Nitisinone Oral Tablet (NITISINONE - ORAL)

Instructions

If medicine is mixed with food, use it immediately after mixing. Throw away any leftover food. Do not save for later use.

If unable to swallow the tablet, crush and mix with small amount of water or applesauce. Mix well and eat immediately.

This medicine may be taken with or without food.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Tell your doctor if symptoms do not get better or if they get worse.

Check product labels carefully and avoid foods, beverages and supplements that contain aspartame, phenylalanine or tyrosine.

The foods you eat can change how well this medicine works. Tell your doctor about the types of food you normally eat. Ask your doctor for a list of foods that can affect this medicine. Do not significantly change the foods you normally eat while on this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than twice during 24 hours.

Cautions

You should have an eye exam before starting this medicine.

Do not switch between tablet and capsule forms of this medicine unless instructed by your doctor. They do not work the same.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Taking this medicine in high doses or for a long time can damage the eyes and cause blindness. Stop taking this medicine and call your doctor immediately if you notice any changes in vision. These changes may be blurred vision, light streaks or flashes, or swelling or color changes in the eye.

Do not use the medication any more than instructed.

Call the doctor if there are any signs of confusion or unusual changes in behavior.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• diarrhea
• headaches
• stomach upset or abdominal pain

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• bleeding or bruising
• delays in development such as holding head up, rolling over and crawling
• eye pain, redness, or itching
• fever or chills
• sores or blisters on hands or feet
• signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
• dry skin
• sore throat
• sudden change or loss of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.