2. What should I know before I take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200?
Do not take if you have ever had an allergic reaction to tenofovir disoproxil maleate/emtricitabine
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. For more information, see Section
2. What should I know before I take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
and affect how it works. A list of these medicines is in Section
3. What if I am taking other medicines? in the full CMI.
4. How do I take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200?
Take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 exactly as prescribed. The
usual dose is one TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 tablet once daily.
5. What should I know while taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking this medicine.
Tell your doctor if you become pregnant or are trying to become pregnant.
Tell your doctor if for any reason you have not taken your medicine exactly as prescribed.
|
|
Things you should not do
|
Do not stop taking this medicine or change the dose without first checking with your
doctor.
Do not give this medicine to anyone else even if their symptoms seem similar to yours.
|
|
Driving or using machines
|
Be careful before you drive or use any machines or tools until you know how TENOFOVIR
DISOPROXIL EMTRICITABINE VIATRIS 300/200 affects you.
|
|
Looking after your medicine
|
Keep tablets below 25°C.
Keep your tablets in the bottle with the cap tightly closed until you take them.
|
6. Are there any side effects?
Check with your doctor as soon as possible if you have any problems while taking TENOFOVIR
DISOPROXIL EMTRICITABINE VIATRIS 300/200, even if you do not think the problems are
connected with the medicine or are not listed in this leaflet.
Active ingredient(s):
tenofovir disoproxil maleate and emtricitabine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200. 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 EMTRICITABINE
VIATRIS 300/200.
Where to find information in this leaflet:
1. Why am I taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200?
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 contains the active ingredients
tenofovir disoproxil maleate and emtricitabine. These are combined in one tablet to help control Human Immunodeficiency Virus (HIV)
infection.
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 contains two active ingredients
that belong to a group of antiviral medicines known as nucleoside and nucleotide reverse
transcriptase inhibitors (NRTI).
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 is
used:
to treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults when taken in
combination with other anti-HIV medicines;
to help reduce the risk of getting HIV infection when used with safer sex practices
in:
HIV-negative men who have sex with men, who are at high risk of getting infected with
HIV-1 through sex.
Male-female sex partners when one partner has HIV-1 infection and the other does not.
When TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 is used to treat HIV infection
When used with other HIV-1 medicines to treat HIV-1 infection, TENOFOVIR DISOPROXIL
EMTRICITABINE VIATRIS 300/200 may help:
Reduce the amount of HIV-1 in your blood. This is called “viral load”.
Increase the number of CD4+ (T) cells in your blood that help fight off other infections.
Reducing the amount of HIV-1 and increasing the CD4+ (T) cells in your blood may help
improve your immune system.
This may reduce your risk of death or infections that can happen when your immune
system is weak.
Does TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 cure HIV OR AIDS?
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 is not a cure for HIV infection
or AIDS. While taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 you may still
develop infections or other illnesses associated with HIV infection.
If you have HIV-1 infections, you must keep taking HIV-1 medicines to control HIV-1
infection and decrease HIV-related illnesses.
Does TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 reduce the risk of HIV to
others?
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 does not reduce the risk of passing
HIV to others through sexual contact or blood contamination.
It is important to continue to take appropriate precautions to prevent passing HIV
to others.
When TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 is used to reduce the risk
of HIV infection
When used with safer sex practices, TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
may help to reduce the risk of getting HIV-1 infection if you are at high risk of
getting HIV infection.
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 reduces the risk of getting HIV-1
when you have been taking it before you are exposed to HIV-1.
2. What should I know before I take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200?
Warnings
Together with your doctor, you need to decide whether TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200 is right for you.
Do not take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 if:
you are allergic to:
tenofovir
tenofovir disoproxil maleate
tenofovir disoproxil fumarate
or any of the 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
rash, itching or hives on the skin
swelling of the face, lips, tongue or other parts of the body
Always check the ingredients to make sure you can take this medicine.
you are already taking any of the components of TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200 (tenofovir disoproxil maleate or emtricitabine)
you are taking lamivudine
you are taking adefovir dipivoxil
you are taking tenofovir alafenamide
the expiry or "use by" date (EXP) printed on the packaging has passed. If you take
it after the expiry date has passed, it may not work as well.
the packaging is torn or shows signs of tampering
If you are not sure whether you should be taking TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200, talk to your doctor.
Do not take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 to help reduce your
risk of getting HIV-1 if:
you already have HIV-1 infection.
