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VALGANCICLOVIR 450 MG FILM-COATED TABLETS

Active substance(s): VALGANCICLOVIR HYDROCHLORIDE

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TEVA UK Ref:

231-30-82232-B LEA VALGANCICLOVIR 450mg FC TABS TUK
VALGANCICLOVIR 450 MG
FILM-COATED TABLETS
Package leaflet: Information for the user

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.

Version:

4

Pregnancy, breast-feeding and fertility
Pregnancy
You should not take Valganciclovir if you are
pregnant unless your doctor recommends
it. If you are pregnant or planning to
become pregnant you must tell your doctor.
Taking Valganciclovir when you are
pregnant could harm your unborn baby.
Breast-feeding
You must not take Valganciclovir if you are
breast-feeding. If your doctor wants you to
begin treatment with Valganciclovir, you
must stop breast-feeding before you start
taking this medicine.
Fertility
Women of childbearing age
Women of childbearing age must use
effective contraception when taking
Valganciclovir.

Men
Men whose partners could become
1. What Valganciclovir is and what it is used pregnant should use condoms while taking
for
Valganciclovir and should continue to use
2. What you need to know before you take
condoms for 90 days after treatment has
Valganciclovir
finished.
3. How to take Valganciclovir
Driving and using machines
4. Possible side effects
Do not drive or use any tools or machines if
5. How to store Valganciclovir
you feel dizzy, tired, shaky or confused
6. Contents of the pack and other
while taking this medicine.
information
What is in this leaflet:

1

What Valganciclovir is and what it
is used for

Valganciclovir belongs to a group of
medicines, which work directly to prevent
the growth of viruses. In the body, the
active ingredient in the tablet called
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.
Valganciclovir 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 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 Valganciclovir

Do not take Valganciclovir:
• if you are allergic to valganciclovir or any
of the other ingredients of Valganciclovir
(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 Valganciclovir.
Take special care with Valganciclovir
• 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 Valganciclovir
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 Valganciclovir 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 Valganciclovir
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 Valganciclovir, 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 Valganciclovir can cause
convulsions (fits)
• zidovudine, didanosine or similar kinds of
drugs used to treat AIDS
• probenecid (a medicine against gout).
Taking probenecid and Valganciclovir 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/sulfa
combinations and dapsone (antibiotics)
• pentamidine (drug to treat parasite or
lung infections)
• flucytosine or amphotericin B (anti-fungal
agents).
Valganciclovir with food and drink
Valganciclovir should be taken with food. If
you are unable to eat for any reason, you
should still take your dose of Valganciclovir
as usual.

Valganciclovir contains lactose
Sugar intolerance
This medicine contains lactose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
Ask your doctor or pharmacist for advice
before taking any medicine.

3

How to take Valganciclovir

Always take this medicine exactly as your
doctor or pharmacist has told you to. 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.
Valganciclovir 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 of Valganciclovir 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 Valganciclovir. 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
Valganciclovir has not been studied in
elderly.
Renal impairment
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.
Hepatic impairment
Valganciclovir 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.
If you take more Valganciclovir 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.

08 March 2016

TEVA UK Ref:

231-30-82232-B LEA VALGANCICLOVIR 450mg FC TABS TUK
Version:

4

• effects on mood or behaviour: having
If you forget to take Valganciclovir
unusual changes in mood and behaviour,
If you forget to take your tablets, take the
losing contact with reality such as hearing
missed dose as soon as you remember and
voices or seeing things that are not there,
take the next dose at the usual time. Do not
feeling agitated.
take a double dose to make up for the
forgotten tablets.
Rare: may affect up to 1 in 1,000 people
• effects on the blood: failure of the
If you stop taking Valganciclovir
production of all types of blood cells (red
You must not stop taking your medicine
blood cells, white blood cells and
unless your doctor tells you to.
platelets) in the bone marrow.
If you have any further questions on the use
Separation of the inner lining of the eye
of this medicine, ask your doctor or
(detached retina) has only happened in
pharmacist.
AIDS patients treated with Valganciclovir for
CMV infection.
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 Valganciclovir and go to the accident
and emergency department at your nearest
hospital immediately 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: may affect more than 1 in 10
people
• 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: may affect up to 1 in 10 people
• 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
neurophathy), 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
• 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.
Uncommon: may affect up to 1 in 100
people
• 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

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 via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

5

How to store Valganciclovir

Keep this medicine out of the sight and
reach of children.
Do not use Valganciclovir 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 condition.
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 to protect the environment.

6

Contents of the pack and other
information

What Valganciclovir contains
The active substance is 450 mg of
valganciclovir, present as 496.3 mg of
valganciclovir hydrochloride.
The other ingredients in the tablet are
microcrystalline cellulose (E460(i)),
mannitol (E421), magnesium stearate
(E572), colloidal anhydrous silica (E551),
crospovidone, type A (E1202). The
ingredients in the film-coat are
hypromellose (E464), lactose monohydrate,
titanium dioxide (E171), triacetin (E1518)
and iron oxide red (E172).
What Valganciclovir looks like and contents
of the pack
Valganciclovir tablets are oval, pink
film-coated tablets with bevelled edges and
debossing “93” on one side, “5465” on the
other side.
Valganciclovir 450 mg Film-coated Tablets
are available in the following pack sizes:
PVC/ACLAR/PVC//Aluminium blister
available in packs of 10, 30 and 60 tablets.
High density polyethylene (HDPE) bottles
with one canister of desiccant (3 g) and a
polypropylene (PP) child resistant closures
available in packs of 30 and 60 tablets.
For bottles:
The medicine should be used within 9
months after the first opening of the bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG,
UK
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, 10000 Zagreb
Croatia
This leaflet was last revised in: 03/2016
PL 00289/1798

82232-B
500 x 155

08 March 2016

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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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