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VALCYTE 450MG FILM-COATED TABLETS

Active substance: VALGANCICLOVIR HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Women of childbearing age must use effective
contraception when taking Valcyte.

Valcyte® 450 mg

Men whose partners could become pregnant
should use condoms while taking Valcyte and
should continue to use condoms for 90 days
after treatment has finished.

film-coated tablets
valganciclovir
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.
See section 4.
What is in this leaflet:
1. What Valcyte is and what it is used for
2. What you need to know before you take
Valcyte
3. How to take Valcyte
4. Possible side effects
5. How to store Valcyte
6. Contents of the pack and other information

1. What Valcyte is and what it is
used for
Valcyte belongs to a group of medicines,
which work directly to prevent the growth of
viruses. In the body the active ingredient in the
tablets, valganciclovir, is changed into
ganciclovir. Ganciclovir prevents a virus
called cytomegalovirus (CMV) from
multiplying and invading healthy cells. In
patients with a weakened immune system,
CMV can cause an infection in the body’s
organs. This can be life threatening.
Valcyte is used:
● for the treatment of CMV-infections of the
retina of the eye in adult patients with
acquired immunodeficiency syndrome
(AIDS). CMV-infection of the retina of the
eye can cause vision problems and even
blindness.
● to prevent CMV-infections in adults and
children who are not infected with CMV
and who have received an organ transplant
from somebody who was infected by CMV.

2. What you need to know before
you take Valcyte
Do not take Valcyte:
● if you are allergic to valganciclovir or any
of the other ingredients of this medicine
(listed in section 6).
● if you are allergic to ganciclovir, acyclovir
or valaciclovir, which are medicines used to
treat other virus infections.
● if you are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Valcyte.
Take special care with
Valcyte
● if you have low
numbers of white blood
cells, red blood cells or
platelets (small cells
involved in blood
clotting) in your blood.
Your doctor will carry
out blood tests before
you start taking Valcyte
tablets and more tests
will be done while you
are taking the tablets.
● if you are having radiotherapy or
haemodialysis
● if you have a problem with your kidneys.
Your doctor may need to prescribe a
reduced dose for you and may need to
check your blood frequently during
treatment.
● if you are currently taking ganciclovir
capsules and your doctor wants you to
switch to Valcyte tablets. It is important that
you do not take more than the number of
tablets prescribed by your doctor or you
could risk an overdose.
Other medicines and Valcyte
Tell your doctor or pharmacist if you are
taking, have recently taken, or might take any
other medicines, including medicines obtained
without a prescription.
If you take other medicines at the same time as
taking Valcyte the combination could affect
the amount of drug that gets into your blood
stream or could cause harmful effects. Tell
your doctor if you are already taking
medicines that contain any of the following:
● imipenem-cilastatin (an antibiotic). Taking
this with Valcyte can cause convulsions
(fits)
● zidovudine, didanosine, lamivudine,
tenofovir, abacavir, emtricitabine or similar
kinds of drugs used to treat AIDS
● ribavirin, pegylated interferons, adefovir
and entecavir used to treat Hepatitis B/C
● probenecid (a medicine against gout).
Taking probenecid and Valcyte at the same
time could increase the amount of
ganciclovir in your blood
● mycophenolate mofetil (used after
transplantations)
● vincristine, vinblastine, adriamycin,
hydoxyurea or similar kinds of drugs to
treat cancer
● cidofovir or foscarnet used against viral
infections
● trimethoprim, trimethoprim/sulpha
combinations and dapsone (antibiotics)
● pentamidine (drug to treat parasite or lung
infections)
● flucytosine or amphotericin B (anti-fungal
agents)
Valcyte with food and drink
Valcyte should be taken with food. If you are
unable to eat for any reason, you should still
take your dose of Valcyte as usual.
Pregnancy, breast-feeding and fertility
You should not take Valcyte if you are
pregnant unless your doctor recommends it.
If you are pregnant or planning to become
pregnant you must tell your doctor. Taking
Valcyte when you are pregnant could harm
your unborn baby.
You must not take Valcyte if you are breastfeeding. If your doctor wants you to begin
treatment with Valcyte you must stop breastfeeding before you start to take your tablets.

Driving and using machines
Do not drive or use any tools or machines if
you feel dizzy, tired, shaky or confused while
taking this medicine.
Ask your doctor or pharmacist for advice
before taking any medicine.

