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VALACICLOVIR 500 MG FILM-COATED TABLETS

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

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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 herpes
simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV).
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
2. BEFORE YOU TAKE VALACICLOVIR
Do not take Valaciclovir
·
if you are allergic (hypersensitive) to valaciclovir or aciclovir or
any of the other ingredients Valaciclovir (listed in Section 6).
·
Don't take Valaciclovir if this applies to you. 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.
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.
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,
methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus,
cimetidine and probenecid.
Always tell your doctor or pharmacist about other medicines if you
are taking Valaciclovir for treatment of shingles or after having an
organ transplant.

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Valaciclovir

PACKAGE LEAFLET: INFORMATION FOR THE USER
Valaciclovir 500 mg film-coated tablets
Valaciclovir
Read all of this leaflet carefully before you start taking this
medicine.
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. Do not pass it on to
others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please your doctor or
pharmacist.
In this leaflet:
1. What Valaciclovir is and what it is used for
2. Before you take Valaciclovir
3. How to take Valaciclovir
4. Possible side effect
5. How to store Valaciclovir
6. Further information

Valaciclovir

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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 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'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
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 (one 1000 mg tablet or two 500 mg
tablets) three times a day.
·
You should take Valaciclovir for seven days.
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) 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 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.
Children under 12 years of age
Valaciclovir should not be used in children under 12 years of age.
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.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Valaciclovir can cause side effects, although not
everybody gets them.
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 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)
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
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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
5. HOW TO STORE VALACICLOVIR
Keep out of the reach and sight of children.
Do not use Valaciclovir after the expiry date which is stated on the
carton after 'EXP:'. The expiry date refers to the last day of the
month.
This medicinal product does not require any special storage
conditions.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Valaciclovir contains
·
The active substance is valaciclovir.
Each film-coated tablet contains valaciclovir hydrochloride
(hydrated) equivalent to 500 mg valaciclovir.
·
The other ingredients are:
Tablet core: Cellulose, microcrystalline, crospovidone (Type
A), povidone (K-90), magnesium stearate
Film coat:
Hypromellose 6cP, indigo carmine aluminium lake
(E132), titanium dioxide (E171), macrogol 400,
polysorbate 80
What Valaciclovir look like and contents of the pack
Film-coated tablet.
Blue, film-coated, capsule shaped tablets with a partial score bar
on both sides containing 'F' on one side and '9' and '3' on the other
side.
The tablet can be divided into equal halves.
Valaciclovir film-coated tablets are available in clear PVC/PVdC
Aluminium foil blister.
Pack sizes;
Blister: 7, 10, 21, 30, 42, 50, 90 & 112 tablets
Bottle: 30 & 500 tablets
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the Member States of
the EEA under the following names:
France
Valaciclovir Arrow 500 mg, comprimé pelliculé
sécable
Germany
Valaciclovir Aurobindo 500 mg Filmtabletten
Italy
Valaciclovir Aurobindo 500 mg/ 1000 mg
compresse rivestite con film
Netherlands
Valaciclovir Aurobindo 500 mg, filmomhulde
tabletten
Portugal
Valaciclovir Aurobindo
Spain
Valaciclovir Aurobindo 500 mg/1000 mg
comprimidos recubiertos con película EFG
United Kingdom Valaciclovir 500 mg film-coated tablets
This leaflet was last approved in 09/2014.

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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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