BOREA 160 mg ORAL SUSPENSION GRANULES IN SACHETS

Introduction

Package Leaflet: Information for the User

BOREA 160 mg Granules for Oral Suspension in Sachets

megestrol acetate

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What BOREA Granules are and what they are used for
2. What you need to know before you take BOREA Granules
3. How to take BOREA Granules
4. Possible side effects
5. Storage of BOREA Granules
6. Contents of the pack and further information

1. What BOREA Granules are and what they are used for

BOREA Granules contain 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, as well as antineoplastic properties.

BOREA Granules are indicated in:

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

2. What you need to know before taking BOREA Granules

Do not take BOREA Granules

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

Warnings and Precautions

Consult your doctor or pharmacist before taking BOREA Granules:

• If you have a history of thromboembolism.
• If you experience painful, tense, or crampy sensations, redness, and a feeling of heat, especially in the upper and lower limbs (arms, hands, feet, and legs).
• If you suffer from diabetes or other hormonal disorders.

Children

BOREA Granules should not be administered to children.

Other Medicines and BOREA Granules

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

Never take this medicine on your own initiative, as some drug combinations should be avoided.

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

Tell your doctor or pharmacist if you are taking aminoglutethimide.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

BOREA Granules should not be administered during the first four months of pregnancy.

BOREA Granules may alter the results of pregnancy diagnostic tests.

Breastfeeding

BOREA Granules should not be administered during breastfeeding.

Driving and Using Machines

The influence of BOREA on the ability to drive and use machines is nil.

BOREA Granules contain Sorbitol

This medicine contains 2310 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or 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 medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

3. How to take BOREA Granules

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

Your doctor will indicate the duration of your treatment with BOREA Granules. Do not stop treatment before, as it may be harmful 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 think the action of BOREA Granules is too strong or weak, tell your doctor or pharmacist.

Unless your doctor indicates otherwise, the recommended doses are:

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

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

Cachexia-anorexia paraneoplastic syndrome (state of extreme malnutrition associated with loss of appetite): it is recommended to start treatment with 1 sachet 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 considered appropriate to administer megestrol acetate for at least two months of uninterrupted therapy.

Method of Administration

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

If you think the action of BOREA Granules is too strong or weak, tell your doctor or pharmacist.

If you take more BOREA Granules 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. In case of ingestion of an overdose, the usual measures should be taken (gastric lavage, activated charcoal, parenteral administration of fluids).

If you forget to take BOREA Granules:

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

4. Possible Side Effects

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

Side effects are listed by organ system and frequency, according to the following categories:

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

Uncommon (may affect up to 1 in 100 people) may include endocrine disorders such as tumor flare with or without hypercalcemia, Cushingoid face (typical facial redness due to metabolic alteration), cardiac disorders such as dyspnea (difficulty breathing) and heart failure, and vascular disorders such as hot flashes and hypertension.

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

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of BOREA Granules

Keep out of sight and reach of children.

Store in the original packaging.

Do not take BOREA Granules after the expiry date stated on the packaging after CAD or EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the Pack and Further Information

Composition of BOREA Granules

• The active substance is megestrol acetate. Each sachet contains 160 mg of megestrol acetate.
• The other ingredients are: polyoxyethylene cetostearyl ether (cetomacrogol 1000), sorbitol (E-420), and lemon flavor.

Appearance of the Product and Contents of the Pack

Sachets presented in a pack containing 30 and 500 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

LACHIFARMA S.R.L. Via ss. Zona industriales, 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 medicine by contacting the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of Last Revision of this Package Leaflet:July 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/