VALTREX 250MG FILM COATED TABLETS

Active substance: VALACICLOVIR HYDROCHLORIDE

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10000000120742

PHARMA CODE N° 4773

GSK-ESP-Aranda-ESARA

Package Leaflet: Information for the User
United Kingdom-GBR
Valtrex

®
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250 mg film-coated tablets
500 mg film-coated tablets

valaciclovir
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.

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02-01-XX-273-02

• Keep this leaflet. You may need to read it again.
• f you have any further questions, ask your doctor or
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pharmacist.
• his medicine has been prescribed for you. Do not pass
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it on to others. It may harm them, even if their signs of
illness are the same as yours.
• f you get any side effects, talk to your doctor or
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pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet:
1 hat Valtrex is and what it is used for
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2 hat you need to know before you take Valtrex
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3 ow to take Valtrex
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4 ossible side effects
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5 ow to store Valtrex
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6 ontents of the pack and other information
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Tell your doctor or pharmacist if you are taking any
other medicines that affect the kidneys. These include:
aminoglycosides, organoplatinum compounds, iodinated
contrast media, methotrexate, pentamidine, foscarnet,
ciclosporin, tacrolimus, cimetidine and probenecid.
Always tell your doctor or pharmacist about other medicines
if you are taking Valtrex for treatment of shingles or after
having an organ transplant.

Pregnancy and breast-feeding

Valtrex is not usually recommended for use during
pregnancy. If you are pregnant, or think you could be, or if
you are planning to become pregnant, don’t take Valtrex
without checking with your doctor. Your doctor will weigh
up the benefit to you against the risk to your baby of taking
Valtrex while you’re pregnant or breastfeeding.

Driving or using machines

Valtrex can cause side effects that affect your ability to drive.
➔ on’t drive or use machines unless you are sure you’re
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not affected.

1. What Valtrex is and what it is used for

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3. How to take Valtrex

Valtrex belongs to a group of medicines called antivirals.
It works by killing or stopping the growth of viruses
called herpes simplex (HSV), varicella zoster (VZV) and
cytomegalovirus (CMV).
Valtrex can be used to:
• reat shingles (in adults)
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• reat HSV infections of the skin and genital herpes (in
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adults and adolescents over 12 years old). It is also used
to help prevent these infections from returning.
• reat cold sores (in adults and adolescents over 12 years old)
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• revent infection with CMV after organ transplants (in
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adults and adolescents over 12 years old)
• reat and prevent HSV infections of the eye that continue to
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come back (in adults and adolescents over 12 years old)

Always take this medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.
The dose that you should take will depend on why your
doctor has prescribed Valtrex for you. Your doctor will
discuss this with you.
Treatment of shingles
• he usual dose is 1000 mg (one 1000 mg tablet or two
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500 mg tablets) three times a day.
• You should take Valtrex for seven days.
Treatment of cold sores
• he usual dose is 2000 mg (two 1000 mg tablets or four
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500 mg tablets) twice a day.
• he second dose should be taken 12 hours (no sooner
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than 6 hours) after the first dose
• ou should take Valtrex for one day (two doses) only.
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Treatment of HSV infections of the skin and genital herpes
• he usual dose is 500 mg (one 500 mg tablet or two
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250 mg tablets) twice a day.
• or the first infection you should take Valtrex for five days
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or for up to ten days if your doctor tells you to. For recurrent
infection the duration of treatment is normally 3-5 days.
Helping to prevent HSV infections from returning after you
have had them
• The usual dose is one 500 mg tablet once a day.
• ome people with frequent recurrences may benefit from
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taking one 250 mg tablet twice a day.
• ou should take Valtrex until your doctor tells you to stop.
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To stop you being infected with CMV (Cytomegalovirus)
• he usual dose is 2000 mg (two 1000 mg tablets or four
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500 mg tablets) four times a day.
• You should take each dose about 6 hours apart.
• ou will usually start taking Valtrex as soon as possible
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after your surgery.
• ou should take Valtrex for around 90 days after your
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surgery, until your doctor tells you to stop.
Your doctor may adjust the dose of Valtrex if:
• ou are over 65 years of age
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• ou have a weak immune system
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• ou have kidney problems.
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➔ Talk to your doctor before taking Valtrex if any of the
above apply.

2. What you need to know before you
take Valtrex
Don’t take Valtrex

• if you are allergic to valaciclovir or aciclovir or any of the

other ingredients of this medicine (listed in Section 6).
➔ on’t take Valtrex if the above applies to you. If you are not
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sure, talk to your doctor or pharmacist before taking Valtrex.

Warnings and precautions

Check with your doctor or pharmacist before taking
Valtrex if:
• you have kidney problems

• you have liver problems

• you are over 65 years of age

• your immune system is weak

If you are not sure if the above apply to you, talk to
your doctor or pharmacist before taking Valtrex.

Prevent passing genital herpes on to others

If you are taking Valtrex to treat or prevent genital
herpes, or you have had genital herpes in the past,
you should still practice safe sex, including the use of
condoms. This is important to prevent you passing the
infection on to others. You should not have sex if you
have genital sores or blisters.

Other medicines and Valtrex

Tell your doctor or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines
obtained without a prescription, including herbal medicines.

