2. What should I know before I take TENOFOVIR DISOPROXIL VIATRIS?
Do not take if you have ever had an allergic reaction to TENOFOVIR DISOPROXIL VIATRIS
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 TENOFOVIR DISOPROXIL VIATRIS and affect how it works.
4. How do I take TENOFOVIR DISOPROXIL VIATRIS?
The usual dose of TENOFOVIR DISOPROXIL VIATRIS is one tablet once a day.
Take TENOFOVIR DISOPROXIL VIATRIS exactly as your doctor prescribed it.
5. What should I know while taking TENOFOVIR DISOPROXIL VIATRIS?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking TENOFOVIR DISOPROXIL
VIATRIS.
Stay under a doctor's care when taking TENOFOVIR DISOPROXIL VIATRIS.
When your TENOFOVIR DISOPROXIL VIATRIS supply starts to run low, get more from your
doctor or pharmacist.
|
|
Things you should not do
|
Do not take TENOFOVIR DISOPROXIL VIATRIS for a condition for which it was not prescribed.
Do not share TENOFOVIR DISOPROXIL VIATRIS with other people.
Do not take if seal over bottle opening is broken or missing.
Do not change your treatment or stop treatment without first talking with your doctor.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how TENOFOVIR
DISOPROXIL VIATRIS affects you.
|
|
Looking after your medicine
|
Store TENOFOVIR DISOPROXIL VIATRIS at room temperature below 25°C.
Keep your TENOFOVIR DISOPROXIL VIATRIS tablets in the bottle with the cap tightly
closed until you take them.
|
6. Are there any side effects?
Some common side effects are diarrhoea, nausea, vomiting, dizziness, flatulence (intestinal
gas). TENOFOVIR DISOPROXIL VIATRIS may cause kidney problems, changes in bone mineral
density, lactic acidosis and hepatic flares. All medicines can have side effects.
If they do occur, they are usually minor and temporary. Do not be alarmed by this
list. You may not experience any of them. For more information, including what to
do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
tenofovir disoproxil maleate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking TENOFOVIR DISOPROXIL 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 TENOFOVIR DISOPROXIL VIATRIS.
Where to find information in this leaflet:
1. Why am I taking TENOFOVIR DISOPROXIL VIATRIS?
TENOFOVIR DISOPROXIL VIATRIS contains the active ingredient tenofovir disoproxil maleate.
TENOFOVIR DISOPROXIL VIATRIS is a type of medicine called HBV polymerase inhibitor
and a nucleotide analogue reverse transcriptase inhibitor (NRTI).
TENOFOVIR DISOPROXIL VIATRIS is antiviral medication used to treat two different viruses;
Chronic Hepatitis B (CHB) and
Human Immunodeficiency Virus (HIV) infection.
How TENOFOVIR DISOPROXIL VIATRIS works in the Treatment of CHB:
TENOFOVIR DISOPROXIL VIATRIS is used to treat CHB (an infection with hepatitis B virus
[HBV]) in adults and paediatric patients aged 12 years and older and weighing at least
35 kg.
TENOFOVIR DISOPROXIL VIATRIS works by interfering with the normal working of enzymes
(HBV DNA polymerase) that are essential for HBV to reproduce itself. TENOFOVIR DISOPROXIL
VIATRIS may help lower the amount of hepatitis B virus in your body by lowering the
ability of the virus to multiply and infect new liver cells and can improve the inflammation
and scar tissue caused by the hepatitis B virus in your liver.
Lowering the amount of virus in your body may reduce the chance of developing cirrhosis,
liver failure and liver cancer.
We do not know how long TENOFOVIR DISOPROXIL VIATRIS may help treat your hepatitis.
Sometimes viruses change in your body and medicines no longer work. This is called
drug resistance.
How TENOFOVIR DISOPROXIL VIATRIS works in the Treatment of HIV Infection:
TENOFOVIR DISOPROXIL VIATRIS is also used to treat HIV infection in adults and paediatric
patients aged 12 years and older and weighing at least 35 kg.
TENOFOVIR DISOPROXIL VIATRIS is always used in combination with other anti-HIV medicines
to treat people with HIV-1 infection.
