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EMTRICITABINE/TENOFOVIR DISOPROXIL GLENMARK 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 Glenmark
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 Glenmark is and what it is used for
2. What you need to know before you take Emtricitabine/tenofovir disoproxil
Glenmark
3. How to take Emtricitabine/tenofovir disoproxil Glenmark
4. Possible side effects
5. How to store Emtricitabine/tenofovir disoproxil Glenmark
6. Contents of the pack and other information
1. W
 hat Emtricitabine/tenofovir disoproxil Glenmark 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 Glenmark 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 Glenmark is used to treat Human
Immunodeficiency Virus
(HIV-1) infection, in adults aged 18 years and over.
• Emtricitabine/tenofovir disoproxil Glenmark should always be used combined
with other medicines to treat HIV infection.
• Emtricitabine/tenofovir disoproxil Glenmark can be administered in place of
emtricitabine and tenofovir disoproxil used separately at the same doses.
People who are HIV positive can still pass on HIV when taking this medicine,
although this risk is lowered by effective antiretroviral therapy. Discuss with your
doctor the precautions needed to avoid infecting other people.
This medicine is not a cure for HIV infection. While taking Emtricitabine/
tenofovir disoproxil Glenmark you may still develop infections or other illnesses
associated with HIV infection.
• Emtricitabine/tenofovir disoproxil Glenmark is also used to reduce the risk of
getting HIV-1 infection, when used as a daily treatment,
together with safer sex practices.
See section 2 for a list of precautions to take against HIV infection.

Emtricitabine
Tenofovir disoproxil

Emtricitabine/tenofovir disoproxil Glenmark 200
mg/245 mg Film-coated Tablets

2. W
 hat you need to know before you take Emtricitabine/tenofovir
disoproxil Glenmark
Do not take Emtricitabine/tenofovir disoproxil Glenmark to treat HIV or to
reduce the risk of getting HIV if you are allergic to emtricitabine, tenofovir,
tenofovir disoproxil phosphate or any of the other ingredients of this medicine
(listed in section 6).
Emtricitabine/tenofovir disoproxil Glenmark
200 mg/245 mg Film-coated Tablets
Emtricitabine
Tenofovir disoproxil

If this applies to you, tell your doctor immediately.
Before taking Emtricitabine/tenofovir disoproxil Glenmark to reduce the
risk of getting HIV:

Warnings and precautions
While taking Emtricitabine/tenofovir disoproxil Glenmark to reduce the risk of
getting HIV:
• T
 ake Emtricitabine/tenofovir disoproxil Glenmark every day to reduce your
risk, not just when you think you have been at risk of HIV infection. Do
not miss any doses of Emtricitabine/tenofovir disoproxil Glenmark, or stop
taking it. Missing doses may increase your risk of getting HIV infection.
• Get tested for HIV regularly.
• I f you think you were infected with HIV, tell your doctor straight away. They
may want to do more tests to make sure you are still HIV negative.
• J ust taking Emtricitabine/tenofovir disoproxil Glenmark may not stop you
getting HIV.
-  Always practice safer sex. Use condoms to reduce contact with semen,
vaginal fluids, or blood.
-  Do not share personal items that can have blood or body fluids on them,
such as toothbrushes and razor blades.
-  Do not share or re-use needles or other injection or drug equipment.
-  Get tested for other sexually transmitted infections such as syphilis and
gonorrhoea. These infections make it easier for HIV to infect you.
Ask your doctor if you have any more questions about how to prevent getting
HIV or spreading HIV to other people.
While taking Emtricitabine/tenofovir disoproxil Glenmark to treat HIV or to
reduce the risk of getting HIV:
• Emtricitabine/tenofovir disoproxil Glenmark may affect your kidneys.
Before and during treatment, your doctor may order blood tests to measure
kidney function. Tell your doctor if you have had kidney disease, or if tests
have shown kidney problems. If you have kidney problems, your doctor
may advise you to stop taking Emtricitabine/tenofovir disoproxil Glenmark
or, if you already have HIV, to take Emtricitabine/tenofovir disoproxil
Glenmark less frequently. Emtricitabine/tenofovir disoproxil Glenmark is not
recommended if you have severe kidney disease or are on dialysis.
Bone problems (sometimes resulting in fractures) may also occur due to damage
to kidney tubule cells (see section 4, Possible side effects).
• Talk to your doctor if you have a history of liver disease, including
hepatitis. Patients infected with HIV who also have liver disease (including
chronic hepatitis B or C), who are treated with antiretrovirals, have a higher
risk of severe and potentially fatal liver complications. If you have hepatitis B
or C, your doctor will carefully consider the best treatment regimen for you.
• Know your hepatitis B virus (HBV) infection status before starting this
medicine. If you have HBV, there is a serious risk of liver problems when
you stop taking Emtricitabine/tenofovir disoproxil Glenmark, whether or not
you also have HIV. It is important not to stop taking Emtricitabine/tenofovir
disoproxil Glenmark without talking to your doctor: see section 3, Do not stop
taking Emtricitabine/tenofovir disoproxil Glenmark.
• T
 alk to your doctor if you are over 65. Emtricitabine and tenofovir disoproxil
has not been studied in patients over 65 years of age.
• Talk to your doctor if you are intolerant to lactose (see Emtricitabine/
tenofovir disoproxil Glenmark contains lactose later in this section).
Children and adolescents
Emtricitabine/tenofovir disoproxil Glenmark is not for use in children and
adolescents under 18 years of age.
Other medicines and Emtricitabine/tenofovir disoproxil Glenmark
Do not take Emtricitabine/tenofovir disoproxil Glenmark if you are already
taking other medicines that contain the components of Emtricitabine/tenofovir
disoproxil Glenmark (emtricitabine and tenofovir disoproxil) or any other
antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir
dipivoxil.
Taking Emtricitabine/tenofovir disoproxil Glenmark with other medicines
that can damage your kidneys: it is especially important to tell your doctor if
you are taking any of these medicines, including:
• aminoglycosides (for bacterial infection)
• amphotericin B (for fungal infection)

