Riluzole

WHY is this medicine prescribed?

Riluzole is used to treat amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease). Riluzole is in a class of medications called benzothiazoles. It works by changing the activity of certain natural substances in the body that affect nerves and muscles.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Riluzole comes as a tablet and a suspension (liquid) to take by mouth. It also comes as an oral film to be dissolved on the tongue. It usually is taken on an empty stomach (1 hour before or 2 hours after meals) twice a day, every 12 hours. You should take it at the same times each day (usually in the morning and in the evening). Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take riluzole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Shake the suspension well (at least 30 seconds) before each use to mix the medication evenly. Be sure to turn the bottle up and down until you do not see clear liquid at the top or any particles at the bottom of the bottle. Read the instructions for use before you start taking riluzole suspension. Be sure that you understand these directions, and ask your pharmacist if you have any questions.

To use the oral film follow these steps:

1. Wash your hands and make sure your hands are completely dry before handling the film.
2. Remove riluzole oral film from the foil patch and place on the top of the tongue.
3. Close mouth and swallow saliva normally while allowing riluzole oral film to dissolve. Do not take any liquids or chew, spit, or talk while riluzole dissolves.
4. Wash your hands after you have finished handling riluzole oral film.

Riluzole may slow progression of ALS but does not cure it. Continue to take riluzole even if you feel well. Do not stop taking riluzole without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking riluzole,

• tell your doctor and pharmacist if you are allergic to riluzole, any other medications, or any of the ingredients in riluzole tablets, suspension or oral film. Ask your pharmacist for a list of the ingredients..

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking riluzole. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with riluzole: acetaminophen. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking riluzole. Do not start any of these medications while taking riluzole without discussing you're your healthcare provider.

• tell your doctor if you are of Japanese descent and if you have or have ever had kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking riluzole, call your doctor.

• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.

What SPECIAL DIETARY instructions should I follow?

Avoid eating charcoal-broiled foods.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Riluzole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• weakness
• dizziness
• dry mouth
• mouth numbness
• difficulty falling asleep or staying asleep
• drowsiness
• swelling of the hands, feet, ankles, or lower legs
• fast heart rate

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• dry cough
• nausea
• stomach pain
• vomiting
• extreme tiredness
• unusual bleeding or bruising
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• dark urine
• fever, chills, cough, or other signs of infection
• muscle or joint pain
• headache

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature, away from light and excess heat and moisture (not in the bathroom). Do not freeze the suspension. Be sure to store the suspension bottle upright. Be sure to use the suspension within 15 days of opening the bottle and discard any remaining medication after 15 days.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• memory loss
• bluish coloring of the skin, headache, tiredness, shortness of breath, lack of energy
• hard to concentrate, involuntary movements, seizures
• coma

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to riluzole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.