Taking this medicine

• ake this medicine by mouth.
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• wallow the tablets whole with a drink of water.
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• ake Valtrex at the same time each day.
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• ake Valtrex according to instructions from your doctor or
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pharmacist.

People over 65 years of age or with kidney problems

GSK-ESP-Aranda-ESARA

Other rare side effects:
• idney problems where you pass little or no urine.
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If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information
on the safety of this medicine.

It is very important while you are taking Valtrex that
you drink water regularly during the day. This will help
to reduce side effects that can affect the kidney or nervous
system. Your doctor will closely monitor you for signs of
these. Nervous system side effects might include feeling
confused or agitated, or feeling unusually sleepy or drowsy.

United Kingdom-GBR
Valtrex

If you take more Valtrex than you should

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Valtrex is not usually harmful, unless you take too much
over several days. If you take too many tablets you may feel
sick, vomit, get kidney problems, may be confused, agitated,
feel less aware, see things that aren’t there, or become
unconscious. Talk to your doctor or pharmacist if you take
too much Valtrex. Take the medicine pack with you.

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If you forget to take Valtrex
PHARMA CODE N° 4773

02-01-XX-273-02

• f you forget to take Valtrex, take it as soon as you
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remember. However, if it is nearly time for your next dose,
skip the missed dose.
• on’t take a double dose to make up for a forgotten dose.
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4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them. The following side
effects may happen with this medicine:

Conditions you need to look out for

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• evere allergic reactions (anaphylaxis). These are rare in
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people taking Valtrex. Rapid development of symptoms
including:
• lushing, itchy skin rash
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• welling of the lips, face, neck and throat, causing
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difficulty in breathing (angiodema)
• all in blood pressure leading to collapse.
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➔ If you have an allergic reaction, stop taking Valtrex and
see a doctor straight away.
Very Common (may affect more than 1 in 10 people):
• eadache
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Common (may affect up to 1 in 10 people)
• eeling sick
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• izziness
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• omiting
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• iarrhoea
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• kin reaction after exposure to sunlight (photosensitivity).
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• ash
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• itching (pruritus)
Uncommon (may affect up to 1 in 100 people)
• eeling confused
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• eeing or hearing things that aren’t there (hallucinations)
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• eeling very drowsy
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• remors
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• eeling agitated
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These nervous system side effects usually occur in people
with kidney problems, the elderly or in organ transplant
patients taking high doses of 8 grams or more of Valtrex a
day. They usually get better when Valtrex is stopped or the
dose reduced.
Other uncommon side effects:
• hortness of breath (dyspnoea)
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• tomach discomfort
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• ash, sometimes itchy, hive-like rash (urticaria)
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• ow back pain (kidney pain)
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• lood in urine (haematuria)
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Uncommon side effects that may show up in blood tests:
• eduction in the number of white blood cells (leucopenia)
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• eduction in the number of blood platelets which are cells
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that help blood to clot (thrombocytopenia)
• ncrease in substances produced by the liver.
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Rare (may affect up to 1 in 1,000 people)
• nsteadiness when walking and lack of coordination
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(ataxia)
• low, slurred speech (dysarthria)
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• its (convulsions)
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• ltered brain function (encephalopathy)
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• nconsciousness (coma)
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• onfused or disturbed thoughts (delirium)
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These nervous system side effects usually occur in people with
kidney problems, the elderly or in organ transplant patients
taking high doses of 8 grams or more of Valtrex a day. They
usually get better when Valtrex is stopped or the dose reduced.

Reporting of side effects

5. How to store Valtrex
• eep this medicine out of the sight and reach of children.
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• o not use this medicine after the expiry date which is
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stated on the carton. The expiry date (Exp.) refers to the
last day of that month.
• tore below 30°C.
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• o not throw away any medicines via wastewater or
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household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

6. Contents of the pack and other
information
What Valtrex contains
• he active substance is valaciclovir. Each tablet contains
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250 mg or 500 mg of valaciclovir (as valaciclovir
hydrochloride).
The other ingredients are:
Tablet core
Microcrystalline cellulose
Crospovidone
Povidone
Magnesium stearate
Silica colloidal anhydrous
Film coat
Hypromellose
Titanium dioxide
Macrogol 400
Polysorbate 80 (500 mg tablets only)
Carnauba wax

What Valtrex tablets look like and contents of
the pack
Valtrex tablets are contained in polyvinyl chloride/aluminium
foil blister packs.
Valtrex Tablets 250 mg are supplied to you in cartons
containing 60 film-coated tablets. They are white and
marked with “GX CE7” on one side.
Valtrex Tablets 500 mg are supplied in cartons containing
10, 30, 42, 90 or 112 film-coated tablets. They are white and
marked with “GX CF1” on one side.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
The Wellcome Foundation Ltd, Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer
Glaxo Wellcome, S.A. Avenida de Extremadura 3,
09400 Aranda de Duero, Burgos, Spain
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Valtrex Tablets 250 mg
Valtrex Tablets 500 mg
Reference number
0
0003/0371
This is a service provided by the Royal National Institute of
Blind People.
Leaflet date: March 2014
Valtrex is a registered trademark of the GlaxoSmithKline
group of companies.
© 2014 GlaxoSmithKline group of companies.
All rights reserved

10000000120742

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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