valganciclovir hydrochloride
CONSUMER MEDICINE INFORMATION
What’s on this leaflet
This leaflet solutions some frequent questions on VALGANCICLOVIR VIATRIS tablets.
It doesn’t comprise all of the obtainable info.
It doesn’t take the place of speaking to your physician or pharmacist.
All medicines have advantages and dangers. Your physician has weighed the dangers of you taking
VALGANCICLOVIR VIATRIS in opposition to the advantages anticipated for you.
If in case you have any issues about taking this medication, speak to your physician or pharmacist.
Maintain this leaflet together with your medication.
Chances are you’ll must learn it once more.
What VALGANCICLOVIR VIATRIS is used for
VALGANCICLOVIR VIATRIS comprises the energetic ingredient valganciclovir. Within the physique
valganciclovir quickly adjustments to ganciclovir.
VALGANCICLOVIR VIATRIS belongs to a category of medicines used to stop the expansion
of viruses.
VALGANCICLOVIR VIATRIS acts in opposition to a virus referred to as cytomegalovirus or CMV (a sort
of herpes virus). It prevents this virus from rising and multiplying within the physique.
CMV causes infections, primarily in folks with poor immunity. Poor immunity could be triggered
by HIV/AIDS or by drugs taken after an organ transplant.
VALGANCICLOVIR VIATRIS is used to deal with CMV eye infections (referred to as CMV retinitis)
in AIDS sufferers, which, if left untreated could cause blindness. It isn’t a remedy for
CMV eye infections.
VALGANCICLOVIR VIATRIS isn’t efficient in opposition to any underlying HIV an infection.
VALGANCICLOVIR VIATRIS can be used to stop CMV an infection in sufferers following
organ transplantation.
Your physician, nonetheless, might have prescribed VALGANCICLOVIR VIATRIS for an additional objective.
Ask your physician when you’ve got any questions on why VALGANCICLOVIR VIATRIS has been
prescribed for you.
VALGANCICLOVIR VIATRIS isn’t addictive.
This medication is obtainable solely with a health care provider’s prescription.
Earlier than you are taking VALGANCICLOVIR VIATRIS
Animal and different laboratory research have proven VALGANCICLOVIR VIATRIS causes infertility,
beginning defects and most cancers. It’s attainable that these results might also happen in people.
When it’s essential to not take it
Don’t take VALGANCICLOVIR VIATRIS when you’ve got had an allergy to VALGANCICLOVIR VIATRIS,
ganciclovir or any elements on the finish of this leaflet:
A number of the signs of an allergic response might embrace:
shortness of breath
wheezing or problem respiratory
swelling of the face, lips, tongue or different elements of the physique
rash, itching or hives on the pores and skin
Don’t take VALGANCICLOVIR VIATRIS when you’ve got very low blood counts for platelets
(which assist clotting), neutrophils (a sort of white blood cell which defends in opposition to
an infection) or low haemoglobin (oxygen carrying substance within the blood).
Don’t take VALGANCICLOVIR VIATRIS after the expiry date (EXP) printed on the pack
has handed or if the packaging is torn or exhibits indicators of tampering.
If it has expired or is broken, return it to your pharmacist for disposal.
In case you are unsure whether or not it is best to begin taking VALGANCICLOVIR VIATRIS, speak to
your physician.
Use in kids
There’s restricted info on the security and effectiveness of using VALGANCICLOVIR
VIATRIS in kids. Your physician will advise you whether or not VALGANCICLOVIR VIATRIS is
appropriate in your baby.
Earlier than you begin to take it
Inform your physician if:
– you might be allergic to medicines comparable to aciclovir, valaciclovir, famciclovir, penciclovir.
These medicines are from the identical class as VALGANCICLOVIR VIATRIS and allergic reactions
might happen.
– you might be allergic to another medicines, meals, dyes or preservatives, particularly
any medication which you may have taken beforehand to deal with your present situation.
You will have, another well being issues, particularly the next:
you may have a historical past of low blood counts for platelets (thrombocytopenia), neutrophils
(neutropenia) or anaemia
you may have, or beforehand have had, poor kidney operate.
you might be pregnant or intend to turn out to be pregnant.