If you are HIV positive, you need to take other medicines with TENOFOVIR DISOPROXIL
EMTRICITABINE VIATRIS 300/200 to treat HIV. TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS
300/200 by itself is not a complete treatment for HIV.
you do not know your HIV-1 infection status.
You may already be HIV-positive. You need to take other HIV-1 medicines with TENOFOVIR
DISOPROXIL EMTRICITABINE VIATRIS 300/200 to treat HIV-1.
Many HIV-1 tests can miss HIV-1 infection in a person who has recently become infected.
If you have flu-like symptoms, you could have recently become infected with HIV-1.
Tell your healthcare provider if you had a flu-like illness within the last month
before starting TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 or at any time
while taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200. Symptoms of new HIV-1
infection include: tiredness, fever, joint or muscle aches, headache, sore throat,
vomiting or diarrhoea, rash, night sweats or enlarged lymph nodes in the neck or groin.
Check with your doctor if you:
are allergic to foods, dyes, preservatives or any other medicines
have or have had any of the following medical conditions:
liver problems, including hepatitis B, or C virus infection
Tell your doctor if you are taking medication to treat your hepatitis C virus (HCV)
infection (e.g. ledipasvir/sofosbuvir, sofosbuvir/velpatasvir
kidney problems
abnormal bones or bone difficulties
take any medicines for any other condition
This medicine is only available from a pharmacist after it has been prescribed by
a doctor who specialises in the treatment of HIV infection.
If you wish to continue receiving treatment with TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200 it is important you remain under the care of a hospital or doctor
who specialises in the treatment of HIV infection.
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?
Avoid doing things that increase your risk of getting HIV-1 or spreading HIV-1 to
other people:
Do not have any kind of sex without protection. Always practice safer sex. Use latex
or non-latex condoms, except lambskin, to reduce contact with semen, vaginal fluids,
or blood.
Do not share personal items that can have blood or body fluids on them, such as toothbrushes
and razor blades.
Do not share or re-use needles or other injection equipment.
Ask your healthcare provider if you have any questions about how to prevent getting
HIV-1 or spreading HIV-1 to other people.
If you have a long standing viral infection of your liver (hepatitis B) it may flare
up when you stop taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200.
This can cause serious illness particularly if your liver is already not working very
well. If you have both HIV and hepatitis B, when you start taking TENOFOVIR DISOPROXIL
EMTRICITABINE VIATRIS 300/200 and even after you stop, your doctor is likely to arrange
tests from time to time to check how well your liver is working.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or are trying to become pregnant or breastfeeding.
The safe use of TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 in pregnancy has
not been demonstrated. For this reason, it is important that women of child-bearing
age receiving treatment with TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 use
an effective method of contraception to avoid becoming pregnant.
If you are a female who is taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
to reduce the risk of getting HIV-1 infection and you become pregnant while taking
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200, talk to your healthcare provider
to decide if you should keep taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200.
The active substances in this medicine (tenofovir disoproxil maleate and emtricitabine)
have been found in breast milk at low concentrations.
Consequently, it is recommended that nursing mothers do not breastfeed during treatment
with TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200. In general, women infected
with HIV should not breast-feed their infants in order to avoid transmission of HIV
to their newborn infant.
Use in children
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 is for adults.
Do not take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 if you are under the
age of 18 years.
Use in elderly
Do not take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 if you are over the
age of 65 before discussing with your doctor.
3. What if I am taking other medicines?
If you have HIV infections your doctor will generally prescribe TENOFOVIR DISOPROXIL
EMTRICITABINE VIATRIS 300/200 in combination with other anti-HIV 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 EMTRICITABINE VIATRIS 300/200
and affect how it works. These include:
didanosine
ledipasvir with sofosbuvir
sofosbuvir/velpatasvir
sofosbuvir/velpatasvir/voxilaprevir
Some medicines may affect the way others work. Your doctor or pharmacist will be able
to tell you what to do when taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
tablets with other medicines.
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 EMTRICITABINE
VIATRIS 300/200.
4. How do I take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200?
How much to take
Take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 exactly as prescribed. The
usual dose is one TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 tablet once daily.
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 is best taken with a meal or just
afterwards, however taking it without food should not reduce the effectiveness of
the medicine.
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 is absorbed rapidly. Do not take
another TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 dose if vomiting has occurred
unless it occurs within 1 hour after taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS
300/200.
When to take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 should be taken at the same time
each day to keep the tenofovir and emtricitabine blood levels constant.
How to take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
Take one TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 tablet once daily or as
advised by your doctor.
