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EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL TEVA 600 MG/ 200 MG/ 245 MG FILM-COATED TABLETS

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

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TEVA UK Ref: 231-30-32584-A LEA EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISPROXIL 600/200/245mg FC TABS TUK
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08 February 2017
PANTONE® GREEN C
BLACK

Efavirenz/Emtricitabine/Tenofovir disoproxil
600 mg/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.

GLUE AREA
NO PRINTING

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

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and what it is used for

Efavirenz/Emtricitabine/Tenofovir disoproxil contains three active
substances that are used to treat human immunodeficiency virus
(HIV) infection:
• Efavirenz is a non-nucleoside reverse transcriptase inhibitor
(NNRTI).
• Emtricitabine is a nucleoside reverse transcriptase inhibitor
(NRTI).
• Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI).
PHARMA CODE

OPTICAL
CODE

PRODUCT
NAME
CODE

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Each of these active substances, also known as antiretroviral
medicines, work by interfering with an enzyme (reverse
transcriptase) that is essential for the virus to multiply.
Efavirenz/Emtricitabine/Tenofovir disoproxil is a treatment for
Human Immunodeficiency Virus (HIV) infection in adults aged 18
years and over who have previously been treated with other
antiretroviral medicines and have their HIV-1 infection under
control for at least three months. Patients must not have
experienced failure of a previous HIV therapy.

2 What you need to know before you take

Efavirenz/Emtricitabine/Tenofovir disoproxil

Do not take Efavirenz/Emtricitabine/Tenofovir disoproxil if you:
• are allergic to efavirenz, emtricitabine, tenofovir, tenofovir
disoproxil or any of the other ingredients of this medicine (listed
in section 6)
• have severe liver disease
• are currently taking any of the following medicines:
• astemizole or terfenadine (used to treat hay fever or other
allergies)
• bepridil (used to treat heart disease)
• cisapride (used to treat heartburn)
• ergot alkaloids (for example, ergotamine,
dihydroergotamine, ergonovine, and methylergonovine)
(used to treat migraines and cluster headaches)
• midazolam or triazolam (used to help you sleep)
• pimozide (used to treat certain mental conditions)
• St. John’s Wort (Hypericum perforatum) (a herbal
preparation used for depression and anxiety)
• voriconazole (used to treat fungal infections).



Warnings and precautions



Talk to your doctor or pharmacist before taking
Efavirenz/Emtricitabine/Tenofovir disoproxil.


What is in this leaflet

1 What Efavirenz/Emtricitabine/Tenofovir disoproxil is

OPTICAL
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If you are taking any of these medicines, tell your doctor
immediately. Taking these medicines with
Efavirenz/Emtricitabine/Tenofovir disoproxil could cause serious or
life-threatening side effects or stop these medicines from working
properly.





