Prospect: information for the user

BOREA 160 mg powder for oral suspension in sachets

megestrol acetate

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isBOREA powderand for what it is used

2. What you need to know before starting to takeBOREA powder

3. How to takeBOREA powder

4. Possible adverse effects

5. Storage ofBOREA powder

6. Contents of the package and additional information

BOREA granulado contains 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 granulado 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 granulated

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

Warnings and precautions

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

• If you have a history of thromboembolism.
• If you experience painful, tight, or cramping sensations, redness, and warmth, especially in the upper and lower extremities (arms, hands, legs, and feet).
• If you suffer from diabetes or other hormonal disorders.

Children

BOREA granulated should not be administered to children.

Other medications and BOREA granulated

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

This medication should never be taken on your own initiative, as some combinations of medications must 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 if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

BOREA granulated should not be administered in the first 4 months of pregnancy.

BOREA granulated may affect the results of pregnancy diagnostic tests.

Breastfeeding

BOREA granulated should not be administered during breastfeeding.

Driving and operating machinery

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

BOREA granulated contains sorbitol

This medication contains 2310 mg of sorbitol in each packet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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 granulated. Do not discontinue treatment prematurely, as it 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 granulated is too strong or too weak, inform your doctor or pharmacist.

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

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

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

Cachexia-anorexia paraneoplastic (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 drug, it is generally advisable to administer megestrol acetate for at least two months of uninterrupted therapy.

Administration form

Dissolve the contents of each tablet in half a glass of water and mix until completely dissolved, leaving the preparation ready for oral administration.

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

If you take more BOREA granulated 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 overdose ingestion, standard measures should be taken (gastric lavage, activated charcoal administration, parenteral administration of liquids).

If you forgot to take BOREA granulated:

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

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

Adverse effects are listed by organs and systems, in accordance with the following frequency categories:

Very frequently (may affect more than 1 in 10 people) gastrointestinal disorders may appear: nausea, vomiting, and pyrosis (heartburn).

Rarely (may affect up to 1 in 100 people) endocrine disorders such as: tumor recurrence with or without hypercalcemia, cushingoid facies (typical facial flushing due to metabolic alteration), cardiac disorders such as dyspnea (difficulty breathing) and heart failure, and vascular disorders such as shortness of breath and hypertension.

Infrequently (may affect up to 1 in 1,000 people) immunological disorders such as rash (skin eruption) and pruritus (itching), skin or subcutaneous tissue disorders such as hair loss, and reproductive and breast disorders such as vaginal bleeding.

Frequency not known (cannot be estimated from available data) may appear metabolic and nutritional disorders such as hyperglycemia (elevated blood glucose), vascular disorders such as deep vein thrombosis and pulmonary embolism.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 safety of this medication.

Keep out of sight and reach of children.

Store in the original packaging.

Do not take BOREA granule after the expiration date shown on the container 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 containers and medicines you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need.This will help protect the environment.

Composition of BOREA granulated

- The active ingredient is megestrol acetate. Each blister contains 160 mg of megestrol acetate.

- The other components are: polyoxyethylene cetyl ether (cetomacrogol 1000), sorbitol (E-420) and lemon aroma.

Appearance of the product and content of the packaging

Blister packs presented in a container containing 30 and 500 blister packs.

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

LACHIFARMA S.R.L. Via ss. Industrial zones, Zollino – Italy

Or

CIT S.R.L.

Via Primo Villa 17

20875 – Burago di Molgora (MB) – Italy

Or

DOPPEL FARMACEUTICI, S.R.L.

Via Martiri delle Foibe, 1

29016 Cortemaggiore (Piacenza)

Italy

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

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/