Emtricitabine/tenofovir disoproxil Glenmark can only help reduce your risk of
getting HIV before you are infected.

• foscarnet (for viral infection)

• Y
 ou must be HIV negative before you start to take Emtricitabine/tenofovir
disoproxil Glenmark to reduce the risk of getting HIV. You must get tested
to make sure that you do not already have HIV infection. Do not take
Emtricitabine/tenofovir disoproxil Glenmark to reduce your risk unless
you are confirmed to be HIV negative. People who do have HIV must take
Emtricitabine/tenofovir disoproxil Glenmark in combination with other drugs.

• pentamidine (for infections)

• M
 any HIV tests can miss a recent infection. If you get a flu-like illness, it could
mean you have recently been infected with HIV.
These may be signs of HIV infection:
-  tiredness
-  fever
-  joint or muscle aches
-  headache
-  vomiting or diarrhoea
-  rash
-  night sweats
-  enlarged lymph nodes in the neck or groin
Tell your doctor about any flu-like illness – either in the month before
starting Emtricitabine/tenofovir disoproxil Glenmark, or at any time while
taking this medicine.

• ganciclovir (for viral infection)
• vancomycin (for bacterial infection)
• interleukin-2 (to treat cancer)
• cidofovir (for viral infection)
• n on-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle
pains)
If you are taking another antiviral medicine called a protease inhibitor to treat
HIV, your doctor may order blood tests to closely monitor your kidney function.
It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir to
treat hepatitis C infection.
Taking Emtricitabine/tenofovir disoproxil Glenmark with other medicines
containing didanosine (for treatment of 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 and didanosine were taken together. Your doctor
will carefully consider whether to treat you with combinations of tenofovir and
didanosine.

