Important Safety Information About VALTREX

VALTREX is for adults with healthy immune systems and is available by prescription only. There is no cure for herpes, and even with treatment, it may be possible to spread herpes. VALTREX may not prevent all recurrences.

If you are taking VALTREX to reduce the risk of spreading genital herpes, always use safer sex practices. This includes always using a condom made of latex and avoiding sexual contact when you have an outbreak or think you are about to get an outbreak. It is not known if VALTREX reduces the risk of spreading genital herpes in same-sex couples.

While taking VALTREX for cold sores, you should not exceed one day of treatment, two doses taken 12 hours apart.

Tell your doctor if you have kidney problems because the dosage may need to be changed.

To avoid a potentially serious complication, tell your doctor if your immune system is not normal because of advanced HIV disease, bone marrow or kidney transplant. Common side effects include headache, nausea, vomiting, stomach pain, dizziness, cold, and sore throat.

Who should not take VALTREX?

Do not take VALTREX if you are allergic to any of its ingredients or to acyclovir. The active ingredient is valacyclovir. See the end of this leaflet for a complete list of ingredients in VALTREX.

Before taking VALTREX, tell your healthcare provider:

About all your medical conditions,

if you have had a bone marrow transplant or kidney transplant, or if you have advanced HIV disease or "AIDS". Patients with these conditions may have a higher chance for getting a blood disorder called thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS). TTP/HUS can result in death.
if you have kidney problems. Patients with kidney problems may have a higher chance for getting side effects or more kidney problems with VALTREX. Your healthcare provider may give you a lower dose of VALTREX.
if you are 65 years of age or older. Elderly patients have a higher chance of certain side effects. Also, elderly patients are more likely to have kidney problems. Your healthcare provider may give you a lower dose of VALTREX.
if you are pregnant or planning to become pregnant. Talk with your healthcare provider about the risks and benefits of taking prescription drugs (including VALTREX) during pregnancy.
if you are breastfeeding. VALTREX may pass into your milk and it may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking VALTREX.
about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. VALTREX may affect other medicines, and other medicines may affect VALTREX. It is a good idea to keep a complete list of all the medicines you take. Show this list to your healthcare provider and pharmacist any time you get a new medicine.

How should I take VALTREX?

Do not stop VALTREX or change your treatment without talking to your healthcare provider.
VALTREX can be taken with or without food.
If you are taking VALTREX to treat cold sores, chickenpox, shingles, or genital herpes, you should start treatment as soon as possible after your symptoms start. VALTREX may not help you if you start treatment too late.
If you miss a dose of VALTREX, take it as soon as you remember and then take your next dose at its regular time. However, if it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at the regular time.
Do not take more than the prescribed number of VALTREX Caplets each day. Call your healthcare provider right away if you take too much VALTREX.

What are the possible side effects of VALTREX?

Kidney failure and nervous system problems are not common, but can be serious in some patients taking VALTREX. Nervous system problems include aggressive behavior, unsteady movement, shaky movements, confusion, speech problems, hallucinations (seeing or hearing things that are really not there), seizures, and coma. Kidney failure and nervous system problems have happened in patients who already have kidney disease and in elderly patients whose kidneys do not work well due to age. Always tell your healthcare provider if you have kidney problems before taking VALTREX. Call your doctor right away if you get a nervous system problem while you are taking VALTREX.

Common side effects of VALTREX in adults include headache, nausea, stomach pain, vomiting, and dizziness. Side effects in HIV-infected adults include headache, tiredness, and rash. These side effects usually are mild and do not cause patients to stop taking VALTREX. Other less common side effects in adults include painful periods in women, joint pain, depression, low blood cell counts, and changes in tests that measure how well the liver and kidneys work.

The most common side effect seen in children <18 years of age was headache.

Talk to your healthcare provider if you develop any side effects that concern you.

These are not all the side effects of VALTREX. For more information ask your healthcare provider or pharmacist.

Please see additional important information about VALTREX^® (valacyclovir HCl) Caplets (PDF) (In English)