Borea 160 mg granules for oral suspension in sachets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
BOREA 160 mg granules for oral suspension in sachets
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 must not be given to other people, even if they have the same symptoms as you. It may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What BOREA granules are and what they are used for
- What you need to know before taking BOREA granules
- How to take BOREA granules
- Possible side effects
- How to store BOREA granules
- Contents of the pack and other 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 promoting weight gain. This makes it useful in states of malnutrition, as well as having antineoplastic properties.
BOREA granules 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 granules
Do not take BOREA granules
- If you are allergic (hypersensitive) to megestrol acetate or to any of the other components of Borea sachets (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take BOREA granules:
- If you have a history of thromboembolism.
- If you experience painful sensations, tightness or cramps, redness, and warmth, especially in the upper and lower limbs (arms, hands, legs, and feet).
- If you suffer from diabetes or other hormonal disorders.
Children
BOREA granules must not be administered to children.
Other medicines and BOREA granules
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
BOREA granules must not be administered during the first 4 months of pregnancy.
BOREA granules may alter the results of pregnancy diagnostic tests.
Breastfeeding
BOREA granules must not be administered during breastfeeding.
Driving and using machines
The influence of BOREA on the ability to drive and use machines is negligible.
BOREA granules contain sorbitol
This medicine contains 2310 mg of sorbitol per sachet.
Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
3. How to take BOREA granules
Follow exactly the instructions for administration 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 granules. Do not discontinue treatment prematurely, as this may be harmful to your health.
The dosage will be determined by your doctor depending on the location of the condition and the individual patient's response.
If you feel that the effect of BOREA granules is too strong or too weak, inform your doctor or pharmacist.
Unless otherwise directed by your doctor, 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.
Cancer-related cachexia-anorexia (a state of extreme malnutrition associated with loss of appetite): treatment should be initiated with 1 sachet per day (160 mg of megestrol acetate daily).
This dosage may be adjusted at the physician's discretion during treatment depending on the clinical response.
To assess the drug's efficacy, megestrol acetate is generally administered 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, resulting in a preparation ready for oral administration.
If you feel that the effect of BOREA granules is too strong or too weak, inform your doctor or pharmacist.
If you take more BOREA granules 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 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 granules:
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 are listed by organs and systems, according to the following frequency categories:
Very commonly (may affect more than 1 in 10 people): gastrointestinal disorders may occur, such as nausea, vomiting, and pyrosis (heartburn).
Uncommonly (may affect up to 1 in 100 people): endocrine disorders such as tumour flare with or without hypercalcaemia, Cushingoid facies (characteristic facial redness due to metabolic disturbance), cardiac disorders such as dyspnoea (difficulty breathing) and cardiac failure, and vascular disorders such as hot flushes and hypertension.
Rarely (may affect up to 1 in 1,000 people): immune system disorders such as rash and pruritus (itching), skin and subcutaneous tissue disorders such as hair loss, and reproductive system and breast disorders such as vaginal bleeding or spotting (vaginal discharge).
Frequency not known (cannot be estimated from available data): metabolism and nutrition disorders such as hyperglycaemia (elevated blood glucose), vascular disorders such as thromboembolism (venous thrombosis) and pulmonary embolism.
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 Medicines: www.notificaRAM.es. By reporting adverse 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 use BOREA granules after the expiry date stated on the container after CAD or EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of BOREA granules
- The active substance is megestrol acetate. Each sachet contains 160 mg of megestrol acetate.
- The other components are: cetostearyl alcohol (cetomacrogol 1000), sorbitol (E-420), and lemon flavour.
Appearance of the medicine and pack contents
Sachets presented in a container containing 30 or 500 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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
For further information about this medicine, please contact 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 about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): https://www.aemps.gob.es/