contains the active ingredient valganciclovir
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common questions about VALGANCICLOVIR MYLAN tablets.
It does not contain all the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
VALGANCICLOVIR MYLAN against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What VALGANCICLOVIR MYLAN is used for
VALGANCICLOVIR MYLAN contains the active ingredient valganciclovir. In the body valganciclovir
rapidly changes to ganciclovir.
VALGANCICLOVIR MYLAN belongs to a class of medicines used to prevent the growth of
VALGANCICLOVIR MYLAN acts against a virus called cytomegalovirus or CMV (a type of
herpes virus). It prevents this virus from growing and multiplying in the body. CMV
causes infections, mainly in people with poor immunity. Poor immunity can be caused
by HIV/AIDS or by medications taken after an organ transplant.
VALGANCICLOVIR MYLAN is used to treat CMV eye infections (known as CMV retinitis)
in AIDS patients, which, if left untreated can cause blindness. It is not a cure for
CMV eye infections.
VALGANCICLOVIR MYLAN is not effective against any underlying HIV infection.
VALGANCICLOVIR MYLAN is also used to prevent CMV infection in patients following organ
Your doctor, however, may have prescribed VALGANCICLOVIR MYLAN for another purpose.
Ask your doctor if you have any questions about why VALGANCICLOVIR MYLAN has been
prescribed for you.
VALGANCICLOVIR MYLAN is not addictive.
This medicine is available only with a doctor's prescription.
Before you take VALGANCICLOVIR MYLAN
Animal and other laboratory studies have shown VALGANCICLOVIR MYLAN causes infertility,
birth defects and cancer. It is possible that these effects may also occur in humans.
When you must not take it
Do not take VALGANCICLOVIR MYLAN if you have an allergy to:
ganciclovir, valaciclovir or aciclovir or any ingredients listed at the end of this
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you have very low blood counts for platelets (which help
clotting), neutrophils (a type of white blood cell which defends against infection)
or low haemoglobin (oxygen carrying substance in the blood).
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking VALGANCICLOVIR MYLAN, talk to
Use in children
There is limited information on the safety and effectiveness of the use of VALGANCICLOVIR
MYLAN in children. Your doctor will advise you whether VALGANCICLOVIR MYLAN is suitable
for your child.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if:
1. you are pregnant or intend to become pregnant.
VALGANCICLOVIR MYLAN is not recommended for use during pregnancy. VALGANCICLOVIR MYLAN
may affect your developing baby if you take it during pregnancy. Your doctor will
discuss the risks and benefits of using VALGANCICLOVIR MYLAN if you are pregnant.
2. you are breastfeeding or intend to breastfeed.
It is not known whether VALGANCICLOVIR MYLAN passes into breast milk. Breast-feeding
is not recommended during therapy with VALGANCICLOVIR MYLAN.
3. you are allergic to any other medicines, foods, dyes or preservatives.
Especially any medicine which you have taken previously to treat your current condition.
4. you have, or have had any other health problems, especially the following:
you have a history of low blood counts for platelets (thrombocytopenia), neutrophils
(neutropenia) or anaemia
you have, or previously have had, poor kidney function.
If you have not told your doctor about any of the above, tell him/her before you start
taking VALGANCICLOVIR MYLAN.
Taking other medicines
Tell your doctor and pharmacist if you are taking any other medicines, including any
that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with VALGANCICLOVIR MYLAN. These medicines include:
probenecid, a medicine used to treat gout
zidovudine (AZT) a medicine used to treat HIV infection
didanosine (ddI), a medicine used to treat HIV infection
imipenem/cilastatin, a combination of medicines used to treat some infections
mycophenolate mofetil, a medicine used to prevent organ rejection after a transplant
medicines for the treatment of cancer such as vincristine, adriamycin, hydroxyurea
anti-infective agents such as dapsone, pentamidine, flucytosine and amphotericin B
other medicines for the treatment of HIV or HIV-related infections such as nucleoside
analogues (lamivudine, also known as 3TC; stavudine, also known as D4T; zalcitabine
also known as ddc; abacavir; lamivudine / zidovudine or; abacavir / lamivudine / zidovudine
These medicines may be affected by VALGANCICLOVIR MYLAN, may affect how well it works
or may increase the risk of side effects with VALGANCICLOVIR MYLAN. You may need different
amounts of your medicines, or you may need to take different medicines. Your doctor
will advise you.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking VALGANCICLOVIR MYLAN.
You should tell any doctor who is prescribing a new medication for you that you are
taking VALGANCICLOVIR MYLAN.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
How to take VALGANCICLOVIR MYLAN
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
How much to take
Take VALGANCICLOVIR MYLAN exactly as your doctor has prescribed.
Your doctor will tell you how many VALGANCICLOVIR MYLAN tablets to take each day.
Treatment of CMV Retinitis in AIDS
1. Induction Treatment (for active CMV retinitis)
The usual dose is 900 mg (two 450 mg tablets) twice daily with food for 21 days.