VALGANCICLOVIR VIATRIS isn’t really useful to be used throughout being pregnant. VALGANCICLOVIR
VIATRIS might have an effect on your growing child should you take it throughout being pregnant. Your physician
will talk about the dangers and advantages of utilizing VALGANCICLOVIR VIATRIS if you’re pregnant.
you might be breast-feeding or intend to breast-feed.
It isn’t recognized whether or not VALGANCICLOVIR VIATRIS passes into breast milk. Breast-feeding
isn’t really useful throughout remedy with VALGANCICLOVIR VIATRIS.
you’re a lady who might turn out to be pregnant and you aren’t utilizing contraception
it’s essential to use a dependable type of contraception throughout VALGANCICLOVIR VIATRIS remedy,
and for at the least 30 days after stopping VALGANCICLOVIR VIATRIS, except you aren’t
sexually energetic.
you’re a sexually energetic man
it is best to use condoms throughout and for at the least 90 days following remedy with VALGANCICLOVIR
VIATRIS except it’s sure that your feminine accomplice isn’t vulnerable to being pregnant.
If in case you have not instructed your physician about any of the above, inform him/her earlier than you begin
taking VALGANCICLOVIR VIATRIS.
Taking different medicines
Inform your physician or pharmacist if you’re taking another medicines, together with any
that you just get with out a prescription from a pharmacy, grocery store or well being meals store.
Some medicines and VALGANCICLOVIR VIATRIS might intervene with one another. These medicines
embrace:
imipenem/cilastatin (Primaxin®), a mixture of medicines used to deal with some infections
probenecid (e.g. Benemid®), a medication used to deal with gout
zidovudine (AZT, Retrovir®, Combivir), didanosine (ddl or Videx®), stavudine, often known as D4T, different medicines used to deal with HIV an infection
medicines for the remedy of most cancers comparable to vincristine, adriamycin, hydroxyurea
mycophenolate mofetil (CellCept®), and different medicines used to stop organ rejection after a transplant e.g. ciclosporin,
tacrolimus
anti-infective brokers comparable to trimethoprim / sulphonamides dapsone, pentamidine, flucytosine,
pegylated interferons plus ribavirin and amphotericin B
These medicines could also be affected by VALGANCICLOVIR VIATRIS, or might have an effect on how effectively
it really works. Chances are you’ll want totally different quantities of your medication, or it’s possible you’ll must take
totally different medicines.
Your physician or pharmacist have extra info on medicines to watch out with or
keep away from whereas taking VALGANCICLOVIR VIATRIS.
Ask your physician or pharmacist if you’re unsure about this checklist of medicines.
How one can take VALGANCICLOVIR VIATRIS
Comply with all instructions given to you by your physician or pharmacist rigorously.
They might differ from the knowledge contained on this leaflet.
If you don’t perceive the directions on the bottle, ask your physician or pharmacist
for assist.
How a lot to take
Take VALGANCICLOVIR VIATRIS precisely as your physician has prescribed.
Your physician will inform you what number of VALGANCICLOVIR VIATRIS tablets to take every day.
Remedy of CMV Retinitis in AIDS
Induction Remedy for adults (for energetic CMV retinitis)
The same old dose is 900 mg (two 450 mg tablets) twice day by day with meals for 21 days.
Upkeep Remedy for adults (after induction remedy or for inactive CMV retinitis)
The same old dose is 900 mg (two 450 mg tablets) as soon as day by day with meals.
Prevention of CMV Illness in Transplantation for adults
The same old dose is 900 mg (two 450 mg tablets) as soon as day by day with meals, beginning inside
10 days publish transplantation till 100 days publish transplantation.
If in case you have acquired a kidney transplant, the identical day by day dose is required till 200
days publish transplantation.
Your dose might should be diminished or stopped when you’ve got or develop low blood counts,
have kidney illness, or if you’re older than 65 years.
Prevention of CMV Illness in Transplantation for kids
Your physician will let you know the way many VALGANCICLOVIR VIATRIS tablets it is best to give
your baby every day.
