Valcyte - Consumer Medicine Information
|Condition:||Cytomegalovirus Infection, CMV Retinitis|
|Ingredients:||valganciclovir, microcrystalline cellulose (460), povidone K-30, crospovidone, stearic acid (570), hypromellose, titanium dioxide (171), macrogol 400, polysorbate 80 (433), red iron oxide (172)|
contains the active ingredient valganciclovir
What Valcyte is used for
Valcyte contains the active ingredient valganciclovir. In the body valganciclovir rapidly changes to ganciclovir.
Valcyte belongs to a class of medicines used to prevent the growth of viruses.
Valcyte 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.
Valcyte 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.
Valcyte is not effective against any underlying HIV infection.
Valcyte is also used to prevent CMV infection in patients following organ transplantation.
Your doctor, however, may have prescribed Valcyte for another purpose.
Ask your doctor if you have any questions about why Valcyte has been prescribed for you.
Valcyte is not addictive.
This medicine is available only with a doctor's prescription.
Before you take Valcyte
Animal and other laboratory studies have shown Valcyte 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 Valcyte if
- you have had an allergic reaction to Valcyte, ganciclovir, valaciclovir or aciclovir or any 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
- 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)
- the package is torn or shows signs of tampering
- the expiry date (EXP) printed on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should be taking Valcyte, talk to your doctor.
Use in children
There is limited information on the safety and effectiveness of the use of Valcyte in children. Your doctor will advise you whether Valcyte is suitable for your child.
Before you start to take it
Tell 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
- 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
Valcyte is not recommended for use during pregnancy. Valcyte may affect your developing baby if you take it during pregnancy. Your doctor will discuss the risks and benefits of using Valcyte if you are pregnant.
- you are breast-feeding or intend to breast-feed
It is not known whether Valcyte passes into breast milk. Breast-feeding is not recommended during therapy with Valcyte.
If you have not told your doctor about any of the above, tell them before you start taking Valcyte.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you have bought without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Valcyte. 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, pegylated interferons plus ribavirin 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 combinations).
These medicines may be affected by Valcyte, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Valcyte.
Ask your doctor or pharmacist if you are not sure about this list of medicines.
How to take Valcyte
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take
Take Valcyte exactly as your doctor has prescribed.
Your doctor will tell you how many Valcyte tablets to take each day.
Treatment of CMV Retinitis in AIDS for adults
- 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 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.
Prevention of CMV Disease in Transplantation for children
Your doctor will let you know how many VALCYTE tablets you should give your child each day.
How to take it
Swallow tablets whole with a glass of water. VALCYTE must be taken with food.
When to take it
Take VALCYTE during or immediately after a meal.
If you take VALCYTE on an empty stomach, it may not work as well.
Take VALCYTE 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 VALCYTE.
How long to take it
Continue taking VALCYTE 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), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much VALCYTE. 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 VALCYTE
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking VALCYTE.
A barrier contraceptive should be used while taking VALCYTE and for 90 days after stopping treatment.
Tell your doctor if you become pregnant while taking VALCYTE.
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 unnecessarily.
Be sure to keep all of your appointments with your doctor so that your progress can be checked.
Things you must not do
Do not stop taking VALCYTE 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 VALCYTE to anyone else even if they have the same condition as you.
Be careful when handling VALCYTE 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.
Things to be careful of
Be careful driving or operating machinery until you know how VALCYTE affects you.
VALCYTE may cause drowsiness, dizziness, confusion or seizures (fits) in some people and therefore may affect alertness. Make sure you know how you react to VALCYTE 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 VALCYTE.
VALCYTE 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.
Do not be alarmed by this 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:
- looking pale
These are more common side effects of VALCYTE and are usually short- lived.
Tell your doctor immediately if you notice any of the following:
- skin rash
- abdominal pain
- 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 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
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 if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
After taking VALCYTE
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 VALCYTE in a cool dry place where the temperature stays below 30°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 window sills.
Heat and dampness can destroy some medicines.
Keep VALCYTE 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.
If your doctor tells you to stop taking VALCYTE, or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
VALCYTE comes in 450 mg film- coated tablets.
VALCYTE comes in bottles containing 60 tablets.
VALCYTE is also available as a Powder for Oral Solution.
What VALCYTE looks like
VALCYTE 450 mg tablets are pink convex oval tablets with "VGC" on one side and "450" on the other side.
Active ingredient - valganciclovir
- each VALCYTE tablet contains 450 mg of valganciclovir
Inactive ingredients -
VALCYTE film-coated tablets also contain
- microcrystalline cellulose (460)
- povidone K-30
- stearic acid (570)
- titanium dioxide (171)
- macrogol 400
- polysorbate 80 (433)
- red iron oxide (172)
VALCYTE tablets are lactose and gluten free.
VALCYTE is distributed by:
Roche Products Pty Limited
ABN 70 000 132 865
4-10 Inman Road
Dee Why NSW 2099
Medical enquiries: 1800 233 950
Please check with your pharmacist for the latest Consumer Medicine Information.
Australian Registration Number
AUST R 82903