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VALACICLOVIR 500MG FILM COATED TABLETS

Active substance(s): VALACICLOVIR HYDROCHLORIDE DIHYDRATE

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

Version:

1

16 December 2015

Valaciclovir 500 mg
Film-Coated Tablets

TEVA UK Ref:

231-30-86543-Y LEA VALACICLOVIR 500mg TAB TUK
1

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.

2

BEFORE YOU TAKE VALACICLOVIR

Do NOT take Valaciclovir
• if you are allergic (hypersensitive) to valaciclovir
or aciclovir or any of the other ingredients of
Valaciclovir (listed in Section 6). If you are not
sure, talk to your doctor or pharmacist before
taking Valaciclovir.
Take special care with Valaciclovir
Check with your doctor or pharmacist before taking
Valaciclovir 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 Valaciclovir.
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.
Tell your doctor or pharmacist if you are taking any
other medicines that affect the kidneys. These
include aminoglycosides, organoplatinum
compounds, iodinated contrast media,

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
• You will usually start taking Valaciclovir as soon
as possible after your surgery
• You should take Valaciclovir for around 90 days
after your surgery, until your doctor tells you to
stop.
Your doctor may adjust the dose of Valaciclovir if:
• you are over 65 years of age
• you have a weak immune system
• you have kidney problems.
Talk to your doctor before taking Valaciclovir if any
of the above apply.
Taking this medicine
• Take this medicine by mouth
• Swallow the tablets whole with a drink of water
• Take Valaciclovir at the same time each day
• Take Valaciclovir according to instructions from
your doctor or pharmacist.
People over 65 years of age or with kidney
problems
It is very important while you are taking
Valaciclovir 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.

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 following side effects have also been reported:
the last day of the month
Very common (affects more than 1 in 10 patients
• Store below 30°C
receiving the medicine):
• Medicines should not be disposed of via
• headache.
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
Common (affects less than 1 in 10 patients
required. These measures will help to protect the
receiving the medicine):
environment.
• feeling sick
• dizziness
FURTHER INFORMATION
• vomiting
• diarrhoea
What
Valaciclovir
contains
• skin reaction after exposure to sunlight
• The active substance is valaciclovir. Each tablet
(photosensitivity)
contains 500 mg valaciclovir (as valaciclovir
• rash.
hydrochloride dihydrate)
Uncommon (affects less than 1 in 100 patients
• The other ingredients are maize starch,
receiving the medicine):
croscarmellose
sodium, sodium stearyl fumarate
• feeling confused
and cellulose powdered in the tablet core, and
• seeing or hearing things that aren’t there
hypromellose
(E464),
titanium dioxide (E171),
(hallucinations)
macrogol 400 and polysorbate 80 (E433) in the
• feeling very drowsy
film
coating.
• tremors
What Valaciclovir looks like and contents of the pack
• feeling agitated.
These nervous system side effects usually occur in • Valaciclovir are white, biconvex, oblong,
people with kidney problems, the elderly or in organ
film-coated tablets, debossed “VL”, breakline and
transplant patients taking high doses of 8 grams or
“D” on one side and plain on the other. The tablets
more of Valaciclovir a day. They usually get better
can be divided into equal halves
when Valaciclovir is stopped or the dose reduced.
• Valaciclovir are available in pack sizes of 1, 4, 6, 8,
10,
24, 30, 42, 90 and 112 film-coated tablets.
Other uncommon side effects:
Hospital packs of 50 (50 x 1) film-coated tablets are
• shortness of breath (dyspnoea)
also
available
• stomach discomfort
• Not all pack sizes may be marketed.
• rash, sometimes itchy, hive-like rash (urticaria)
• low back pain (kidney pain).
Marketing Authorisation Holder and Manufacturer
Uncommon side effects that may show up in blood The Marketing Authorisation holder and
tests:
manufacturer is TEVA UK Limited, Eastbourne,
• reduction in the number of white blood cells
BN22 9AG
(leucopenia)
This leaflet was last revised in December 2015
• reduction in the number of blood platelets which
PL 00289/1002
are cells that help blood to clot
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.

4

5

6

(thrombocytopenia)
• increase in substances produced by the liver.

86543-Y
20051580

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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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