HIV infection destroys CD4 (T) cells, which are important to the immune system. After
a large number of T cells are destroyed, acquired immune deficiency syndrome (AIDS)
develops.
TENOFOVIR DISOPROXIL VIATRIS helps to block HIV-1 reverse transcriptase, a chemical
(enzyme) in your body that is needed for HIV-1 to multiply. TENOFOVIR DISOPROXIL VIATRIS
lowers the amount of HIV-1 in the blood (called viral load) and may help to increase
the number of T cells (called CD4 cells). Lowering the amount of HIV-1 in the blood
lowers the chance of death or infections that happen when your immune system is weak
(opportunistic infections).
You do not have to have HIV infection to be treated with TENOFOVIR DISOPROXIL VIATRIS
for HBV and vice versa.
Does TENOFOVIR DISOPROXIL VIATRIS cure HIV or AIDS?
TENOFOVIR DISOPROXIL VIATRIS does not cure HIV infection or AIDS.
The long-term effects of TENOFOVIR DISOPROXIL VIATRIS are not known at this time.
People taking TENOFOVIR DISOPROXIL VIATRIS may still get opportunistic infections
or other conditions that happen with HIV-1 infection.
Opportunistic infections are infections that develop because the immune system is
weak.
Some of these conditions are:
pneumonia,
herpes virus infections, and
Mycobacterium avium complex
(MAC) infections.
Does TENOFOVIR DISOPROXIL VIATRIS reduce the risk of passing HIV-1 or HBV to others?
TENOFOVIR DISOPROXIL VIATRIS does not reduce the risk of passing HIV-1 or HBV to others
through sexual contact or blood contamination.
Continue to practice safe sex and do not use or share dirty needles.
2. What should I know before I take TENOFOVIR DISOPROXIL VIATRIS?
Warnings
Together with your doctor, you need to decide whether TENOFOVIR DISOPROXIL VIATRIS
is right for you.
Do not take TENOFOVIR DISOPROXIL VIATRIS if:
you are allergic to:
tenofovir disoproxil maleate
tenofovir disoproxil fumarate
any of the ingredients listed at the end of this leaflet
Always check the ingredients to make sure you can take this medicine.
you are already taking any other medicines containing tenofovir disoproxil maleate
or tenofovir disoproxil fumarate
you are already taking adefovir dipivoxil to treat hepatitis B virus (HBV) infection
you are already taking tenofovir alafenamide to treat HIV or hepatitis B virus (HBV)
infection.
Check with your doctor if you:
have any of the following medical conditions:
kidney problems
bone problems
liver problems, including HBV and hepatitis C virus (HCV)
HIV infection
take any medicines for any other condition.
Tell your doctor or pharmacist about all your medical conditions.
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
Tell your doctor if you are pregnant or planning to become pregnant.
The effects of TENOFOVIR DISOPROXIL VIATRIS on pregnant women or their unborn babies
are not known.
Tell your doctor if you are breastfeeding.
Do not breastfeed if you are taking TENOFOVIR DISOPROXIL VIATRIS or if you have HIV
or HBV.
The active substance in this medicine (tenofovir disoproxil maleate) has been found
in breast milk at low concentrations.
If you are a woman who has or will have a baby, talk with your doctor or pharmacist
about the best way to feed your baby. If your baby does not already have HIV or HBV,
there is a chance that the baby can get HIV or HBV through breastfeeding.
Use in children
TENOFOVIR DISOPROXIL VIATRIS is for adults and paediatric patients aged 12 years and
older and weighing at least 35 kg.
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 may interfere with TENOFOVIR DISOPROXIL VIATRIS and affect how it works.
These include:
didanosine
atazanavir sulfate
lopinavir/ritonavir
sofosbuvir/velpatasvir/voxilaprevir
ledipasvir/sofosbuvir
sofosbivir/velpatasvir
These medicines may increase the amount of TENOFOVIR DISOPROXIL VIATRIS in your blood,
which could result in more side effects . You may need to be followed more carefully
if you are taking TENOFOVIR DISOPROXIL VIATRIS and atazanavir sulfate or lopinavir/ritonavir
together. TENOFOVIR DISOPROXIL VIATRIS may decrease the amount of atazanavir sulfate
in your blood. If you are taking TENOFOVIR DISOPROXIL VIATRIS and atazanavir sulfate
together you should also be taking ritonavir.
