MAYGACE HIGH DOSE 40 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the Patient.

Maygace High Doses 40 mg/ml Oral Suspension

Megestrol Acetate

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, ask your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Maygace High Doses is and what it is used for.
2. What you need to know before taking Maygace High Doses.
3. How to take Maygace High Doses.
4. Possible side effects.
5. Storage of Maygace High Doses.
6. Package Contents and Additional Information.

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

Maygace High Doses contains megestrol acetate, a synthetic derivative of the natural steroid progesterone, which has the property of increasing appetite and weight gain, hence its usefulness in states of malnutrition.

Maygace High Doses is indicated for the treatment of anorexia (loss of appetite), cachexia (state of extreme malnutrition), or significant unexplained weight loss in patients diagnosed with Acquired Immune Deficiency Syndrome (AIDS) or advanced cancer.

2. What you need to know before taking Maygace High Doses

This medicine should be administered exclusively under medical prescription.

Do not take Maygace High Doses

• if you are allergic to megestrol acetate or any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Maygace High Doses.

• progestagen agents are not recommended during the first four months of pregnancy (see section Pregnancy, Breastfeeding, and Fertility).
• you should not take megestrol acetate to prevent weight loss.
• note that this medicine may alter the results of pregnancy diagnostic tests.
• close monitoring is recommended if you are being treated for metastatic or recurrent cancer.
• the safety and efficacy of this medicine have not been established in children, so your doctor will assess the benefit/risk.

Children and Adolescents

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

Elderly Patients

Available data in patients aged 65 and over are insufficient to determine whether they respond differently to younger patients.

In general, the selection of dose for an elderly patient should be made with caution, usually starting with the lower end of the dose range, as these patients often have a decrease in renal, hepatic, or cardiac function.

Megestrol acetate is excreted mainly through the kidneys, so the risk of adverse reactions to this medicine may increase in patients with renal insufficiency, and monitoring of renal function is advised.

Taking Maygace High Doses with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines.

Some medicines, such as hormones or aminoglutethimide (a medicine used to treat adrenal cortex tumors), may interact with Maygace High Doses.

Taking Maygace High Doses 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.

Progestagen 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 taking Maygace High Doses.

You should stop breastfeeding during treatment with this medicine.

Driving and Using Machines

No effects on the ability to drive or use machines have been reported.

Maygace High Doses Contains Saccharose, Ethanol, Sodium Benzoate (E-211), and Sodium

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

Maygace High Doses 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 in this medicine does not produce any noticeable effect.

This medicine contains 40 mg of sodium benzoate (E-211) in each 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 old).

This medicine contains less than 1 mmol of sodium (23 mg) per 20 ml dose; it is essentially "sodium-free".

3. How to Take Maygace High Doses

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Maygace High Doses is an oral suspension.

Your doctor will prescribe the appropriate dose of this medicine, depending on the severity of the condition you are suffering from.

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

If you think the action of Maygace High Doses is too strong or too weak, tell your doctor or pharmacist.

Instructions for Correct Administration of the Preparation

To administer the oral suspension of this medicine:

1. Shake the bottle vigorously.
2. To administer the correct amount, use the plastic dosing cup.
3. Make sure the bottle is properly 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 Toxicology Information Service, Phone: 91 562 04 20, indicating the medicine and the amount used.

If You Forget to Take Maygace High Doses

Do not take a double dose to make up for forgotten doses.

Consult your doctor. The doctor will determine what actions to take.

If You Stop Taking Maygace High Doses

Do not stop taking this medicine, 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 medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of the adverse reactions described with megestrol acetate are related to the symptoms of cachexia or anorexia in patients with cancer or AIDS.

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

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

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

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 due to fat accumulation in the face and neck), tumor deposits (worsening of tumor symptoms), hyperglycemia (elevated blood glucose), alopecia (hair loss), and carpal tunnel syndrome (hand inflammation) have also been described, as well as adrenal insufficiency (the adrenal glands do not function properly), diabetes mellitus, glucose intolerance, increased appetite, lethargy (prolonged and deep drowsiness), constipation, increased urination frequency (need to urinate frequently), and weight gain.

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

Other reported adverse reactions included flatulence, asthenia, and pain.

Reporting of Side Effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Maygace High Doses

Keep out of the reach and sight of children.

Store below 25°C.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated. It should be used within 24 days of opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Maygace High Doses

• The active ingredient is megestrol acetate. Each ml of oral suspension contains 40 mg of megestrol acetate.
• The other ingredients are: saccharose, anhydrous citric acid, polyethylene glycol 1450, polysorbate 80, sodium citrate, sodium benzoate (E-211), xanthan gum, lime-lemon flavor (ethanol, water, and natural and artificial flavor), and purified water.

Appearance of the Product and Package Contents

The oral suspension of Maygace High Doses is white or creamy in color with a milky appearance that disperses easily with shaking.

Maygace High Doses is available 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

You can request more information about this medicine 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

Date of Last Revision of this Package Leaflet:May 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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