Skip to Content

EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 200 MG/245 MG FILM-COATED TABLETS

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL PHOSPHATE / EMTRICITABINE / TENOFOVIR DISOPROXIL PHOSPHATE

View full screen / Print PDF » Download PDF ⇩
Transcript
EMTRICITABINE/TENOFOVIR DISOPROXIL
200 mg/245 mg FILM-COATED TABLETS
Package leaflet: Information for the user

Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:

1. What Emtricitabine/Tenofovir disoproxil is and
what it is used for
2. What you need to know before you take
Emtricitabine/Tenofovir disoproxil
3. How to take Emtricitabine/Tenofovir disoproxil
4. Possible side effects
5. How to store Emtricitabine/Tenofovir disoproxil
6. Contents of the pack and other information

1

What Emtricitabine/Tenofovir disoproxil
is and what it is used for

Emtricitabine/Tenofovir disoproxil contains two
active substances, emtricitabine and tenofovir
disoproxil. Both of these active substances are
antiretroviral medicines which are used to treat HIV
infection. Emtricitabine is a nucleoside reverse
transcriptase inhibitor and tenofovir is a nucleotide
reverse transcriptase inhibitor. However, both are
generally known as NRTIs and they work by
interfering with the normal working of an enzyme
(reverse transcriptase) that is essential for the virus
to reproduce itself.
• Emtricitabine/Tenofovir disoproxil is used to
treat Human Immunodeficiency Virus 1(HIV-1)
infection, in adults aged 18 years and over.
• Emtricitabine/Tenofovir disoproxil should
always be used combined with other
medicines to treat HIV infection.
• Emtricitabine/Tenofovir disoproxil can be
administered in place of emtricitabine and
tenofovir disoproxil used separately at the
same doses.
People who are HIV positive can still pass on HIV
when taking this medicine, although the risk is
lowered by effective antiretroviral therapy. Discuss
with your doctor the precautions needed to avoid
infecting other people.
This medicine is not a cure for HIV infection. While
taking Emtricitabine/Tenofovir disoproxil you may
still develop infections or other illnesses associated
with HIV infection.
• Emtricitabine/Tenofovir disoproxil is also used to
reduce the risk of getting HIV-1 infection, when
used as a daily treatment, together with safer sex
practices:
See section 2 for a list of precautions to take
against HIV infection.

2

What you need to know before you take
Emtricitabine/Tenofovir disoproxil

Do not take Emtricitabine/Tenofovir disoproxil to
treat HIV or to reduce the risk of getting HIV if you
are allergic to emtricitabine, tenofovir, tenofovir
disoproxil phosphate, or any of the other ingredients
of this medicine (listed in section 6).
➔If this applies to you, tell your doctor immediately.
Before taking Emtricitabine/Tenofovir disoproxil to
reduce the risk of getting HIV:
Emtricitabine/Tenofovir disoproxil can only help
reduce your risk of getting HIV before you are
infected.
• You must be HIV negative before you start to take
Emtricitabine/Tenofovir disoproxil to reduce the
risk of getting HIV. You must get tested to make
sure that you do not already have HIV infection.
Do not take Emtricitabine/Tenofovir disoproxil to
reduce your risk unless you are confirmed to be
HIV negative. People who do have HIV must take
Emtricitabine/Tenofovir disoproxil in combination
with other drugs.
• Many HIV tests can miss a recent infection. If you
get a flu-like illness, it could mean you have
recently been infected with HIV. These may be
signs of HIV infection:
• tiredness
• fever
• joint or muscle aches
• headache
• vomiting or diarrhoea
• rash
• night sweats
• enlarged lymph nodes in the neck or groin
➔ Tell your doctor about any flu-like illness –
either in the month before starting
Emtricitabine/Tenofovir disoproxil, or at any time
while taking Emtricitabine/Tenofovir disoproxil.
Warnings and precautions
While taking Emtricitabine/Tenofovir disoproxil to
reduce the risk of getting HIV:
• Take Emtricitabine/Tenofovir disoproxil every day
to reduce your risk, not just when you think you
have been at risk of HIV infection. Do not miss
any doses of Emtricitabine/Tenofovir disoproxil, or
stop taking it. Missing doses may increase your
risk of getting HIV infection.
• Get tested for HIV regularly.
• If you think you were infected with HIV, tell your
doctor straight away. They may want to do more
tests to make sure you are still HIV negative.
• Just taking Emtricitabine/Tenofovir disoproxil
may not stop you getting HIV.
• Always practice safer sex. Use condoms 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
or drug equipment.
• Get tested for other sexually transmitted
infections such as syphilis and gonorrhoea. These
infections make it easier for HIV to infect you.
Ask your doctor if you have any more questions
about how to prevent getting HIV or spreading HIV
to other people.
While taking Emtricitabine/Tenofovir disoproxil to
treat HIV or to reduce the risk of getting HIV:
• Emtricitabine/Tenofovir disoproxil may affect
your kidneys. Before and during treatment, your
doctor may order blood tests to measure kidney
function. Tell your doctor if you have had kidney
disease, or if tests have shown kidney problems.
If you have kidney problems, your doctor may
advise you to stop taking Emtricitabine/Tenofovir

