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EMTRICITABINE/TENOFOVIR DISOPROXIL ARISTO 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 Aristo 200 mg/245 mg film-coated tablets
Emtricitabine
Tenofovir disoproxil

• Do not breast-feed during treatment with Emtricitabine/Tenofovir
disoproxil Aristo. This is because the active substances in this medicine
pass into human breast milk.

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

1. What Emtricitabine/Tenofovir disoproxil Aristo
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 Aristo 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 Aristo is used to treat Human
Immunodeficiency Virus (HIV-1) infection, in adults aged 18 years and
over.
• This medicine should always be used combined with other medicines to
treat HIV infection.
• This medicine 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
Emtricitabine/Tenofovir disoproxil Aristo, 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 Aristo, you may still develop infections or other illnesses
associated with HIV infection.

2. What you need to know before you take
Emtricitabine/Tenofovir disoproxil Aristo
Do not take Emtricitabine/Tenofovir disoproxil Aristo to treat 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 Aristo
200 mg/245 mg film-coated tablets

• If this applies to you, tell your doctor immediately.
Warnings and precautions
While taking Emtricitabine/Tenofovir disoproxil Aristo to treat HIV:
• Emtricitabine/Tenofovir disoproxil Aristo 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 this medicine or, if you already have HIV, to take
this medicine less frequently. Emtricitabine/Tenofovir disoproxil Aristo 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
Emtricitabine/Tenofovir disoproxil Aristo. If you have HBV, there is a serious
risk of liver problems when you stop taking this medicine, whether or not

If you have taken Emtricitabine/Tenofovir disoproxil Aristo 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.

you also have HIV. It is important not to stop taking this medicine without
talking to your doctor: see section 3, “Do not stop taking Emtricitabine/
Tenofovir disoproxil Aristo”.
• Talk 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 Aristo contains lactose” later in this section).

• 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 Aristo contains lactose
Tell your doctor if you are lactose-intolerant or intolerant to other sugars.
Emtricitabine/Tenofovir disoproxil Aristo contains phosphate
Tell your doctor if you cannot take phosphates or if you are on a reduced
phosphate diet.

Children and adolescents
Emtricitabine/Tenofovir disoproxil Aristo is not for use in children and
adolescents under 18 years of age.
Other medicines and Emtricitabine/Tenofovir disoproxil Aristo
Do not take Emtricitabine/Tenofovir disoproxil Aristo if you are already
taking other medicines that contain the components of Emtricitabine/
Tenofovir disoproxil Aristo (emtricitabine and tenofovir disoproxil) or any
other antiviral medicines that contain tenofovir alafenamide, lamivudine or
adefovir dipivoxil.
Taking Emtricitabine/Tenofovir disoproxil Aristo 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)
• 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)
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.

3. How to take Emtricitabine/Tenofovir
disoproxil Aristo
• 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 Aristo to
treat HIV or to reduce the risk of getting HIV is:
• Adults: one tablet each day. Whenever possible, the tablet 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 Aristo with other antiretroviral medicines.
Please refer to the patient information leaflets of the other antiretrovirals
for guidance on how to take those medicines.
Ask your doctor if you have any questions about how to prevent getting HIV
or prevent spreading HIV to other people.

Taking Emtricitabine/Tenofovir disoproxil Aristo 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.

If you take more Emtricitabine/Tenofovir disoproxil Aristo than you
should

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

• If you notice within 12 hours of the time you usually take this medicine,
take the tablet preferably with food as soon as possible. Then take the next
dose at your usual time.

Emtricitabine/Tenofovir disoproxil Aristo with food and drink

• If you notice 12 hours or more after the time you usually take this
medicine, forget about the missed dose. Wait and take the next dose,
preferably with food, at your usual time.

• Whenever possible, this medicine 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 Emtricitabine/Tenofovir disoproxil Aristo.
• 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 accidentally take more than the recommended dose of this medicine,
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 Aristo.

If you vomit less than 1 hour after taking Emtricitabine/Tenofovir
disoproxil Aristo, take another tablet. You do not need to take another
tablet if you were sick more than 1 hour after taking the last tablet.
Do not stop taking Emtricitabine/Tenofovir disoproxil Aristo
• If you take Emtricitabine/Tenofovir disoproxil Aristo for treatment
of HIV infection, stopping tablets may reduce the effectiveness of the antiHIV therapy recommended by your doctor.

• 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.

• Do not stop taking Emtricitabine/Tenofovir disoproxil Aristo without
contacting your doctor.

• 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 hepatitis B, it is especially important not to stop your
treatment with this medicine 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.

4. Possible side effects
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.
• Any 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.
• Autoimmune 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.
Possible side effects:
Very common side effects
(may affect more than 1 in 10 people)
• 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.
Common side effects
(may affect up to 1 in 10 people)
• 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.
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)
• 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.
Rare side effects
(may affect up to 1 in 1,000 people)
• lactic acidosis (see Possible serious side effects)
• 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
• softening of the bones (with bone pain and sometimes resulting in
fractures)
• back pain caused by kidney problems.

5. How to store Emtricitabine/Tenofovir
disoproxil Aristo
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 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.

6. Contents of the pack and other information
What Emtricitabine/Tenofovir disoproxil Aristo 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).
What Emtricitabine/Tenofovir disoproxil Aristo looks like and contents
of the pack
The tablets are blue, oval shaped, biconvex, 18.6 mm x 9.5 mm film-coated
tablets, plain on both sides.

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.

The tablets are supplied in white plastic bottles. Each bottle contains one (in
30’s pack) or three (in 100’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.

• 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 following pack sizes are available:
• 30 and 90 (3 packs of 30) tablets

The frequency of the following side effects is not known.
• Bone problems. Some patients taking combination antiretroviral medicines
such as Emtricitabine/Tenofovir disoproxil Aristo 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

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany
This leaflet was last revised in April 2017.

• 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.

GI206000-01/UK/0417

50000739/1

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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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