Sapropterin Dihydrochloride Oral tablet

What is this medicine?

SAPROPTERIN (SAP roe TER in) works to lower phenylalanine levels in the blood. It is used with a special diet to treat phenylketonuria. This medicine is not a cure.

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:

• eating disorder like anorexia, bulimia
• fever
• infection
• kidney disease
• liver disease
• seizures
• an unusual or allergic reaction to sapropterin, 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 food. Follow the directions on the prescription label. Dissolve tablets in 4 to 8 ounces (1/2 to 1 cup) of water or apple juice. Drink within 15 minutes of mixing. To make tablets dissolve faster, you may crush or stir them. Tablets may not dissolve completely, and you may see small pieces floating in the glass. If small pieces remain in the glass after taking the medicine, add more water or apple juice to the glass and drink it to make sure you get all of the medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years of age 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?

• levodopa
• medicines for erectile dysfunction
• methotrexate

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?

Your condition will be monitored carefully while you are receiving this medicine. Visit your doctor for regular check ups and for blood tests. It may take up to 4 weeks for your body to respond to this medicine.

Tell your doctor or health care professional if your symptoms do not start to get better or if they get worse.

You will need to be on a special diet while you are taking this medicine. Talk with your health care professional before making any changes to your diet.

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
• fever, chills or sore throat
• seizures

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

• abdominal pain
• diarrhea
• dizziness
• headache
• nausea, vomiting
• runny or congested nose

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.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store this medicine in the original container. Keep the container tightly closed. 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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.