Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking VALGANCICLOVIR VIATRIS?
VALGANCICLOVIR VIATRIS contains the active ingredient valganciclovir. VALGANCICLOVIR
VIATRIS acts against a virus called cytomegalovirus or CMV. VALGANCICLOVIR VIATRIS
is used to treat CMV eye infections in AIDS patients and to prevent CMV infection
in patients following organ transplantation.
2. What should I know before I take VALGANCICLOVIR VIATRIS?
Do not take if you have ever had an allergic reaction to valganciclovir or any of
the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with VALGANCICLOVIR VIATRIS and affect how it works.
4. How do I take VALGANCICLOVIR VIATRIS?
Induction treatment for adults (for active CMV retinitis): 900 mg twice daily with
food for 21 days. Take two 450 mg tablets in the morning and two 450 mg tablets in
the evening with food.
Maintenance treatment for adults (after induction treatment or for inactive CMV retinitis):
900mg once daily with food. Take two 450 mg tablets at the same time each day with
food.
Prevention of CMV disease in transplantation for adults: 900 mg once daily with food,
starting 10 days post transplantation until 100 days post transplantation. If you
have received a kidney transplant, the same daily dose is required until 200 days
post transplantation. Take two 450 mg tablets once at the same time each day with
food.
Prevention of CMV disease in transplantation for children: Your doctor will advise
the appropriate dose.
5. What should I know while taking VALGANCICLOVIR VIATRIS?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking VALGANCICLOVIR
VIATRIS.
Tell your doctor if you become pregnant while taking VALGANCICLOVIR VIATRIS.
See your doctor regularly so that your CMV disease and blood cell counts can be monitored.
If you have CMV eye infection, see your doctor regularly to monitor your retina (part
of your eye).
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Things you should not do
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Do not stop taking VALGANCICLOVIR VIATRIS or change the dose without checking with
your doctor.
Do not take any other medicines whether they require a prescription or not without
first telling your doctor or consulting a pharmacist.
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Driving or using machines
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Be careful driving or operating machinery until you know how VALGANCICLOVIR VIATRIS
affects you.
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Looking after your medicine
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Keep VALGANCICLOVIR VIATRIS in a cool dry place where the temperature stays below
25°C.
Keep medicine in the bottle until it is time to take them.
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6. Are there any side effects?
Go to your nearest hospital if you experience: swelling of the tongue, lips or throat,
any sign of infection such as fever, chills sore throat or mouth ulcers, unexplained
bruising or bleeding, hallucinations, confusion, agitation; or fits.
Active ingredient(s): valganciclovir
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking VALGANCICLOVIR VIATRIS. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking VALGANCICLOVIR VIATRIS.
Where to find information in this leaflet:
1. Why am I taking VALGANCICLOVIR VIATRIS?
VALGANCICLOVIR VIATRIS contains the active ingredient valganciclovir.
In the body valganciclovir rapidly changes to ganciclovir.
VALGANCICLOVIR VIATRIS belongs to a group of medicines used of prevent the growth
of viruses.
VALGANCICLOVIR VIATRIS 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 VIATRIS 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 VIATRIS is not effective against any underlying HIV infection.
VALGANCICLOVIR VIATRIS is also used to prevent CMV in patients following organ transplantation.
VALGANCICLOVIR VIATRIS is not addictive.
This medicine is available only with a doctor's prescription.
Your doctor, however, may have prescribed VALGANCICLOVIR VIATRIS for another purpose.
2. What should I know before I take VALGANCICLOVIR VIATRIS?
Animal and other laboratory studies have shown VALGANCICLOVIR VIATRIS causes infertility,
birth defects and cancer. It is also possible that these effects may occur in humans.
Warnings
Do not take VALGANCICLOVIR VIATRIS if:
you are allergic to valganciclovir, ganciclovir, valaciclovir, aciclovir, famciclovir
or penciclovir. These medicines come from the same class as VALGANCICLOVIR VIATRIS
and allergic reactions may occur. Or any of the ingredients listed at the end of this
leaflet.
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
Always check the ingredients to make sure you can take this medicine.
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).