If you are not sure how much TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 you
should take, check with your doctor or pharmacist. Do not change the amount of TENOFOVIR
DISOPROXIL EMTRICITABINE VIATRIS 300/200 you take unless told to do so by your doctor.
Your doctor will tell you how much TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
to take and how often to take it. You will also find this information on the label
of your medicine container.
Because your medicine helps to control your condition, but does not cure it, you will
need to take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 every day. If you
are taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 to reduce the risk of
HIV-1 infection, take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 every day
for the period of time as prescribed by your doctor.
Do not miss any doses of TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200. Missing
a dose lowers the amount of medicine in your blood.
Do not stop taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 without first
talking to your doctor.
If you forget to take TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
It is important to take the prescribed daily dose in order to get the maximum benefit
of treatment.
If you forget to take your daily dose of TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS
300/200 take it as soon as you remember that day and then go back to taking your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
Do not take more than one TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 tablet
in a day.
If you take too much TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
If you think that you or anyone else has taken too much TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200, 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 EMTRICITABINE VIATRIS 300/200?
Things you should do
Tell your doctor or pharmacist that you are taking TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200 if you are about to be started on any other medicines.
Tell your doctor if you become pregnant or are trying to become pregnant.
Tell your doctor if for any reason you have not taken your medicine exactly as prescribed.
If you are taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 to reduce your
risk of getting HIV
Just taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 may not keep you from
getting HIV.
You must continue using safer sex practices while you are taking TENOFOVIR DISOPROXIL
EMTRICITABINE VIATRIS 300/200 to reduce your risk of getting HIV.
You must stay HIV-negative to keep taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS
300/200 to reduce your risk of infection.
Know your HIV status and the HIV status of your partners.
Get tested for HIV at least every 3 months or when your healthcare provider tells
you.
Get tested for other sexually transmitted infections such as syphilis and gonorrhoea.
These infections make it easier for HIV to infect you. TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200 will not stop you from getting these other infections.
If you think you were exposed to HIV, tell your healthcare provider right away. They
may want to do more tests to be sure you are still HIV-negative.
Get information and support to help reduce risky sexual behaviour.
Have fewer sex partners.
Do not miss any doses of TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200. Missing
doses may increase your risk of getting HIV infection.
If you do become HIV-positive, you need more medicine than TENOFOVIR DISOPROXIL EMTRICITABINE
VIATRIS 300/200 alone to treat HIV.
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 by itself is not a complete treatment
for HIV.
If you have HIV and take only TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200,
over time your HIV may become harder to treat.
Call your doctor straight away if you:
Become pregnant or are trying to become pregnant.
For any reason you have not taken your medicine exactly as prescribed.
Think you were exposed to HIV. Your doctor may want to do more tests to be sure you
are still HIV-negative.
Remind any doctor, dentist or pharmacist you visit that you are taking TENOFOVIR DISOPROXIL
EMTRICITABINE VIATRIS 300/200.
Things you should not do
Do not stop taking TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 or change the
dose without first checking with your doctor.
Do not give this medicine to anyone else even if their symptoms seem similar to yours.
Do not use TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 to treat any other complaints
unless you doctor says to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TENOFOVIR
DISOPROXIL EMTRICITABINE VIATRIS 300/200 affects you.
Looking after your medicine
Keep TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 tablets below 25°C.
Keep your TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 tablets in the bottle
with the cap tightly closed until you take them.
If you take tablets out of their pack 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.
Keep it 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 them.
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.
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.
Check with your doctor as soon as possible if you have any problems while taking TENOFOVIR
DISOPROXIL EMTRICITABINE VIATRIS 300/200, even if you do not think the problems are
connected with the medicine or are not listed in this leaflet.
Do not be alarmed by this list of possible side-effects. Most of them are very rare
and you may not experience any of them.
Less serious side effects
Serious 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 EMTRICITABINE VIATRIS 300/200 contains
|
Active ingredient
(main ingredient)
|
300 mg tenofovir disoproxil maleate
200 mg emtricitabine
|
|
Other ingredients
(inactive ingredients)
|
microcrystalline cellulose
hyprolose
iron oxide red
colloidal anhydrous silica
lactose monohydrate
magnesium stearate
Opadry II complete film coating system 32K510087 GREEN (ID: 114524)
|
|
Potential allergens
|
lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 looks like
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
tablets are light green, filmcoated, capsule shaped, biconvex tablets debossed with
‘M’ on one side of the tablet and ‘ETM’ on the other side (AUST R 265834).
Who distributes TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200
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 EMTRICITABINE VIATRIS 300/200_cmi\Dec25/00