Evrysdi 5 mg film-coated tablets

• 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’.

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

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.

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

• stop muscle control getting worse
• improve muscle control.

• 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.

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.

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

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.

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
• 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.

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.

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.

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

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.

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.

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

• 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.

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, talk to a doctor or go to hospital straight away.

• Take the medicine pack and this leaflet with you.

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 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 or your child 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• 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 flavor and sodium stearyl fumarate, polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350 (E 1521), talc (E 553b) and yellow iron oxide (E 172).

• 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

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.

• 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.

• 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.

Step 1. Wash your hands. (Figure A).

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

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.

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.

Step 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).

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).

Step B5

Drink immediately (Figure F).

Step B6

Wash your hands with soap and water.

• 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.