 ell your doctor if you are taking any of these medicines. Tell your doctor or
T
pharmacist if you are taking, have recently taken or might take any other
medicines.
Emtricitabine/tenofovir disoproxil Glenmark with food and drink
Whenever possible, Emtricitabine/tenofovir disoproxil Glenmark 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.
• 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 Glenmark 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 Glenmark. 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 Glenmark contains lactose
Tell your doctor if you are on a reduced phosphate diet. Each tablet of
Emtricitabine/tenofovir disoproxil Glenmark contains 46 mg of phosphate.
3. How to take Emtricitabine/tenofovir disoproxil Glenmark
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose of Emtricitabine/tenofovir disoproxil Glenmark to
treat HIV or to reduce the risk of getting HIV is:
• Adults: one tablet each day. Whenever possible, Emtricitabine/tenofovir
disoproxil Glenmark should be taken with food.
If you have difficulty swallowing, you can use the tip of a spoon to crush the
tablet. Then mix the powder with about 100 ml (half a glass) of water, orange
juice or grape juice, and drink immediately.
• Always take the dose recommended by your doctor. This is to make sure
that your medicine is fully effective, and to reduce the risk of developing
resistance to the treatment. Do not change the dose unless your doctor tells
you to.
• If you are being treated for HIV infection your doctor will prescribe
Emtricitabine/tenofovir disoproxil Glenmark with other antiretroviral
medicines. Please refer to the patient information leaflets of the other
antiretrovirals for guidance on how to take those medicines.
• If you are taking Emtricitabine/tenofovir disoproxil Glenmark to reduce
the risk of getting HIV, take Emtricitabine/tenofovir disoproxil Glenmark
every day, not just when you think you have been at risk of HIV infection.
Ask your doctor if you have any questions about how to prevent getting HIV or
prevent spreading HIV to other people.
If you take more Emtricitabine/tenofovir disoproxil Glenmark than you
should
If you accidentally take more than the recommended dose of Emtricitabine/
tenofovir disoproxil Glenmark disoproxil, contact your doctor or nearest
emergency department for advice. Keep the tablet bottle with you so that you can
easily describe what you have taken.
If you miss a dose
It is important not to miss a dose of Emtricitabine/tenofovir disoproxil Glenmark.
• If you notice within 12 hours of the time you usually take Emtricitabine/
tenofovir disoproxil Glenmark disoproxil, take the tablet preferably with food
as soon as possible. Then take the next dose at your usual time.
• If you notice 12 hours or more after the time you usually take Emtricitabine/
tenofovir disoproxil Glenmark disoproxil, forget about the missed dose. Wait
and take the next dose, preferably with food, at your usual time.
If you vomit less than 1 hour after taking Emtricitabine/tenofovir disoproxil
Glenmark, take another tablet. You do not need to take another tablet if you were
sick more than 1 hour after taking Emtricitabine/tenofovir disoproxil Glenmark.
Do not stop taking Emtricitabine/tenofovir disoproxil Glenmark
• If you take Emtricitabine/tenofovir disoproxil Glenmark for treatment of
HIV infection, stopping tablets may reduce the effectiveness of the anti-HIV
therapy recommended by your doctor.
• If you are taking Emtricitabine/tenofovir disoproxil Glenmark to reduce
the risk of getting HIV, do not stop taking Emtricitabine/tenofovir disoproxil
Glenmark or miss any doses. Stopping use of Emtricitabine/tenofovir
disoproxil Glenmark, or missing doses, may increase your risk of getting HIV
infection

o not stop taking Emtricitabine/tenofovir disoproxil Glenmark without
D
contacting your doctor.
• If you have hepatitis B, it is especially important not to stop your
Emtricitabine/tenofovir disoproxil Glenmark treatment without talking to your
doctor first. You may require blood tests for several months after stopping
treatment. In some patients with advanced liver disease or cirrhosis, stopping
treatment is not recommended as this may lead to worsening of your hepatitis,
which may be life-threatening.
Tell your doctor immediately about new or unusual symptoms after you

stop treatment, particularly symptoms you associate with hepatitis B
infection.
If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

• increased creatinine in your blood

4. Possible side effects

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.

Like all medicines, this medicine can cause side effects, although not everybody
gets them.
Possible serious side effects:
• Lactic acidosis (excess lactic acid in the blood) is a rare but potentially
life-threatening side effect. Lactic acidosis occurs more often in women,
particularly if they are overweight, and in people with liver disease. The
following may be signs of lactic acidosis:
- deep rapid breathing
- drowsiness
- feeling sick (nausea), being sick (vomiting)
- stomach pain
If you think you may have lactic acidosis, get medical help immediately.
• A
 ny signs of inflammation or infection. In some patients with advanced HIV
infection (AIDS) and a history of opportunistic infections (infections that occur
in people with a weak immune system), signs and symptoms of inflammation
from previous infections may occur soon after anti-HIV treatment is started.
It is thought that these symptoms are due to an improvement in the body’s
immune response, enabling the body to fight infections that may have been
present with no obvious symptoms.
• A
 utoimmune disorders, when the immune system attacks healthy body
tissue, may also occur after you start taking medicines to treat HIV infection.
Autoimmune disorders may occur many months after the start of treatment.
Look out for any symptoms of infection or other symptoms such as:
- muscle weakness
- weakness beginning in the hands and feet and moving up towards the trunk
of the body
- palpitations, tremor or hyperactivity
If you notice these or any symptoms of inflammation or infection, get medical
help immediately.

