Label:information for the user

Valtrex 1.000mg film-coated tablets

valaciclovir

Read this label carefully before starting to takethismedicine,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyou experienceadverse effects, consult your doctor or pharmacist,evenifthey are not listed in this label. See section 4.

1.What is Valtrex and what it is used for

2.What you need to knowbeforestarting totake Valtrex

3.How to take Valtrex

4.Adverse effects

5.Storage of Valtrex

6.Contents of the package and additional information

Valtrex belongs to a group of medications called antivirals. It works by stopping or slowing the growth of viruses called herpes simplex (HSV), varicella zoster (VZV), and cytomegalovirus (CMV).

Valtrex can be used for:

• treat shingles (in adults)

• treat skin and genital herpes infections (in adults and adolescents over 12 years old). It is also used to prevent these infections from recurring

• treat fevers (in adults and adolescents over 12 years old)

• prevent CMV infection after organ transplants (in adults and adolescents over 12 years old)
• treat and prevent recurring eye infections caused by HSV (in adults and adolescents over 12 years old).

Do not take Valtrex

• if you are allergic to valaciclovir or aciclovir or any of the other components of this medication (listed in section 6)
• if you have ever developed a widespread skin rash associated with fever, lymph node swelling, elevated liver enzyme levels, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

• Do not take Valtrex if the above point applies to you. If you are unsure, consult your doctor or pharmacist before taking Valtrex.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valtrex if:

• you have kidney problems
• you have liver problems
• you are over 65 years old
• your immune system is weakened.

If you are unsure whether any of the above points apply to you, consult your doctor or pharmacist before taking Valtrex.

Be especially careful with Valtrex – Important Information:

A drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir.DRESS initially presents with symptoms similar to the flu, with a skin rash on the face that spreads to other areas, high body temperature, elevated liver enzyme levels in blood tests, increased eosinophils, and lymph node swelling.

• if you develop a skin rash associated with fever and lymph node swelling, stop taking valaciclovir and seek medical attention immediately.

Preventing the spread of genital herpes to others

if you are taking Valtrex to treat or prevent genital herpesor have had genital herpes in the past,you must practice safe sex,including the use of condoms.This is important to prevent infecting others. Do not have sex if you have genital ulcers or blisters.

Other medications and Valtrex

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication,including over-the-counter medications or herbal remedies.

Inform your doctor or pharmacist if you are taking any medication that affects the kidneys. These include: aminoglycosides, platinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.

Always inform your doctor or pharmacist about other medications you are taking if you are taking Valtrex for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding

Valtrex is usually not recommended for use during pregnancy.

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.Your doctor will weigh the benefits for you against the risks to the baby if you take Valtrex while pregnant or breastfeeding.

Driving and operating machinery

Valtrex may cause side effects that affect your ability to drive.

→ Do not drive or operate machinery unless you are sure it will not affect you.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt,consultagainyour doctor or pharmacist.

The dose you should take will depend on why your doctor prescribed Valtrex for you. Your doctor will indicate the appropriate dosage.

Herpes zoster treatment

• The usual dose is 1,000mg (one 1,000mg tablet or two 500mg tablets) three times a day.
• You should take Valtrex for seven days.

Febrile treatment

• The usual dose is 2,000mg (two 1,000mg tablets or four 500mg tablets) twice a day.
• The second dose should be taken 12 hours after the first dose (not before 6 hours).
• You should only take Valtrex for one day (two doses).

Epidermal and genital herpes virus infections treatment

• The usual dose is 500mg (one 500mg tablet) twice a day.
• For the first infection, you should take Valtrex for five days or up to ten days if your doctor indicates it. For recurrent infections, the treatment duration is usually 3-5 days.

Prevention of recurrent infections by VHS once you have had them

• The usual dose is one 500mg tablet per day.
• Some people with frequent recurrences may benefit from taking 250mg twice a day.
• You should take Valtrex until your doctor tells you to stop treatment.

To avoid CMV (cytomegalovirus) infection

• The usual dose is 2,000mg (two 1,000mg tablets or four 500mg tablets) four times a day.
• You should space the doses 6 hours apart.
• You should start taking Valtrex as soon as possible after surgery.
• You should take Valtrex for about 90 days after surgery, until your doctor tells you to stop treatment.

