Valtrex 1,000 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valtrex 1,000 mg film-coated tablets

valaciclovir

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet; you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Valtrex is and what it is used for
2. What you need to know before taking Valtrex
3. How to take Valtrex
4. Possible side effects
5. How to store Valtrex
6. Contents of the pack and other information

1. What Valtrex is and what it is used for

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

Valtrex can be used to:

• treat shingles (in adults)

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

• treat cold sores (in adults and adolescents over 12 years of age)

• prevent CMV infection following organ transplantation (in adults and adolescents over 12 years of age)

• treat and prevent recurrent HSV eye infections (in adults and adolescents over 12 years of age)

2. What you need to know before taking Valtrex

Do not take Valtrex

• if you are allergic to valaciclovir or aciclovir, or to any of the other ingredients of this medicine (listed in section 6)

• if you have ever developed a widespread rash associated with fever, swollen lymph nodes, elevated liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms syndrome).

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Valtrex if:

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

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

Take special care with Valtrex – Important Information:

Cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported with the use of valaciclovir. DRESS initially presents with flu-like symptoms, rash on the face that spreads to other areas, high body temperature, elevated liver enzymes in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes.

• If you develop a rash associated with fever and swollen lymph nodes, stop taking valaciclovir and contact your doctor or seek immediate medical attention.

Preventing the spread of genital herpes to others

If you are taking Valtrex to treat or prevent genital herpes, or have had genital herpes in the past, you should practice safe sex, including using condoms. This is important to avoid spreading the infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Other medicines and Valtrex

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or herbal medicines.

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

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

Pregnancy and breastfeeding

Valtrex is generally not recommended for use during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will weigh the benefit to you against the risk to the baby if you take Valtrex during pregnancy or while breastfeeding.

Driving and using machines

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

→ Do not drive or operate machinery unless you are certain that it does not affect you.

3. How to take Valtrex

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Treatment of herpes zoster

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

Treatment of cold sores

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

Treatment of skin VHS infections and genital herpes

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

Prevention of recurrent VHS infections once they have occurred

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

To prevent CMV (cytomegalovirus) infection

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

Your doctor may adjust the dose of Valtrex if:

• you are over 65 years of age

• you have a weakened immune system

• you have kidney problems.

• Talk to your doctor before taking Valtrex if any of the above apply to you.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take Valtrex at the same time each day.
• Take Valtrex according to the instructions given by your doctor or pharmacist.

Patients aged 65 years or older or with kidney problems

It is very important that you drink water regularly throughout the day while taking Valtrex. This will help reduce adverse effects that may affect the kidneys or the nervous system. Your doctor will monitor you for signs of such effects. Nervous system side effects may include confusion, agitation, or feeling abnormally sleepy or drowsy.

If you take more Valtrex than you should

Valtrex is usually not harmful unless taken in excess over several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, confusion, agitation, reduced alertness, hallucinations, or loss of consciousness. Contact your doctor or pharmacist if you take too much Valtrex. Take the packaging with you. You may also call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Valtrex

• If you forget to take Valtrex, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Symptoms to watch for

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

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

• skin rash with redness, itching
• swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
• drop in blood pressure leading to collapse.

Skin rashes or redness. Adverse skin reactions may appear as rashes with or without blisters. Skin irritation, edema (DRESS syndrome), fever, and flu-like symptoms may occur.

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 sun exposure (photosensitivity)
• rash
• itching (pruritus).

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

• feeling confused
• seeing or hearing things that are not there (hallucinations)
• feeling very drowsy
• tremors
• feeling agitated.

These nervous system adverse effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of Valtrex per day. They usually improve when treatment with Valtrex is stopped or the dose is reduced.

Other uncommon adverse effects:

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

Uncommon adverse effects may appear in blood tests:

• reduction in the number of white blood cells (leukopenia)
• reduction in the number of platelets, which are cells that help blood to clot (thrombocytopenia)
• increase in substances produced by the liver.

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

• unsteadiness when walking and lack of coordination (ataxia)
• slow and slurred speech (dysarthria)
• seizures (convulsions)
• altered brain function (encephalopathy)
• loss of consciousness (coma)
• confused or disturbed thoughts (delirium).

These nervous system adverse effects usually occur in people with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of Valtrex per day. They usually improve when treatment with Valtrex is stopped or the dose is reduced.

Other rare adverse effects:

• kidney problems causing little or no urine production.

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valtrex

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• Store below 30°C.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valtrex

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

The other components are:

Tablet core

Microcrystalline cellulose
Crospovidone
Povidone
Magnesium stearate
Colloidal anhydrous silica

Coating

Hydroxypropylmethylcellulose
Titanium dioxide
Macrogol 400
Polysorbate 80
Carnauba wax

Nature and contents of the container

Valtrex tablets are supplied in aluminum/polyvinyl chloride blisters.

Valtrex 1,000 mg tablets are available in packs of 21 film-coated tablets. The tablets are white and marked with “GX CF2” on one side.

Marketing Authorization Holder and Manufacturer

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 medicinal product is authorized in the European Economic Area member states under 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.

Date of latest revision of this leaflet: 12/2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.