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. This medicine is not a cure for HIV infection. While taking
Efavirenz/Emtricitabine/Tenofovir disoproxil you may still develop
infections or other illnesses associated with HIV infection.
You must remain under the care of your doctor while taking
Efavirenz/Emtricitabine/Tenofovir disoproxil.
Tell your doctor:
• if you are taking other medicines that contain efavirenz,
emtricitabine, tenofovir disoproxil, tenofovir alafenamide,
lamivudine or adefovir dipivoxil.
Efavirenz/Emtricitabine/Tenofovir disoproxil should not be
taken with any of these medicines.
• if you have or have had kidney disease, or if tests have
shown problems with your kidneys.
Efavirenz/Emtricitabine/Tenofovir disoproxil is not recommended
if you have moderate to severe kidney disease.
Efavirenz/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.
Efavirenz/Emtricitabine/Tenofovir disoproxil is not usually
taken with other medicines that can damage your kidneys
(see Other medicines and Efavirenz/Emtricitabine/Tenofovir
disoproxil). If this is unavoidable, your doctor will monitor
your kidney function once a week.
• if you have a history of mental illness, including depression,
or of substance or alcohol abuse. Tell your doctor
immediately if you feel depressed, have suicidal thoughts or
have strange thoughts (see section 4, Possible side effects).
• if you have a history of convulsions (fits or seizures) or if you
are being treated with anticonvulsant therapy such as
carbamazepine, phenobarbital and phenytoin. If you are
taking any of these medicines, your doctor may need to
check the level of anticonvulsant medicine in your blood to
ensure that it is not affected while taking
Efavirenz/Emtricitabine/Tenofovir disoproxil. Your doctor may
give you a different anticonvulsant.
• if you have a history of liver disease, including chronic active
hepatitis. Patients with liver disease including chronic
hepatitis B or C, who are treated with combination
antiretrovirals, have a higher risk of severe and potentially
life-threatening liver problems. Your doctor may conduct
blood tests in order to check how well your liver is working
or may switch you to another medicine. If you have severe
liver disease, do not take Efavirenz/Emtricitabine/Tenofovir
disoproxil (see earlier in section 2, Do not take
Efavirenz/Emtricitabine/Tenofovir disoproxil).
If you have hepatitis B infection, your doctor will carefully
consider the best treatment regimen for you. Tenofovir
disoproxil and emtricitabine, two of the active substances in
Efavirenz/Emtricitabine/Tenofovir disoproxil, show some
activity against hepatitis B virus although emtricitabine is not
approved for the treatment of hepatitis B infection.
Symptoms of your hepatitis may become worse after
discontinuation of Efavirenz/Emtricitabine/Tenofovir
disoproxil. Your doctor may then conduct blood tests at

regular intervals in order to check how well your liver is
working (see section 3, If you stop taking
Efavirenz/Emtricitabine/Tenofovir disoproxil).
independent of a history of liver disease, your doctor will
consider regular blood tests to check how your liver is
working.
if you are over 65. Insufficient numbers of patients over 65
years of age have been studied. If you are over 65 years of
age and are prescribed Efavirenz/Emtricitabine/Tenofovir
disoproxil, your doctor will monitor you carefully.

Once you start taking Efavirenz/Emtricitabine/Tenofovir
disoproxil, look out for:
• Signs of dizziness, difficulty sleeping, drowsiness, difficulty
concentrating or abnormal dreaming. These side effects may
start in the first 1 or 2 days of treatment and usually go away
after the first 2 to 4 weeks.
• Any signs of skin rash. Rashes may be caused by
Efavirenz/Emtricitabine/Tenofovir disoproxil. If you see any
signs of a severe rash with blistering or fever, stop taking
Efavirenz/Emtricitabine/Tenofovir disoproxil and tell your
doctor at once. If you had a rash while taking another NNRTI,
you may be at higher risk of getting a rash with
Efavirenz/Emtricitabine/Tenofovir disoproxil.
• Any signs of inflammation or infection. In some patients with
advanced HIV infection (AIDS) and a history of opportunistic
infection, signs and symptoms of inflammation from
previous infections may occur soon after anti-HIV treatment
is started. It is believed that these symptoms are due to
improvement in the body’s immune response, enabling the
body to fight infections that may have been present with no
obvious symptoms. If you notice any symptoms of infection,
please 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
please 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


Do not give Efavirenz/Emtricitabine/Tenofovir disoproxil to
children and adolescents under 18 years of age. The use of
Efavirenz/Emtricitabine/Tenofovir disoproxil in children and
adolescents has not been studied.

Other medicines and Efavirenz/Emtricitabine/Tenofovir disoproxil
You must not take Efavirenz/Emtricitabine/Tenofovir disoproxil
with certain medicines. These are listed under Do not take

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Efavirenz/Emtricitabine/Tenofovir disoproxil, at the start of

section 2. They include some common medicines and some herbal
preparations (including St. John’s Wort) which can cause serious
interactions.
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.



Also, Efavirenz/Emtricitabine/Tenofovir disoproxil should not be
taken with any other medicines that contain efavirenz (unless
recommended by your doctor), emtricitabine, tenofovir disoproxil,
tenofovir alafenamide, lamivudine or adefovir dipivoxil.



