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VALACICLOVIR 250MG FILM-COATED TABLETS

Active substance(s): VALACICLOVIR HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Valaciclovir 250 mg and 500 mg film-coated tablets
Valaciclovir (as valaciclovir hydrochloride monohydrate)
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.
This medicine has been prescribed for you only. Do 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.






What is in this leaflet
1. What Valaciclovir tablets are and what they are used for
2. What you need to know before you take 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

Always tell your doctor or pharmacist about other medicines if
you are taking Valaciclovir 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, do not take Valaciclovir
without checking with your doctor.
Your doctor will weigh up the benefit to you against the risk to
your baby of taking Valaciclovir while you are pregnant or
breast-feeding.
Driving and using machines
Valaciclovir can cause side effects that affect your ability to drive.
Do not drive or use machines unless you are sure you are not
affected.
3. How to take Valaciclovir tablets

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).

Always take Valaciclovir tablets exactly as your doctor has told
you. You should check with your doctor or pharmacist if you are
not sure.

Valaciclovir can be used to:
treat shingles (in adults).
treat HSV infections of the skin and genital herpes (in adults
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).
prevent infection with CMV after organ transplants
(in adults and adolescents over 12 years old).
treat and prevent HSV infections of the eye.




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 (one 1000 mg tablet or two 500 mg
tablets) three times a day.
You should take Valaciclovir for seven days.

2. What you need to know before you take Valaciclovir tablets
Do NOT take Valaciclovir tablets
if you are allergic (hypersensitive) to valaciclovir or aciclovir or
any of the other ingredients of Valaciclovir tablets (see section 6).



Do not take Valaciclovir if this applies to you. If you are not sure,
talk to your doctor or pharmacist before taking Valaciclovir.
Warnings and precautions
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.
Prevent passing genital herpes on to others
If you are taking Valaciclovir 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
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.
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.




Treatment of cold sores
The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg
tablets) 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 500 mg (one 500 mg tablet or two 250 mg
tablets) twice a day.
For the first infection you should take Valaciclovir 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 one 500 mg tablet once a day.
Some people with frequent recurrences may benefit from
taking one 250 mg tablet twice a day.
You should take Valaciclovir until your doctor tells you to stop.





To stop you being infected with CMV (Cytomegalovirus)
The usual dose is 2000 mg (two 1000 mg tablets or 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.
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. Possible side effects
Like all medicines, valaciclovir can cause side effects in some
people.
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. 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 and see a
doctor straight away.



-

Very Common (affects more than 1 in 10 people):
headache



Common (affects up to 1 in 10 people)
feeling sick
dizziness
vomiting
diarrhoea
skin reaction after exposure to sunlight (photosensitivity)
rash








Uncommon (affects up to 1 in 100 people)
feeling confused
seeing or hearing things that are not there (hallucinations)
feeling very drowsy
tremors
feeling agitated
blood in urine








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)






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 up to 1 in 1,000 people)
unsteadiness when walking and lack of coordination (ataxia)
slow, slurred speech (dysarthria)
fits (convulsions)
altered brain function (encephalopathy)
unconsciousness (coma)
confused or disturbed thoughts
severe confusion









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:
kidney problems where you pass little or no urine.



If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
5. How to store Valaciclovir tablets
Keep out of the sight and reach of children.
Do not store above 30°C.
Do not use Valaciclovir tablets after the expiry date stated on the
label, carton or bottle. The expiry date refers to the last day of
that month.
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.
6. Contents of the pack and other information
What Valaciclovir tablets contain
The active substance is valaciclovir.
Each film-coated tablet contains 250 mg or 500 mg
valaciclovir (as valaciclovir hydrochloride monohydrate).
The other ingredients are microcrystalline cellulose,
povidone, magnesium stearate, hypromellose, hydroxypropyl
cellulose, titanium dioxide (E171) and macrogol.





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:
250 mg tablets: 13.8 x 6.9 mm with VC1 on one side
500 mg tablets: 17.6 x 8.8 mm with VC2 on one side
All strengths are available in blister packs or plastic tablet
containers of 4, 7, 10, 14, 28, 30, 42, 50, 56, 60, 90, 100 and 500
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road
Ealing, London
W5 5TL
Manufacturer
Actavis Hf.
Reykjavikurvegi 78,
IS-220 Hafnafjordur,
Iceland
This leaflet was last revised in 09/2012.

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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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