not be used as a test for diagnosing pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking Megestil.
If you have a recurrence of the tumor or metastases, your doctor will monitor you constantly and carefully
during treatment with Megestil.
If you suffer from or have suffered from thrombophlebitis (inflammation of a vein, with formation of blood clots
that can occlude the vein itself), your doctor will use particular caution when prescribing Megestil.

Children and adolescents
The safety and efficacy of Megestil in pediatric age have not been studied.

Other medicines and Megestil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Currently, no interactions of Megestil 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.
Pregnancy
Women of childbearing potential should avoid pregnancy during treatment with Megestil,
using an effective contraceptive system.
Megestil should not be used in the first 4 months of pregnancy. If you need to take Megestil during the first 4
months of pregnancy or if you become pregnant during therapy, your doctor will inform you of the possible risks to the
fetus.
Following the administration of female sex hormones (including progestins such as Megestil)
even for a few days during pregnancy, negative effects on the fetus have been reported, including:

• defects at the heart level,
• deformities of the limbs (phocomelic limbs),
• alteration of the female and male genital organs.

Breastfeeding
During therapy with Megestil you must stop breastfeeding with breast milk, due to possible
undesirable effects on the newborn.

Driving and using machines
Megestil does not alter the ability to drive vehicles and use machines.

Megestil 160 mg tablets contains lactose:if your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

Megestil 160 mg tablets contains hydrogenated polyoxyl castor oil, which may cause gastrointestinal
disorders and diarrhea.

Megestil 160 mg granules for oral suspension contains sorbitol
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this
medicine.

3. How to take Megestil

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
In the case of sachets, you must dissolve the contents of each sachet in half a glass of water,
stirring until completely dispersed. The suspension thus obtained must be taken by mouth.
Breast cancer
The recommended dose is 1 tablet or 1 sachet per day.
Endometrial cancer
The recommended dose is 1-2 tablets or 1-2 sachets per day.
You will have to take Megestil for at least 2 months without interruption. Only in this way will it be possible to verify its effectiveness.
Loss of appetite (anorexia) and/or physical wasting (cachexia) associated with cancer or in HIV-
positive patients
The recommended dose at the beginning of treatment is 1 tablet or 1 sachet per day for at least 15 days; if
no improvements are observed, your doctor may increase the dose up to a maximum of 800 mg per
day.
The duration of treatment should not exceed 90 days; the doctor may prescribe repetition of the treatment
cycle.

If you take more Megestil than you should
In case of accidental ingestion of an excessive dose of Megestil, inform your doctor immediately or
go to the nearest hospital.

If you forget to take Megestil
Do not take a double dose to make up for a missed dose.

If you stop taking Megestil
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Do not abruptly stop treatment with Megestil, as rare cases of serious
problems with the glands above the kidneys (adrenal insufficiency) have been observed.
If you stop treatment, inform your doctor who will have you undergo tests to check the activity of your
adrenal glands.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During treatment with Megestil, the following side effects may occur:

• weight gain due to increased appetite and not necessarily due to fluid retention;
• formation of blood clots inside a vein or an artery, which may also move and obstruct other veins or arteries (thromboembolic events), including: o inflammation of a vein with formation of blood clots that can occlude the vein itself (thrombophlebitis); o blockage of a pulmonary artery by a clot carried by the blood (pulmonary embolism), which can also be fatal;
• nausea and vomiting;
• swelling caused by fluid accumulation (edema);
• vaginal bleeding;
• difficulty breathing (dyspnea);
• serious heart problems (heart failure);
• high blood pressure (hypertension);
• hot flashes;
• mood changes;
• moon face and fat accumulation especially in the neck and abdomen (appearance similar to that of patients with Cushing's disease);
• tumor growth, with or without high levels of calcium in the blood (hypercalcemia);
• high blood sugar levels (hyperglycemia);
• hair loss (alopecia);
• irritation of the nerves in the hand (carpal tunnel syndrome);
• skin rash
• serious problems at the level of the glands located above the kidneys (adrenal insufficiency), after abrupt discontinuation of treatment.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Megestil

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 Megestil contains
Megestil 160 mg tablets

• The active ingredient is megestrol acetate. Each tablet contains 160 mg of megestrol acetate.
• The other ingredients are hydrogenated castor oil polyoxyl 35, microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, hypromellose, magnesium stearate.

Megestil 160 mg granules for oral suspension

• The active ingredient is megestrol acetate. Each sachet contains 160 mg of megestrol acetate.
• The other ingredients are cetomacrogol 1000, sorbitol, lemon flavour.

Description of the appearance of Megestil and contents of the pack
Megestil 160 mg tablets
Each pack contains 30 tablets of 160 mg.

Megestil 160 mg granules for oral suspension
Each pack contains 30 sachets of 160 mg.

Marketing Authorisation Holder
TEOFARMA S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Tablets
AMAREG GmbH - manufacturing site in Regensburg (Germany) Donaustaufer Strasse, 378
DOPPEL Farmaceutici Srl – via Martiri delle Foibe, 1 Cortemaggiore - Piacenza (Italy)
Granules for oral suspension
PATHEON ITALIA S.P.A. – Monza (Italy) - Viale G.B. Stucchi 110