Borea 160 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.
Contents of the leaflet:
- What BOREA 160 mg tablets are and what they are used for
- What you need to know before taking BOREA 160 mg tablets
- How to take BOREA 160 mg tablets
- Possible side effects
- How to store BOREA 160 mg tablets
- Contents of the pack and other 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 promoting weight gain. For this reason, it is useful in states of malnutrition, as well as having antineoplastic properties.
BOREA tablets are indicated for:
- Palliative treatment of certain cancers, such as breast and endometrial cancer
- Treatment of cancer-related cachexia-anorexia syndrome (a state of severe 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 to 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 sensation, tightness or cramps, redness, and warmth, especially in the upper and lower limbs (arms, hands, feet, and legs).
♦ If you have diabetes or other hormonal disorders.
Children
BOREA tablets must not be administered to children.
Other medicines and BOREA tablets
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.
This medicine should never be taken on your own initiative, as certain drug combinations must be avoided.
Like all progestogen derivatives, megestrol acetate interferes with circulating hormones in your body, blocking both their production and their effects.
Inform your doctor or pharmacist if you are taking aminoglutethimide.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
BOREA tablets must not be administered during the first 4 months of pregnancy. BOREA tablets may alter the results of pregnancy diagnostic tests.
Breastfeeding
BOREA tablets must not be administered during the breastfeeding period.
Driving and using machines
BOREA tablets have no influence on the ability to drive or use machinery.
BOREA tablets contain lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free”.
3. How to take BOREA tablets
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Your doctor will determine the duration of your treatment with BOREA tablets. Do not stop treatment prematurely, as this may be harmful to your health.
The dosage will be determined by your doctor according to the condition being treated and the individual patient's response.
If you feel that the effect of BOREA tablets is too strong or too weak, inform your doctor or pharmacist.
Unless otherwise directed by your doctor, the recommended doses are:
Breast pathology: 1 tablet daily (160 mg of megestrol acetate).
Endometrial (uterine) pathology: 1–2 tablets (160 to 320 mg of megestrol acetate) daily.
Cancer-related cachexia-anorexia (a state of extreme malnutrition associated with loss of appetite): treatment should be initiated with 1 tablet daily (160 mg of megestrol acetate daily).
This dosage may be adjusted at the physician’s discretion during the course of treatment depending on the clinical response.
To assess the drug's effectiveness, megestrol acetate is generally administered for at least two months of uninterrupted therapy.
Method of administration
Take the tablets whole with water. The tablets must not be chewed or crushed.
If you feel that the effect of BOREA tablets is too strong or too weak, inform your doctor or pharmacist.
If you take more BOREA tablets than you should:
Contact your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested. In the event of an overdose, standard 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 missed doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The adverse effects reported include:
- Allergic/dermatological disorders: occasionally, skin rashes. Rarely, hair loss
- Cardiovascular disorders: rarely, thromboembolism (venous thrombosis), pulmonary embolism, suffocation
- Gastrointestinal disorders: occasionally, gastric intolerance
- Endocrine/metabolic disorders: tumour flare with or without hypercalcaemia, hyperglycaemia (elevated blood glucose), Cushingoid facies (facial redness typical of metabolic disturbance)
- Genitourinary disorders: rarely, vaginal haemorrhage or spotting (vaginal bleeding)
Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of BOREA tablets
Keep out of the sight and reach of children. Store in the original packaging.
Do not take BOREA tablets after the expiry date stated on the container, following CAD or EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater drains or household waste. Return any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Additional Information
Composition of BOREA tablets
- The active substance is megestrol acetate. Each tablet contains 160 mg of megestrol acetate.
- The other components are: lactose, microcrystalline cellulose, polyethylene glycol stearate, sodium croscarmellose, magnesium stearate, methylhydroxypropylcellulose.
Appearance of the medicinal product and contents of the pack
Round, almost white tablets presented in a container 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
Further information on this medicine is available from the local representative of the Marketing Authorization Holder:
Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain
Date of the most recent review of this leaflet: July 2021
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/