Tell your doctor if you are taking other medicines which may
damage your kidneys. Some examples include:
• aminoglycosides, vancomycin (medicines for bacterial
infections)
• foscarnet, ganciclovir, cidofovir (medicines for viral infections)
• amphotericin B, pentamidine (medicines for fungal infections)
• interleukin-2 (to treat cancer)
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone

or muscle pains).
Efavirenz/Emtricitabine/Tenofovir disoproxil may interact with
other medicines, including herbal preparations such as Ginkgo
biloba extracts. As a result, the amounts of
Efavirenz/Emtricitabine/Tenofovir disoproxil or other medicines in
your blood may be affected. This may stop your medicines from
working properly, or may make any side effects worse. In some
cases, your doctor may need to adjust your dose or check your
blood levels. It is important to tell your doctor or pharmacist if you
are taking any of the following:
• Medicines containing didanosine (for HIV infection): Taking
Efavirenz/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.
Inflammation of the pancreas and lactic acidosis (excess lactic
acid in the blood), which sometimes caused death, have been
reported rarely when medicines containing tenofovir disoproxil
and didanosine were taken together. Your doctor will carefully
consider whether to treat you with medicines containing
tenofovir and didanosine.
• Other medicines used for HIV infection: The following protease
inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, or
ritonavir boosted atazanavir or saquinavir. Your doctor may
consider giving you an alternative medicine or changing the
dose of the protease inhibitors. Also, tell your doctor if you are
taking maraviroc.
• Medicines used to treat infection with the hepatitis C virus:
boceprevir, telaprevir, simeprevir.
• Medicines used to lower blood fats (also called statins):
Atorvastatin, pravastatin, simvastatin.
Efavirenz/Emtricitabine/Tenofovir disoproxil can reduce the
amount of statins in your blood. Your doctor will check your
cholesterol levels and will consider changing the dose of your
statin, if needed.
• Medicines used to treat convulsions/seizures (anticonvulsants):
Carbamazepine, phenytoin, phenobarbital.
Efavirenz/Emtricitabine/Tenofovir disoproxil can reduce the
amount of the anticonvulsant in your blood. Carbamazepine can
reduce the amount of efavirenz, one of the components of
Efavirenz/Emtricitabine/Tenofovir disoproxil, in your blood. Your
doctor may need to consider giving you a different
anticonvulsant.
• Medicines used to treat bacterial infections, including
tuberculosis and AIDS-related mycobacterium avium complex:
Clarithromycin, rifabutin, rifampicin. Your doctor may need to
consider changing your dose or giving you an alternative
antibiotic. In addition, your doctor may consider giving you an
additional dose of efavirenz to treat your HIV infection.












Medicines used to treat fungal infections (antifungals):
Itraconazole or posaconazole. Efavirenz/Emtricitabine/Tenofovir
disoproxil can reduce the amount of itraconazole or
posaconazole in your blood. Your doctor may need to consider
giving you a different antifungal.
Medicines used to treat malaria: Atovaquone/proguanil or
artemether/lumefantrine. Efavirenz/Emtricitabine/Tenofovir
disoproxil may reduce the amount of atovaquone/proguanil or
artemether/lumefantrine in your blood.
Hormonal contraceptive, such as birth control pills, an injected
contraceptive (for example, Depo-Provera), or a contraceptive
implant (for example, Implanon): You must also use a reliable
barrier method of contraception (see Pregnancy and
breast-feeding). Efavirenz/Emtricitabine/Tenofovir disoproxil
may make hormonal contraceptives less likely to work.
Pregnancies have occurred in women taking efavirenz, a
component of Efavirenz/Emtricitabine/Tenofovir disoproxil while
using a contraceptive implant, although it has not been
established that the efavirenz therapy caused the contraceptive
to fail.
Methadone, a medicine used to treat opiate addiction, as your
doctor may need to change your methadone dose.
Sertraline, a medicine used to treat depression, as your doctor
may need to change your dose of sertraline.
Bupropion, a medicine used to treat depression or to help you
stop smoking, as your doctor may need to change your dose of
bupropion.
Diltiazem or similar medicines (called calcium channel
blockers): When you start taking
Efavirenz/Emtricitabine/Tenofovir disoproxil, your doctor may
need to adjust your dose of the calcium channel blocker.
Medicines used to prevent organ transplant rejection (also
called immunosuppressant’s), such as cyclosporine, sirolimus
or tacrolimus. When you start or stop taking
Efavirenz/Emtricitabine/Tenofovir disoproxil your doctor will
closely monitor your plasma levels of the immunosuppressant
and may need to adjust its dose.
Warfarin or acenocoumarol (medicines used to reduce clotting
of the blood): Your doctor may need to adjust your dose of
warfarin or acenocoumarol.
Ginkgo biloba extracts (herbal preparation).

