Package leaflet: Information for the patient

BEYONTTRA 356 mg film-coated tablets

acoramidis
This medicinal product is subject to additional monitoring. This will allow any new safety information to be rapidly identified. You can help by reporting any side effects you may experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What BEYONTTRA is and what it is used for
What you need to know before taking BEYONTTRA
How to take BEYONTTRA
Possible side effects
How to store BEYONTTRA
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)
due to transthyretin amyloidosis (ATTR-CM).
In people with transthyretin amyloidosis, a protein called transthyretin (TTR) does not function
properly and breaks down, forming fibrous deposits known as amyloid. When amyloid forms
in the heart, the heart muscle becomes stiff and the heart is no longer able to function normally.
BEYONTTRA stabilizes TTR, which may prevent its breakdown and the formation of amyloid.
This helps people whose hearts have been affected by transthyretin amyloid cardiomyopathy.

2. What you need to know before taking BEYONTTRA

Do not take BEYONTTRA
If you are allergic to acoramidis or to any of the other ingredients of this medicine (listed in
section 6).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking BEYONTTRA, especially if you have
liver problems or severe kidney problems.
At the start of treatment, changes in blood tests related to kidney function may occur, but these changes should not be harmful to your kidneys.

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

Other medicines and BEYONTTRA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
BEYONTTRA may alter blood tests related to thyroid function, but these changes should not be harmful to your thyroid.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine, as it is not known whether BEYONTTRA may harm the unborn child.
It is not known whether this medicine is excreted in human milk. If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine.
There are no data available on the use of BEYONTTRA in pregnant women.

Driving and using machines
BEYONTTRA has no effect or has a negligible effect on the ability to drive and use machines.

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

3. How to take BEYONTTRA

Take this medicine exactly as your doctor or pharmacist has told you. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is two film-coated tablets (712 mg) to be taken orally twice
daily. The total daily dose is 1,424 mg of acoramidis.
BEYONTTRA tablets must be swallowed whole. You may take them with water, with or without
food.
If you take more BEYONTTRA than you should
Do not take more tablets than prescribed by your doctor. Contact your doctor if you think you have
taken too much of this medicine.
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 a forgotten dose.
If you stop taking BEYONTTRA
Do not stop taking BEYONTTRA without first talking to your doctor. Your condition
may worsen if you stop treatment with BEYONTTRA.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are:
Very common (may affect more than 1 in 10 people)

diarrhoea
painful joint inflammation (gout)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BEYONTTRA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BEYONTTRA contains

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), hydrated colloidal silica (E 551), magnesium stearate (E 470b), polyvinyl alcohol graft copolymer with macrogol (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 information about sodium.

Description of the appearance of BEYONTTRA and pack contents
BEYONTTRA 356 mg film-coated tablets (tablets) are white, oval-shaped, film-coated tablets, approximately 15 mm × 7.5 mm, with the BridgeBio logo followed by “ACOR” printed in black ink on one side.
BEYONTTRA is available in PVC/PCTFE double-cavity blisters with aluminum foil lidding, in a pack containing 120 tablets.

Marketing Authorization Holder
Manufacturer
Bayer AG Rottendorf Pharma GmbH
51368 Leverkusen Ostenfelder Strasse 51-61
Germany Ennigerloh, 59320
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Bayer SA-NV UAB Bayer
Tél/Tel: +32-(0)2-535 63 11 Tel. +37 05 23 36 868

България Luxembourg/Luxemburg
Байер България ЕООД Bayer SA-NV
Tел.: +359 (0)2 4247280 Tél/Tel: +32-(0)2-535 63 11

Česká republika Magyarország
Bayer s.r.o. Bayer-Hungária Kft.
Tel: +420 266 101 111 Tel.: +36 1 487 4100

Danmark Malta
Bayer A/S Alfred Gera and Sons Ltd.
Tlf.: +45 45 23 50 00 Tel: +35 621 44 62 05

Deutschland Nederland
Bayer Vital GmbH Bayer B.V.
Tel: +49 (0)214-30 513 48 Tel: +31-23 – 799 1000

Eesti Norge
Bayer OÜ Bayer AS
Tel: +372 655 8565 Tlf: +47 23 13 05 00

Ελλάδα Österreich
Bayer Ελλάς ΑΒΕΕ Bayer Austria Ges.m.b.H.
Τηλ: +30-210-61 87 500 Tel: +43-(0)1-711 46-0

España Polska
Bayer Hispania S.L. Bayer Sp. z o.o.
Tel: +34-93-495 65 00 Tel.: +48 22 572 35 00

France Portugal
Bayer HealthCare Bayer Portugal, Lda.
Tél (N° vert): +33-(0)800 87 54 54 Tel: +351 21 416 42 00

Hrvatska România
Bayer d.o.o. SC Bayer SRL
Tel: +385-(0)1-6599 900 Tel: +40 21 529 59 00

Ireland Slovenija
Bayer Limited Bayer d. o. o.
Tel: +353 1 216 3300 Tel: +386 (0)1 58 14 400

Ísland Slovenská republika
Icepharma hf. Bayer spol. s r.o.
Sími: +354 540 8000 Tel. +421 2 59 21 31 11

Italia Suomi/Finland
Bayer S.p.A. Bayer Oy
Tel: +39 02 397 8 1 Puh/Tel: +358- 20 785 21

Κύπρος Sverige
NOVAGEM Limited Bayer AB
Tηλ: +357 22 48 38 58 Tel: +46 (0) 8 580 223 00

Latvija
SIA Bayer
Tel: +371 67 84 55 63

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

BeYondtra