Rilutek (Riluzole)

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use RILUTEK if you are allergic to it.

To make sure RILUTEK is safe for you, tell your doctor if you have:

• liver disease.

RILUTEK can cause liver problems, especially in women, older adults, and people with a history of liver disease, or people using certain other medications harmful to the liver, such as: antibiotics or antifungal medication; antiviral or HIV/AIDS medicine; birth control pills or hormone replacement therapy; pain or arthritis medications; seizure medicine such as carbamazepine or phenytoin; or "statin" cholesterol-lowering medication.

FDA pregnancy category C. It is not known whether RILUTEK will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether RILUTEK passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using RILUTEK and call your doctor at once if you have:

• sudden chest pain or discomfort, wheezing, dry cough or hack, feeling short of breath;
• cough with mucus, stabbing chest pain;
• low white blood cells--fever, swollen gums, painful mouth sores, pain when swallowing, cold or flu symptoms; or
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• dizziness, spinning sensation;
• weakness, drowsiness;
• stomach pain, nausea, vomiting, loss of appetite;
• diarrhea; or
• numbness or tingling around your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Avoid drinking alcohol. It may increase your risk of liver damage while taking RILUTEK.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid coffee, tea, cola, or other products that contain caffeine. Caffeine may cause too much RILUTEK to build up in your body.

Avoid smoking. Smoking cigarettes may make RILUTEK less effective.

RILUTEK can harm your liver. This effect is increased when you also use certain other medicines. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with RILUTEK.

Other drugs may interact with RILUTEK, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

RILUTEK is usually taken once every 12 hours. Take the medicine at the same times each day.

Take RILUTEK on an empty stomach, at least 1 hour before or 2 hours after a meal.

Before and during your treatment with RILUTEK, you may need frequent blood tests to check your liver function.

Store at room temperature away from moisture, heat, and light.

Seek emergency medical attention or call the Poison Help line.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.