VALACICLOVIR 500MG TABLETS

Active substance: VALACICLOVIR HYDROCHLORIDE

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Valaciclovir 500mg tablets
Read all of this 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 further questions, ask your doctor or

pharmacist.
•   his medicine has been prescribed for you only. Do
T
not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist.This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet:
1 What Valaciclovir tablets are and what they
are used for
2  hat you need to know before you take
W
Valaciclovir tablets
3 How to take Valaciclovir tablets
4 Possible side effects
5 How to store Valaciclovir tablets
6 Contents of the pack and other information
1 What Valaciclovir tablets are and what they

are used for

Valaciclovir 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).
Valaciclovir can be used to:
• treat shingles (in adults).
•  reat HSV infections of the skin and genital herpes (in adults
t
and adolescents over 12 years old). It is also used to help
prevent these infections from returning.
• treat cold sores (in adults and adolescents over 12 years old).
•  revent infection with CMV after organ transplants (in adults
p
and adolescents over 12 years old).
• treat and prevent HSV infections of the eye.

2  hat you need to know before you take
W

Valaciclovir tablets

Do not take Valaciclovir tablets

• f you are allergic to valaciclovir or aciclovir or any of the
i
other ingredients of this medicine (listed in Section 6).
•  o not take Valaciclovir tablets if this applies to you. If you
D
are not sure, talk to your doctor or pharmacist before taking
Valaciclovir tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valaciclovir
tablets 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.

Prevent passing genital herpes on to others

If you are taking Valaciclovir tablets 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 Valaciclovir tablets

Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
This includes medicines obtained without a prescription,
including herbal medicines.
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AAAG2058

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 Valaciclovir tablets for treatment of shingles or
after having an organ transplant.

Pregnancy and breast-feeding

Valaciclovir 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 Valaciclovir
tablets without checking with your doctor. Your doctor
will weigh up the benefit to you against the risk to your
baby of taking Valciclovir tablets while you’re pregnant or
breastfeeding.

Driving and using machines

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

3 How to take Valaciclovir tablets
Always take this medicine exactly as your doctor has told you.
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 Valciclovir tablets for you. Your doctor
will discuss this with you.

• Treatment of shingles

The usual dose is 1000mg three times a day. You should take
Valaciclovir tablets for seven days.

• Treatment of cold sores

The usual dose is 2000mg twice a day. The second dose should
be taken 12 hours (no sooner than 6 hours) after the first dose.
You should take valaciclovir for one day (two doses) only.

• Treatment of HSV infections of the skin and genital

herpes
The usual dose is 500mg twice a day. For the first infection
you should take Valaciclovir tablets for five days 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 250mg twice a day. Taking one 250mg tablet
twice a day may give benefit to some people with frequent
recurrences (instead of one 500mg tablet once a day). You
should take Valaciclovir tablets until your doctor tells you to
stop.

• To stop you being infected with CMV

(Cytomegalovirus)

The usual dose is 2000mg four times a day. You should take
each dose about 6 hours apart. You will usually start taking
Valaciclovir tablets as soon as possible after your surgery. You
should take Valaciclovir tablets for around 90 days after your
surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of valaciclovir
tablets 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 tablets 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 tablets at the same time each
day. Take Valaciclovir tablets according to instructions from
your doctor or pharmacist.

continued over page

Valaciclovir 500mg Film Coated Tablets PIL - UK
item no: AAAG2058

dimensions: 170 x 320

print proof no: 3

pharmacode:

origination date: 12.11.13

min pt size: 8pts

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 27.11.13

Technical Approval

revised by: S.Anson

date sent: 12.11.13

supplier: Actavis Iceland

technically app. date: 14.11.13

Non Printing Colours
1.
2.
3.

People over 65 years of age or with kidney problems
It is very important while you are taking valaciclovir
tablets 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.
Children below 12 years of age
Valaciclovir tablets are not recommended for use in children
below 12 years of age.
If you take more valaciclovir tablets 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 tablets
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.