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.
Women should not get pregnant during treatment with
Efavirenz/Emtricitabine/Tenofovir disoproxil and for 12 weeks
thereafter.
Your doctor may require you to take a pregnancy test to ensure
you are not pregnant before starting treatment with
Efavirenz/Emtricitabine/Tenofovir disoproxil.
If you could get pregnant while receiving
Efavirenz/Emtricitabine/Tenofovir disoproxil, you need to use a
reliable form of barrier contraception (for example, a condom) with
other methods of contraception including oral (pill) or other
hormonal contraceptives (for example, implants, injection).
Efavirenz, one of the active components of
Efavirenz/Emtricitabine/Tenofovir disoproxil, may remain in your
blood for a time after therapy is stopped. Therefore, you should
continue to use contraceptive measures, as above, for 12 weeks
after you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil.
Tell your doctor immediately if you are pregnant or intend to
become pregnant. If you are pregnant, you should take
Efavirenz/Emtricitabine/Tenofovir disoproxil only if you and your
doctor decide it is clearly needed.

TEVA UK Ref: 231-30-32584-A LEA EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISPROXIL 600/200/245mg FC TABS TUK
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Width:
Depth:
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Serious birth defects have been seen in unborn animals and in the
babies of women treated with efavirenz during pregnancy.
Ask your doctor or pharmacist for advice before taking any
medicine.
If you have taken Efavirenz/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
Efavirenz/Emtricitabine/Tenofovir disoproxil. Both HIV and the
ingredients of Efavirenz/Emtricitabine/Tenofovir disoproxil may
pass through breast milk and cause serious harm to your baby.
Driving and using machines

Version:

4

08 February 2017
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If you throw up the tablet (within 1 hour after taking
Efavirenz/Emtricitabine/Tenofovir disoproxil), you should take
another tablet. Do not wait until your next dose is due. You do not
need to take another tablet if you were sick more than 1 hour after
taking Efavirenz/Emtricitabine/Tenofovir disoproxil.
If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil
Don’t stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil
without talking to your doctor. Stopping
Efavirenz/Emtricitabine/Tenofovir disoproxil can seriously affect
your response to future treatment. If
Efavirenz/Emtricitabine/Tenofovir disoproxil is stopped, speak to
your doctor before you restart taking
Efavirenz/Emtricitabine/Tenofovir disoproxil tablets. Your doctor
may consider giving you the components of
Efavirenz/Emtricitabine/Tenofovir disoproxil separately if you are
having problems or need your dose adjusted.

When your supply of Efavirenz/Emtricitabine/Tenofovir disoproxil
Efavirenz/Emtricitabine/Tenofovir disoproxil may cause dizziness, starts to run low, get more from your doctor or pharmacist. This is
impaired concentration and drowsiness. If you are affected, do not very important because the amount of virus may start to increase if
drive and do not use any tools or machines.
the medicine is stopped for even a short time. The virus may then
become harder to treat.

