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VALACICLOVIR 500MG FILM COATED TABLETS

Active substance(s): VALACICLOVIR HYDROCHLORIDE DIHYDRATE / VALACICLOVIR HYDROCHLORIDE DIHYDRATE

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PAGE 1: FRONT FACE (INSIDE OF REEL)

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Valaciclovir 500 mg
Film-Coated Tablets

compounds, iodinated contrast media,
methotrexate, pentamidine, foscarnet, ciclosporin,
tacrolimus, cimetidine and probenecid.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Always tell your doctor or pharmacist about other
medicines if you are taking Valaciclovir for
Read all of this leaflet carefully before you start
treatment of shingles or after having an organ
taking this medicine.
transplant.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your
Pregnancy and breast-feeding
doctor or pharmacist
Valaciclovir is not usually recommended for use
• This medicine has been prescribed for you. Do
during pregnancy. If you are pregnant, or think you
not pass it on to others. It may harm them, even could be, or if you are planning to become
if their symptoms are the same as yours
pregnant, don’t take Valaciclovir without checking
• If you get any side effects, talk to your doctor,
with your doctor. Your doctor will weigh up the
pharmacist or nurse. This includes any possible
benefit to you against the risk to your baby of
side effects not listed in this leaflet. See section 4. taking Valaciclovir while you're pregnant or
breast-feeding.
In this leaflet:
Ask your doctor or pharmacist for advice before
1. What Valaciclovir is and what it is used for
taking any medicine.
2. Before you take Valaciclovir
Driving and using machines
3. How to take Valaciclovir
4. Possible side effects
Valaciclovir can cause side effects that affect your
5. How to store Valaciclovir
ability to drive.
6. Further information
Don’t drive or use machines unless you are sure
you’re not affected.

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WHAT VALACICLOVIR IS AND WHAT IT IS
USED FOR

Valaciclovir belongs to a group of medicines called
antivirals. It works by killing or stopping the
growth of viruses called varicella zoster (VZV) and
cytomegalovirus (CMV).
Valaciclovir can be used to:
• treat shingles (in adults)
• prevent infection with CMV after organ
transplants (in adults and adolescents over 12
years old).
Valaciclovir which is contained in Valaciclovir 500 mg
Film-Coated Tablets may also be authorised to treat
other conditions which are not mentioned in this
leaflet. Ask your doctor or pharmacist if you have
further questions.

3

HOW TO USE VALACICLOVIR

Always take Valaciclovir 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 Valaciclovir for you. Your
doctor will discuss this with you.
Treatment of shingles
• The usual dose is 1000 mg (two 500 mg tablets)
three times a day
• You should take Valaciclovir for seven days.
To stop you being infected with CMV
(Cytomegalovirus)
• The usual dose is 2000 mg (four 500 mg tablets)
four times a day
• You should take each dose about 6 hours apart
BEFORE YOU TAKE VALACICLOVIR
• You will usually start taking Valaciclovir as soon
as possible after your surgery
Do NOT take Valaciclovir
• You should take Valaciclovir for around 90 days
• if you are allergic (hypersensitive) to valaciclovir
after your surgery, until your doctor tells you to
or aciclovir or any of the other ingredients of
stop.
Valaciclovir (listed in Section 6). If you are not
Your doctor may adjust the dose of Valaciclovir if:
sure, talk to your doctor or pharmacist before
• you are over 65 years of age
taking Valaciclovir.
• you have a weak immune system
Take special care with Valaciclovir
• you have kidney problems.
Check with your doctor or pharmacist before taking Talk to your doctor before taking Valaciclovir if any
Valaciclovir if:
of the above apply.
• you have kidney problems
Taking this medicine
• you have liver problems
• Take this medicine by mouth
• you are over 65 years of age
• Swallow the tablets whole with a drink of water
• your immune system is weak.
• Take Valaciclovir at the same time each day
If you are not sure if the above apply to you, talk to • Take Valaciclovir according to instructions from
your doctor or pharmacist before taking
your doctor or pharmacist.
Valaciclovir.
People over 65 years of age or with kidney
Taking other medicines
problems
Tell your doctor or pharmacist if you are taking or
It is very important while you are taking
have recently taken any other medicines. This
Valaciclovir that you drink water regularly during
includes medicines obtained without a
the day. This will help to reduce side effects that can
prescription, including herbal medicines.
affect the kidney or nervous system. Your doctor
Tell your doctor or pharmacist if you are taking any will closely monitor you for signs of these. Nervous
other medicines that affect the kidneys. These
system side effects might include feeling confused
include aminoglycosides, organoplatinum
or agitated, or feeling unusually sleepy or drowsy.

