Nitisinone capsules

What is this medicine?

NITISINONE slows the breakdown of tyrosine. It is used to treat a rare disease called hereditary tyrosinemia type I.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine at least 1 hour before meals. Do not take with food. The capsules may be opened and the medicine mixed in a small amount of water, formula, or apple sauce immediately before use. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as newborn for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• dark urine

• eye pain, redness, sensitivity to light

• general ill feeling or flu-like symptoms

• loss of appetite, nausea

• light-colored stools

• painful growths on hands, soles of feet

• right upper belly pain

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of eyes, skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea

• dry skin

• hair loss

What may interact with this medicine?

Interactions are not expected.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an unusual or allergic reaction to nitisinone, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor for regular check ups. You will need to have important blood work done while you are taking this medicine.

You will need to be on a special diet while taking this medicine. Talk to your health care provider about the foods you eat and the vitamins you take. Follow your diet carefully to limit your intake of tyrosine and phenylalanine.