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

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

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Package leaflet: Information for the patient

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Efavirenz/Emtricitabine/Tenofovir Disoproxil
600 mg/ 200 mg/ 245 mg
film-coated tablets
Efavirenz/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 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

1 - What Efavirenz/Emtricitabine/Tenofovir disoproxil is 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)
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).
• if you have severe liver disease.
• if you 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)
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
• 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 this medicine you may still develop infections or other illnesses associated
with HIV infection.
• You must remain under the care of your doctor while taking this medicine.
• Tell your doctor:
- if you are taking other medicines that contain efavirenz, emtricitabine, tenofovir
disoproxil, tenofovir alafenamide or lamivudine or adefovir dipivoxil. This medicine
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. This medicine is not recommended if you have moderate to severe
kidney disease.
This medicine 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.
This medicine 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 this medicine. 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 this medicine, 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 this medicine. 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 this medicine,
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 this medicine. 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 this medicine.
- 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 this medicine 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 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, this medicine should not be taken with any other medicines that contain
efavirenz (unless recommended by your doctor), emtricitabine, tenofovir disoproxil,
tenofovir alafenamide or 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 this
medicine 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 this medicine 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, sofosbuvir/velpatasvir.
• Medicines used to lower blood fats (also called statins): Atorvastatin,
pravastatin, simvastatin. This medicine 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 this medicine, 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. This medicine 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. This medicine 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 this medicine, 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 this medicine, your doctor may need to adjust your dose of the calcium
channel blocker.
• Medicines used to prevent organ transplant rejection (also called
immunosuppressants), such as cyclosporine, sirolimus or tacrolimus. When you
start or stop taking this medicine 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
this medicine.
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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 this medicine, 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 this medicine.
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.
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 this medicine may pass through breast milk
and cause serious harm to your baby.
Driving and using machines
Efavirenz/Emtricitabine/Tenofovir disoproxil may cause dizziness, impaired
concentration and drowsiness. If you are affected, do not drive and do not use any
tools or machines.

3 - How to take Efavirenz/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:
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 the tablet whole with water.
Efavirenz/Emtricitabine/Tenofovir disoproxil must be taken every day.
If your doctor decides to stop one of the components of this medicine, 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 bottle 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 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 regular time. Do not take a double
dose to make up for a forgotten tablet.
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 the tablet.
If you stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil
Don’t stop taking Efavirenz/Emtricitabine/Tenofovir disoproxil without talking to
your doctor. Stopping this medicine can seriously affect your response to future
treatment. If this medicine is stopped, speak to your doctor before you restart taking
tablets. Your doctor may consider giving you the components of this medicine
separately if you are having problems or need your dose adjusted.
When your supply of Efavirenz/Emtricitabine/Tenofovir disoproxil starts to run
low, get more from your doctor or pharmacist. This is very important because the
amount of virus may start to increase if the medicine is stopped for even a short time.
The virus may then become harder to treat.
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 this medicine). If this medicine 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.
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.
Possible serious side effects: tell your doctor immediately
Lactic acidosis (excess lactic acid in the blood) is a rare (affect up to 1 in 1,000
people) 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 you think you may have lactic acidosis, contact your doctor immediately.
Other possible serious side effects
The following side effects are uncommon (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1,000 people):
• 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 working properly
• softening of the bones (with bone pain and sometimes resulting in fractures) which
may occur due to damage to the kidney tubule cells
• fatty liver
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 (may affect more than 1 in 10 people)
• 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
The following side effects are common (may affect up to 1 in 10 people)
• allergic reactions
• disturbances of coordination and balance
• 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 (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1,000 people)
• 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 (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 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 bottle and
carton after {EXP}. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Use within 30 days after first opening.
• 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 (as succinate).
• The other ingredients in the tablet are cellulose, microcrystalline (E460),
croscarmellose sodium, Type A (E468), hydroxypropylcellulose (E463), sodium
laurilsulfate (E487), magnesium stearate (E470b), poloxamer 407 and iron oxide
red (E172).
• The other ingredients in the tablet film coating are poly(vinyl alcohol) (E1203),
titanium dioxide (E171), macrogol 3350 (E1521), talc (E553b), iron oxide red (E172)
and iron oxide black (E172).
What Efavirenz/Emtricitabine/Tenofovir disoproxil looks like and contents of the pack
Efavirenz/Emtricitabine/Tenofovir disoproxil film-coated tablets are pink, capsule
shaped tablets, plain on both sides with dimensions of 11 mm x 22 mm approximately.
They are supplied in bottles containing 30 tablets, packed in a carton. 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.
The following pack sizes are available:
30 (1 x 30) film-coated tablets
90 (3 x 30) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK
Manufacturer
Remedica Ltd
Aharnon Street, Limassol Industrial Estate, Limassol, 3056, Cyprus
or

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179 Barleben,
Germany
This leaflet was last revised in 08/2017.

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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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