3 How to take Efavirenz/Emtricitabine/Tenofovir
disoproxil

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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:
One tablet taken each day by mouth.
Efavirenz/Emtricitabine/Tenofovir disoproxil should be taken on an
empty stomach (commonly defined as 1 hour before or 2 hours
after a meal) preferably at bedtime. This may make some side
effects (for example, dizziness, drowsiness) less troublesome.
Swallow Efavirenz/Emtricitabine/Tenofovir disoproxil whole with
water.
Efavirenz/Emtricitabine/Tenofovir disoproxil must be taken every
day.
If your doctor decides to stop one of the components of
Efavirenz/Emtricitabine/Tenofovir disoproxil, you may be given
efavirenz, emtricitabine and/or tenofovir disoproxil separately or
with other medicines for the treatment of your HIV infection.
If you take more Efavirenz/Emtricitabine/Tenofovir disoproxil than
you should
If you accidentally take too many Efavirenz/Emtricitabine/Tenofovir
disoproxil tablets you may be at increased risk of experiencing
possible side effects with this medicine (see section 4, Possible
side effects). Contact your doctor or nearest emergency
department for advice. Keep the tablet pack with you so that you
can easily describe what you have taken.
If you forget to take Efavirenz/Emtricitabine/Tenofovir disoproxil
It is important not to miss a dose of
Efavirenz/Emtricitabine/Tenofovir disoproxil.
If you do miss a dose of Efavirenz/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 you have both HIV infection and hepatitis B, it is especially
important not to stop your Efavirenz/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 or tenofovir
disoproxil (two of the three components of
Efavirenz/Emtricitabine/Tenofovir disoproxil). If
Efavirenz/Emtricitabine/Tenofovir disoproxil is stopped your doctor
may recommend that you resume hepatitis B treatment. You may
require blood tests to check how your liver is working for 4 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.

Other possible serious side effects
The following side effects are uncommon (these may affect up to 1
in every 100 patients):
• allergic reaction (hypersensitivity) that may cause severe skin
reactions (Stevens-Johnson syndrome, erythema multiforme,
see section 2)
• swelling of the face, lips, tongue or throat
• angry behaviour, suicidal thoughts, strange thoughts, paranoia,
unable to think clearly, mood being affected, seeing or hearing
things that are not really there (hallucinations), suicide
attempts, personality change (psychosis)
• pain in the abdomen (stomach), caused by inflammation of the
pancreas
• forgetfulness, confusion, fitting (seizures), incoherent speech,
tremor (shaking)
• yellow skin or eyes, itching, or pain in the abdomen (stomach)
caused by inflammation of the liver
• damage to kidney tubules.
Psychiatric side effects in addition to those listed above include
delusions (false beliefs), neurosis. Some patients have committed
suicide. These problems tend to occur more often in those who
have a history of mental illness. Always notify your doctor
immediately if you have these symptoms.
Side effects to the liver: If you are also infected with hepatitis B
virus, you may experience a worsening of hepatitis after
discontinuation of treatment (see section 3).

The following side effects are rare (these may affect up to 1 in
every 1,000 patients):
• liver failure, in some cases leading to death or liver transplant.
Most cases occurred in patients who already had liver disease,
but there have been a few reports in patients without any
existing liver disease
• inflammation of the kidney, passing a lot of urine and feeling
thirsty
• back pain caused by kidney problems, including kidney failure.
Your doctor may do blood tests to see if your kidneys are
Tell your doctor immediately about new or unusual symptoms
working properly
after you stop treatment, particularly symptoms you associate with • softening of the bones (with bone pain and sometimes resulting
hepatitis B infection.
in fractures) which may occur due to damage to the kidney
tubule cells
If you have any further questions on the use of this medicine, ask
• fatty liver.
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.
Possible serious side effects: tell your doctor immediately
• lactic acidosis (excess lactic acid in the blood) is a rare (may
affect up to 1 in every 1,000 patients) but serious side effect that
can be fatal. The following side effects may be signs of lactic
acidosis:
• deep rapid breathing
• drowsiness
• feeling sick (nausea), being sick (vomiting) and stomach pain.

If it is almost time (less than 12 hours) for your next dose anyway,
do not take the missed dose. Wait and take the next dose at the
If you think you may have lactic acidosis, contact your doctor
regular time. Do not take a double dose to make up for a forgotten immediately.
tablet.