• changes to your urine
Rare side effects
(may affect up to 1 in 1,000 people)
• Lactic acidosis (see Possible serious side effects)
• fatty liver
• y ellow 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
• softening of the bones (with bone pain and sometimes resulting in fractures)
• back pain caused by kidney problems

If you notice any of the side effects listed above or if any of the side effects get
serious, talk to your doctor or pharmacist.
The frequency of the following side effects is not known.
• Bone problems. Some patients taking combination antiretroviral medicines
such as Emtricitabine/tenofovir disoproxil Glenmark may develop a bone
disease called osteonecrosis (death of bone tissue caused by loss of blood
supply to the bone). Taking this type of medicine for a long time, taking
corticosteroids, drinking alcohol, having a very weak immune system, and
being overweight, may be some of the many risk factors for developing this
disease. Signs of osteonecrosis are:
• joint stiffness
• joint aches and pains (especially of the hip, knee and shoulder)
• difficulty with movement
If you notice any of these symptoms tell your doctor.
During treatment for HIV there may be an increase in weight and in levels of
blood lipids and glucose. This is partly linked to restored health and life style,
and in the case of blood lipids sometimes to the HIV medicines themselves. Your
doctor will test for these changes.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system. By
reporting side effects you can help provide more
information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

Possible side effects:

5. How to store Emtricitabine/tenofovir disoproxil Glenmark

Very common side effects
(may affect more than 1 in 10 people)
• diarrhoea, being sick (vomiting), feeling sick (nausea)

Keep this medicine out of the sight and reach of children.

• dizziness, headache
• rash
• feeling weak
Tests may also show:
• decreases in phosphate in the blood

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 25°C.
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.

• increased creatine kinase

6. Contents of the pack and other information

Common side effects
(may affect up to 1 in 10 people)
• pain, stomach pain

What Emtricitabine/tenofovir disoproxil Glenmark contains
The active substances are emtricitabine and tenofovir disoproxil (as phosphate).
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir
disoproxil (equivalent to 291 mg of tenofovir disoproxil phosphate or 136 mg of
tenofovir).
The other ingredients are microcrystalline cellulose (E460), mannitol (E421),
croscarmellose sodium, silica, hydrophobic colloidal, stearic acid (E570), lactose
monohydrate, hypromellose (E464), titanium dioxide (E171),triacetin (E1518) and
indigo carmoine aluminium lake (E132).

• difficulty sleeping, abnormal dreams
• p roblems with digestion resulting in discomfort after meals, feeling bloated,
flatulence
• r ashes (including red spots or blotches sometimes with blistering and swelling
of the skin), which may be allergic reactions, itching, changes in skin colour
including darkening of the skin in patches
• other allergic reactions, such as wheezing, swelling or feeling light-headed
Tests may also show:
• low white blood cell count (a reduced white blood cell count can make you
more prone to infection)
• increased triglycerides (fatty acids), bile or sugar in the blood
• liver and pancreas problems
Uncommon side effects
(may affect up to 1 in 100 people)
• pain in the abdomen (tummy) caused by inflammation of the pancreas
• swelling of the face, lips, tongue or throat
• anaemia (low red blood cell count)
• b reakdown 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

What Emtricitabine/tenofovir disoproxil Glenmark looks like and contents of
the pack
Emtricitabine/tenofovir disoproxil Glenmark Film-coated tablets are blue
coloured, oval shaped, biconvex, 18.6 mm x 9.5 mm film-coated tablets plain on
both sides.
Emtricitabine/tenofovir disoproxil Glenmark is supplied in white plastic bottles.
Each bottle contains one (in 30’s pack) or three (in 90’s pack) silica gel dessicant
sachets depending on the pack size.The sachets must be kept in the bottle to help
protect your tablets and should not be swallowed.
The following pack sizes are available:
-30 film-coated tablets
-multipacks containing 90 (3 packs of 30) film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2 B Draycott Avenue,
Kenton, Middlesex HA3 0BU,
United Kingdom
Manufacturer
Pharmadox Healthcare Ltd
KW20A Kordin Industrial Estate, Paola, PLA 3000, Malta
This leaflet was last revised in July 2017

+ 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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