This medication is used to treat a certain muscle disorder (spinal muscular atrophy - SMA).

Read the Patient Information Leaflet if available from your pharmacist before you start taking risdiplam and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the tablet whole with some water. Do not chew, cut, or crush the tablet. The dosage is based on your age and body weight.

If you have trouble swallowing the tablet whole, you may place the tablet in a small cup and mix it in one teaspoonful (5 milliliters) of non-chlorinated water (such as filtered water). Do not use any other liquids. Protect the mixture from sunlight. Swirl the cup gently for about 3 minutes until the tablet and water are mixed (some particles may remain) and take the mixture right away. Rinse the cup with at least an additional one tablespoon (15 milliliters) of filtered water, then swirl and drink the remaining mixture to make sure you get the full dose. Once mixed, the mixture must be taken right away. If the dose is not taken within 10 minutes, throw away the mixture and prepare a new dose. Do not give the mixture through a feeding tube.

Wash your hands before and after handling this medication.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

If you vomit after taking a dose or did not take the full dose, do not take another dose at that time. Take your next dose at the regular time.

Tell your doctor if your condition does not get better or if it gets worse.

Diarrhea, constipation, mouth sores, or joint pain may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of infection (such as sore throat that doesn't go away, fever, chills)

Risdiplam can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking risdiplam, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using risdiplam. Risdiplam may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about the use of reliable forms of birth control during treatment and for some time after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include dabigatran, dofetilide, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you miss a dose, take it as soon as you remember. If it is more than 6 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature away from light and moisture. Tightly close the bottle when not in use. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.