3. How to take Valcyte
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
You have to be careful when handling your
tablets. Do not break or crush them. You
should swallow them whole and with food
whenever possible. If you accidentally touch
damaged tablets, wash your hands thoroughly
with soap and water. If any powder from the
tablets gets in your eyes, rinse your eyes with
sterile water or clean water if you do not have
sterile water.
You must stick to the number of tablets as
instructed by your doctor to avoid overdose.
Valcyte tablets should, whenever possible, be
taken with food – see section 2.
Adults:
Prevention of CMV disease in transplant
patients
You should start to take this medicine within
10 days of your transplant. The usual dose is
two tablets taken ONCE daily. You should
continue with this dose for up to 100 days
following your transplant. If you have received
a kidney transplant, your doctor may advise
you to take the tablets for 200 days.
Treatment of active CMV retinitis in AIDS
patients (called induction treatment)
The usual dose Valcyte is two tablets taken
TWICE a day for 21 days (three weeks). Do
not take this dose for more than 21 days unless
your doctor tells you to, as this may increase
your risk of possible side effects.
Longer term treatment to prevent
recurrence of active inflammation in AIDS
patients with CMV retinitis (called
maintenance treatment)
The usual dose is two tablets taken ONCE
daily. You should try to take the tablets at the
same time each day. Your doctor will advise
you how long you should continue to take
Valcyte. If your retinitis worsens while you are
on this dose, your doctor may tell you to
repeat the induction treatment (as above) or
may decide to give you a different medicine to
treat the CMV infection.
Elderly patients
Valcyte has not been studied in elderly
patients.
Patients with kidney problems
If your kidneys are not working properly, your
doctor may instruct you to take fewer tablets
each day or only to take
your tablets on certain
days each week. It is very
important that you only
take the number of tablets
prescribed by your doctor.
Patients with liver problems
Valcyte has not been studied in patients with
liver problems.
Use in children and adolescents:
Prevention of CMV disease in transplant
patients
Children should start to take this medicine
within 10 days of their transplant. The dose
given will vary depending on the size of the
child and should be taken ONCE daily. Your
doctor will decide the most appropriate dose
based on your child’s height, weight and renal
function. You should continue with this dose
for up to 100 days. If your child has received a
kidney transplant, your doctor may advise you
to take the dose for 200 days.
For children who are unable to swallow
Valcyte film-coated tablets, Valcyte powder for
oral solution can be used.
If you take more Valcyte than you should
Contact your doctor or hospital immediately if
you have taken, or think that you have taken,
more tablets than you should. Taking too many
tablets can cause serious side effects,
particularly affecting your blood or kidneys.
You may need hospital treatment.
If you forget to take Valcyte
If you forget to take your tablets take the missed
dose as soon as you remember and take the next
dose at the usual time. Do not take a double
dose to make up for the forgotten tablets.
If you stop taking Valcyte
You must not stop taking your medicine unless
your doctor tells you to.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets them.
Allergic reactions
Up to 1 in every 100 people may have a
sudden and severe allergic reaction to
valganciclovir (anaphylactic shock). STOP
taking Valcyte and go to the accident and
emergency department at your nearest hospital
if you experience any of the following:
● a raised, itchy skin rash (hives)
● sudden swelling of the throat, face, lips and
mouth which may cause difficulty
swallowing or breathing
● sudden swelling of the hands, feet or ankles.
The side effects that have occurred during
treatment with valganciclovir or ganciclovir
are given below.
Very common side effects (may affect more
than 1 in 10 users):
● Effects on the blood: a reduction in the
number of white blood cells in the blood
(neutropenia) - which will make you more
likely to get infections, a reduction in the
pigment in the blood that carries oxygen
(anaemia) - which can cause tiredness and
breathlessness when you exercise

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● Effects on breathing: feeling short of breath
or having trouble breathing (dyspnoea)
● Effects on the stomach and digestive
system: diarrhoea

