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

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

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Package leaflet: Information for the user

SZ00000LT000

Emtricitabine/Tenofovir disoproxil 200 mg/245 mg
Film-coated Tablets
emtricitabine/tenofovir disoproxil
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, 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 medicines.
• 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
gonorrhea. 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.
Emtricitabine/Tenofovir disoproxil has
not been studied in patients over 65
years of age.
• Talk to your doctor if you are intolerant
to lactose (see Emtricitabine/Tenofovir
disoproxil contains lactose later in this
section).
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 the components of
Emtricitabine/Tenofovir disoproxil,
emtricitabine and tenofovir disoproxil or any
other antiviral medicines that contain tenofovir
alafenamide, lamivudine or adefovir dipivoxil.
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 Emtricitabine/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
Emtricitabine/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 lactose.
Tell your doctor if you are lactose-intolerant
or intolerant to other sugars.

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.

Continued on the next page >>

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 tablet bottle with you so that you
can easily describe what you have taken.
If you forget to take Emtricitabine/
Tenofovir disoproxil
It is important not to miss a dose of
Emtricitabine/Tenofovir disoproxil.
If you do miss a dose
• If you notice Emtricitabine/Tenofovir
disoproxil within 12 hours of the time
you usually take, 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 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

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
or pharmacist. This includes any possible
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow
Card Scheme (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 label and carton
after {EXP}. The expiry date refers to the last
day of that month.
Bottle:
Store in the original package in order to
protect from moisture. Keep the bottle tightly
closed.
This medicine does not require any special
temperature storage conditions.
After first opening of the bottle: Use within
30 days.
Blister:
Store below 30°C.
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 film-coated tablet contains 200 mg
emtricitabine and 245mg tenofovir
disoproxil.
• The other excipients are:
Tablet core: microcrystalline cellulose,
croscarmellose sodium, magnesium
stearate, pregelatinised maize starch,
lactose monohydrate
Tablet coating: Hypromellose, lactose
monohydrate, titanium dioxide (E171),
triacetin, indigo carmine aluminum lake
(E132)
What Emtricitabine/Tenofovir disoproxil
looks like and contents of the pack
Emtricitabine/Tenofovir disoproxil is a blue,
capsule shaped, film coated tablet, with
dimensions of approximately 19 mm x 9 mm,
debossed with ‘H’ on one side and ‘E29’ on
the other side.
Emtricitabine/Tenofovir disoproxil are
available packed in OPA-Al-PVC/Al blisters
and in white opaque HDPE bottles of
30 tablets, containing a silica gel desiccant
canister that must be kept in the bottle
to help protect your tablets, with a white
opaque polypropylene child resistant cap.
The following pack sizes are available:
Outer cartons containing bottles of 30, 60
(2 2 x 30) or 90 (3 x 30) film-coated tablets.
Outer cartons containing blister packs with
10, 30, 60 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley, Camberley,
Surrey,
GU16 7SR,
UK
Manufacturer
Pharmadox Healthcare Ltd,
KW20A Kordin Industrial Park,
Paola, PLA 3000,
Malta
This leaflet was last revised in 04/2017

Common side effects
(may affect up to 1 in 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
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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.

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