How one can take it
Swallow tablets entire with a glass of water. VALGANCICLOVIR VIATRIS have to be taken
with meals.
When to take it
Take VALGANCICLOVIR VIATRIS throughout or instantly after a meal.
When you take VALGANCICLOVIR VIATRIS on an empty abdomen, it might not work as effectively.
Take VALGANCICLOVIR VIATRIS at about the identical time every day.
Taking your medication on the identical time every day could have the perfect impact. It’s going to
additionally allow you to bear in mind when to take VALGANCICLOVIR VIATRIS.
How lengthy to take it for
Proceed taking VALGANCICLOVIR VIATRIS till your physician tells you to cease.
When you overlook to take it
Whether it is virtually time in your subsequent dose, skip the dose you missed and take your subsequent
dose when you’re meant to.
In any other case, take it as quickly as you bear in mind after which return to taking it as you’ll
usually.
Don’t take a double dose to make up for the dose you missed.
In case you are unsure what to do, ask your physician or pharmacist.
If in case you have hassle remembering your dose, ask your pharmacist for some hints.
When you take an excessive amount of (overdose)
Instantly phone your physician, or the Poisons Info Centre (phone 13
11 26) for recommendation, or go to Accident and Emergency at your nearest hospital, should you
assume that you just or anybody else might have taken an excessive amount of VALGANCICLOVIR VIATRIS. Do that
even when there aren’t any indicators of discomfort or poisoning.
Chances are you’ll want pressing medical consideration.
Maintain phone numbers for these locations useful.
In case you are unsure what to do, contact your physician or pharmacist.
If you are taking VALGANCICLOVIR VIATRIS
Issues it’s essential to do
Inform all medical doctors, dentists and pharmacists who deal with you that you’re taking VALGANCICLOVIR
VIATRIS.
See your physician recurrently in order that your CMV illness, blood cell counts and another
potential unwanted side effects could also be monitored rigorously.
If blood cell counts are low then this may occasionally scale back your capacity to struggle an infection,
or in your blood to clot effectively. If left undetected these results on blood cells
might contribute to loss of life or critical sickness.
If in case you have a CMV eye an infection, it’s essential to additionally see your physician recurrently to observe
the situation of your retina (a part of the attention).
When you turn out to be pregnant whereas taking VALGANCICLOVIR VIATRIS, inform your physician instantly.
Condoms needs to be utilized by sexually energetic males whereas taking VALGANCICLOVIR VIATRIS
and for 90 days after stopping remedy.
Girls who’re of childbearing potential ought to use contraception throughout and for at
least 30 days after stopping VALGANCICLOVIR VIATRIS.
Inform your physician if for any cause you haven’t taken your medication precisely as prescribed.
In any other case, your physician might imagine that it was not efficient and alter your remedy
unnecessarily.
Maintain all your physician’s appointments in order that your progress could be checked.
Issues it’s essential to not do
Don’t take VALGANCICLOVIR VIATRIS to deal with another complaints except your physician
tells you to.
Don’t give VALGANCICLOVIR VIATRIS to anybody else even when they’ve the identical situation
as you.
Don’t cease taking VALGANCICLOVIR VIATRIS or change the dosage with out first checking
together with your physician.
Don’t let your self run out of medication over the weekend or on holidays.
Don’t take another medicines whether or not they require a prescription or not with out
first telling your physician or consulting a pharmacist.
Watch out when dealing with VALGANCICLOVIR VIATRIS tablets. Don’t break or crush them.
When you by chance contact damaged or crushed tablets, wash your fingers completely with
cleaning soap and water. If any powder from the pill will get in your eyes, rinse your eyes completely
with water.
Watch out driving or working equipment till you know the way VALGANCICLOVIR VIATRIS
impacts you.
VALGANCICLOVIR VIATRIS might trigger drowsiness, dizziness, confusion or seizures (matches)
in some folks and subsequently might have an effect on alertness. If in case you have any of those signs,
don’t drive or function equipment or do anything that could possibly be harmful.
