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

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE

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Package leaflet: Information for the user
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
This medicine 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 fumarate,
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
Talk to your doctor or pharmacist before taking Emtricitabine/Tenofovir
disoproxil.
• Tell your doctor if you have had kidney disease, or if tests have shown
problems with your kidneys. Emtricitabine and 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. 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. 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 Emtricitabine/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 and 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
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
You should not take Emtricitabine/Tenofovir disoproxil if you are already taking
other medicines that contain emtricitabine and tenofovir disoproxil fumarate,
or any other antiviral medicines that contain lamivudine or adefovir dipivoxil.
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 and 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.
Do not stop your treatment without contacting your doctor.
Emtricitabine/Tenofovir disoproxil with food and drink
This medicine should be taken with food.
Pregnancy and 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.
• 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 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 and 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 and 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 and tenofovir disoproxil can cause dizziness. If you feel dizzy
while taking this medicine, 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.
Emtricitabine/Tenofovir disoproxil contains lactose monohydrate. If you know
you are lactose-intolerant, or if you have been told that you have an intolerance
to any other sugars, talk to your doctor before taking this medicine.
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 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
this medicine less frequently.
• If your doctor decides to stop one of the components of Emtricitabine/
Tenofovir disoproxil or change the dose of this medicine, 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 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 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 anti-HIV 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/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 Emtricitabine/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
Like all medicines, this medicine can cause side effects, although not everybody
gets them. Tell your doctor about any of the following 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.
Possible serious side effects: tell a doctor immediately
The following side effects are 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
Emtricitabine/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 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, Website: 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.
Store below 25oC.
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 of emtricitabine and 245  mg of
tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or
136 mg of tenofovir).
The other ingredients are microcrystalline cellulose (E460), mannitol,
croscarmellose sodium, colloidal silicon dioxide, magnesium stearate (E572),
lactose monohydrate, hypromellose (E464), titanium dioxide, triacetin (E171)
and indigo carmoine aluminium lake (E132).
What Emtricitabine/Tenofovir disoproxil looks like and contents of the pack
Emtricitabine/Tenofovir disoproxil are blue coloured, capsule shaped, biconvex,
18.6  mm x 8.4  mm film-coated tablets debossed with “ET” on one side and
plain on the other side.
Emtricitabine/Tenofovir disoproxil is supplied in bottles. Each bottle contains a
silica gel dessicant that must be kept in the bottle to help protect your tablets.
The silica gel dessicant is contained in a separate sachet or canister and should
not be swallowed.
The following pack sizes are available: 30 film-coated tablets and 90 film-coated
tablets in bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court, Bexton Road,
Knutsford, Cheshire, WA16 0PF
United Kingdom
This leaflet was last revised in April 2016.
Code No. GO/DRUGS/654

ID#: 242421

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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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