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 may affect
more than 1 in 10 patients):
• dizziness, headache, diarrhoea, feeling sick (nausea), being sick
(vomiting)
• rashes (including red spots or blotches sometimes with
blistering and swelling of the skin), which may be allergic
reactions
• feeling weak.
Tests may also show:
• decreases in phosphate levels in the blood
• increased levels of creatine kinase in the blood that may result
in muscle pain and weakness.
Other possible side effects










feeling worried or depressed
difficulty sleeping, abnormal dreams, difficulty concentrating,
drowsiness
pain, stomach pain
problems with digestion resulting in discomfort after meals,
feeling bloated, wind (flatulence)
loss of appetite
tiredness
itching
changes in skin colour including darkening of the skin in
patches often starting on hands and soles of feet.

Tests may also show:
• low white blood cell count (a reduced white blood cell count
can make you more prone to infection)
• liver and pancreas problems
• increased fatty acids (triglycerides), bilirubin or sugar levels in
the blood.
The following side effects are uncommon (these may affect up to 1
in every 100 patients):
• breakdown of muscle, muscle pain or weakness
• anaemia (low red blood cell count)
• a feeling of spinning or tilting (vertigo), whistling, ringing or
other persistent noise in the ears
• blurred vision
• chills
• breast enlargement in males
• decreased sexual drive
• flushing
• dry mouth
• increased appetite.
Tests may also show:
• decreases in potassium in the blood
• increases in creatinine in the blood
• proteins in urine
• increased cholesterol in the blood.
The 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
may occur due to damage to kidney tubule cells.
The following side effects are rare (these may affect up to 1 in
every 1,000 patients):
• itchy rash to the skin caused by a reaction to sunlight.
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

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 Efavirenz/Emtricitabine/Tenofovir disoproxil contains






The active substances are efavirenz, emtricitabine and tenofovir
disoproxil. Each Efavirenz/Emtricitabine/Tenofovir disoproxil
film-coated tablet contains 600 mg of efavirenz, 200 mg of
emtricitabine and 245 mg of tenofovir disoproxil (equivalent to
291.22mg of tenofovir disoproxil phosphate or 136 mg of
tenofovir).
The other ingredients are cellulose microcrystalline,
croscarmellose sodium, mannitol (E421),
hydroxypropylcellulose, hydroxypropylcellulose low
substituted, poloxamer 407, crospovidone, hypromellose,
hydrogenated vegetable oil, sodium stearyl fumarate.
The other ingredients in the film-coating (Opadry II 85F240144
PINK) are polyvinyl alcohol part-hydrolyzed, titanium dioxide
(E171), macrogol 3350, talc, carmine (E120).

What Efavirenz/Emtricitabine/Tenofovir disoproxil looks like and
contents of the pack
Efavirenz/Emtricitabine/Tenofovir disoproxil film-coated tablets are
pink, oval shaped tablets, debossed with “TEE” on one side of the
tablet and plain on the other side of the tablet. Bottles may contain
a HDPE canister with silica gel that must be kept in the bottle to
help protect your tablets. The silica gel canister should not be
swallowed.

GLUE AREA
NO PRINTING

The following pack sizes are available:
Blister: 10, 30, 90 film-coated tablets and a unit dose of 30x1
film-coated tablets.
Bottle: 30 and a multipack containing 90 (3 packs of 30) 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 02/2017.
PL 00289/2068

By reporting side effects you can help provide more information on
the safety of this medicine.

5 How to store Efavirenz/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 blister, carton or bottle after {EXP}.The expiry date refers to the
last day of that month.

Blister: Store in the original blister in order to protect from
The following side effects are common (these may affect up to 1 in moisture. This medicinal product does not require any special
10 patients):
temperature storage conditions.
• allergic reactions
• disturbances of coordination and balance

660 mm

Bottle: Store in the original bottle in order to protect from
moisture. Keep the bottle tightly closed. This medicinal product
does not require any special temperature storage conditions.

PHARMA CODE

32584-A

+ 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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