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VALGANCICLOVIR 450MG FILM-COATED TABLETS

Active substance(s): VALGANCICLOVIR HYDROCHLORIDE

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PACKAGE LEAFLET:INFORMATION FOR THE PATIENT

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

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 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.
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 patients who are not infected with CMV
and who have received an organ transplant from somebody who
was infected by CMV.

you need to know before you take
2 What
Valganciclovir
Do not take Valganciclovir
• 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 breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking 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, 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
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 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)

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.
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
You should not take Valganciclovir if you are pregnant unless your
doctor recommends it.
Taking Valganciclovir when you are pregnant could harm your unborn
baby.
You must not take Valganciclovir if you are breastfeeding. If your
doctor wants you to begin treatment with Valganciclovir you must stop
breastfeeding before you start to take your tablets.
Women of childbearing age must use effective contraception when
taking Valganciclovir.
Men whose partners could become pregnant should use condoms
while taking Valganciclovir 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 Valganciclovir
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.
Valganciclovir tablets should, whenever possible, be taken with food –
see section 2.
Other suitable dosage forms are available for children and
adolescents who need dose adjustments.
Adults:
Prevention of CMV disease in transplant patients
You should start to take this medicine within 10 days of your transplant.
The recommended 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 recommended dose 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 recommended 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.
Continued on the next page >>

Elderly patients
Valganciclovir has not been studied in elderly patients.

• Effects on mood or behaviour: depression, feeling anxious,
confused, having unusual thoughts

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.

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
• 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

Patients with liver problems
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.
If you forget to take Valganciclovir
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 Valganciclovir
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
Valganciclovir 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 (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: diarrhea
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 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,
stomachache, 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)

Rare (may affect up to 1 in 1000 people):
• 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 valganciclovir 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 via the Yellow Card Scheme:
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.
Shelf life for bottles:
After first opening: 2 months
Do not use this medicine after the expiry date which is stated on the
label, carton, or bottle 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 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 Content of the pack and other information
What Valganciclovir contains
• The active substance is valganciclovir.
Each tablet contains 496.3 mg of valganciclovir hydrochloride
equivalent to 450 mg of valganciclovir (as free base).
• The other ingredients are:
Tablet core: Cellulose microcrystalline (PH101), Crospovidone
(Type A), Povidone (K-30), Stearic acid 50
• Film-coating: Opadry Pink 15B24005:
Hypromellose (3 cP), Hypromellose (6 cP), Titanium dioxide (E171),
Macrogol 400 , Iron oxide red (E172), Polysorbate 80
What Valganciclovir looks like and contents of the pack
Valganciclovir are pink, oval, biconvex, film coated tablets (16.7 x
7.8 mm), debossed with “J” on one side and “156” on the other side
embossed on the other side.
Aluminium/PVC/Aluminium/OPA blister: 10, 30, 60, 90, 120
film-coated tablets.
HDPE container with child resistant polypropylene screw caps: 60
film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, United Kingdom
Manufacturer
Salutas Pharma GmbH, Otto- von- Guericke- Allee 1, 39179 Barleben,
Germany or Lek Pharmaceuticals d.d., Verovskova ulica 57, 1526
Ljubljana, Slovenia or LEK S.A., Ul. Domaniewska 50 C, 02- 672
Warszawa, Poland
This leaflet was last revised in 11/2014.

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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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