VALTREX 250MG FILM COATED TABLETS

Active substance: VALACICLOVIR HYDROCHLORIDE

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10000000101785

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

®
1

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

valaciclovir
Read all of this leaflet carefully before you start
taking this medicine.

K

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 it
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on to others. It may harm them, even if their symptoms
are the same as yours.
• f any of the side effects gets serious, or if you notice any
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side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1 hat Valtrex is and what it is used for
W
2 efore you take Valtrex
B
3 ow to take Valtrex
H
4 ossible side effects
P
5 ow to store Valtrex
H
6 urther information
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1. What Valtrex is and what it is used for

FRONT PAGE
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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
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old)
• 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
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2. Before you take Valtrex
Don’t take Valtrex

• if you are allergic (hypersensitive) to valaciclovir or aciclovir

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

Take special care with Valtrex

Check with your doctor or pharmacist before taking
Valtrex if:
• ou have kidney problems
y
• ou have liver problems
y
• ou are over 65 years of age
y
• our immune system is weak
y
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.

Taking other medicines

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.

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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.

3. How to take Valtrex
Always take Valtrex 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
y
• ou have a weak immune system
y
• ou have kidney problems.
y
➔ Talk to your doctor before taking Valtrex if any of the
above apply.
10000000101785

PHARMA CODE N° 3998

GSK-ESP-Aranda-ESARA

3
10000000101785

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.

GSK-ESP-Aranda-ESARA
United Kingdom-GBR

People over 65 years of age or with kidney problems
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.

Valtrex
1

PHARMA CODE N° 3998

02-01-XX-273-02

Valtrex is not usually harmful, unless you take too much over
several days. If you take too many tablets you may feel sick,
vomit, or be confused, agitated or unusually sleepy. Talk to
your doctor or pharmacist if you take too much Valtrex. Take
the medicine pack with you.

If you forget to take Valtrex

6. Further information

• 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, Valtrex can cause side effects in some
people. The following side effects may happen with this
medicine:

Conditions you need to look out for

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5. How to store Valtrex
• eep out of the reach and sight of children.
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• o not use Valtrex after the expiry date which is stated on
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the carton. The expiry date (Exp.) refers to the last day of
that month.
• tore below 30°C.
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• edicines should not be disposed of via wastewater or
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household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the
environment.

If you take more Valtrex than you should
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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 rare side effects:
• idney problems where you pass little or no urine.
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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 (affects more than 1 in 10 people):
• eadache
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Common (affects 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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Uncommon (affects 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
f
• remors
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• eeling agitated
f
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
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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 (affects 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
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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
GlaxoSmithKline UK, 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: April 2013
Valtrex is a registered trademark of the GlaxoSmithKline
group of companies.
© 2013 GlaxoSmithKline group of companies.
All rights reserved

10000000101785

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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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