disoproxil or, if you already have HIV, to take
Emtricitabine/Tenofovir disoproxil less frequently.
Emtricitabine/Tenofovir disoproxil is not
recommended if you have severe kidney disease
or are on dialysis.
Bone problems (sometimes resulting in fractures)
may also occur due to damage to kidney tubule
cells (see section 4, Possible side effects).
• Talk to your doctor if you have a history of liver
disease, including hepatitis. Patients infected
with HIV who also have liver disease (including
chronic hepatitis B or C), who are treated with
antiretrovirals, have a higher risk of severe and
potentially fatal liver complications. If you have
hepatitis B or C, your doctor will carefully
consider the best treatment regimen for you.
• Know your hepatitis B virus (HBV) infection
status before starting Emtricitabine/Tenofovir
disoproxil. If you have HBV, there is a serious risk
of liver problems when you stop taking
Emtricitabine/Tenofovir disoproxil, whether or not
you also have HIV. It is important not to stop
taking Emtricitabine/Tenofovir disoproxil without
talking to your doctor: see section 3, Do not stop
taking Emtricitabine/Tenofovir disoproxil.
Talk to your doctor if you are over 65. The
combination of emtricitabine and tenofovir
disoproxil has not been studied in patients over
65 years of age.
Children and adolescents
Emtricitabine/Tenofovir disoproxil is not for use in
children and adolescents under 18 years of age.
Other medicines and Emtricitabine/Tenofovir
disoproxil
Do not take Emtricitabine/Tenofovir disoproxil if
you are already taking other medicines that contain
emtricitabine and tenofovir disoproxil or any other
antiviral medicines that contain tenofovir
alafenamide, lamivudine or adefovir dipivoxil.
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Taking Emtricitabine/Tenofovir disoproxil with
other medicines that can damage your kidneys: it is
especially important to tell your doctor if you are
taking any of these medicines, including:
• aminoglycosides (for bacterial infection)
• amphotericin B (for fungal infection)
• foscarnet (for viral infection)
• ganciclovir (for viral infection)
• pentamidine (for infections)
• vancomycin (for bacterial infection)
• interleukin-2 (to treat cancer)
• cidofovir (for viral infection)
• non-steroidal anti-inflammatory drugs
(NSAIDs, to relieve bone or muscle pains).
If you are taking another antiviral medicine called a
protease inhibitor to treat HIV, your doctor may
order blood tests to closely monitor your kidney
function.
It is also important to tell your doctor if you are
taking ledipasvir/sofosbuvir to treat hepatitis C
infection.
Taking Emtricitabine/Tenofovir disoproxil with
other medicines containing didanosine (for
treatment of HIV infection): Taking
Emtricitabine/Tenofovir disoproxil with other
antiviral medicines that contain didanosine can
raise the levels of didanosine in your blood and may
reduce CD4 cell counts. Rarely, inflammation of the
pancreas and lactic acidosis (excess lactic acid in
the blood), which sometimes causes death, have
been reported when medicines containing tenofovir
disoproxil and didanosine were taken together. Your
doctor will carefully consider whether to treat you
with combinations of tenofovir and didanosine.
➔ Tell your doctor if you are taking any of these
medicines. Tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines.
Emtricitabine/Tenofovir disoproxil with food and
drink
• Whenever possible, Emtricitabine/Tenofovir
disoproxil should be taken with food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
• Although there are limited clinical data on the use
of the combination of emtricitabine and tenofovir
disoproxil in pregnant women, it is not usually
used unless absolutely necessary.
• If you are a woman who could get pregnant
during treatment with Emtricitabine/Tenofovir
disoproxil, you must use an effective method of
contraception to avoid becoming pregnant.
• If you become pregnant, or plan to become
pregnant, ask your doctor about the potential
benefits and risks of therapy with
Emtricitabine/Tenofovir disoproxil to you and your
child.
If you have taken Emtricitabine/Tenofovir disoproxil
during your pregnancy, your doctor may request
regular blood tests and other diagnostic tests to
monitor the development of your child. In children
whose mothers took NRTIs during pregnancy, the
benefit from the protection against HIV outweighed
the risk of side effects.
• Do not breast-feed during treatment with
Emtricitabine/Tenofovir disoproxil. This is
because the active substances in this medicine
pass into human breast milk.
• If you are a woman with HIV it is recommended
that you do not breast-feed, to avoid passing the
virus to the baby in breast milk.
Driving and using machines
The combination of emtricitabine and tenofovir
disoproxil can cause dizziness. If you feel dizzy
while taking Emtricitabine/Tenofovir disoproxil, do
not drive and do not use any tools or machines.
Emtricitabine/Tenofovir disoproxil contains sodium
This medicinal product contains less than 1 mmol
sodium (23 mg) per dose, i.e. essentially
‘sodium-free’.

