EVRYSDI 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Evrysdi 5 mg film-coated tablets

risdiplam

This medicine is subject to additional monitoring, which will allow for quicker identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you 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 the leaflet only refers to “you”.

Contents of the pack

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

1. What is Evrysdi and what is it used for

Evrysdi contains the active substance risdiplam, which belongs to a group of medicines known as “messenger ribonucleic acid precursor processing modifiers”.

Evrysdi is used to treat spinal muscular atrophy (SMA) in adults and children.

• SMA is a hereditary disease: a genetic disease.
• It is caused by a lack of a protein called "survival motor neuron" (SMN) in the body.

The lack of sufficient SMN protein causes the loss of motor neurons.

Motor neurons are nerve cells that control muscles.

• This causes muscle weakness and loss of muscle mass.
• This can make it more difficult to perform everyday movements, such as controlling the head and neck, sitting, crawling, and walking.
• The muscles used for breathing and swallowing can also become weak.

How Evrysdi works

Evrysdi works by helping the body produce more SMN protein.

• This means that fewer motor neurons are lost, which can improve muscle function in people with SMA.

In babies with SMA Type 1, Evrysdi can:

• increase life expectancy,
• reduce the need for a ventilator to help them breathe,
• help them to continue being fed by mouth.

In children (from toddlers to adolescents) and adults with SMA Type 2 and 3, Evrysdi can:

• prevent muscle control from 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 unsure, consult your doctor, pharmacist, or nurse before taking Evrysdi.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Evrysdi.

Treatment with Evrysdi may harm the unborn baby or 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 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 starting treatment with this medicine, your doctor may perform a pregnancy test. This is because Evrysdi may harm the unborn baby.

• Do not take this medicine if you are pregnant.
• Do not become pregnant:

• during treatment with Evrysdi and
• for 1 month after stopping Evrysdi.

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

Contraception

For women

You must use a highly effective contraceptive method:

• while taking this medicine and
• for 1 month after stopping this medicine.

Talk to your doctor about highly effective contraceptive methods that you and your partner can use.

For men

If your partner is a woman of childbearing age, she must not become pregnant.

You must use a condom:

• while taking this medicine and
• for 4 months after stopping this medicine.

Talk to your doctor about highly effective contraceptive methods 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 harm the baby.

Consult your doctor if you must either stop breast-feeding or stop Evrysdi.

Male fertility

Evrysdi may reduce male fertility during treatment and for 4 months after the last dose.

• If you are planning to have a child, consult your doctor for advice.
• Do not donate sperm during treatment or for 4 months after the last dose of this medicine.

Driving and using machines

It is unlikely that this medicine will affect your ability to drive or use machines.

Evrysdi contains sodium

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

3. How to take Evrysdi

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

You will receive Evrysdi in blister packs as film-coated tablets, referred to as “tablets” in this leaflet. This medicine is also available as an oral solution. Your doctor will help you choose the right option for you.

How much Evrysdi to take

If you receive Evrysdi film-coated tablets, the dose is 5 mg (one tablet) once a day.

You must take the daily dose as indicated by your doctor.

• do not change the dose without talking to your doctor.

When and how to take Evrysdi

Read the “Instructions for use” at the end of this leaflet. Follow the instructions carefully. They explain exactly how to prepare and take Evrysdi as a mixture.

Take Evrysdi:

• once a day, approximately at the same time. This will help you remember when to take the medicine.
• with or without food.

Your doctor may tell you to take Evrysdi film-coated tablets in one of two ways:

• Take Evrysdi by mouth. Swallow each tablet whole with a little water.

• Do not break, crush, or chew the tablets.

Or

• Take Evrysdi by mouth after dispersing it in a little water at room temperature.

• Do not mix Evrysdi with any liquid except water.
• Take the Evrysdi tablet immediately after it has been mixed with water. If you do not take it within 10 minutes of adding water, discard the mixture and prepare a new dose.
• Do not expose the prepared tablet mixture to sunlight.
• Avoid contact of the Evrysdi tablet mixture with skin and eyes. If Evrysdi comes into contact with your skin, wash the area with water and soap. If Evrysdi comes into contact with your eyes, rinse them with water.
• Do not administer the prepared mixture using a feeding tube.

