Betaine, Anhydrous Oral solution

What is this medicine?

BETAINE (BEE ta een) is a nutrient. It is used to treat homocystinuria. This drug helps regulate homocysteine levels and can improve how you feel. It is not a cure.

This nutrient 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 betaine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

This nutrient is taken by mouth. Follow the directions on the prescription label. Shake the bottle of powder lightly before removing the cap. Using the scoop that comes with the bottle, measure the number of scoops prescribed for the dose. Then, mix the dose with 4-6 ounces (120-180 ml) of water, juice, milk, or formula until completely dissolved, or mix the dose with food. Take the dose immediately.

Contact your pediatrician regarding the use of this medicine in children. Special care may be needed. Betaine has been used in children, including in very young infants. Compared to adults, children or infants may require more frequent changes in dose to get the right effect.

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?

No drug interactions are known. Vitamins such as folate, pyridoxine (vitamin B-6), and cyanocobalamin (vitamin B-12) may be used with betaine.

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 or health care professional for regular checks on your progress. Blood tests will be drawn regularly to check the level of homocysteine.

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

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

• body odor

• diarrhea

• nausea

• upset stomach

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 15 to 30 degrees C (59 to 86 degrees F). Keep tightly closed. Protect from moisture. Throw away any unused medicine after the expiration date.