3

How to take Emtricitabine/Tenofovir
disoproxil

• Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The recommended dose of Emtricitabine/Tenofovir
disoproxil to treat HIV or to reduce the risk of
getting HIV is:
• Adults: one tablet each day. Whenever possible,
Emtricitabine/Tenofovir disoproxil should be taken
with food.

If you have difficulty swallowing, you can use the tip
of a spoon to crush the tablet. Then mix the powder
with about 100 ml (half a glass) of water, orange
juice or grape juice, and drink immediately.
• Always take the dose recommended by your
doctor. This is to make sure that your medicine is
fully effective, and to reduce the risk of
developing resistance to the treatment. Do not
change the dose unless your doctor tells you to.
• If you are being treated for HIV infection your
doctor will prescribe Emtricitabine/Tenofovir
disoproxil with other antiretroviral medicines.
Please refer to the patient information leaflets of
the other antiretrovirals for guidance on how to
take those medicines.
• If you are taking Emtricitabine/Tenofovir
disoproxil to reduce the risk of getting HIV, take
Emtricitabine/Tenofovir disoproxil every day, not
just when you think you have been at risk of HIV
infection.
Ask your doctor if you have any questions about
how to prevent getting HIV or prevent spreading HIV
to other people.
If you take more Emtricitabine/Tenofovir disoproxil
than you should
If you accidentally take more than the
recommended dose of Emtricitabine/Tenofovir
disoproxil, contact your doctor or nearest
emergency department for advice. Keep the outer
carton or tablet bottle with you so that you can
easily describe what you have taken.
If you miss a dose
It is important not to miss a dose of
Emtricitabine/Tenofovir disoproxil.
• If you notice within 12 hours of the time you
usually take Emtricitabine/Tenofovir disoproxil,
take the tablet preferably with food as soon as
possible. Then take the next dose at your usual
time.
• If you notice 12 hours or more after the time you
usually take Emtricitabine/Tenofovir disoproxil,
forget about the missed dose. Wait and take the
next dose, preferably with food, at your usual time.
If you vomit less than 1 hour after taking
Emtricitabine/Tenofovir disoproxil, take another
tablet. You do not need to take another tablet if you
were sick more than 1 hour after taking
Emtricitabine/Tenofovir disoproxil.
Do not stop taking Emtricitabine/Tenofovir disoproxil
• If you take Emtricitabine/Tenofovir disoproxil for
treatment of HIV infection, stopping tablets may
reduce the effectiveness of the anti-HIV therapy
recommended by your doctor.
• If you are taking Emtricitabine/Tenofovir
disoproxil to reduce the risk of getting HIV, do
not stop taking Emtricitabine/Tenofovir disoproxil
or miss any doses. Stopping use of
Emtricitabine/Tenofovir disoproxil, or missing
