Patient Information Leaflet

Megestil 160 mg tablets, 160 mg oral suspension granules

Megestrol acetate
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Megestil is and what it is used for
What you need to know before taking Megestil
How to take Megestil
Possible side effects
How to store Megestil
Contents of the pack and other information

1. What Megestil is and what it is used for

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

of advanced breast cancer;
of advanced endometrial cancer (the tissue lining the inner cavity of the uterus);
of loss of appetite (anorexia) and/or physical wasting (cachexia) due to any advanced malignant tumour or to AIDS.

2. What you need to know before taking Megestil

Do not take Megestil

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

Megestil must not be used as a test for the diagnosis of pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist before taking Megestil.
If you have a recurrence of tumor or metastases, your doctor will monitor you continuously and carefully
during treatment with Megestil.
If you currently have or have previously had thrombophlebitis (inflammation of a vein, with formation of blood clots
that may block the vein), your doctor will exercise particular caution when prescribing Megestil.
Children and adolescents
The safety and efficacy of Megestil in the pediatric population have not been studied.
Other medicines and Megestil
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
To date, no interactions between Megestil and other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Pregnancy
Women of childbearing potential should avoid pregnancy during treatment with Megestil by using an effective
contraceptive method.
Megestil must not be used during 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 treatment, your doctor will inform you about the possible
risks to the fetus.
Following administration of female sex hormones (including progestins such as Megestil), even for only a few days
during pregnancy, adverse effects on the fetus have been reported, including:

heart defects,
limb deformities (phocomelia),
abnormalities of male and female genital organs.

Breastfeeding
During treatment with Megestil, you must discontinue breastfeeding, due to the possible adverse effects on the newborn.
Driving and using machines
Megestil does not impair the ability to drive vehicles or operate machinery.
Megestil 160 mg tablets contain lactose: if your doctor has diagnosed you with an intolerance to certain
sugars, contact him or her before taking this medicine.
Megestil 160 mg tablets contain hydrogenated polyoxyl 40 castor oil, which may cause gastrointestinal disturbances and diarrhea.
Megestil 160 mg oral suspension granules contain sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this
medicine.

3. How to take Megestil

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For the sachets, dissolve the contents of each sachet in half a glass of water, stirring until completely dispersed. The resulting suspension should be taken orally.

Breast cancer
The recommended dose is 1 tablet or 1 sachet daily.

Endometrial cancer
The recommended dose is 1–2 tablets or 1–2 sachets daily.

You must take Megestil continuously for at least 2 months. Only in this way can its effectiveness be assessed.

Loss of appetite (anorexia) and/or physical wasting (cachexia) associated with cancer or in HIV-positive patients
The recommended initial dose is 1 tablet or 1 sachet daily for at least 15 days; if no improvement is observed, your doctor may increase the dose up to a maximum of 800 mg daily.

The duration of treatment should not exceed 90 days; however, your doctor may prescribe repetition of the treatment cycle.

If you take more Megestil than you should
In case of accidental overdose, contact 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 the missed dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur during treatment with Megestil:

weight gain due to increased appetite, not necessarily related to fluid retention;
formation of blood clots within a vein or artery, which may also travel and block other veins or arteries (thromboembolic events), including:
o inflammation of a vein with formation of blood clots that may obstruct the vein itself (thrombophlebitis);
o blockage of a lung artery by a blood clot carried through the bloodstream (pulmonary embolism), which may also be fatal;
nausea and vomiting;
swelling due to fluid accumulation (oedema);
vaginal bleeding;
difficulty in breathing (dyspnoea);
severe heart problems (heart failure);
high blood pressure (arterial hypertension);
hot flushes;
mood changes;
moon-shaped face and fat accumulation, especially in the neck and abdomen (Cushing-like appearance);
tumour growth, with or without high levels of calcium in the blood (hypercalcaemia);
high blood sugar levels (hyperglycaemia);
hair loss (alopecia);
nerve irritation in the hand (carpal tunnel syndrome);
skin rash;
severe problems affecting the glands located above the kidneys (adrenal insufficiency), after abrupt discontinuation of treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the website 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 special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Megestil contains
Megestil 160 mg tablets

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

Megestil 160 mg oral suspension granules

The active substance is megestrol acetate. Each sachet contains 160 mg of megestrol acetate.
The other components are cetomacrogol 1000, sorbitol, lemon flavouring.

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

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

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