Megexia
Italy
Table of Contents
Package leaflet: Information for the patient
MEGEXIA 160 mg tablets
Megestrol Acetate
Generic medicine
Please read all of 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 others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What MEGEXIA is and what it is used for
- What you need to know before taking MEGEXIA
- How to take MEGEXIA
- Possible side effects
- How to store MEGEXIA
- Contents of the pack and other information
1. What MEGEXIA is and what it is used for
MEGEXIA is a medicine whose active substance is megestrol, which belongs to a group of medicines used for hormonal therapy in the treatment of certain types of cancer.
This medicine is indicated for the palliative treatment of symptoms of certain cancers (advanced breast or endometrial carcinoma) or to counteract severe physical wasting (anorexia-cachexia syndrome) caused by advanced malignant tumours 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 to 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 section “Pregnancy, breastfeeding and fertility”).
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 unborn baby (see section “Pregnancy, breastfeeding and fertility”).
Take this medicine with caution if you have or have had vein problems (thrombophlebitis).
MEGEXIA will be prescribed by your doctor only after a careful assessment of the risks and benefits of treatment, and your clinical condition will be closely monitored during therapy. This medicine may also be used for other types of tumours not listed in section 1 and in individuals infected with HIV (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
Inform 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 may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist 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 cardiac anomalies);
- impaired development of arms and legs (phocomelia);
- malformation of the urethra and external genital organs in males (hypospadias) and in females with problems (virilization) of female genital organs.
Breastfeeding
Discontinue breastfeeding during treatment with MEGEXIA, as it may cause adverse effects in the newborn.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
MEGEXIA contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor 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 exactly as directed by 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) daily;
- cancer of the uterus (endometrial carcinoma): 1–2 tablets (160–320 mg) daily. In general, treatment should be continued for at least 2 consecutive months;
- severe wasting (anorexia/cachexia) due to cancer or in patients suffering from AIDS (HIV positive): start with 1 tablet (160 mg) daily for at least 15 days, then increase the dose in case of no response up to a maximum of 800 mg/day. The duration of treatment should not exceed 90 days; treatment cycles are possible.
If you take more MEGEXIA than you should
No cases of serious overdose have been reported following intake of this medicine up to a dose of 800 mg daily (five tablets per day).
In case of accidental ingestion of an excessive dose of MEGEXIA, contact your doctor immediately or go to the nearest hospital emergency department.
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 treatment with MEGEXIA, as you may experience problems with the adrenal gland (adrenal insufficiency). After stopping treatment, you will need to undergo monitoring of adrenal gland function.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Frequency not known (frequency cannot be estimated from the available data):
- weight gain associated with increased appetite, but not necessarily with reduced fluid elimination (fluid retention);
- serious problems with blood circulation (thromboembolic events such as thrombophlebitis and pulmonary embolism), in some cases fatal;
- nausea and vomiting, fluid accumulation (edema), vaginal bleeding, difficulty in 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);
- tumour growth (with or without increased calcium levels in the blood), increased blood glucose levels (hyperglycaemia), hair loss (alopecia), inflammation of the wrist tendon (carpal tunnel syndrome), and skin rash;
- problems with the adrenal gland (adrenal insufficiency) following abrupt discontinuation of treatment. See section “If you stop taking MEGEXIA”.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report side effects directly via 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 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 use this medicine if you notice any visible signs of deterioration.
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 MEGEXIA contains
The active substance is megestrol acetate. Each tablet contains 160 mg of megestrol acetate.
The other components are: glycerol polyethylene glycol oxystearate, microcrystalline cellulose, sodium croscarmellose, lactose, methylhydroxypropylcellulose, magnesium stearate.
Description of the appearance of MEGEXIA and package contents
Carton pack containing 3 blisters of 10 tablets of 160 mg.
Marketing Authorization 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