doses, may increase your risk of getting HIV
infection.
➔ Do not stop taking Emtricitabine/Tenofovir
disoproxil without contacting your doctor.
• If you have hepatitis B, it is especially important
not to stop your Emtricitabine/Tenofovir disoproxil
treatment without talking to your doctor first. You
may require blood tests for several months after
stopping treatment. In some patients with
advanced liver disease or cirrhosis, stopping
treatment is not recommended as this may lead to
worsening of your hepatitis, which may be
life-threatening.
➔ Tell your doctor immediately about new or
unusual symptoms after you stop treatment,
particularly symptoms you associate with hepatitis
B infection.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Possible serious side effects:
• Lactic acidosis (excess lactic acid in the blood)
is a rare but potentially life-threatening side
effect. Lactic acidosis occurs more often in
women, particularly if they are overweight, and in
people with liver disease. The following side
effects may be signs of lactic acidosis:
• deep rapid breathing
• drowsiness
• feeling sick (nausea), being sick (vomiting)
• stomach pain.
➔ If you think you may have lactic acidosis, get
medical help immediately.
• Any signs of inflammation or infection. In some
patients with advanced HIV infection (AIDS) and
a history of opportunistic infections (infections
that occur in people with a weak immune system),
signs and symptoms of inflammation from
previous infections may occur soon after anti-HIV
treatment is started. It is thought that these
symptoms are due to an improvement in the
body’s immune response, enabling the body to
fight infections that may have been present with
no obvious symptoms.
• Autoimmune disorders, when the immune system
attacks healthy body tissue, may also occur after
you start taking medicines to treat HIV infection.
Autoimmune disorders may occur many months
after the start of treatment. Look out for any
symptoms of infection or other symptoms such as:
• muscle weakness
• weakness beginning in the hands and feet and
moving up towards the trunk of the body
• palpitations, tremor or hyperactivity.
➔ If you notice these or any symptoms of
inflammation or infection, get medical help
immediately.
Possible side effects
Very common side effects (may affect more than 1
in 10 people)
• diarrhoea, being sick (vomiting), feeling sick
(nausea)
• dizziness, headache
• rash
• feeling weak.
Tests may also show:
• decreases in phosphate in the blood
• increased creatine kinase.
Common side effects (may affect up to 1 in every 10
people):
• pain, stomach pain
• difficulty sleeping, abnormal dreams
• problems with digestion resulting in discomfort
after meals, feeling bloated, flatulence
• rashes (including red spots or blotches
sometimes with blistering and swelling of the
skin), which may be allergic reactions, itching,

