Leaflet: Information for the patient.

Maygace High Dose 40 mg/ml oral suspension

Acetate of megestrol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribedonlyfor you and must not be given to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects,consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Maygace High Dose and what it is used for.

2. What you need to know before starting to take Maygace High Dose.

3. How to take Maygace High Dose.

4. Possible side effects.

5. Storage of Maygace High Dose.

6. Contents of the pack and additional information.

Maygace Altas Dosis contains megestrol acetate, a synthetic derivative of the natural steroid progesterone that has the property of increasing appetite and weight gain, hence its utility in states of malnutrition.

Maygace Altas Dosis is indicated for the treatment of anorexia (loss of appetite), cachexia (a state of extreme malnutrition) or significant unexplained weight loss in patients diagnosed with Acquired Immunodeficiency Syndrome (AIDS) or advanced neoplasia.

This medication must be administered exclusively under medical prescription.

Do not take Maygace Altas Dosis in high doses

-if you are allergic to megestrol acetate or any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Maygace Altas Dosis.

-the use of progestogenic agents is not recommended during the first four months of pregnancy (see sectionPregnancy, lactation and fertility).

-if you have a history of thrombophlebitis (venous inflammation).

-do not take megestrol acetate to prevent weight loss.

-be aware that this medication may alter the results of the diagnostic pregnancy test.

-it is recommended to exercise increased vigilance if you are being treated for metastatic or recurrent cancer.

-the safety and efficacy of this medication have not been established in children, so your doctor will evaluate the benefit/risk.

Children and adolescents

The efficacy and safety of Maygace Altas Dosis oral suspension have not been established in pediatric patients.

Older patients

The available data in patients aged 65 years and older are insufficient to determine if they respond differently to younger patients.

Generally, the selection of dosage for an elderly patient should be made with caution, usually starting with the lowest end of the dosage range, as these patients are more likely to have a decrease in their renal, hepatic, or cardiac functions.

Megestrol acetate is primarily excreted through the kidney, so the risk of adverse reactions to this medication may increase in patients with renal insufficiency, so renal function monitoring is advised.

Taking Maygace Altas Dosis 40 mg/ml with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications, such as hormones or aminoglutethimide (a medication used in the treatment of adrenal cortex tumors), may interact with Maygace Altas Dosis.

Taking Maygace Altas Dosis with food and beverages

The daily dose of this medication should be taken as a single dose 1 hour before or 2 hours after food intake.

Pregnancy, lactation and fertility

Consult your doctor or pharmacist before using any medication.

Progestogenic agents are not recommended during the first four months of pregnancy. If you become pregnant during treatment with this medication, your doctor will warn you of the potential risk to the fetus.

Women of childbearing age are advised to avoid becoming pregnant while being treated with Maygace Altas Dosis.

You should discontinue breastfeeding during treatment with this medication.

Driving and operating machinery

No effects on the ability to drive or operate machinery have been described.

Maygace Altas Dosis contains saccharose, ethanol, sodium benzoate (E-211) and sodium

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Maygace Altas Dosis contains ethanol (a natural and artificial lemon-lime flavor component).

This medication 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 medication is equivalent to less than 1 ml of beer.

The small amount of alcohol contained in this medication does not produce any perceptible effect.

This medication contains 40 mg of sodium benzoate (E-211) in each 20 ml dose, 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 medication contains less than 1 mmol of sodium (23 mg) per 20 ml dose; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Maygace High Doses is a suspension that is administered orally.

Your doctor will prescribe the appropriate dose of this medication, depending on the severity of the process you are experiencing.

As a guideline in Acquired Immunodeficiency Syndrome (AIDS) and advanced neoplasia, the recommended dose is 400-800 mg/day (10-20 ml/day).

If you estimate that the action of Maygace High Doses 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 medication:

1. Shake the bottle vigorously.

2. To administer the correct amount, use the plastic dosing cup.

3. Ensure that the bottle is correctly closed.

If you take more Maygace High Doses than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or contact the Toxicological Information Service, Telephone: 91 562 04 20 indicating the medication and the amount used.

If you forget to take Maygace High Doses

Do not take a double dose to compensate for the missed doses.

Consult your doctor. The doctor will determine the actions to be taken.

If you interrupt treatment with Maygace High Doses

Do not interrupt treatment with this medication, as it may be harmful to you.

Your doctor will indicate the duration of treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The majority of adverse reactions described with megestrol acetate are related to the symptomatology of cachexia or anorexia in patients affected by cancer or AIDS.

The undesirable effects detected most frequently are: diarrhea, impotence, skin rash (sudden appearance of red patches on the skin), flatulence (gas), asthenia (physical or mental weakness) and pain.

In approximately between 1% and 2% of patients, the following have been described: nausea, vomiting, edema (swelling due to fluid retention) and uterine bleeding.

Thromboembolic events, including phlebitis (venous inflammation) and pulmonary embolism (pulmonary obstruction), have been reported.

Also, dyspnea (difficulty breathing), heart failure (the heart does not pump enough blood), hypertension (high blood pressure), hot flashes, mood changes, moon face (round and red face and neck due to fat accumulation), tumor deposits (aggravation of tumor symptoms), hyperglycemia (high blood glucose levels), alopecia (hair loss), carpal tunnel syndrome (hand inflammation), adrenal insufficiency (adrenal glands do not function properly), diabetes mellitus, glucose intolerance, increased appetite, lethargy (deep and prolonged sleepiness), constipation, increased urination frequency (need to urinate frequently) and weight gain have been described.

The adverse reactions reported with a frequency > 5% in clinical trial patients included diarrhea, impotence and rash.

Other adverse reactions reported included flatulence, asthenia and pain.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Store below 25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated. It should be used within 24 days from the first opening of the bottle.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Maygace High Dose

-The active ingredient 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, lemon-lime flavoring (ethanol, water, and natural and artificial flavor) and purified water.

Appearance of the product and contents of the packaging

Maygace High Dose oral suspension is a white or creamy liquid with a milky appearance that disperses easily upon agitation.

Maygace High Dose is presented in 240 ml bottles. It includes a plastic dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland.

Responsible for manufacturing:

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

You can request more information about this medication by contacting 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

Last review date of this leaflet:May 2023

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/