Unwanted effects
Inform your physician or pharmacist as quickly as attainable if you don’t really feel effectively whilst you
are taking VALGANCICLOVIR VIATRIS.
VALGANCICLOVIR VIATRIS helps most individuals with CMV infections however it might have undesirable
unwanted side effects in just a few folks.
All medicines can have unwanted side effects. Typically they’re critical, more often than not
they don’t seem to be. Your physician has weighed the dangers of utilizing this medication in opposition to the
advantages they anticipate it should have for you.
In case you are over 65 years of age you’ll have an elevated likelihood of getting unwanted side effects.
Do not be alarmed by the checklist of attainable unwanted side effects.
Chances are you’ll not expertise any of them
Ask your physician or pharmacist to reply any questions you’ll have.
Inform your physician should you discover any of the next and so they fear you:
dizziness
trying pale
diarrhoea
nausea
fever
vomiting
headache
These are the extra frequent unwanted side effects of VALGANCICLOVIR VIATRIS and are normally quick
lived.
Inform your physician instantly should you discover any of the next:
pores and skin rash
stomach ache
cough
fatigue (tiredness)
oral thrush (sore, creamy yellow raised patches within the mouth)
insomnia (lack of ability to sleep)
worsening of your eyesight
These unwanted side effects could also be critical. Chances are you’ll require pressing medical consideration.
Inform your physician instantly, or go to Accident and Emergency at your nearest hospital,
should you discover any of the next.
swelling of the tongue, lips or throat
any signal of an infection comparable to fever, chills, sore throat or mouth ulcers
unexplained bruising or bleeding
considering, listening to or seeing issues that aren’t actual
confusion
agitation
matches
Inform your physician or pharmacist should you discover anything that’s making you’re feeling
unwell, even when it’s not on the checklist.
This isn’t an entire checklist of all attainable unwanted side effects. Others might happen in some
folks
Ask your physician or pharmacist should you do not perceive something on this checklist.
After utilizing VALGANCICLOVIR VIATRIS
Storage
Maintain your tablets within the bottle till it’s time to take them.
When you take the tablets out of the bottle they might not preserve effectively.
Maintain VALGANCICLOVIR VIATRIS in a cool dry place the place the temperature stays beneath
25°C.
Don’t retailer it or another medication in a toilet or close to a sink. Don’t go away it
within the automobile or on a window sill.
Warmth and dampness can destroy some medicines.
Maintain VALGANCICLOVIR VIATRIS the place kids can’t attain it.
A locked cabinet at the least one-and-a-half metres above the bottom is an effective place
to retailer medicines.
Disposal
In case your physician tells you to cease taking VALGANCICLOVIR VIATRIS, or the tablets have
handed their expiry date, ask your pharmacist what to do with any tablets which can be
left over.
Product description
Availability
VALGANCICLOVIR VIATRIS is available in 450 mg film-coated tablets, in bottles containing
60 tablets.
What VALGANCICLOVIR VIATRIS seems like
VALGANCICLOVIR VIATRIS – valganciclovir 450 mg are pink, film-coated, oval, biconvex,
beveled edge tablets debossed with M on one aspect of the pill and V45 on the opposite
aspect.
Elements
Lively Elements – valganciclovir:
every VALGANCICLOVIR VIATRIS pill comprises 450 mg of valganciclovir
Inactive Elements –
VALGANCICLOVIR VIATRIS film-coated tablets additionally comprise
Crospovidone
Stearic acid
Microcrystalline cellulose
Hypromellose
Titanium dioxide
Macrogol 400
Polysorbate 80
Iron oxide purple
Provider
VALGANCICLOVIR VIATRIS is provided in Australia by:
Alphapharm Pty Ltd buying and selling as Viatris
Stage 1, 30 The Bond
30-34 Hickson Street
Millers Level NSW 2000
Cellphone: 1800 274 276
Australian registration numbers:
VALGANCICLOVIR VIATRIS: AUST R 218477
This leaflet was ready in
Might 2022.
VALGANCICLOVIR VIATRIS_cmiMay22/00
