Package Leaflet: Information for the User

BOREA 160 mg Tablets

megestrol acetate

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What BOREA 160 mg Tablets are and what they are used for

2. What you need to know before you start taking BOREA 160 mg Tablets

3. How to take BOREA 160 mg Tablets

4. Possible side effects

5. Storage of BOREA 160 mg Tablets

6. Contents of the pack and additional information

BOREA tablets contain megestrol acetate, a synthetic derivative of the natural steroid progesterone, which has the property of increasing appetite and weight gain, hence its utility in states of malnutrition, as well as antineoplastic properties.

BOREA tablets is indicated for:

• Palliative treatment in certain cancers such as breast and endometrial cancer
• Treatment of cachexia-anorexia syndrome (a state of extreme malnutrition associated with loss of appetite) caused by advanced cancer

Do not take BOREA tablets

♦ If you are allergic (hypersensitive) to megestrol acetate or to any of the other components of Borea tablets (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take BOREA tablets:

♦ If you have a history of thromboembolism.

♦ If you experience painful, tense, or cramping sensations, redness, and warmth, especially in the upper and lower extremities (arms, hands, legs, and feet).

♦ If you have diabetes or other hormonal disorders.

Children

BOREA tablets should not be administered to children.

Other medicines and BOREA tablets

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

This medication should never be taken on your own initiative, as some combinations of medications should be avoided.

Like all progestogen derivatives, megestrol acetate interferes with circulating hormones in your body, blocking both production and effect.

Inform your doctor or pharmacist if you are taking aminoglutethimide.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

BOREA tablets should not be administered in the first 4 months of pregnancy. BOREA tablets may affect the results of pregnancy diagnosis tests.

Breastfeeding

BOREA tablets should not be administered during the breastfeeding period.

Driving and operating machinery

The influence of BOREA tablets on the ability to drive and operate machinery is negligible.

BOREA tablets contain lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; 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.

Your doctor will inform you of the duration of your treatment with BOREA tablets. Do not discontinue treatment prematurely, as this may be detrimental to your health.

The dosage will be established by your doctor based on the location of the condition and the response of each patient.

If you estimate that the action of BOREA tablets is too strong or too weak, inform your doctor or pharmacist.

Unless your doctor instructs you otherwise, the recommended doses are:

Breast pathology: 1 tablet per day (160 mg of megestrol acetate).

Endometrial pathology (uterus): 1-2 tablets (160 to 320 mg of megestrol acetate) per day.

Cachexia-anorexia paraneoplastic (state of extreme malnutrition associated with loss of appetite): It is recommended to initiate treatment with 1 tablet per day (160 mg of megestrol acetate per day).

This dosage will be adjusted, at the doctor's discretion, throughout treatment based on clinical response.

To evaluate the efficacy of the medication, it is generally advisable to administer megestrol acetate for at least two months of uninterrupted therapy.

Administration form

Take the tablets whole with water. The tablets should not be chewed or crushed.

If you estimate that the action of BOREA tablets is too strong or too weak, inform your doctor or pharmacist.

If you take more BOREA tablets than you should:

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. In case of ingestion of an overdose, standard measures should be taken (gastric lavage, activated charcoal administration, parenteral administration of liquids).

If you forgot to take BOREA tablets:

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

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

The detected adverse effects include:

• Allergic/dermatological disorders: occasionally, skin eruptions. Rarely, hair loss
• Cardiovascular disorders: rarely, venous thrombosis, pulmonary embolism, shortness of breath
• Digestive disorders: occasionally, gastric intolerance
• Endocrine/metabolic disorders: tumor recurrence with or without hypercalcemia, hyperglycemia (elevated blood glucose), cushingoid facies (typical facial flushing due to metabolic alteration)
• Genitourinary disorders: rarely, vaginal bleeding

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 Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safetyof this medication.

Keep out of sight and reach of children. Store in the original packaging.

Do not take BOREA tablets after the expiration date shown on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of BOREA Tablets

• The active ingredient is megestrol acetate. Each tablet contains 160 mg of megestrol acetate.
• The other components are: lactose, microcrystalline cellulose, glycerol polyethylene glycol oxistearate, sodium croscarmellose, magnesium stearate, methylhydroxypropylcellulose.

Appearance of the Product and Contents of the Package

Round, almost white tablets that are presented in a package containing 30 units and 500.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for Manufacturing:

DOPPEL FARMACEUTICI, S.R.L.

Via Martiri delle Foibe, 1.

Cortemaggiore (Piacenza) - 29016 –

Italy

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last Review Date of this Leaflet:July 2021

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/