Valganciclovir Viatris

valganciclovir hydrochloride


VALGANCICLOVIR VIATRIS

valganciclovir hydrochloride

CONSUMER MEDICINE INFORMATION

What is in this leaflet

This leaflet answers some common questions about VALGANCICLOVIR VIATRIS 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 VIATRIS 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 VIATRIS is used for

VALGANCICLOVIR VIATRIS contains the active ingredient valganciclovir. In the body valganciclovir rapidly changes to ganciclovir.

VALGANCICLOVIR VIATRIS belongs to a class of medicines used to 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 infection in patients following organ transplantation.

Your doctor, however, may have prescribed VALGANCICLOVIR VIATRIS for another purpose.

Ask your doctor if you have any questions about why VALGANCICLOVIR VIATRIS has been prescribed for you.

VALGANCICLOVIR VIATRIS is not addictive.

This medicine is available only with a doctor's prescription.

Before you take VALGANCICLOVIR VIATRIS

Animal and other laboratory studies have shown VALGANCICLOVIR VIATRIS 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 VIATRIS if you have had an allergy to VALGANCICLOVIR VIATRIS, ganciclovir or any ingredients 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

Do not take VALGANCICLOVIR VIATRIS 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 VALGANCICLOVIR VIATRIS after the expiry date (EXP) printed on the pack has passed 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 VIATRIS, talk to your doctor.

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.

Before you start to take it

Tell your doctor if:

- you are allergic to medicines such as aciclovir, valaciclovir, famciclovir, penciclovir. These medicines are from the same class as VALGANCICLOVIR VIATRIS and allergic reactions may occur.

- you are allergic to any other medicines, foods, dyes or preservatives, especially any medicine which you have taken previously to treat your current condition.

You 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.

you 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.

you 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.

you are a woman who could 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.

you 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 that 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.

Taking other medicines

Tell your doctor or 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 and VALGANCICLOVIR VIATRIS may interfere with each other. These medicines 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, also known as D4T, other medicines used to treat HIV infection

medicines for the treatment of cancer such as vincristine, adriamycin, hydroxyurea

mycophenolate mofetil (CellCept®), and other medicines used to prevent organ rejection after a transplant e.g. ciclosporin, tacrolimus

anti-infective agents such as trimethoprim / sulphonamides dapsone, pentamidine, 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 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.

Ask your doctor or pharmacist if you are not sure about this list of medicines.

How to 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

Induction Treatment for adults (for active CMV retinitis)

The usual dose is 900 mg (two 450 mg tablets) twice daily with food for 21 days.

Maintenance Treatment for adults (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 for adults

The usual dose is 900 mg (two 450 mg tablets) once daily with food, starting within 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.

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.

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 it

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.

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 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 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 (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much VALGANCICLOVIR VIATRIS. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

While you are taking VALGANCICLOVIR VIATRIS

Things you must do

Tell all doctors, dentists and pharmacists who treat you that you are taking 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).

If you become pregnant while taking VALGANCICLOVIR VIATRIS, tell your doctor immediately.

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.

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 unnecessarily.

Keep all of your doctor's appointments so that your progress can be checked.

Things you must 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.

Be careful when handling VALGANCICLOVIR VIATRIS 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 with water.

Be careful driving or operating machinery 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking VALGANCICLOVIR VIATRIS.

VALGANCICLOVIR VIATRIS 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.

If you are over 65 years of age you may have an increased chance of getting side effects.

Don't be alarmed by the list of possible side effects.

You may not experience any of them

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

dizziness

looking pale

diarrhoea

nausea

fever

vomiting

headache

These are the more common side effects of VALGANCICLOVIR VIATRIS and are usually short lived.

Tell your doctor immediately if you notice any of the following:

skin rash

abdominal pain

cough

fatigue (tiredness)

oral thrush (sore, creamy yellow raised patches in the mouth)

insomnia (inability to sleep)

worsening of your eyesight

These side effects may be serious. You may require urgent medical attention.

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital, if you notice any of the following.

swelling of the tongue, lips or throat

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

confusion

agitation

fits

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell, even if it is not on the list.

This is not a complete list of all possible side effects. Others may occur in some people

Ask your doctor or pharmacist if you don't understand anything in this list.

After using VALGANCICLOVIR VIATRIS

Storage

Keep your 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.

Do not store it or any other medicine in a bathroom or near a sink. Do not leave it in the car or on a window sill.

Heat and dampness can destroy some medicines.

Keep VALGANCICLOVIR VIATRIS 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.

Disposal

If your doctor tells you to stop taking VALGANCICLOVIR VIATRIS, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.

Product description

Availability

VALGANCICLOVIR VIATRIS comes in 450 mg film-coated tablets, in bottles containing 60 tablets.

What VALGANCICLOVIR VIATRIS looks like

VALGANCICLOVIR VIATRIS - valganciclovir 450 mg are pink, film-coated, oval, biconvex, beveled edge tablets debossed with M on one side of the tablet and V45 on the other side.

Ingredients

Active Ingredients - valganciclovir:

each VALGANCICLOVIR VIATRIS tablet contains 450 mg of valganciclovir

Inactive Ingredients -

VALGANCICLOVIR VIATRIS film-coated tablets also contain

Crospovidone

Stearic acid

Microcrystalline cellulose

Hypromellose

Titanium dioxide

Macrogol 400

Polysorbate 80

Iron oxide red

Supplier

VALGANCICLOVIR VIATRIS is supplied in Australia by:

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au

Phone: 1800 274 276

Australian registration numbers:

VALGANCICLOVIR VIATRIS: AUST R 218477

This leaflet was prepared in

May 2022.

VALGANCICLOVIR VIATRIS_cmi\May22/00

Sponsored and funded by

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GuildLink Pty Ltd
ABN 83 090 249 960
P.O. Box A284, South Sydney NSW 1235 Australia

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