Other rare side effects:
• kidney problems where you pass little or no urine.

Reporting of side effects

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 internet at
www.mhra.gov.uk/yellowcard. Alternatively you can call
Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m.
Mondays to Fridays) or fill in a paper form available from your
local pharmacy. By reporting side effects you can help provide
more information on the safety of this medicine.

5 How to store Valaciclovir tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated
on the label, carton or bottle after EXP. The expiry date refers
to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect
the environment.

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

• severe allergic reactions (anaphylaxis). These are rare in

people taking valaciclovir tablets. Rapid development of
symptoms including: flushing, itchy skin rash, swelling of
the lips, face, neck and throat, causing difficulty in breathing
(angiodema), fall in blood pressure leading to collapse.
If you have an allergic reaction, stop taking valaciclovir tablets
and see a doctor straight away.
Very Common (affects more than 1 user in 10):
• headache
Common (affects 1 to 10 users in 100):
• feeling sick
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight (photosensitivity).
• rash
Uncommon (affects 1 to 10 users in 1,000):
• feeling confused
• seeing or hearing things that aren’t there (hallucinations)
• feeling very drowsy
• tremors
• feeling agitated
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 uncommon side effects:
• shortness of breath (dyspnoea)
• stomach discomfort
• rash, sometimes itchy, hive-like rash (urticaria)
• low back pain (kidney pain)
• blood in the urine (haematuria)

6 Contents of the pack and other information
What Valaciclovir tablets contain

•  he active substance is valaciclovir. Each tablet contains
T
500mg valaciclovir (as valaciclovir hydrochloride
monohydrate).
•  he other ingredients are tablet core: cellulose
T
microcrystalline, povidone, magnesium stearate,
tablet coating (Opadry White Y-5-7068): hypromellose,
hydroxypropyl cellulose, titanium dioxide (E171), macrogol
400, hypromellose.
What Valaciclovir tablets look like and contents of the
pack
Valaciclovir tablets are oval, white, biconvex and film-coated
with the following size and markings:
500mg tablets: 17.6 x 8.8mm with VC2 on one side
PVC/aluminium blister
Pack sizes (Blisters): 10, 20, 21, 24, 30, 42, 60, 90 film-coated
tablets
HDPE containers with tamper evident LDPE cap
Pack sizes (Bottles): 10, 30, 100, 250 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Actavis Group PTC ehf,
Reykjavikurvegur 76-78,
220 Hafnarfjordur,
Iceland
Manufacturer
Actavis hf
Reykjavikurvegur 76
IS-220 Hafnarfjordur,
Iceland
This leaflet was last revised in November 2013.

Uncommon side effects that may show up in blood tests:
• reduction in the number of white blood cells (leucopenia)
• reduction in the number of blood platelets which are cells that

help blood to clot (thrombocytopenia)
• increase in substances produced by the liver.
Rare (affects 1 to 10 users in 10,000)
• unsteadiness when walking and lack of coordination (ataxia)
• slow, slurred speech (dysarthria)
• fits (convulsions)
• altered brain function (encephalopathy)
• unconsciousness (coma)
• confused or disturbed thoughts
• disorientation and confusion often accompanied by

hallucinations (delirium)
These nervous system side effects usually occur in people with
kidney problems, the elderly or in organ transplant patients
taking high doses of 8grams or more of valaciclovir a day. They
usually get better when valaciclovir is stopped or the dose
reduced.
continued top of next column
AAAG2058

Valaciclovir 500mg Film Coated Tablets PIL - UK
item no: AAAG2058

dimensions: 170 x 320

print proof no: 3

pharmacode:

origination date: 12.11.13

min pt size: 8pts

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 27.11.13

Technical Approval

revised by: S.Anson

date sent: 12.11.13

supplier: Actavis Iceland

technically app. date: 14.11.13

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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