It is a good idea to keep a complete list of all the medicines that you take.
Make a new list when medicines are added or stopped. Give copies of this list to your
doctor or pharmacist every time you visit your doctor or fill a prescription.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TENOFOVIR DISOPROXIL VIATRIS.
4. How do I take TENOFOVIR DISOPROXIL VIATRIS?
How much to take
Take TENOFOVIR DISOPROXIL VIATRIS exactly as your doctor prescribed it.
Follow the directions from your doctor or pharmacist, exactly as written on the label.
Set up a dosing schedule and follow it carefully.
The usual dose of TENOFOVIR DISOPROXIL VIATRIS is one tablet once a day.
If you have kidney problems, your doctor may recommend that you take TENOFOVIR DISOPROXIL
VIATRIS less frequently.
When to take TENOFOVIR DISOPROXIL VIATRIS
TENOFOVIR DISOPROXIL VIATRIS is best taken with a meal or just afterwards, however
taking it without food should not reduce the effectiveness of the medicine.
How to take TENOFOVIR DISOPROXIL VIATRIS
If you are taking TENOFOVIR DISOPROXIL VIATRIS to treat HIV or if you have HIV and
HBV coinfection and are taking TENOFOVIR DISOPROXIL VIATRIS, always take TENOFOVIR
DISOPROXIL VIATRIS in combination with other anti-HIV medicines.
TENOFOVIR DISOPROXIL VIATRIS and other medicines like TENOFOVIR DISOPROXIL VIATRIS,
may be less likely to work in the future if you are not taking TENOFOVIR DISOPROXIL
VIATRIS with other anti-HIV medicines because you may develop resistance to those
medicines. If you have any questions about what medicines you should or should not
be taking, please see your doctor or pharmacist.
If you have been given TENOFOVIR DISOPROXIL VIATRIS to treat CHB, you are advised
to get a HIV test before you start taking TENOFOVIR DISOPROXIL VIATRIS and at any
time after that when there is a chance you were exposed to HIV.
Only take medicine that has been prescribed specifically for you.
If you forget to take TENOFOVIR DISOPROXIL VIATRIS
It is important that you do not miss any doses.
If you miss a dose of TENOFOVIR DISOPROXIL VIATRIS, take it as soon as possible and
then take your next scheduled dose at its regular time.
If it is almost time for your next dose, do not take the missed dose. Wait and take
the next dose at the regular time. Do not double the next dose.
If you take too much TENOFOVIR DISOPROXIL VIATRIS
If you think that you or anyone else has taken too much TENOFOVIR DISOPROXIL VIATRIS,
urgent medical attention may be needed.
You should immediately:
phone the Poisons Information Centre
(by calling 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 TENOFOVIR DISOPROXIL VIATRIS?
Things you should do
Stay under a doctor's care when taking TENOFOVIR DISOPROXIL VIATRIS.
When your TENOFOVIR DISOPROXIL VIATRIS supply starts to run low, get more from your
doctor or pharmacist.
This is very important because the amount of virus in your blood may increase if the
medicine is stopped for even a short time. The virus may develop resistance to TENOFOVIR
DISOPROXIL VIATRIS, and may become harder to treat. If you are taking TENOFOVIR DISOPROXIL
VIATRIS to treat CHB, stopping treatment may result in very severe hepatitis and serious
liver problems.
Remind any doctor, dentist or pharmacist you visit that you are taking TENOFOVIR DISOPROXIL
VIATRIS.
Things you should not do
Do not take TENOFOVIR DISOPROXIL VIATRIS for a condition for which it was not prescribed.
Do not share TENOFOVIR DISOPROXIL VIATRIS with other people.
Do not take if seal over bottle opening is broken or missing.
Do not change your treatment or stop treatment without first talking with your doctor.
Do not give TENOFOVIR DISOPROXIL VIATRIS to others or take medicine prescribed for
someone else.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TENOFOVIR
DISOPROXIL VIATRIS affects you.
