VALCYTE 450MG FILM-COATED TABLETS

Active substance: VALGANCICLOVIR HYDROCHLORIDE

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Package Leaflet:
Information for the user

VALCYTE® 450 mg
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.
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 treatment of CMV-infections
of the retina of the eye in 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
patients 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.

Children and adolescents

Present studies do not sufficiently show
how the medicine works in children.

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)
- zalcitabine, zidovudine, didanosine
or similar kinds of drugs used to
treat AIDS
10144180_NP9344.indd 1

- 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, foscarnet, or nucleoside
analogues
used
against
viral
infections
- trimethoprim, trimethoprim/sulpha
combinations and dapsone (antibiotics)
- pentamidine (drug to treat parasite
or lung infections)
- flucytosine or amphotericin B (antifungal 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
breast-feeding. If your doctor wants
you to begin treatment with VALCYTE
you must stop breast-feeding before
you start to take your tablets.
Women of childbearing age must use
effective contraception when taking
VALCYTE.
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.

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.
10144180 GB 1212.1078

13.12.2012 16:18:44

Patients with kidney problems

● 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

Patients with liver problems

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

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.
VALCYTE has not been studied in
patients with liver problems.

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 means that the effect
may occur in more than 1 in every
10 patients.
– Common means that the effect may
occur in 1 to 10 users in 100.
– Uncommon means
that the effect may
occur in 1 to 10 users
in 1000.
– Rare means that the
effect may occur in
1 to 10 users in
10,000.
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
● Effects on breathing: feeling short
of breath or having trouble breathing
(dyspnoea)
● Effects on the stomach and digestive
system: diarrhoea
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 back 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
10144180_NP9344.indd 2

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
If you get any side effects, talk to your
doctor or pharmacist. This includes any
side effects not listed in this leaflet.

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.

6. Contents of the pack and
other information
What VALCYTE contains
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 filmcoated 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,
Cyprus, Czech Republic, Denmark,
Estonia, Finland, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxemburg, The Netherlands,
Norway, Poland, Romania, Slovak
Republic, Spain, Sweden, United
Kingdom
RoVALCYTE: France, Portugal
This leaflet was last revised in
December 2012
10144180 GB 1212.1078

13.12.2012 16:18:45

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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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