BOREA 160 mg TABLETS

Introduction

Package Leaflet: Information for the User

BOREA 160 mg tablets

megestrol acetate

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

• Keep this 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What BOREA 160 mg tablets are and what they are used for
2. What you need to know before you take 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 further information

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

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 usefulness in states of malnutrition, as well as antineoplastic properties.

BOREA tablets 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 160 mg tablets

Do not take BOREA tablets

♦ If you are allergic (hypersensitive) to megestrol acetate or any of the other components of Borea tablets (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 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 tablets should not be administered to children.

Other medicines and BOREA tablets

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 the 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 tablets should not be administered during the first four months of pregnancy. BOREA tablets may alter the results of pregnancy diagnostic tests.

Breastfeeding

BOREA tablets should not be administered during breastfeeding.

Driving and using machines

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

BOREA tablets contain lactose and sodium

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

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

3. How to take BOREA tablets

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

Your doctor will indicate the duration of your treatment with BOREA tablets. 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 tablets is too strong or too weak, tell your doctor or pharmacist.

Unless your doctor indicates 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.

Paraneoplastic cachexia-anorexia (state of extreme malnutrition associated with loss of appetite): it is recommended to start treatment with 1 tablet per day (160 mg of megestrol acetate per day).

This dosage will be adjusted, at medical 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

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

If you think the action of BOREA tablets is too strong or too weak, tell 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 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, administration of activated charcoal, parenteral administration of fluids).

If you forget to take BOREA tablets:

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.

The detected side effects include:

• Allergic/dermatological disorders: occasionally, skin rashes. Rarely, hair loss
• Cardiovascular disorders: rarely, thromboembolism (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 face (typical facial redness due to metabolic alteration)
• Genitourinary disorders: rarely, vaginal bleeding spotting

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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of BOREA tablets

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

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

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

6. Further information

Composition of BOREA tablets

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

Appearance of the product and packaging contents

Round, almost white tablets, presented in a packaging containing 30 units and 500.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

DOPPEL FARMACEUTICI, S.R.L.

Via Martiri delle Foibe, 1.

Cortemaggiore (Piacenza) - 29016 –

Italy

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this leaflet:July 2021

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