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VALCYTE 50 MG/ML POWDER FOR ORAL SOLUTION

Active substance(s): VALGANCICLOVIR HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

Valcyte contains sodium
For patients on a sodium-controlled diet, this
medicinal product contains a total of 0.188 mg/ml
sodium.

Valcyte®
50 mg/ml

3. How to take Valcyte

powder for oral solution

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.

valganciclovir

You have to be careful when handling the
Valcyte solution. You should avoid getting the
solution on your skin or in your eyes. If you
accidentally get the solution on your skin,
wash the area thoroughly with soap and water.
If you accidentally get any solution in your
eyes, rinse your eyes thoroughly with water.

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.

You must stick to the daily dose of the
oral solution as instructed by your doctor
to avoid overdose.
Valcyte oral solution should, whenever
possible, be taken with food – see section 2.
It is important that you use the dispenser
provided in the pack to measure your dose
of Valcyte solution. Two dispensers are
provided in case one of them gets lost or
damaged. Each dispenser is designed to
measure up to a 500 mg amount of solution in
25 mg increments.

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

Always wash the dispenser thoroughly and
allow it to dry after you have taken your dose.
Contact your doctor or pharmacist if both
dispensers are lost or damaged, and they will
advise you on how to continue to take your
medication.

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 powder,
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.

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
900 mg Valcyte solution taken ONCE daily.
Use the dispenser provided to take two 450 mg
amounts (i.e. 2 dispensers filled to 450 mg
graduation) of solution. You should continue
with this dose for up to 100 days. If you have
received a kidney transplant, your doctor may
advise you to take the dose for 200 days.

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.

Treatment of active CMV retinitis in AIDS
patients (called induction treatment)
The usual dose is 900 mg of Valcyte solution
taken TWICE a day for 21 days (three weeks).
Use the dispenser provided and take two
450 mg amounts (i.e. 2 dispensers filled to
450 mg graduation) of the solution in the
morning and two 450 mg amounts (i.e.
2 dispensers filled to 450 mg graduation) in
the evening.
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.

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.

Longer term treatment to prevent
recurrence of active inflammation in AIDS
patients with CMV retinitis (called
maintenance treatment)
The usual dose is 900 mg Valcyte solution
taken ONCE daily. Use the dispenser provided
and take two 450 mg amounts of solution (i.e.
2 dispensers filled to 450 mg graduation).You
should try to take the solution 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.

Warnings and precautions
 alk to your doctor or pharmacist before
T
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
and more tests will be
done while you are
taking the medication.
● if you are having radiotherapy.
● 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.

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 a lower dose of
Valcyte solution each day. It is very
important that you follow the dose 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.
Use the dispenser provided in the pack to
measure the dose of Valcyte solution.
Method and route of administration
It is recommended that the Valcyte solution be
prepared by the pharmacist prior to it being
provided to you.
Once the solution has been prepared, follow
the instructions below to withdraw and take
your medication.

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 (an antibiotic)
● 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 taking your medication.
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.

child
safety
bottle
cap

DISPENSER

bottle
adapter

plunger

tip

1. Shake closed bottle well for about 5 seconds
before each use.
2. Remove the child-resistant cap.
3. Before inserting the tip of the dispenser into
bottle adapter, push the plunger completely
down toward the tip of the dispenser. Insert
tip firmly into opening of the bottle adapter.
4. Turn the entire unit (bottle and dispenser)
upside down.
5. Pull the plunger out slowly until the desired
amount of solution is withdrawn into the
dispenser (see diagram).
6. Turn the entire unit right side up and
remove the dispenser slowly from the
bottle.
7. Dispense directly into mouth and swallow.
Do not mix with any liquid prior to
dispensing.

Please turn over 

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8. Close bottle with child-resistant cap after
each use.
9. Immediately after administration:
Disassemble the dispenser, rinse under
running tap water and air dry prior to next
use.
Care should be taken to avoid contact of the
skin with the solution. If such contact occurs,
wash thoroughly with soap and water.
Do not use the solution after the expiry date
which is 49 days from the day of preparation.
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 Valcyte solution than you should. Taking
more than the recommended dose 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 dose of Valcyte 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 a missed dose.
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
● 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 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 (pruritus), 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 side effects (may affect 1 to
10 users in 1,000):
● 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 the powder after the expiry date
which is stated on the carton and bottle label
(EXP). The expiry date refers to the last day of
that month.
Powder: does not require any special storage
condition.
Reconstituted solution: Store in a refrigerator
(2°C - 8°C).
The shelf-life of the oral solution is 49 days.
Do not use the solution 49 days after
preparation or after the expiry date which will
be written on the bottle by the pharmacist.
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 to protect the
environment.

6. Contents of the pack and other
information
What Valcyte contains
The active substance is valganciclovir
hydrochloride. Following dissolution of the
powder, 1 ml solution contains 55 mg
valganciclovir hydrochloride corresponding to
50 mg valganciclovir as hydrochloride.
The other ingredients
(excipients) are: povidone,
fumaric acid, sodium
benzoate (E211), sodium
saccharin and mannitol,
tutti-frutti flavour
[maltodextrins (maize),
propylene glycol, arabic gum (E414) and
natural identical flavouring substances mainly
consisting of banana, pineapple and peach
flavour].
What Valcyte looks like and contents of the
pack
Valcyte powder is a granulate with a white to
slightly yellow colour. A quantity of 12 g
powder is supplied in a glass bottle. Upon
reconstitution, the volume of the solution is
100 ml, providing a usable volume of 88 ml.
The solution is clear and colourless to brown.
The pack also contains a bottle adapter and
2 dispensers that are graduated to 500 mg with
25 mg graduations.
Pack size: One bottle containing 12g powder.
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,
Luxembourg, Malta, The Netherlands,
Norway, Poland, Romania, Slovak Republic,
Slovenia, Spain, Sweden, United Kingdom
RoValcyte: France, Portugal
This leaflet was last revised in January 2015
-------------------------------------------------------The following information is intended for
healthcare professionals only:
It is recommended that the Valcyte solution be
prepared by a pharmacist as follows:
1. Measure 91 ml of water in a graduated
cylinder.
2. Remove the child resistant cap, add the
water to the bottle, close the bottle with the
child resistant cap and shake the closed
bottle until the powder is dissolved.
3. Remove the child resistant cap and push the
bottle adapter into the neck of the bottle.
4. Close the bottle with child resistant cap
tightly to assure the proper seating of the
bottle adapter in the bottle and child
resistant status of the cap.
5. Write the date of expiration of the solution
on the bottle label.
Avoid inhalation or direct contact of skin or
mucous membranes with the powder and
direct contact with the solution. If contact
occurs, wash thoroughly with soap and water;
rinse eyes with plain water.

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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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