Valganciclovir Hydrochloride Oral solution

What is this medicine?

VALGANCICLOVIR (val gan SYE kloh veer) is an antiviral medicine. It is used to treat or prevent infections caused by certain kinds of viruses. It is commonly used to treat and prevent cytomegalovirus (CMV) infections of the eye and body.

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:

• kidney disease

• low blood counts, like low white cell, platelet, or red cell counts

• an unusual or allergic reaction to ganciclovir, valganciclovir, 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 directions on the prescription label. Use a specially marked spoon or container to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Do not touch the solution with bare hands. Wash skin with soap and water if the solution touches your skin.

Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 month for selected conditions, precautions do apply.

Overdosage: If you think you've 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?

• adriamycin

• amphotericin B

• certain medicines for HIV like didanosine, zidovudine

• dapsone

• flucytosine

• imipenem; cilastatin

• pentamidine

• probenecid

• sulfamethoxazole; trimethoprim

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?

Drink 6 to 8 glasses of water or fluids daily while taking this medicine to help prevent side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. If you are a female who can become pregnant, you should use effective birth control during treatment with and for at least 30 days after treatment. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Men should not father a child while taking this medicine. Men should use a condom during sexual contact with a female partner who might become pregnant during, and for at least 90 days after, treatment. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

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

• breathing problems

• changes in vision

• dizziness, lightheaded

• fever or chills, sore throat

• hallucination, loss of contact with reality

• pain, tingling, numbness in the hands or feet

• seizures

• suicidal thoughts or other mood changes

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

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

• constipation

• cough or runny nose

• diarrhea

• loss of appetite

• nausea

• stomach pain

• trouble sleeping

• vomiting

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 this medicine is mixed by your pharmacist, store it in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Throw away any unused medicine after 49 days.

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.

Valganciclovir Hydrochloride Oral tablet

What is this medicine?

VALGANCICLOVIR (val gan SYE kloh veer) is an antiviral medicine. It is used to treat or prevent infections caused by certain kinds of viruses. It is commonly used to treat and prevent cytomegalovirus (CMV) infections of the eye and body.

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:

• kidney disease

• low blood counts, like low white cell, platelet, or red cell counts

• an unusual or allergic reaction to ganciclovir, valganciclovir, 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 full glass of water. Follow the directions on the prescription label. Take with food. Do not chew or crush. Do not touch broken tablets with bare hands. Wash skin with soap and water if broken tablets touch your skin. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 month 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?

• adriamycin

• amphotericin B

• certain medicines for HIV like didanosine, zidovudine

• dapsone

• flucytosine

• imipenem; cilastatin

• pentamidine

• probenecid

• sulfamethoxazole; trimethoprim

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 check ups. Discuss any new symptoms with your doctor. You will need to have important blood work done while on this medicine. If you have a CMV eye infection have your eyes checked every 4 to 6 weeks.

Drink 6 to 8 glasses of water or fluids daily while taking this medicine to help prevent side effects.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. If you are a female who can become pregnant, you should use effective birth control during treatment with and for at least 30 days after treatment. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

Men should not father a child while taking this medicine. Men should use a condom during sexual contact with a female partner who might become pregnant during, and for at least 90 days after, treatment. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

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

• breathing problems

• changes in vision

• dizziness, lightheaded

• fever or chills, sore throat

• hallucination, loss of contact with reality

• pain, tingling, numbness in the hands or feet

• seizures

• suicidal thoughts or other mood changes

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

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

• constipation

• cough or runny nose

• diarrhea

• loss of appetite

• nausea

• stomach pain

• trouble sleeping

• vomiting

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). Throw away any unused medicine after the expiration date.