2. Maintenance Treatment (after induction treatment or for inactive CMV retinitis)
The usual dose is 900 mg (two 450 mg tablets) once daily with food.
Prevention of CMV Disease in Transplantation
The usual dose is 900 mg (two 450 mg tablets) once daily with food, starting within
10 days of your organ transplant until 100 days after the transplant.
If you have received a kidney transplant, the same daily dose is required until 200
days after the transplant.
Your dose may have to be reduced or stopped if you have or develop low blood counts,
have kidney disease, or if you are older than 65 years.
How to take it
Swallow tablets whole with a glass of water. VALGANCICLOVIR MYLAN must be taken with
When to take it
Take VALGANCICLOVIR MYLAN during or immediately after a meal.
If you take VALGANCICLOVIR MYLAN on an empty stomach, it may not work as well.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help
you remember when to take your dose.
How long to take it for
Continue taking VALGANCICLOVIR MYLAN until your doctor tells you to stop.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to. Otherwise, take it as soon as you remember, and then go
back to taking your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you have trouble remembering to take your medicine, ask your pharmacist for some
If you are not sure what to do or whether to skip the dose, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have taken too much VALGANCICLOVIR MYLAN. Do this
even if there are no signs of discomfort or poisoning.
While you are taking VALGANCICLOVIR MYLAN
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking
A barrier contraceptive should be used while taking VALGANCICLOVIR MYLAN and for 90
days after stopping treatment.
Tell your doctor if you become pregnant while taking VALGANCICLOVIR MYLAN.
See your doctor regularly so that your CMV disease, blood cell counts and any other
potential side effects may be monitored carefully.
If blood cell counts are low then this may reduce your ability to fight infection,
or for your blood to clot efficiently. If left undetected these effects on blood cells
may contribute to death or serious illness.
If you have a CMV eye infection, you must also see your doctor regularly to monitor
the condition of your retina (part of the eye).
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
Be sure to keep all of your appointments with your doctor so that your progress can
Things you must not do
Do not stop taking VALGANCICLOVIR MYLAN or change the dose without first checking
with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting a pharmacist.
Do not give VALGANCICLOVIR MYLAN to anyone else even if they have the same condition
Be careful when handling VALGANCICLOVIR MYLAN tablets. Do not break or crush them.
If you accidentally touch broken or crushed tablets, wash your hands thoroughly with
soap and water. If any powder from the tablet gets in your eyes, rinse your eyes thoroughly
Things to be careful of
Be careful driving or operating machinery until you know how VALGANCICLOVIR MYLAN
VALGANCICLOVIR MYLAN may cause drowsiness, dizziness, confusion or seizures (fits)
in some people and therefore may affect alertness. Make sure you know how you react
to VALGANCICLOVIR MYLAN before you drive a car or operate machinery or do anything
else that could be dangerous if you are drowsy, dizzy or not alert.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking VALGANCICLOVIR MYLAN.
VALGANCICLOVIR MYLAN helps most people with CMV infections but it may have unwanted
side effects in a few people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. Your doctor has weighed the risks of using this medicine against the
benefits they expect it will have for you.
Tell your doctor immediately or go to accident and emergency at your nearest hospital
if you notice any of the following.
swelling of the face, lips, mouth, throat or tongue which may cause difficulty in
swallowing or breathing
any sign of infection such as fever, chills, sore throat or mouth ulcers
unexplained bruising or bleeding
thinking, hearing or seeing things that are not real
This is not a complete list of all possible side effects. Others may occur in some
people and there may be some side effects not yet known.
Tell your doctor immediately if you notice any of the following:
oral thrush (sore, creamy yellow raised patches in the mouth)
insomnia (inability to sleep)
worsening of your eyesight
These may be serious side effects. You may require urgent medical attention. Serious
side effects are rare.
Tell your doctor if you notice any of the following:
These are the more common side effects of VALGANCICLOVIR MYLAN and are usually short
Do not be alarmed by these lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
After taking VALGANCICLOVIR MYLAN
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store VALGANCICLOVIR MYLAN or any other medicine in the bathroom or near a
sink. Do not leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
If your doctor tells you to stop taking VALGANCICLOVIR MYLAN or the expiry date has
passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
VALGANCICLOVIR MYLAN comes in one strength:
VALGANCICLOVIR MYLAN - valganciclovir 450 mg: A pink, biconvex, oval, beveled edge
film-coated tablet with "M" on one side and "V45" on the other side. Bottles of 60
VALGANCICLOVIR MYLAN contains valganciclovir as the active ingredient.
VALGANCICLOVIR MYLAN - 450 mg valganciclovir.
VALGANCICLOVIR MYLAN also contains the following inactive ingredients:
The film-coat applied to the tablets contains Opadry Brown 15B565009, which consists
of the following inactive ingredients:
Iron oxide red
VALGANCICLOVIR MYLAN does not contain, sucrose, gluten, tartrazine or any other azo
VALGANCICLOVIR MYLAN is supplied in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
Australian registration numbers:
VALGANCICLOVIR MYLAN: AUST R 218477
This leaflet was prepared on