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

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL PHOSPHATE

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Package leaflet: Information for the user
EMTRICITABINE/TENOFOVIR DISOPROXIL 200 mg/245 mg FILM-COATED TABLETS
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 is a treatment for Human Immunodeficiency Virus (HIV) infection
in adults aged 18 years and over.
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 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.
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. You 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.
2.

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

Do NOT take Emtricitabine/Tenofovir disoproxil


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.

Warnings and precautions


Tell your doctor if you have had kidney disease, or if tests have shown problems with your
kidneys. Emtricitabine/Tenofovir disoproxil may affect your kidneys. Before starting treatment, your
doctor may order blood tests to assess kidney function. Your doctor may also order blood tests during
treatment to monitor your kidneys and may advise you to take the tablets less often.
1

Emtricitabine/Tenofovir disoproxil is NOT recommended if you have severe kidney disease or are
receiving haemodialysis.
Emtricitabine/Tenofovir disoproxil is not usually taken with other medicines that can damage your
kidneys (see Other medicines and Emtricitabine/Tenofovir disoproxil). If this is unavoidable, your
doctor will monitor your kidney function once a week.


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. If you are older than this and are prescribed
Emtricitabine/Tenofovir disoproxil, your doctor will monitor you carefully.



Talk to your doctor if you have a history of liver disease, including hepatitis. Patients with 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 infection, your doctor will
carefully consider the best treatment regimen for you. Both active substances in the combination of
emtricitabine and tenofovir disoproxil show some activity against hepatitis B virus although
emtricitabine is not approved for the treatment of hepatitis B infection. If you have a history of liver
disease or chronic hepatitis B infection your doctor may conduct blood tests in order to carefully
monitor liver function.

Other precautions
Look out for infections. If you have advanced HIV infection (AIDS) and have an infection, you may
develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once
treatment with Emtricitabine/Tenofovir disoproxil is started. These symptoms may indicate that your body’s
improved immune system is fighting infection. Look out for signs of inflammation or infection soon after
you start taking Emtricitabine/Tenofovir disoproxil. If you notice signs of inflammation or infection, tell
your doctor at once.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune
system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your
HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice 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, please inform your
doctor IMMEDIATELY to seek necessary treatment.
Bone problems. Some patients taking combination antiretroviral therapy may develop a bone disease called
osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination
antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass
index, among others, may be some of the many risk factors for developing this disease. Signs of
osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in
movement. If you notice any of these symptoms inform your doctor.
Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see
section 4, Possible side effects).
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
You should 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 lamivudine or adefovir dipivoxil.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


It is especially important to tell your doctor if you are taking other medicines which may
damage your kidneys.
These include:












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)

Other medicines containing didanosine (for 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.

Do NOT stop your treatment without contacting your doctor.
Emtricitabine/Tenofovir disoproxil with food and drink


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.


You must NOT take Emtricitabine/Tenofovir disoproxil during pregnancy unless specifically
discussed with your doctor. 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 is:


Adults: one tablet each day 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 have problems with your kidneys, your doctor may advise you to take
Emtricitabine/Tenofovir disoproxil less frequently.



If your doctor decides to stop one of the components of Emtricitabine/Tenofovir disoproxil or
change the dose of Emtricitabine/Tenofovir disoproxil, you may be given emtricitabine and/or
tenofovir separately instead of the combined medicine or other medicines for the treatment of 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 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 forget to take Emtricitabine/Tenofovir disoproxil
It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil.
If you do miss a dose of Emtricitabine/Tenofovir disoproxil within 12 hours of when it is usually taken,
take it as soon as you can, and then take your next dose at its regular time.
If it is almost time (less than 12 hours) for your next dose anyway, forget about the missed dose. Wait and
take the next dose at the regular time. Do NOT take a double dose to make up for a forgotten tablet.
If you throw up 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.

If you stop taking Emtricitabine/Tenofovir disoproxil


Stopping treatment with Emtricitabine/Tenofovir disoproxil may reduce the effectiveness of the antiHIV therapy recommended by your doctor. Speak with your doctor before you stop taking
Emtricitabine/Tenofovir disoproxil for any reason, particularly if you are experiencing any side effects
or you have another illness. Contact your doctor before you restart taking Emtricitabine/Tenofovir
disoproxil tablets.



If you have HIV infection and hepatitis B, it is especially important NOT to stop your emtricitabine
and tenofovir disoproxil treatment without talking to your doctor first. Some patients have had blood
tests or symptoms indicating that their hepatitis has got worse after stopping the combination of
emtricitabine and tenofovir disoproxil. 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.
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

During HIV therapy 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor about any of the following side effects:
Possible serious side effects: tell a doctor IMMEDIATELY
The following side effect is rare (this can affect up to 1 in every 1,000 patients):

Lactic acidosis (excess lactic acid in the blood) is a serious side effect that can be life-threatening.
The following side effects may be signs of lactic acidosis:

deep rapid breathing

drowsiness

feeling sick (nausea), being sick (vomiting) and stomach pain
If you think you may have lactic acidosis, contact your doctor immediately.
Other possible serious side effects
The following side effects are uncommon (these can affect up to 1 in every 100 patients):

pain in the abdomen (tummy) caused by inflammation of the pancreas

swelling of the face, lips, tongue or throat
The following side effects are rare (these can affect up to 1 in every 1,000 patients):

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. Your doctor may do blood tests to see if your kidneys are working properly.

softening of the bones (with bone pain and sometimes resulting in fractures)

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 think that you may have any of these serious side effects, talk to your doctor.
Most frequent side effects
The following side effects are very common (these can affect at least 10 in every 100 patients):

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
Other possible side effects
The following side effects are common (these can affect up to 10 in every 100 patients):

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
The following side effects are uncommon (these can affect up to 1 in every 100 patients):

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
The following side effects are rare (these can affect up to 1 in every 1,000 patients):

back pain caused by kidney problems
Other possible effects
Children who were administered emtricitabine, one of the components of the combination of emtricitabine
and tenofovir disoproxil, also experienced anaemia (low red blood cell count), commonly and changes in
skin colour including darkening of the skin in patches, very commonly. If the production of red blood cells is
reduced, a child may have symptoms of tiredness or breathlessness.
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
*OR
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Kraków, 31-546, Poland
*OR
Merckle GmbH, Ludwig-Merckle-Strasse 3, Blaubeuren, Baden-Wuerttemberg, 89143, Germany

*OR
Teva Pharma B.V., Swensweg 5, Haarlem, 2031GA, Netherlands
This leaflet was last revised in 04/2016
PL 00289/1997
* Only the actual site of batch release will appear on the printed version of the leaflet

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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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