Valganciclovir Mylan

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

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 viruses.
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 transplantation.
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 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 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 your doctor.

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 or dyes.
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 combinations).
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 for help.

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 food.

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 hints.
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 VALGANCICLOVIR MYLAN.
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 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 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 as you.
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 with water.

Things to be careful of

Be careful driving or operating machinery until you know how VALGANCICLOVIR MYLAN affects you.
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.

Side effects

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
confusion
agitation
fits
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:
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 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:
headache
nausea
dizziness
looking pale
fever
diarrhoea
vomiting
These are the more common side effects of VALGANCICLOVIR MYLAN and are usually short lived.
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

Storage

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.

Disposal

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.

Product description

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 tablets.

Ingredients

Active Ingredients:
VALGANCICLOVIR MYLAN contains valganciclovir as the active ingredient.
VALGANCICLOVIR MYLAN - 450 mg valganciclovir.
Inactive Ingredients:
VALGANCICLOVIR MYLAN also contains the following inactive ingredients:
Crospovidone
Stearic acid
Microcrystalline cellulose
The film-coat applied to the tablets contains Opadry Brown 15B565009, which consists of the following inactive ingredients:
Hypromellose
Titanium dioxide
Macrogol 400
Polysorbate 80
Iron oxide red
VALGANCICLOVIR MYLAN does not contain, sucrose, gluten, tartrazine or any other azo dyes.

Supplier

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
www.alphapharm.com.au
 
Australian registration numbers:
VALGANCICLOVIR MYLAN: AUST R 218477
 
This leaflet was prepared on
October 2015.
 
 
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