MEGEXIA 160 mg Tabletka

Treść ulotki

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

MEGEXIA 160 mg tablets

Megestrolo Acetato
Generic medicine

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

1. What MEGEXIA is and what it is used for

MEGEXIA is a medicine whose active ingredient is megestrol, which belongs to a group of medicines
used for hormonal therapy in the treatment of certain types of tumors.
This medicine is indicated in the treatment of symptoms (palliative) of some tumors (breast or endometrial carcinoma in advanced stage) or to counteract the severe weakening of the body
(anorexia-cachexia syndrome) caused by advanced malignant tumors and by AIDS, a disease caused
by a virus (HIV virus).

2. What you need to know before taking MEGEXIA

Do not take MEGEXIA

• if you are allergic to megestrol or any of the other ingredients of this medicine (listed in section 6);
• during the first 4 months of pregnancy or if you are breastfeeding (see the “Pregnancy, breastfeeding and fertility” section).

Warnings and precautions
Talk to your doctor or pharmacist before taking MEGEXIA.
Avoid taking this medicine during the first four months of pregnancy as it may cause serious harm
to the newborn (see section “Pregnancy, breastfeeding and fertility”).

Take with cautionthis medicine if you suffer from or have suffered from problems with your veins (thrombophlebitis).
MEGEXIA will only be prescribed by your doctor after a careful assessment of the risks/benefits of therapy
and, during therapy, your clinical condition will be carefully monitored. This medicine may
also be used for other types of tumors besides those listed in section 1 and in people who have
an infection caused by the human immunodeficiency virus (HIV positive).

Children
Use in children is not recommended as the safety and efficacy of MEGEXIA have not yet been
established.

Other medicines and MEGEXIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other medicines have been reported.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take this medicine during the first four months of pregnancy as it may cause serious harm to the
newborn, such as:

• heart problems (congenital heart defects);
• problems with the development of the arms and legs (phocomelic limbs);
• malformation of the urethra and external genitalia in the case of males (hypospadias) and in females with problems (virilization) of the female genital organs.

Breastfeeding
Stop breastfeeding during therapy with MEGEXIA as it may cause undesirable effects in the
newborn.

Driving and operating machinery
This medicine does not impair the ability to drive and operate machinery.

MEGEXIA contains lactose
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take MEGEXIA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:

• breast cancer (mammary carcinoma): 1 tablet (160 mg) per day;
• uterine cancer (endometrial carcinoma): 1-2 tablets (160-320 mg) per day. In general, it is advisable to continue therapy for at least 2 months continuously;
• severe wasting (anorexia/cachexia) due to cancer or in patients suffering from AIDS (HIV positive): start with one tablet (160 mg) per day for at least 15 days, then increase the dosage if there is no response up to a maximum of 800 mg/day. The duration of treatment should not exceed 90 days; therapy cycles are possible.

If you take more MEGEXIA than you should
No cases of serious overdose have been reported after taking this medicine up to a dose of 800 mg per
day (five tablets per day).
In case of accidental intake/ingestion of an excessive dose of MEGEXIA, immediately inform
your doctor or go to the Emergency Room of the nearest hospital.

If you forget to take MEGEXIA
Do not take a double dose to make up for the missed tablet.

If you stop taking MEGEXIA
Avoid abruptly stopping therapy with MEGEXIA because you may experience problems with the
adrenal gland (adrenal insufficiency). After stopping treatment, you will need to undergo
checks of the adrenal gland.
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.

Frequency not known(the frequency of which cannot be estimated from the available data):

• weight gain (weight increase) associated with increased appetite but not necessarily reduced fluid elimination (fluid retention);
• serious blood circulation problems (thromboembolic events such as thrombophlebitis and pulmonary embolism), in some cases fatal;
• nausea and vomiting, fluid accumulation (edema), vaginal bleeding, difficulty breathing (dyspnea), heart problems (heart failure), high blood pressure (hypertension), hot flushes, mood changes;
• obesity of the trunk and face with reduced development of the lower limbs (cushingoid appearance);
• tumor growth (with or without increased calcium levels in the blood), increased blood glucose levels (hyperglycemia), hair loss (alopecia), tendon inflammation at the wrist level (carpal tunnel syndrome) and skin rash;
• adrenal gland problems (adrenal insufficiency) following abrupt discontinuation of treatment. See the paragraph “If you stop taking MEGEXIA”.

Reporting of side effects
If you get any side effects, even those 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 MEGEXIA

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. Do not use this medicine if you notice visible signs of
deterioration.
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 MEGEXIA contains
The active ingredient is megestrol acetate. Each tablet contains 160 mg of megestrol acetate.
The other ingredients are: polyethyleneglycol hydroxystearate glycerol, microcrystalline cellulose, sodium
croscarmellose, lactose, methylhydroxypropylcellulose, magnesium stearate.

Description of the appearance of MEGEXIA and contents of the pack
Pack containing 3 blisters of 10 tablets of 160 mg.

Marketing Authorisation Holder
Sophos Biotech S.r.l.
Via Modica 6
20143 Milan

Manufacturer
DOPPEL FARMACEUTICI S.r.l, Via Martiri delle Foibe, 1, 29016 Cortemaggiore (PC), Italy