Use in children
There is limited information on the safety and effectiveness of the use of VALGANCICLOVIR
VIATRIS in children. Your doctor will advise you whether VALGANCICLOVIR VIATRIS is
suitable for your child.
Check with your doctor if you:
are allergic to any other medicines, foods, dyes or preservatives, especially any
medicine which you have taken previously to treat your current condition.
have 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.
are pregnant or intend to become pregnant
VALGANCICLOVIR VIATRIS is not recommended for use during pregnancy. VALGANCICLOVIR
VIATRIS may affect your developing baby if you take it during pregnancy.
your doctor will discuss the risks and benefits of using VALGANCICLOVIR VIATRIS if
you are pregnant.
are breast-feeding or intend to breast-feed
It is not known whether VALGANCICLOVIR VIATRIS passes into breast milk. Breast-feeding
is not recommended during therapy with VALGANCICLOVIR VIATRIS.
are a woman who could not become pregnant and you are not using contraception
you must use a reliable form of contraception during VALGANCICLOVIR VIATRIS therapy,
and for at least 30 days after stopping VALGANCICLOVIR VIATRIS, unless you are not
sexually active.
are a sexually active man
you should use condoms during and for at least 90 days following treatment with VALGANCICLOVIR
VIATRIS unless it is certain your female partner is not at risk of pregnancy.
If you have not told your doctor about any of the above, tell him/her before you start
taking VALGANCICLOVIR VIATRIS.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Make sure your doctor is aware that you are pregnant or plan to become pregnant or
are breastfeeding or intend to breastfeed. You must use a reliable form of contraception
during VALGANCICLOVIR VIATRIS therapy, and for at least 30 days after stopping VALGANCICLOVIR
VIATRIS, unless you are not sexually active.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and VALGANCICLOVIR VIATRIS may interfere with each other. These include:
imipenem/cilastatin (Primaxin®), a combination of medicines used to treat some infections
probenecid (e.g. Benemid®), a medicine used to treat gout
zidovudine (AZT, Retrovir®, Combivir®), didanosine (ddl or Videx®), stavudine, or
other medicines used to treat HIV infection
medicines for the treatment of cancer such as doxorubicin, vinblastine, vincristine,
hydroxyurea, adriamycin
mycophenolate motetil (CellCept®), and other medicines used to prevent organ rejection
after a transplant e.g. ciclosporin, tacrolimus
anti-infective agents such as trimpethroprim / sulphonamides, dapsone, pentamide,
flucytosine pegylated interferons plus ribavirin and amphotericin B
These medicines may be affected by VALGANCICLOVIR VIATRIS, or may affect how well
it works. You may need to take different amounts of your medicine, or you may need
to take different medicines.
Your doctor or pharmacist have more information on medicines to be careful with or
avoid while taking VALGANCICLOVIR VIATRIS.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect VALGANCICLOVIR VIATRIS.
4. How do I take VALGANCICLOVIR VIATRIS?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the bottle, ask your doctor or pharmacist
for help.
How much to take
Take VALGANCICLOVIR VIATRIS exactly as your doctor has prescribed.
Your doctor will tell you how many VALGANCICLOVIR VIATRIS tablets to take each day.
Treatment of CMV Retinitis in AIDS (adult patients)
Induction Treatment for adults (for active CMV retinitis).
The usual dose is 900 mg twice daily with food for 21 days. Take two 450 mg tablets
in the morning and two 450 mg tablets in the evening with food.
Maintenance Treatment for adults (after induction treatment or for inactive CMV retinitis).
The usual dose is 900 mg once daily with food.
Take two 450 mg tablets once at the same time each day with food. Prevention of CMV
Disease in Transplantation for adults
The usual dose is 900 mg (two 450 mg tablets) once daily with food, starting with
10 days post transplantation until 100 days post transplantation.
If you have received a kidney transplant, the same daily dose is required until 200
days post transplantation.
Take two 450 mg tablets once at the same time each day with food.
Your dose may have been reduced or stopped if you have or develop low blood counts,
have kidney disease or if you are older than 65 years.
Prevention of CMV Disease in Transplantation for children
Your doctor will let you know how many VALGANCICLOVIR VIATRIS tablets you should give
your child each day.
