Skip to Content

VALACICLOVIR 500 MG FILM-COATED TABLETS

Active substance(s): VALACICLOVIR HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PKG. DEV. PAONTA

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.

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 effects
5. How to store Valaciclovir
6. Further information
1. WHAT VALACICLOVIR IS AND WHAT IT IS
USED FOR
Valaciclovir are a prescription only anti viral
medicine.
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 to help prevent infections of the eye
2. BEFORE YOU TAKE VALACICLOVIR
Do not use Valaciclovir
- if you are allergic (hypersensitive) to
valaciclovir or aciclovir or any of the other
ingredients (listed in 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.
Take special care with Valaciclovir
Check with your doctor or pharmacist before
taking Valaciclovir if:
Ÿ
you have kidney problems
Ÿ
you have liver problems
Ÿ
you are over 65 years of age
Ÿ
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.

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.

If you forget to take Valaciclovir
If you forget to take Valaciclovir, take it as
soon as you remember. However, if it is almost
time for your next dose, skip the missed dose.
l
Do not take a double dose to make up for a
forgotten dose.

Driving and using machines
Valaciclovir can cause side effects such as
dizziness that affect your ability to drive.
→Don't drive or use machines unless you are sure
you're not affected.

If you want to stop taking Valaciclovir
You should not stop or adjust valaciclovir
treatment without consulting your medical
professional. Also when the symptoms disappear,
the course of treatment should be finished.
Otherwise the infection may recur

3. HOW TO TAKE VALACICLOVIR
Dosage
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
l
The usual dose is 1000 mg (one 1000 mg tablet
or two 500 mg tablets) three times a day.
l
You should take Valaciclovir for seven days.
Treatment of cold sores (in adults and adolescents
over 12 years old)
l
The usual dose is 2000 mg (two 1000 mg
tablets or four 500 mg tablets) twice a day.
l
The second dose should be taken 12 hours (no
sooner than 6 hours) after the first dose
l
You should take Valaciclovir for one day (two
doses) only.
You should start taking the tablets at the earliest
symptoms of cold sores (e.g tingling, itching or
burning)
Treatment of HSV infections of the skin and genital
herpes (in adults and adolescents over 12 years
old)
l
The usual dose is 500 mg (one 500 mg tablet or
two 250 mg tablets) twice a day.
l
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 (in adults and adolescents
over 12 years old)
l
The usual dose is one 500 mg tablet once a
day.
l
Some people with frequent recurrences may
benefit from taking one 250 mg tablet twice a
day.
l
You should take Valaciclovir until your doctor
tells you to stop.
To stop you being infected with CMV
(Cytomegalovirus)
l
The usual dose is 2000 mg (two 1000 mg
tablets or four 500 mg tablets) four times a day.
l
You should take each dose about 6 hours
apart.
l
You will usually start taking Valaciclovir as
soon as possible after your surgery.
l
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
l
you have a weak immune system
l
you have kidney problems.
→ Talk to your doctor before taking Valaciclovir if
any of the above apply.
l

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.
Pregnancy and breast-feeding
Valaciclovir is not usually recommended for use
during pregnancy. If you are pregnant, or think you

Black
Ref.
Blue

l

Taking this medicine
l
Take this medicine by mouth.
l
Swallow the tablets whole with a drink of water.
l
Take Valaciclovir at the same time each day.
l
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

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 label after EXP. The expiry date
refers to the last day of that month.
Store Valaciclovir below 30 °C.
Store Valaciclovir in the original packaging.
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

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 in some people. The following side effects
may happen with this medicine:
Conditions you need to look out for
Ÿ
severe allergic reactions (anaphylaxis). These
are rare in people taking Valaciclovir. Rapid
development of symptoms including:
Ÿ
flushing, itchy skin rash
Ÿ
swelling of the lips, face, neck and throat,
causing difficulty in breathing (angiodema)
Ÿ
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)
Ÿ
headache
Common (affects up to 1 in 10 people)
Ÿ
feeling sick
Ÿ
dizziness
Ÿ
vomiting
Ÿ
diarrhoea
Ÿ
skin reaction after exposure to sunlight
(photosensitivity).
Ÿ
rash
Ÿ
itching
Uncommon (affects up to 1 in 100 people)
Ÿ
feeling confused
Ÿ
seeing or hearing things that aren't there
(hallucinations)
Ÿ
feeling very drowsy
Ÿ
tremors
Ÿ
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:
Ÿ
shortness of breath (dyspnoea)
Ÿ
stomach discomfort
Ÿ
rash, sometimes itchy, hive-like rash (urticaria)
Ÿ
low back pain (kidney pain)
Ÿ
blood in the urine (haematuria)

The active substance is valaciclovir (as
hydrochloride)
The other ingredients are microcrystalline
cellulose (E460), crospovidone (E1202),
FD&C Blue #2 Aluminium Lake (11-14%)
(E132), povidone (K 30) (E1201), povidone (K
90D) (E1201), magnesium stearate (E470b),
opadry 02C 50740 Blue consisting of:
hypromellose (5 cP) (E464), titanium dioxide
(E171), macrogol/PEG 400, macrogol/PEG
6000, FD&C Blue #2 Aluminium Lake (3036%) (E132), polysorbate 80 (E433).

What Valaciclovir looks like and contents of the
pack
Valaciclovir are blue, capsule shaped, biconvex,
film-coated tablets with 'V' and '5' embossed on
each side of the score line on one side and a notch
on each side of the score line and smooth on the
other side of the tablet.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Ranbaxy (UK) Limited
Building 4, Chiswick Park,
566 Chiswick High Road,
London, W4 5YE
United Kingdom
Manufacturer
Ranbaxy Ireland Ltd., Spafield, Cork Road,
Cashel, Co-Tippererary, Ireland
Basics GmbH, Hemmelrather Weg 201, 51377
Leverkussen, Germany
This medicinal product is authorised in the
Member States of the EEA under the following
names:
The Netherlands Valaciclovir 500mg Ranbaxy
filmomhulde tabletten
United Kingdom Valaciclovir 500mg Film Coated
Tablets
This leaflet was last approved in February 2012.

Uncommon side effects that may show up in blood
tests:
Ÿ
frequent infections such as fever, severe chills,
sore throat or mouth ulcers. These symptoms
may be due to reduction in the number of white
blood cells (leucopenia)
Ÿ
reduction in the number of blood platelets
which are cells that help blood to clot
(thrombocytopenia)
Ÿ
increase in substances produced by the liver.
Rare (affects up to 1 in 1,000 people)
Ÿ
unsteadiness when walking and lack of
coordination (ataxia)
Ÿ
slow, slurred speech (dysarthria)
Ÿ
fits (convulsions)
Ÿ
altered brain function (encephalopathy)
Ÿ
unconsciousness (coma)
Ÿ
confused or disturbed thoughts
Ÿ
acute confusional state (delirium)
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.

5085011

Read all of this leaflet carefully before you
start using 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 tell your doctor or pharmacist.

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

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.

Hide