How long to take Evrysdi

Your doctor will tell you how long to take Evrysdi. 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, consult a doctor or go to the hospital immediately.

• Take the medicine pack and this leaflet with you.

If you forget to take Evrysdi, or vomit after administration of the dose

If you forget to take a dose:

• If it is less than 6 hours since you normally take Evrysdi, take the missed dose as soon as you remember.
• If it is more than 6 hours since you normally take Evrysdi, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you vomit after taking Evrysdi:

• Do not take an additional dose. Instead, take the next dose at the usual time the following day.

If you spill Evrysdi

If you spill the Evrysdi tablet mixture, wipe the area with a dry paper towel and clean it with soap and water. Dispose of the paper towel in the trash 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

• diarrhea
• rash
• headache
• fever

Common:may affect up to 1 in 10 people

• feeling sick (nausea)

• mouth ulcers
• bladder infection
• joint pain

Frequency not known:frequency cannot be estimated from the available data

• small blood vessels inflamed, mainly in the skin (cutaneous vasculitis).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is 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. Storage of Evrysdi

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage temperature.
• Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Evrysdi Composition

• The active ingredient of the film-coated tablet is risdiplam.
• Each film-coated tablet contains 5 mg of risdiplam.
• The other ingredients are tartaric acid (E 334), mannitol (E 421), microcrystalline cellulose, colloidal anhydrous silica (E 551), crospovidone, strawberry flavor, and sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b), and yellow iron oxide (E 172).

Appearance of Evrysdi and Container Contents

• Evrysdi tablets are pale yellow, round, and curved film-coated tablets with EVR engraved on one side.
• Evrysdi is available in packs containing 28 x 1 film-coated tablets. Each pack contains 4 single-dose aluminum blisters with 7 tablets in each.

• Each blister strip is marked with the days of the week in abbreviated form as a reminder for daily dosing:

Mon. Tue. Wed. Thu. Fri. Sat. Sun.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer

Roche Pharma AG

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

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

Date of Last Revision of this Leaflet:

Other Sources of Information

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

INSTRUCTIONS FOR USE - ADMINISTRATION

Evrysdi Film-Coated Tablets

These Instructions for Use contain information on how to prepare and take Evrysdi.

The information contained in these Instructions for Use is for the administration of this medicinal product, but in this document, we only refer to "taking".

Read these Instructions for Usebefore taking Evrysdi film-coated tablets for the first time and each time you are dispensed them again. They may contain new information.

Evrysdi film-coated tablets can be swallowed whole or mixed with a little water and taken orally.

Do not administer Evrysdi film-coated tablets through a feeding tube.

• Your doctor, pharmacist, or nurse will teach you how to prepare and take Evrysdi tablets. Always take Evrysdi exactly as your healthcare professional has instructed you to do.
• Do not take or administer this medicinal product until you have been taught how to prepare and take Evrysdi properly.
• Wash your hands before and after preparing or taking Evrysdi.
• Check the expiration date and that the medicinal product is not damaged before using it. Do not use it if it has expired or is damaged.
• Avoid contact of the Evrysdi tablet mixture with the skin and eyes. If the Evrysdi tablet mixture comes into contact with your skin, wash the area with water and soap. If the mixture comes into contact with your eyes, rinse them with water.
• Protect the Evrysdi tablet mixture from sunlight.
• If you spill the Evrysdi tablet mixture, dry the area with a dry paper towel and clean it with soap and water. Throw the paper towel in the trash and wash your hands well with water and soap.

• If you take Evrysdi in tablet form, the daily dose is 1 tablet.
• Take the tablet whole with water or in liquid form, for which you must mix 1 tablet with at least 1 teaspoon (5 ml) of room-temperature water.
• Do notchew, break, or crush the tablet.
• Do notmix Evrysdi with any liquid except water.
• Do nottake the Evrysdi tablet mixture if more than 10 minutes have passed since you added water to the tablet. Discard the mixture according to local requirements and prepare a new dose.
• Do nottake an additional dose if you vomit at any time after taking Evrysdi.

What is Needed to Mix Evrysdi with Water:

• 1 Evrysdi tablet
• a small empty and clean glass
• at least 1 teaspoon (5 ml) of room-temperature water for mixing
• at least 1 tablespoon (15 ml) of water for rinsing