InfoCons Consumer Protection informs you – Evrysdi – Package Leaflet

Before anything else

Read all of this leaflet carefully before 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 or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.  If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.  The information in this leaflet is for you, your caregiver or your child – but in the leaflet we just say ‘you’.

ℹ️ 1. What Evrysdi is and what it is used for

Evrysdi contains the active substance risdiplam. It is part of a group of medicines known as ‘ pre- mRNA splicing modifiers’ .

Evrysdi is used to treat spinal muscular atrophy (SMA) in adults and children.  SMA is an illness that runs in families – a genetic illness.  It is caused by a shortage of a protein called ‘survival motor neuron’ (SMN) in the body.

If you do not have enough SMN protein, you lose motor neurons. Motor neurons are nerve cells that control muscles.  This leads to muscle weakness and wasting.  This can make everyday movements difficult, such as head and neck control, sitting, crawling and walking.  The muscles used for breathing and swallowing may also become weaker.

How Evrysdi works

Evrysdi works by helping the body produce more SMN protein.  This means you lose fewer motor neurons – this may improve how well muscles work in people with SMA.

In infants with SMA Type 1, Evrysdi may:  increase how long they live  reduce the need for a ventilator to help with breathing  help them be able to keep being fed by mouth.

75In children (toddlers to adolescents) and adults with SMA Type 2 and 3, Evrysdi may:  stop muscle control getting worse  improve muscle control.

⚠️ 2. What you need to know before you take Evrysdi

Do not take Evrysdi

 if you are allergic to risdiplam or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor, pharmacist, or nurse before you take Evrysdi.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you take Evrysdi.

Treatment with Evrysdi may harm your unborn baby or may affect male fertility. See “ Pregnancy”, “Contraception”, and “Male fertility ” for more information.

Other medicines and Evrysdi

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken or might take any other medicines in the future.

In particular tell your doctor, pharmacist, or nurse if you are taking or have ever taken any of the following medicines:  metformin – a medicine used to treat type 2 diabetes  medicines for the treatment of SMA

Pregnancy

Before you start treatment with this medicine, your doctor should do a pregnancy test. This is because Evrysdi may harm your unborn baby.  Do not take this medicine if you are pregnant.  Do not become pregnant:

• during your treatment with Evrysdi and
• for one month after you stop taking Evrysdi.

If you do become pregnant during your treatment, tell your doctor straight away. You and your doctor will decide what is best for you and your unborn baby.

Contraception For women You must use a highly effective method of birth control:  while taking this medicine and  for one month after you stop taking this medicine.

Talk to your doctor about highly effective methods of birth control that you and your partner can use.

For men If your partner is a woman who can have children, she must not become pregnant.

Use condoms:  while taking this medicine and 76 for 4 months after you stop taking this medicine.

Talk to your doctor about highly effective methods of birth control that you and your partner can use.

Breast-feeding

Do not breast-feed while taking this medicine. This medicine may pass into breast milk and may harm your baby.

Talk to your doctor about whether you should stop breast-feeding or if you should stop taking Evrysdi.

Male fertility Evrysdi may reduce male fertility during treatment and for up to 4 months after your last dose.  If you are planning to have a child, ask your doctor for advice.  Do not donate sperm during your treatment and for 4 months after your last dose of this medicine.

Driving and using machines

This medicine is unlikely to affect your ability to drive and use machines.

Evrysdi contains sodium

Evrysdi contains a small amount of sodium (salt) – there is less than 1 mmol (23 mg) sodium. This means it is essentially ‘sodium-free’ and can be used by people on a sodium-restricted diet.

💊 3. How to take Evrysdi

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You will get blister packs of Evrysdi as film-coated tablets, referred to as a ‘tablet’ in this leaflet. This medicne is also available as an oral solution. Your doctor will help you choose the right one for you.

How much Evrysdi to take If you get Evrysdi film-coated tablets, the dose is 5 mg (one tablet) once daily.

You must take your daily dose as instructed by your doctor.  Do not change the dose without speaking with your doctor.

When and how to take Evrysdi Read the ‘ Instructions for Use’ at the end of this leaflet. Follow the instructions carefully. It shows you exactly how to make and take Evrysdi as a mixture.  Take Evrysdi:  once a day, at around the same time – this will help you remember when to take your medicine  with or without food.