6. Contents of the pack and other
information
What Valcyte contains

Common side effects (may affect 1 to 10 users
in 100):
● Effects on the blood: a reduction in the
number of leucocytes (blood cells that fight
infection) in the blood (leucopenia), a
reduction in the number of platelets in the
blood (thrombocytopenia) - which can
cause bruising and bleeding, a reduction in
the number of several types of blood cells at
the same time (pancytopenia)
● Effects on the nervous system: headache,
difficulty sleeping (insomnia), strange tastes
(dysgeusia), becoming less sensitive to
touch (hypoaesthesia), prickly or tingling
skin (paraesthesia), loss of feeling in the
hands or feet (peripheral neuropathy),
dizziness, fits (convulsions)
● Effects in the eye: eye pain, swelling within
the eye (oedema), separation of the inner
lining of the eye (detached retina), seeing
floaters
● Effects in the ear: earache
● Effects on breathing: coughing
● Effects on the stomach and digestion:
feeling and being sick, stomach ache,
constipation, wind, indigestion (dyspepsia),
difficulty swallowing (dysphagia)
● Effects on the skin: inflamed skin
(dermatitis), itching (pruritis), sweating at
night
● Effects on the muscles, joints or bones:
back pain, pain in the muscles (myalgia) or
joints (arthralgia), stiff muscles (rigor),
muscle cramps
● Infections: fungal infection in the mouth
(oral candidiasis), infections caused by
bacteria or viruses in the blood,
inflammation of cellular tissue (cellulitis),
inflammation or infection of the kidneys or
bladder
● Effects in the liver: a rise in some liver
enzymes, which will only be seen during
blood tests
● Effects in the kidney: changes to the normal
working of the kidneys
● Effects on eating: loss of appetite
(anorexia), weight loss
● General effects: tiredness, fever, pain, chest
pain, loss of energy (asthenia), generally
feeling unwell (malaise)
● Effects on mood or behaviour: depression,
feeling anxious, confused, having unusual
thoughts

The active substance is 450 mg of
valganciclovir, present as 496.3 mg of
valganciclovir hydrochloride.
The other ingredients (excipients) in the tablet
are Povidone K30, crospovidone,
microcrystalline cellulose and stearic acid. The
ingredients in the film-coat are hypromellose,
titanium dioxide (E171), macrogol 400, red
iron oxide (E172) and polysorbate 80.
What Valcyte looks like and contents of the
pack
Valcyte tablets are pink oval film-coated
tablets marked “VGC” on one side and
“450” on the other side.
They are packed in bottles containing
60 film-coated tablets.
Marketing Authorisation Holder
Roche Products Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW, United Kingdom
Manufacturer
Roche Pharma AG
Emil-Barell-Str.1
D-79639 Grenzach-Wyhlen
Germany
This medicinal product is authorised in the
Member States of the EEA under the
following names:
Valcyte: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia,
Finland, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Liechtenstein, Lithuania,
Luxemburg, Malta, The Netherlands, Norway,
Poland, Romania, Slovak Republic, Slovenia,
Spain, Sweden, United Kingdom
RoValcyte: France, Portugal
This leaflet was last revised in January 2015

Uncommon side effects (may affect 1 to
10 users in 1000):
● Effects in the heart: changes to the normal
heart beat (arrhythmia)
● Effects on circulation: low blood pressure
(hypotension), which can cause you to feel
light headed or faint
● Effects on the blood: a decrease in the
production of blood cells in the bone
marrow
● Effects in the nerves: shaking or trembling
(tremor)
● Effects in the eyes: red, swollen eyes
(conjunctivitis), abnormal vision
● Effects in the ears: deafness
● Effects on the stomach or digestion:
swollen stomach, mouth ulcers,
inflammation of the pancreas (pancreatitis)
where you may notice severe pain in the
stomach and back
● Effects on the skin: hair
loss (alopecia), itchy
rash or swellings
(urticaria), dry skin
● Effects in the kidneys:
blood in the urine
(haematuria), kidney
failure
● Effects in the liver: a rise in the liver
enzyme called alanine aminotransferase
(which will only be seen during blood tests)
● Effects on fertility: infertility in men
● Effects on mood or behaviour: having
unusual changes in mood and behaviour,
losing contact with reality such as hearing
voices or seeing things that are not there,
feeling agitated
Rare side effects (may affect 1 to 10 users in
10,000):
● Effects on the blood: failure of the
production of all types of blood cells (red
blood cells, white blood cells and platelets)
in the bone marrow
Separation of the inner lining of the eye
(detached retina) has only happened in AIDS
patients treated with Valcyte for CMV
infection.
Additional side effects in children and
adolescents
The side effects reported in children and
adolescents are similar to the side effects
reported for adults.
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 (see details below).
By reporting side effects you can help provide
more information on the safety of this
medicine.
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL-Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting
Website:
http://www.medicinesauthority.gov.mt/adrportal
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

5. How to store Valcyte
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 and carton after
EXP. The expiry date refers to the last day of
that month.
This medicine does not require any special
storage conditions.
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.

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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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