Your doctor may adjust the Valtrex dose if:

• You are over 65years old.
• You have a weakened immune system.
• You have kidney problems.

• Speak with your doctor before taking Valtrex if any of the above points affect you.

Medication intake

People over 65years old or with kidney problems

It is very important that while taking Valtrex, you drink water regularlythroughout the day. This will help you reduce the adverse effects that may affect the kidneys or the nervous system. Your doctor will monitor you to detect any signs of this. Nervous system adverse effects may include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

If you take too much Valtrex

Valtrex is usually not harmful, unless you take too much for several days. If you take too many tablets, you may experience nausea, vomiting,kidney problemsor feel confused, agitated, or less alert, see things that do not exist, or lose consciousness. Speak with your doctor or pharmacist if you take too much Valtrex. Bring the packaging with you.You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Valtrex

• If you forget to take Valtrex, take it as soon as you remember. However, if you have little time left for the next dose, omit the missed dose.
• Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Symptoms to be aware of

• Stop taking Valtrex and seek medical attention immediately if you notice any of the following symptoms:

Severe allergic reactions(anaphylaxis).These are rare in people taking Valtrex. Rapid development of symptoms including:

Skin eruptions or redness. The skin reaction can appear as rashes with or without blisters. They can cause skin irritation, edema (DRESS syndrome) and fever and symptoms similar to the flu.

The following side effects may also occur with this medicine:

Very common(may affect more than 1 in 10 people):

• headache.

Common(may affect up to 1 in 10 people):

• nausea
• dizziness
• vomiting
• diarrhea
• skin reaction after exposure to sunlight (photosensitivity)
• rash
• itching (pruritus).

Uncommon(may affect up to 1 in 100 people):

• feeling confused
• seeing or hearing things that do not exist (hallucinations)
• feeling very drowsy
• shaking
• feeling agitated.

These neurological side effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of8gramsor more of Valtrex per day. They usually improve when treatment with Valtrex is stopped or the dose is reduced.

Other uncommon side effects:

• difficulty breathing (dyspnea)
• stomach pain
• skin rash, sometimes with itching, hives (urticaria)
• lower back pain (renal pain)
• blood in urine (hematuria).

May appear in blood tests:

• reduction in the number of white blood cells (leucopenia)
• reduction in the number ofplateletsthat help blood to clot (thrombocytopenia)
• increase in substances produced by the liver.

Rare(may affect up to 1 in 1,000 people):

These neurological side effects usually occur in people with kidney problems, elderly patients, or transplant patients taking high doses of8gramsor more of Valtrex per day. They usually improve when treatment with Valtrex is stopped or the dose is reduced.

Other rare side effects:

• kidney problems that cause little or no urination.

Unknown frequency(cannot be estimated from available data):

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or drug hypersensitivity syndrome, characterized by generalized rash, high fever, elevated liver enzymes,blood abnormalities (eosinophilia), swollen lymph nodes, and possibly other organs. See section 2.
• inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Store below 30°C.
• Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofValtrex

• The active ingredient isvalaciclovir.Each tablet contains 1,000 mg of valaciclovir (as valaciclovir hydrochloride).

The other componentsare:

Tablet core

Microcrystalline cellulose

Crospovidone

Povidone

Magnesium stearate

Anhydrous colloidal silica

Capsule coating

Hydroxypropylmethylcellulose

Titanium dioxide

Macrogol 400

Polysorbate 80

Carnauba wax

Appearance of the product and contents of the packaging

Valtrex tablets are presented in blisters of aluminum/polyvinyl chloride.

Valtrex 1,000 mg tablets are presented in packs of21 coated tablets. They are white and marked with “GXCF2” on one side.

Marketing authorization holderandmanufacturer

Marketing authorization holder

GlaxoSmithKline, S.A.

P.T.M.C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer

Glaxo Wellcome, S.A.

Avenida de Extremadura, 3

09400 Aranda de Duero (Burgos)

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden: Valtrex.

France, Belgium, Italy, Luxembourg, Netherlands: Zelitrex.

Last review date of thisleaflet: 12/2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.