(valacyclovir hydrochloride) Caplets
Read the Patient Information that comes with VALTREX before you start using it and each time you get a refill.
There may be new information. This information does not take the place of talking to your healthcare provider about
your medical condition or treatment. Ask your healthcare provider or pharmacist if you have questions.
What is VALTREX?
VALTREX is a prescription antiviral medicine. VALTREX lowers the ability of herpes viruses to multiply in your
VALTREX is used:
· to treat cold sores (also called fever blisters or herpes labialis) in adults
to treat shingles (also called herpes zoster) in adults
· to treat or control genital herpes outbreaks in adults with normal immune
· to control genital herpes outbreaks in adults infected with the human
immunodeficiency virus (HIV) with CD4 cell count greater than 100 cells/mm3
· with safer sex practices to lower the chances of spreading genital herpes to
others. Even with safer sex practices, it is still possible to spread genital herpes.
VALTREX used daily with the following safer sex practices can lower the chances of passing genital herpes to your
· Do not have sexual contact with your partner when you have any
symptom or outbreak of genital herpes.
· Use a condom made of latex or polyurethane whenever you have sexual
VALTREX does not cure herpes infections (cold sores, shingles, or genital herpes).
VALTREX has not been studied in children who have not reached puberty.
What are cold sores, shingles, and genital herpes?
Cold sores are caused by a herpes virus that may be spread by kissing or other physical contact with the
infected area of the skin. They are small, painful ulcers that you get in or around your mouth. It is not known if
VALTREX can stop the spread of cold sores to others.
Shingles is caused by the same herpes virus that causes chickenpox. It causes small, painful blisters that
happen on a certain area of your skin. Shingles occurs in people who have already had chickenpox. Shingles can be
spread to people who have not had chickenpox or the chickenpox vaccine by contact with the infected areas of the
skin. It is not known if VALTREX can stop the spread of shingles to others.
Genital herpes is a sexually transmitted disease. It causes small, painful blisters on your genital area.
You can spread genital herpes to others, even when you have no symptoms. If you are sexually active, you can still
pass herpes to your partner, even if you are taking VALTREX. VALTREX, taken every day as prescribed and used with the
following safer sex practices, can lower the chances of passing genital herpes to your partner.
· Do not have sexual contact with your partner when you have any symptom or
outbreak of genital herpes.
· Use a condom made of latex or polyurethane whenever you have sexual
contact. Ask your healthcare provider for more information about safer sex practices.
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, including:
· 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
· 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
· 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
· 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. This may happen if you have certain medical conditions such as kidney problems. 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?
Take VALTREX exactly as prescribed by your healthcare provider. Your dose of VALTREX and length of treatment will
depend on the type of herpes infection that you have and any other medical problems that you have.
· Do not stop VALTREX or change your treatment without talking to your
· VALTREX can be taken with or without food.
· If you are taking VALTREX to treat cold sores, 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 include headache, nausea, stomach pain, vomiting, and dizziness. Side effects in
HIV-infected adults include headache, tiredness, and rash. These side effects are usually mild and usually do not
cause patients to stop taking VALTREX.
Other less common side effects 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.
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
How should I store VALTREX?
· Store VALTREX at room temperature, 59° to
77°F (15° to 25°C).
· Keep VALTREX in a tightly closed container.
· Do not keep medicine that is out of date or that you no longer need.
· Keep VALTREX and all medicines out of the reach of children.
General information about VALTREX
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not
use VALTREX for a condition for which it was not prescribed. Do not give VALTREX to other people, even if they have
the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about VALTREX. If you would like more information, talk
with your healthcare provider. You can ask your healthcare provider or pharmacist for information about VALTREX that
is written for health professionals. More information is available at www.VALTREX.com.
What are the ingredients in VALTREX?
Active Ingredient: valacyclovir hydrochloride
Inactive Ingredients: carnauba wax, colloidal silicon dioxide, crospovidone, FD&C Blue No. 2 Lake,
hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and