Maygace Altas Dosis 40 mg/ml oral suspension
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Maygace High Dose 40 mg/ml oral suspension
Megestrol acetate
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Maygace High Dose is and what it is used for.
- What you need to know before taking Maygace High Dose.
- How to take Maygace High Dose.
- Possible side effects.
- How to store Maygace High Dose.
- Contents of the pack and other information.
1. What Maygace High Dose is and what it is used for
Maygace High Dose contains megestrol acetate, a synthetic derivative of the natural steroid progesterone that has the property of increasing appetite and promoting weight gain, which explains its usefulness in states of malnutrition.
Maygace High Dose is indicated for the treatment of anorexia (loss of appetite), cachexia (a state of severe malnutrition), or significant unexplained weight loss in patients diagnosed with Acquired Immunodeficiency Syndrome (AIDS) or advanced neoplasia.
2. What you need to know before starting Maygace High Dose.
This medicine must be administered exclusively under medical prescription.
Do not take Maygace High Dose
- if you are allergic to megestrol acetate or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting Maygace High Dose.
- the use of progestogenic agents is not recommended during the first four months of pregnancy (see section Pregnancy, breastfeeding and fertility).
- if you have a history of thrombophlebitis (venous inflammation).
- you must not take megestrol acetate to prevent weight loss.
- bear in mind that this medicine may alter the results of pregnancy diagnostic tests.
- increased vigilance is recommended if you are being treated for metastatic or recurrent cancer.
- the safety and efficacy of this medicine in children has not been established, therefore your doctor will assess the benefit/ risk ratio.
Children and adolescents
The efficacy and safety of Maygace High Dose oral suspension have not been established in pediatric patients.
Elderly patients
Available data in patients aged 65 years and older are insufficient to determine whether they respond differently from younger patients.
In general, dose selection for elderly patients should be cautious, usually starting at the lower end of the dosing range, since these patients may more frequently have decreased renal, hepatic, or cardiac function.
Megestrol acetate is primarily excreted by the kidney; therefore, the risk of adverse reactions to this medicine may be increased in patients with renal impairment, and monitoring of renal function is advised.
Taking Maygace High Dose 40 mg/ml with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Some medicines, such as hormones or aminoglutethimide (a medicine used in the treatment of adrenal cortex tumors), may interact with Maygace High Dose.
Taking Maygace High Dose with food and drinks
The daily dose of this medicine should be taken as a single dose 1 hour before or 2 hours after food intake.
Pregnancy, breastfeeding and fertility
Consult your doctor or pharmacist before using any medicine.
Progestogenic agents are not recommended during the first four months of pregnancy. If you become pregnant during treatment with this medicine, your doctor will inform you of the potential risk to the fetus.
Women of childbearing age are advised to avoid becoming pregnant while being treated with Maygace High Dose.
Breastfeeding must be discontinued during treatment with this medicine.
Driving and use of machines
No effects on the ability to drive or use machines have been reported.
Maygace High Dose contains sucrose, ethanol, sodium benzoate (E-211), and sodium
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Maygace High Dose contains ethanol (a component of natural and artificial lime-lemon flavor).
This medicine contains 9.8 mg of alcohol (ethanol) in each 20 ml dose, equivalent to 0.49 mg/ml.
The amount in 20 ml of this medicine is equivalent to less than 1 ml of beer.
The small amount of alcohol contained in this medicine does not produce any noticeable effect.
This medicine contains 40 mg of sodium benzoate (E-211) per 20 ml, equivalent to 2 mg/ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml dose; thus, it is essentially “sodium-free”.
3. How to take Maygace Altas Dosis.
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Maygace Altas Dosis is a suspension administered orally.
Your doctor will prescribe the appropriate dose of this medicine depending on the severity of your condition.
As a general guideline in Acquired Immunodeficiency Syndrome (AIDS) and advanced neoplasia, the recommended dose is 400–800 mg/day (10–20 ml/day).
If you think that the effect of Maygace Altas Dosis is too strong or too weak, inform your doctor or pharmacist.
Instructions for correct administration of the preparation
To administer the oral suspension of this medicine:
- Shake the bottle vigorously.
- To administer the correct amount, use the plastic dosing cup provided.
- Make sure the bottle is properly closed.
If you take more Maygace Altas Dosis than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or reach out to the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount taken.
If you forget to take Maygace Altas Dosis
Do not take a double dose to make up for missed doses.
Consult your doctor. Your doctor will determine the necessary actions to follow.
If you stop treatment with Maygace Altas Dosis
Do not interrupt treatment with this medicine, as it could be harmful to you.
Your doctor will advise you on the duration of treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Most of the adverse reactions described with megestrol acetate are related to symptoms commonly associated with the cachexia or anorexia state in patients affected by cancer or AIDS.
The most frequently reported undesirable effects are: diarrhoea, impotence, rash (sudden appearance of red spots on the skin), flatulence (gas), asthenia (physical or psychological weakness), and pain.
In approximately 1% to 2% of patients, nausea, vomiting, oedema (swelling due to fluid retention), and uterine bleeding have been reported.
Thromboembolic events have been reported, including thrombophlebitis (venous inflammation) and pulmonary embolism (pulmonary obstruction).
Dyspnoea (difficulty breathing), cardiac failure (the heart does not pump enough blood), hypertension (high blood pressure), hot flushes, moon face (round, red face due to fat accumulation in face and neck), tumour deposits (worsening of tumour symptoms), hyperglycaemia (high blood glucose levels), alopecia (hair loss), carpal tunnel syndrome (hand inflammation), adrenal insufficiency (adrenal glands not functioning properly), diabetes mellitus, glucose intolerance, increased appetite, lethargy (deep and prolonged drowsiness), constipation, increased urinary frequency (need to urinate frequently), and weight gain have also been reported.
Adverse reactions reported with a frequency > 5% in patients in clinical trials included diarrhoea, impotence, and rash.
Other reported adverse reactions included flatulence, asthenia, and pain.
Reporting of adverse effects:
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Maygace Altas Dosis.
Keep out of the reach and sight of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated. Must be used within 24 days after first opening of the bottle.
Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information.
Composition of Maygace Altas Doses
- The active substance is megestrol acetate. Each ml of oral suspension contains 40 mg of megestrol acetate.
- The other components are: sucrose, anhydrous citric acid, polyethylene glycol 1450, polysorbate 80, sodium citrate, sodium benzoate (E-211), xanthan gum, lime-lemon flavoring (ethanol, water, and natural and artificial flavoring), and purified water.
Appearance of the product and contents of the pack
Maygace Altas Dosis oral suspension is white or cream-colored with a milky appearance that disperses easily upon shaking.
Maygace Altas Dosis is supplied in 240 ml bottles. It includes a plastic dosing cup.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland.
Manufacturer:
Bausch Health Poland Sp. z o.o.
ul. Przemyslowa 2,
35-959 Rzeszów
Poland
Bausch Health Poland sp. z o.o.
ul. Kosztowska 21
41-409 Myslowice
Poland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Zentiva Spain S.L.U.
Paseo Club Deportivo 1, Edif 4
Pozuelo de Alarcón 28223, Madrid
Spain
Date of the most recent review of this leaflet: May 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/