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VALCYTE 50 MG/ML POWDER FOR ORAL SOLUTION

Active substance: VALGANCICLOVIR HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

VALCYTE®

50 mg/ml
powder for oral solution
valganciclovir

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.

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

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

3. How to take VALCYTE
Always take VALCYTE exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
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.
You must stick to the daily dose of the
oral solution as instructed by your
doctor to avoid overdose.

1. What VALCYTE is and what it is
used for

VALCYTE oral solution should, whenever
possible, be taken with food – see section 2.

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.

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.

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.

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.

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
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.
Children and adolescents
Present studies do not sufficiently show how
the medicine is working 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)
– zidovudine, didanosine, lamivudine,
tenofovir, abacavir, emtricitabine or
similar kinds of drugs 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)

Always wash the dispenser thoroughly and
allow it to dry after you have taken your dose.

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.
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.
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.
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 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.
child
safety
bottle
cap

DISPENSER

bottle
adapter

plunger

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 taking
your medication.
Women of childbearing age must use
effective contraception when taking
VALCYTE.

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.
10139993 GB 1207.1075

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.
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 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
1,000.
– 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 (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
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.
Powder: does not require any special storage
condition.
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.
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.
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, Cyprus,
Czech Republic, Denmark, Estonia, Finland,
Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg,
The Netherlands, Slovak Republic, Spain,
Sweden, United Kingdom
ROVALCYTE: France, Portugal
This leaflet was last revised in
April 2013
----------------------------------------------------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.
10139993 GB 1207.1075

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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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