Some patients taking TENOFOVIR DISOPROXIL VIATRIS have experienced dizziness. Make
sure you know how you react to TENOFOVIR DISOPROXIL VIATRIS before you drive a car,
operate machinery or do anything else that could be dangerous if you are dizzy.
Looking after your medicine
Store TENOFOVIR DISOPROXIL VIATRIS at room temperature below 25°C.
It should remain stable until the expiration date printed on the label.
Keep your TENOFOVIR DISOPROXIL VIATRIS tablets in the bottle with the cap tightly
closed until you take them.
If you take TENOFOVIR DISOPROXIL VIATRIS tablets out of their bottle they may not
keep well.
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 and dampness can destroy some medicines.
Keep it where young children cannot reach it.
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.
If you throw any medicines away make sure that children will not find them.
6. Are there any side effects?
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.
Common side effects
TENOFOVIR DISOPROXIL VIATRIS may cause the following other side effects:
Kidney Problems:
Some patients treated with tenofovir disoproxil have had kidney problems. If you have
had kidney problems in the past or need to take another drug that can cause kidney
problems, your doctor may need to perform additional blood tests. Kidney problems
may be associated with muscle problems and softening of the bones.
Changes in Bone Mineral Density:
Laboratory tests show changes in the bones of patients treated with tenofovir disoproxil.
It is not known whether long-term use of TENOFOVIR DISOPROXIL VIATRIS will cause damage
to your bones. If you have had bone problems in the past, your doctor may need to
perform additional tests or may suggest additional medication.
Lactic Acidosis:
Some patients taking antiviral drugs like TENOFOVIR DISOPROXIL VIATRIS have developed
a condition called lactic acidosis (a build-up in the blood of lactic acid, the same
substance that causes your muscles to burn during heavy exercise). Symptoms of lactic
acidosis include nausea, vomiting, unusual or unexpected stomach discomfort, and weakness.
If you notice these symptoms or if your medical condition changes suddenly, call your
doctor right away.
Hepatic Flares
It is extremely important that you do not stop taking TENOFOVIR DISOPROXIL VIATRIS
without your doctor's advice. If you have Hepatitis B infection or HIV and HBV infection
together, you may have a "flare-up" of Hepatitis B if you stop taking TENOFOVIR DISOPROXIL
VIATRIS, where the disease suddenly returns in a worse way than before. This flare-
up may lead to liver failure and possibly liver transplantation or death.
After stopping TENOFOVIR DISOPROXIL VIATRIS, tell your doctor immediately about any
new, unusual, or worsening symptoms that you notice after stopping treatment. After
you stop taking TENOFOVIR DISOPROXIL VIATRIS, your doctor will still need to check
your health and take blood tests to check your liver for several months.
There have been other side effects in patients taking tenofovir disoproxil.
However, these side effects may have been due to other medicines that patients were
taking or to the illness itself.
Some of these side effects can be serious.
This list of side effects is not complete. If you have questions about side effects,
ask your doctor or pharmacist.
You should report any new or continuing symptoms to your doctor or pharmacist right
away.
Your doctor or pharmacist may be able to help you manage these 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.
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 TENOFOVIR DISOPROXIL VIATRIS contains
|
Active ingredient
(main ingredient)
|
tenofovir disoproxil maleate 300 mg
|
|
Other ingredients
(inactive ingredients)
|
microcrystalline cellulose
lactose monohydrate
hyprolose
colloidal anhydrous silica
magnesium stearate
OPADRY II complete film coating system 32K505018 BLUE (ID: 109808)
|
|
Potential allergens
|
Sugars as lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What TENOFOVIR DISOPROXIL VIATRIS looks like
TENOFOVIR DISOPROXIL VIATRIS is 300 mg film coated tablets are light blue coloured,
12 mm, round, biconvex, film coated tablets debossed with 'TM300' on one side of the
tablet and 'M' on other side (AUST R 261093).
Who distributes TENOFOVIR DISOPROXIL 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 December 2025.
TENOFOVIR DISOPROXIL VIATRIS_cmi\Dec25/00