changes in skin colour including darkening of the
skin in patches
• other allergic reactions, such as wheezing,
swelling or feeling light-headed.
Tests may also show:
• low white blood cell count (a reduced white blood
cell count can make you more prone to infection)
• increased triglycerides (fatty acids), bile or sugar
in the blood
• liver and pancreas problems.
Uncommon side effects (may affect up to 1 in 100
people):
• pain in the abdomen (tummy) caused by
inflammation of the pancreas
• swelling of the face, lips, tongue or throat
• anaemia (low red blood cell count)
• breakdown of muscle, muscle pain or weakness
which may occur due to damage to the kidney
tubule cells.
Tests may also show:
• decreases in potassium in the blood
• increased creatinine in your blood
• changes to your urine.
Rare side effects (may affect up to 1 in 1,000
people):
• lactic acidosis (see Possible serious side effects)
• fatty liver
• yellow skin or eyes, itching, or pain in the
abdomen (tummy) caused by inflammation of the
liver
• inflammation of the kidney, passing a lot of urine
and feeling thirsty, kidney failure, damage to
kidney tubule cells
• softening of the bones (with bone pain and
sometimes resulting in fractures)
• back pain caused by kidney problems.
Damage to kidney tubule cells may be associated
with breakdown of muscle, softening of the bones
(with bone pain and sometimes resulting in
fractures), muscle pain, muscle weakness and
decreases in potassium or phosphate in the blood.
➔ If you notice any of the side effects listed above
or if any of the side effects get serious, talk to your
doctor or pharmacist.
The frequency of the following side effects is not
known.
• Bone problems. Some patients taking
combination antiretroviral medicines such as
Emtricitabine/Tenofovir disoproxil may develop a
bone disease called osteonecrosis (death of bone
tissue caused by loss of blood supply to the
bone). Taking this type of medicine for a long time,
taking corticosteroids, drinking alcohol, having a
very weak immune system, and being overweight,
may be some of the many risk factors for
developing this disease. Signs of osteonecrosis
are:
• joint stiffness
• joint aches and pains (especially of the hip,
knee and shoulder)
• difficulty with movement.
➔ If you notice any of these symptoms tell your
doctor.
During treatment for HIV there may be an increase
in weight and in levels of blood lipids and glucose.
This is partly linked to restored health and life style,
and in the case of blood lipids sometimes to the HIV
medicines themselves. Your doctor will test for
these changes.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5

How to store Emtricitabine/Tenofovir
disoproxil

Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the bottle and carton after {EXP}. The
expiry date refers to the last day of that month.
Blisters: Do not store above 30°C. Store in the
original blister to protect from moisture.
HDPE bottle: Store in the original bottle to protect
from moisture. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6

Contents of the pack and other
information

What Emtricitabine/Tenofovir disoproxil contains
• The active substances are emtricitabine and
tenofovir disoproxil. Each Emtricitabine/Tenofovir
disoproxil film-coated tablet contains 200 mg of
emtricitabine and 245 mg of tenofovir disoproxil
(equivalent to 291.22 mg of tenofovir disoproxil
phosphate or 136 mg of tenofovir).
• The other ingredients are mannitol, sodium
stearyl fumarate, microcystalline cellulose (E460),
hydroxypropylcellulose-low substituted (E463)
and hypromellose (E464).
• The other ingredients in the film-coating are
polyvinyl alcohol part-hydrolyzed (E1203), titanium
dioxide (E171), macrogol 3350 (E1521), talc
(E553b), iron oxide yellow (E172), indigo carmine
aluminium lake (E132).
What Emtricitabine/Tenofovir disoproxil looks like
and contents of the pack
Emtricitabine/Tenofovir disoproxil film-coated
tablets are green to light green, oval shaped film
coated tablets, of approximate dimensions 18mm x
10mm, debossed with “E T” on one side and plain on
the other side.
Each bottle contains a silica gel desiccant that must
be kept in the bottle to help protect your tablets. The
silica gel desiccant is contained in a separate
sachet or canister and should not be swallowed.
The following pack sizes are available:
Blister: Pack size of 30, 30x1 and 90 Film-coated
Tablets.
Bottle: Pack size of 30 and 3x30 Film-coated Tablets.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz
baruna Filipovića 25, Zagreb, 10000, Croatia
This leaflet was last revised in 05/2017
PL 00289/1997

EAS731

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide