Medication Guide — VALTREX

PATIENT INFORMATION

VALTREX (VAL-trex)

(valacyclovir)

tablets

What is VALTREX?

VALTREX is a prescription medicine used in adults:

• to treat cold sores (herpes labialis).
• to treat or control genital herpes outbreaks in adults with normal immune systems.
• to control genital herpes outbreaks in adults with human immunodeficiency virus-1 (HIV-1).
• with safer sex practices to lower the chance of spreading genital herpes to others, in adults with normal immune systems. Even with safer sex practices, it is still possible to spread genital herpes.
  • 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.
• to treat shingles (herpes zoster) in adults with normal immune systems.

VALTREX is used in children to treat:

• cold sores in children 12 years of age and older.
• chickenpox in children with normal immune systems 2 years of age to less than 18 years of age.

VALTREX does not curecold sores, chickenpox, shingles, or genital herpes.

• It is not known if VALTREX is safe and effective in people with weakened immune systems, other than for control of outbreaks of genital herpes in people with HIV-1.
• It is not known if VALTREX is safe and effective in people 18 years of age and older with chickenpox.
• It is not known if VALTREX is safe and effective in children:
  • less than 12 years of age with cold sores
  • less than 2 years of age with chickenpox
  • less than 18 years of age with genital herpes or shingles

Do not take VALTREXif you are allergic to valacyclovir, acyclovir, or any of the ingredients in VALTREX. See the end of this leaflet for a complete list of ingredients in VALTREX.

Before you take VALTREX, tell your healthcare provider about all of your medical conditions, including if you:

• have had severe skin reactionswith VALTREX or acyclovir.
• have had a bone marrow transplant or kidney transplant, or if you have advanced HIV-1 infection or acquired immune deficiency syndrome (AIDS).
• have kidney problems, including if you receive dialysis.
• are pregnant or plan to become pregnant. It is not known if VALTREX will harm your unborn baby. You and your healthcare provider will decide if you will take VALTREX if you are pregnant.
• are breastfeeding or plan to breastfeed. VALTREX may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your child if you take VALTREX.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take VALTREX?

• Take VALTREX exactly as your healthcare provider tells you to take it.
• Your dose of VALTREX and length of treatment will depend on the type of infection that you have and any other medical problems that you have.
• Do not stop VALTREX or change your treatment without talking to your healthcare provider.
• Take VALTREX with or without food.
• Tell your healthcare provider if your child cannot swallow VALTREX tablets. Your healthcare provider can prescribe VALTREX as an oral suspension for your child.
• If you are taking VALTREX to treat outbreaks of cold sores, chickenpox, shingles, or genital herpes, take VALTREX as soon as you have the first symptoms of infection such as tingling, itching, or burning, or when the sore appears.
• It is important for you to stay well hydrated during treatment with VALTREX. Be sure to drink plenty of fluids during this time.
• If you miss a dose of VALTREX, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time or take more VALTREX than prescribed.
• If you take too much VALTREX, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the possible side effects of VALTREX?

VALTREX can cause serious side effects including:

• Thrombotic Thrombocytopenic Purpura (TTP) and Hemolytic Uremic Syndrome (HUS).TTP and HUS have happened in people with weakened immune systems taking VALTREX and have led to death. TTP and HUS are disorders that can cause small blood clots to form throughout the body and decrease blood flow to body organs such as the brain, heart, and kidneys. Your healthcare provider will stop treatment with VALTREX if you have signs or symptoms of TTP and HUS.
• kidney failure.
• nervous system problems.Tell your healthcare provider right away if you get any of these signs or symptoms of nervous system problems during treatment with VALTREX:

• aggressive behavior
• unsteady movement
• shaky movements
• confusion

• speech problems
• hallucinations (seeing or hearing things that are really not there)
• seizures
• coma

• severe skin reactions.Severe skin reactions have happened in people treated with VALTREX. Tell your healthcare provider right away if you develop a rash during treatment with VALTREX. Stop taking VALTREX immediately and get medical help right away if you develop a painful rash with any of the following symptoms:blisters or sores in the mouth, or blisters or peeling of the skin.

Elderly people are more likely to get certain side effects. Talk to your healthcare provider if this is a concern for you.

The most common side effects of VALTREX in adults include:

• headache
• nausea

• stomach (abdominal) pain

The most common side effect of VALTREX in children less than 18 years of age is headache.

These are not all the possible side effects of VALTREX.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.

How should I store VALTREX?

• Store VALTREX tablets at 59°F to 77°F (15°C to 25°C).
• Store VALTREX suspension between 36°F to 46°F (2°C to 8°C) in a refrigerator. Throw away (discard) any remaining VALTREX suspension after 28 days.
• Shake VALTREX suspension bottle well before using.
• Keep VALTREX in a tightly closed container.

Keep VALTREX and all medicines out of the reach of children.

General information about the safe and effective use of VALTREX.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. 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 that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about VALTREX that is written for health professionals.

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 titanium dioxide.

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This Patient Information has been approved by the U.S. Food and Drug Administration.