How to take it
Swallow tablets whole with a glass of water. VALGANCICLOVIR VIATRIS must be taken
with food.
When to take VALGANCICLOVIR VIATRIS
Take VALGANCICLOVIR VIATRIS during or immediately after a meal.
If you take VALGANCICLOVIR VIATRIS on an empty stomach, it may not work as well.
Take VALGANCICLOVIR VIATRIS at about the same time each day for as long as your doctor
tells you to.
Taking your medicine at the same time each day will have the best effect. It will
also help you remember when to take VALGANCICLOVIR VIATRIS.
How long to take it for
Continue taking VALGANCICLOVIR VIATRIS until your doctor tells you to stop.
If you forget to take VALGANCICLOVIR VIATRIS
VALGANCICLOVIR VIATRIS should be taken regularly at the same time each day.
If you miss your dose at the usual time and 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 it as you would
normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some hints.
If you take too much VALGANCICLOVIR VIATRIS
If you think that you or anyone else have taken too much VALGANCICLOVIR VIATRIS, urgent
medical attention may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking VALGANCICLOVIR VIATRIS?
Things you should do
Tell any other doctors, dentists and pharmacists who treat you that you are taking
VALGANCICLOVIR VIATRIS.
Call your doctor straight away if you become pregnant while taking VALGANCICLOVIR
VIATRIS.
Condoms should be used by sexually active men while taking VALGANCICLOVIR VIATRIS
and for 90 days after stopping treatment.
Women who are of childbearing potential should use contraception during and for at
least 30 days after stopping VALGANCICLOVIR VIATRIS.
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 is not effective and change your treatment
unnecessarily.
Keep all of your appointments with your doctor so that your progress can be checked.
Things you should not do
Do not take VALGANCICLOVIR VIATRIS to treat any other complaints unless your doctor
tells you to.
Do not give VALGANCICLOVIR VIATRIS to anyone else even if they have the same condition
as you.
Do not stop taking VALGANCICLOVIR VIATRIS or change the dosage 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 take VALGANCICLOVIR VIATRIS after the expiry date (EXP) printed on the pack
has passed or if the packaging is torn or shows signs of tampering.
Be careful when handling the VALGANCICLOVIR VIATRIS tablets. Do not break or crush
them. Do not get broken or crushed tablets on your skin or in your eyes. If you accidently
touch broken or crushed tablets, wash your hands thoroughly with soap and water. If
any of the powder from the tablets gets in your eyes, rinse your eyes thoroughly with
water.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VALGANCICLOVIR
VIATRIS affects you.
VALGANCICLOVIR VIATRIS may cause drowsiness, dizziness, confusion or seizures (fits)
in some people and therefore may affect alertness. If you have any of these symptoms,
do not drive or operate machinery or do anything else that could be dangerous.
Looking after your medicine
Keep VALGANCICLOVIR VIATRIS tablets in the bottle until it is time to take them.
If you take the tablets out of the bottle they may not keep well.
Keep VALGANCICLOVIR VIATRIS in a cool dry place where the temperature stays below
25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat or dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
6. Are there any side effects?
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking VALGANCICLOVIR VIATRIS.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
If you are over 65 years of age you may have an increased chance of getting side effects.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What VALGANCICLOVIR VIATRIS contains
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Active ingredient
(main ingredient)
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valganciclovir 450 mg per tablet
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Other ingredients
(inactive ingredients)
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crospovidone
stearic acid
microcrystalline cellulose
OPADRY complete film coating system 15B565009 BROWN (ARTG PI No.: 109242)
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Potential allergens
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trace amount of sulfites.
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Do not take this medicine if you are allergic to any of these ingredients.
What VALGANCICLOVIR VIATRIS looks like
VALGANCICLOVIR VIATRIS are pink, film-coated, oval, biconvex, beveled edge tablets
debossed with M on one side of the tablet and V45 on the other side. (AUST R 218477).
Available in bottle of 60 tablets.
Who distributes VALGANCICLOVIR VIATRIS
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in July 2024.
VALGANCICLOVIR VIATRIS_cmi\Jul24/00