Nitisinone Oral capsule

What is this medicine?

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

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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.

Nitisinone Oral suspension

What is this medicine?

NITISINONE (nit IS i none) slows the breakdown of tyrosine. It is used to treat a rare disease called hereditary tyrosinemia type I.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

How should I use this medicine?

Take this medicine by mouth. Follow the direction on the prescription label. Shake well before using. Use the special measuring syringe that comes with this medicine to measure each dose. Household spoons are not accurate. Take your medicine at regular intervals. Do not take it 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 newborns for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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.

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 these to your doctor or health care professional if they continue or are bothersome.):

• diarrhea

• dry skin

• hair loss

• headache

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

After the adapter has been inserted into the bottle, store at room temperature, 25 degrees C (77 degrees F) or below. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.