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Rare (affects less than 1 in 1,000 patients receiving
the medicine):
• unsteadiness when walking and lack of
coordination (ataxia)
• slow, slurred speech (dysarthria)
• fits (convulsions)
• altered brain function (encephalopathy)
• unconsciousness (coma)
• confused or disturbed thoughts.
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 Valaciclovir a day. They usually get better
when Valaciclovir is stopped or the dose reduced.
Other rare side effects:
POSSIBLE SIDE EFFECTS
• kidney problems where you pass little or no urine.
Like all medicines, Valaciclovir can cause side effects, Reporting of side effects
If you get any side effects, talk to your doctor,
although not everybody gets them. The following
pharmacist or nurse. This includes any possible side
side effects may happen with this medicine.
If you experience any of the following, stop taking effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
Valaciclovir and contact your doctor or local
www.mhra.gov.uk/yellowcard.
hospital casualty department immediately:
• severe allergic reactions (anaphylaxis). These are By reporting side effects you can help provide more
information on the safety of this medicine.
rare in people taking Valaciclovir. Rapid
development of symptoms including:
HOW TO STORE VALACICLOVIR
• flushing, itchy skin rash
• swelling of the lips, face, neck and throat,
• Keep out of the reach and sight of children
causing difficulty in breathing (angiodema)
• Do not use Valaciclovir after the expiry date which
• fall in blood pressure leading to collapse.
is stated on the carton. The expiry date refers to
the last day of the month
The following side effects have also been reported:
• Store below 30°C
Very common (affects more than 1 in 10 patients
• Medicines should not be disposed of via wastewater
receiving the medicine):
or household waste. Ask your pharmacist how to
• headache.
dispose of medicines no longer required. These
Common (affects less than 1 in 10 patients
measures will help to protect the environment.
receiving the medicine):
• feeling sick
FURTHER INFORMATION
• dizziness
• vomiting
What Valaciclovir contains
• diarrhoea
• The active substance is valaciclovir. Each tablet
• skin reaction after exposure to sunlight
contains 500 mg valaciclovir (as valaciclovir
(photosensitivity)
hydrochloride dihydrate)
• rash.
• The other ingredients are maize starch,
Uncommon (affects less than 1 in 100 patients
croscarmellose sodium, sodium stearyl fumarate
receiving the medicine):
and cellulose powdered in the tablet core, and
• feeling confused
hypromellose (E464), titanium dioxide (E171),
• seeing or hearing things that aren’t there
macrogol 400 and polysorbate 80 (E433) in the
(hallucinations)
film coating.
• feeling very drowsy
What Valaciclovir looks like and contents of the pack
• tremors
• Valaciclovir are white, biconvex, oblong,
• feeling agitated.
film-coated tablets, debossed “VL”, breakline and
These nervous system side effects usually occur in
“D” on one side and plain on the other. The tablets
people with kidney problems, the elderly or in organ
can be divided into equal halves
transplant patients taking high doses of 8 grams or
• Valaciclovir are available in pack sizes of 1, 4, 6, 8,
more of Valaciclovir a day. They usually get better
10, 24, 30, 42, 90 and 112 film-coated tablets.
when Valaciclovir is stopped or the dose reduced.
Hospital packs of 50 (50 x 1) film-coated tablets are
Other uncommon side effects:
also available
• shortness of breath (dyspnoea)
• Not all pack sizes may be marketed.
• stomach discomfort
Marketing Authorisation Holder and Manufacturer
• rash, sometimes itchy, hive-like rash (urticaria)
• low back pain (kidney pain).
The Marketing Authorisation Holder
Uncommon side effects that may show up in blood TEVA UK Limited, Eastbourne, BN22 9AG
tests:
Manufacturer
• reduction in the number of white blood cells
Teva Pharmaceutical Works Private Limited
(leucopenia)
Company, Pallagi út 13, 4042 Debrecen, Hungary.
• reduction in the number of blood platelets which
This leaflet was last revised in February 2017
are cells that help blood to clot
PL 00289/1002
(thrombocytopenia)
86543-Z
• increase in substances produced by the liver.
If you take more Valaciclovir than you should
Valaciclovir 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 Valaciclovir. Take the medicine pack with you.
If you forget to take Valaciclovir
• If you forget to take Valaciclovir, take it as soon
as you remember. However, if it is nearly time for
your next dose, skip the missed dose
• Do not take a double dose to make up for a
forgotten dose.

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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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