There are two ways your doctor may tell you to take Evrysdi film-coated tablets:  Take Evrysdi by mouth. Swallow each tablet whole with some water.

• Do not cut, crush or chew the tablets.

Or 77 Take Evrysdi by mouth after dispersing it in a small amount of room temperature water.

• Do not mix Evrysdi with any liquids other than water.
• Take Evrysdi tablet straight away after mixing with water. If you do not take it within 10 minutes of adding water, throw the mixture away and make a new dose.
• Do not expose the tablet mixture prepared from the Evrysdi tablet to sunlight.
• Do not get Evrysdi tablet mixture on your skin or in your eyes. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water.
• Do not administer the tablet mixture via a feeding tube How long to take Evrysdi for Your doctor will tell you how long you need to take Evrysdi for. Do not stop treatment with Evrysdi unless your doctor tells you to.

If you take more Evrysdi than you should

If you take more Evrysdi than you should, talk to a doctor or go to hospital straight away.  Take the medicine pack and this leaflet with you.

If you forget to take Evrysdi or vomit after a dose

If you forget to take a dose

 If it is less than 6 hours after you normally take Evrysdi – take the missed dose as soon as you remember.  If it is over 6 hours from when you normally take Evrysdi – skip the missed dose and then take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you are sick (vomit) after taking Evrysdi:  Do not take an extra dose. Instead, take the next dose at the usual time the next day.

If you spill Evrysdi If you spill Evrysdi tablet mixture, dry the area with a dry paper towel and then clean the area with soap and water. Throw away the paper towel in the rubbish and wash your hands well with soap and water.

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common: may affect more than 1 in 10 people

 diarrhoea  rash  headache  fever

Common: may affect up to 1 in 10 people

 feeling sick (nausea)  mouth sores  bladder infection  joint pain 78Not known: it is not known how often these happen  inflamed small blood vessels mainly in the skin (cutaneous vasculitis)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Evrysdi

 Keep this medicine out of the sight and reach of children.  This medicinal product does not require any special temperature storage conditions.  Store in the original package in order to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.

The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

📦 6. Contents of the pack and other information

What Evrysdi contains

 The active substance in the film-coated tablet is risdiplam.  Each film-coated tablet contains 5 mg risdiplam.  The other ingredients are tartaric acid (E 334), mannitol (E 421), microcrystalline cellulose, silica, colloidal anhydrous (E 551), crospovidone, strawberry flavour [natural flavouring substance(s), flavouring preparation(s), maize maltodextrin, modified waxy maize starch (E1450)] and sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b) and yellow iron oxide (E 172).

What Evrysdi looks like and contents of the pack

 Evrysdi tablets are pale yellow film-coated tablets, round and curved, with EVR debossed on one side.  Evrysdi is supplied in packs containing 28 x 1 film-coated tablets. There are 4 aluminium perforated unit-dose blisters with 7 tablets each. -The blisters strips are each marked with abbreviated names of the day as a reminder to take a daily dose:

Mon. Tue. Wed. Thu. Fri. Sat. Sun 79Marketing Authorisation Holder Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

Manufacturer

Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien, Luxembourg/Luxemburg N.V. Roche S.A.

België/Belgique/Belgien Tél/Tel: +32 (0) 2 525 82 11Latvija Roche Latvija SIA Tel: +371 – 6 7039831 България Рош България ЕООД Тел: +359 2 474 5444Lietuva UAB “Roche Lietuva” Tel: +370 5 2546799 Česká republika Roche s. r. o.

Tel: +420 -2 20382111Magyarország Roche (Magyarország) Kft.

Tel: +36 1 279 4500 Danmark Roche Pharmaceuticals A/S Tlf: +45 -36 39 99 99Nederland Roche Nederland B.V.

Tel: +31 (0) 348 438050 Deutschland Roche Pharma AG Tel: +49 (0) 7624 140Norge Roche Norge AS Tlf: +47 -22 78 90 00 Eesti Roche Eesti OÜ Tel: + 372 -6 177 380Österreich Roche Austria GmbH Tel: +43 (0) 1 27739 Ελλάδα , Κύπρος Roche (Hellas) A.E.

Ελλάδα Τηλ: +30 210 61 66 100Polska Roche Polska Sp.z o.o.

Tel: +48 – 22 345 18 88 España Roche Farma S.A.

