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

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

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Package leaflet: Information for the patient
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.
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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 fumarate 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.

2

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.
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Talk to your doctor if you are over 65. The combination of emtricitabine and
tenofovir disoproxil fumarate 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 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 fumarate 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.
4

Emtricitabine/Tenofovir disoproxil with food and drink
Whenever possible, Emtricitabine/Tenofovir disoproxil should be taken with food.
Pregnancy, breast-feeding and fertility
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 fumarate 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.

3.

How to take Emtricitabine/Tenofovir disoproxil

Always take this medicine exactly as your doctor or pharmacist 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.
5






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 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.
6



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.
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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 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,
8




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 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 carton and on the bottle
after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
Store below 30°C and use within 30 days after first opening.

9

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 fumarate. Each film-coated
tablet contains 200 mg emtricitabine and 245 mg tenofovir disoproxil (equivalent to 300 mg
tenofovir disoproxil fumarate or 136 mg tenofovir).
The other ingredients are:
Tablet core: microcrystaline cellulose, croscarmellose sodium, colloidal hydrophobic silica,
talc, magnesium stearate.
Film-coating: Opadry II Blue (mixture of poly(vinyl alcohol), titanium dioxide [E 171],
macrogol 3350, talc, indigo carmine aluminium lake [E 132]).
What Emtricitabine/Tenofovir disoproxil looks like and contents of the pack
Emtricitabine/Tenofovir disoproxil is a blue, oval biconvex film-coated tablet without score
line with dimensions approx. 19.35 x 9.75 mm.
Pack size:
1×30 film-coated tablets.
3×30 film-coated tablets.
Not all pack sizes may be marketed.
Open bottles by pressing the child proof cap down and turning it counter-clockwise.
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 canister and should not be
swallowed.
Marketing Authorisation Holder
Zentiva
One Onslow Street
Guildford, Surrey
GU1 4YS, United Kingdom

10

Manufacturer
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

This leaflet was last revised in March 2017

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Expand Transcript

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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