Beyonttra 356 mg film-coated tablets

Package Leaflet: Information for the user

Introduction

Package leaflet: information for the patient

BEYONTTRA 356 mg film-coated tablets

acoramidis

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any adverse reactions you may experience. The end of section 4 includes information on how to report adverse reactions.

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

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

Leaflet contents

1. What BEYONTTRA is and what it is used for
2. What you need to know before taking BEYONTTRA
3. How to take BEYONTTRA
4. Possible side effects
5. How to store BEYONTTRA
6. Contents of the pack and other information

1. What BEYONTTRA is and what it is used for

BEYONTTRA contains the active substance acoramidis (as hydrochloride).

It is used to treat adults with cardiomyopathy (a disease affecting the heart muscle) caused by transthyretin amyloidosis (ATTR-CM).

In people with transthyretin amyloidosis, a protein called transthyretin (TTR) does not function properly, causing it to break down and form deposits of fibres known as amyloids. When amyloids accumulate in the heart, the heart muscle becomes stiff and the heart no longer functions properly. BEYONTTRA stabilizes TTR, which may prevent it from breaking down and forming amyloids. This helps people whose hearts have been affected by transthyretin amyloid cardiomyopathy.

2. What you need to know before starting BEYONTRA

Do not take BEYONTRA

If you are allergic to acoramidis or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take BEYONTRA, especially if you have liver problems or severe kidney problems.

When starting treatment, you may experience changes in blood tests assessing kidney function, although these changes should not negatively affect your kidneys.

Children and adolescents

BEYONTRA is not used in children and adolescents. Its use has not been studied in this population.

Other medicines and BEYONTRA

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

BEYONTRA may alter blood tests of thyroid function, although these changes should not negatively affect your thyroid function.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine, as it is unknown whether BEYONTRA may harm the unborn baby.

It is unknown whether this medicine passes into breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor or pharmacist before using this medicine. There are no data regarding the use of BEYONTRA in pregnant women.

Driving and using machines

The effect of BEYONTRA on your ability to drive and use machines is none or negligible.

Sodium

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

3. How to take BEYONTTRA

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is two film-coated tablets (712 mg) taken orally twice daily. The total daily dose is 1,424 mg of acoramidis.

BEYONTTRA tablets should be swallowed whole. They can be taken with water and with or without food.

If you take more BEYONTTRA than you should

Do not take more tablets than your doctor has prescribed. Contact your doctor if you think you have taken more tablets than prescribed.

If you forget to take BEYONTTRA

If you forget to take your tablets, take them at your next scheduled time. Do not take a double dose to make up for missed doses.

If you stop taking BEYONTTRA

Do not stop taking BEYONTTRA without first consulting your doctor. If you stop taking BEYONTTRA, your condition may worsen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Possible adverse effects are:

Very common (may affect more than 1 in 10 people)

• Diarrhoea
• Painful joint inflammation (gout)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BEYONTTRA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of BEYONTTRA

• The active substance is acoramidis (as hydrochloride). Each tablet contains acoramidis hydrochloride equivalent to 356 mg of acoramidis.
• The other components are: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), colloidal hydrated silica (E 551), magnesium stearate (E 470b), polyethylene glycol grafted polyvinyl alcohol copolymer (E 1209), talc (E 553b), titanium dioxide (E 171), glycerol monocaprylocaprate type I (E 471), polyvinyl alcohol (E 1203), iron oxide black (E 172), propylene glycol (E 1520), hypromellose 2910 (E 464).
• See section 2 for additional information about sodium.

Appearance of the product and contents of the pack

BEYONTTRA 356 mg film-coated tablets (tablets) are white, oval-shaped, film-coated tablets approximately 15 mm long × 7.5 mm wide, with "BEYONTTRA" printed in black ink on one side.

BEYONTTRA is available in PVC/PCTFE dual-cavity blisters sealed with an aluminum foil lid, packed in a container containing 120 tablets.

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.