Tel: +34 -91 324 81 00Portugal Roche Farmacêutica Química, Lda Tel: +351 -21 425 70 00 France Roche Tél: +33 (0) 1 47 61 40 00România Roche România S.R.L.

Tel: +40 21 206 47 01 80Hrvatska Roche d.o.o.

Tel: +385 1 4722 333Slovenija Roche farmacevtska družba d.o.o.

Tel: +386 -1 360 26 00 Ireland, Malta Roche Products (Ireland) Ltd.

Ireland/L-Irlanda Tel: +353 (0) 1 469 0700Slovenská republika Roche Slovensko, s.r.o.

Tel: +421 – 2 52638201 Ísland Roche Pharmaceuticals A/S c/o Icepharma hf Sími: +354 540 8000Suomi/Finland Roche Oy Puh/Tel: +358 (0) 10 554 500 Italia Roche S.p.A.

Tel: +39 -039 2471Sverige Roche AB Tel: +46 (0) 8 726 1200

This leaflet was last revised in

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

81Instructions for Use – Administration Evrysdi film coated tablets This Instructions for Use contains information on how to prepare and take Evrysdi.  The information in this Instructions for Use is for taking or giving this medicine – but here we just say ‘take’.

Before you start Read this Instructions for Use before taking Evrysdi film-coated tablets for the first time and each time you get a refill. There may be new information.

Evrysdi film-coated tablets can be swallowed whole or mixed with a small amount of room temperature water and taken by mouth.

Do not give Evrysdi film-coated tablets with a feeding tube.

Important Information  Your doctor, pharmacist, or nurse will show you how to prepare and take Evrysdi tablets.

Always take Evrysdi tablets exactly as your healthcare provider tells you.  Do not take or give this medicine until you have been shown how to properly prepare and take Evrysdi.  Wash your hands before and after preparing or taking Evrysdi.  Check the expiry date and check the product for damage before use. Do not use if expired or damaged.  Do not get the Evrysdi tablet mixture on your skin or in your eyes. If the Evrysdi tablet mixture gets on your skin, wash the area with soap and water. If the tablet mixture gets in your eyes, rinse your eyes with water.  Keep the Evrysdi tablet mixture out of sunlight.  If you spill the Evrysdi tablet mixture, dry the area with a dry paper towel and then clean with soap and water. Throw away the paper towel in the rubbish and wash your hands with soap and water.

How to take Evrysdi tablets  If you are taking Evrysdi tablets, the daily dose is 1 tablet.  Take the tablet whole with water or as a liquid by mixing 1 tablet in at least 1 teaspoon (5 ml) of room temperature water.  Do not chew, cut, or crush the tablet.  Do not mix Evrysdi with any liquids other than water.  Do not take Evrysdi tablet mixture if it has been more than 10 minutes since adding water to the tablet. Throw the mixture away according to your local requirements and make a new dose.  Do not take an extra dose if you are sick (vomit) at any time after taking Evrysdi.

82Get ready to take an Evrysdi tablet Step 1. Wash your hands. ( Figure A ).

Figure A Step 2. Take out 1 Evrysdi tablet from the blister (Figure B ).

Figure B Option A:Swallow the Evrysdi tablet whole Step A1 Swallow the tablet whole with some water.

Do not chew, cut, or crush the tablet Do not swallow with any liquids other than water.

Step A2 Wash your hands with soap and water.

83Option B:Take Evrysdi tablet mixed in water What is needed to mix Evrysdi with water : ●1 Evrysdi tablet ●a small, clean empty cup ●at least 1 teaspoon (5ml) of room temperature water for mixing ●at least 1 tablespoon (15ml) of water for rinsing Step B1 Put at least 1 teaspoon (5ml) of water in a cup – and add 1 tablet. ●Do not use any liquids other than water, ●Keep the mixture out of sunlight.

Figure CStep B2 Gently swirl the cup until it is fully mixed – this can take up to 3 minutes ( Figure C ).

Step B3 Drink immediately within 10 minutes of adding water to the tablet ( Figure D ).

Figure D Step B4 Refill the cup with at least 1 tablespoon (15ml) of water and swirl to get any medicine left in the cup (Figure E ).

Figure E Step B5 Drink immediately (Figure F ).

Figure F Step B6 Wash your hands with soap and water.

Storing EVRYSDI This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture. Keep Evrysdi and all medicines out of the sight and reach of children.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Evrysdi (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1531).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.