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TENOFOVIR DISOPROXIL ARISTO 245 MG FILM-COATED TABLETS

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

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Package leaflet: Information for the patient

Tenofovir disoproxil Aristo 245 mg film-coated tablets
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 Tenofovir disoproxil Aristo is and what it is used for
2. What you need to know before you take Tenofovir disoproxil Aristo
3. How to take Tenofovir disoproxil Aristo
4. Possible side effects
5. How to store Tenofovir disoproxil Aristo
6. Contents of the pack and other information

If Tenofovir disoproxil Aristo has been prescribed for your child, please
note that all the information in this leaflet is addressed to your child (in this
case please read “your child” instead of “you”).

1. What Tenofovir disoproxil Aristo is and what it is used for
Tenofovir disoproxil Aristo contains the active substance tenofovir disoproxil.
This active substance is an antiretroviral or antiviral medicine which is used
to treat HIV or HBV infection or both. Tenofovir is a nucleotide reverse
transcriptase inhibitor, generally known as an NRTI and works by interfering
with the normal working of enzymes (in HIV reverse transcriptase; in hepatitis
B DNA polymerase) that are essential for the viruses to reproduce themselves.
In HIV tenofovir disoproxil should always be used combined with other
medicines to treat HIV infection.
Tenofovir disoproxil Aristo tablets are a treatment for HIV (Human
Immunodeficiency Virus) infection. The tablets are suitable for:
• adults
• adolescents aged 12 to less than 18 years who have already been
treated with other HIV medicines which are no longer fully effective due
to development of resistance, or have caused side effects.
Tenofovir disoproxil Aristo tablets are also a treatment for chronic
hepatitis B, an infection with HBV (hepatitis B virus). The tablets are
suitable for:
• adults
• adolescents aged 12 to less than 18 years.
You do not have to have HIV to be treated with tenofovir disoproxil for HBV.
This medicine is not a cure for HIV infection. While taking tenofovir disoproxil
you may still develop infections or other illnesses associated with HIV
infection. You can also pass on HIV or HBV to others, so it is important to take
precautions to avoid infecting other people.

2. What you need to know before you take Tenofovir
disoproxil Aristo

Tenofovir disoproxil is not usually taken with other medicines that can
damage your kidneys (see “Other medicines and Tenofovir disoproxil
Aristo”). If this is unavoidable, your doctor will monitor your kidney function
once a week.
• Bone problems. Some adult patients with HIV 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 tell your doctor.
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 with liver disease including chronic hepatitis B or C, who
are treated with antiretrovirals, have a higher risk of severe and potentially
fatal liver complications. If you have hepatitis B infection, your doctor will
carefully consider the best treatment for you. If you have a history of liver
disease or chronic hepatitis B infection your doctor may conduct blood tests
to monitor your liver function.
• Look out for infections. If you have advanced HIV infection (AIDS)
and have an infection, you may develop symptoms of infection and
inflammation or worsening of the symptoms of an existing infection once
treatment with tenofovir disoproxil is started. These symptoms may indicate
that your body’s improved immune system is fighting infection. Look out
for signs of inflammation or infection soon after you start taking Tenofovir
disoproxil Aristo. If you notice signs of inflammation or infection, tell your
doctor at once.
In addition to the opportunistic infections, autoimmune disorders (a
condition that occurs when the immune system attacks healthy body
tissue) may also occur after you start taking medicines for the treatment of
your HIV infection. Autoimmune disorders may occur many months after
the start of treatment. If you notice any symptoms of infection or other
symptoms such as muscle weakness, weakness beginning in the hands and
feet and moving up towards the trunk of the body, palpitations, tremor
or hyperactivity, please inform your doctor immediately to seek necessary
treatment.
• Talk to your doctor or pharmacist if you are over 65. Tenofovir
disoproxil has not been studied in patients over 65 years of age. If you are
older than this and are prescribed Tenofovir disoproxil Aristo, your doctor
will monitor you carefully.

• It is very important to tell your doctor if you are taking other
medicines that may damage your kidneys.
These include:
• aminoglycosides, pentamidine or vancomycin (for bacterial infection),
• amphotericin B (for fungal infection),
• foscarnet, ganciclovir, or cidofovir (for viral infection),
• interleukin-2 (to treat cancer),
• adefovir dipivoxil (for HBV),
• tacrolimus (for suppression of the immune system),
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle
pains).
• Other medicines containing didanosine (for HIV infection): Taking
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 caused 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.
• It is also important to tell your doctor if you are taking ledipasvir/
sofosbuvir to treat hepatitis C infection.
Tenofovir disoproxil Aristo with food and drink
Take Tenofovir disoproxil Aristo with food (for example, a meal or a snack).
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.
• You must not take Tenofovir disoproxil Aristo during pregnancy
unless specifically discussed with your doctor. Although there are limited
clinical data on the use of tenofovir disoproxil in pregnant women, it is not
usually used unless absolutely necessary.
• Try to avoid getting pregnant during treatment with Tenofovir disoproxil
Aristo. 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 your antiretroviral therapy to you
and your child.
• If you have taken 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
medicines like ‘NRTIs’ during pregnancy, the benefit from the protection
against the virus outweighed the risk of side effects.
• Do not breast-feed during treatment with Tenofovir disoproxil
Aristo. This is because the active substance in this medicine passes into
human breast milk.
• If you are a woman with HIV or HBV do not breast-feed, to avoid passing
the virus to the baby in breast milk.
Driving and using machines
Tenofovir disoproxil can cause dizziness. If you feel dizzy while taking
Tenofovir disoproxil Aristo, do not drive or ride a bicycle and do not use
any tools or machines.
Tenofovir disoproxil Aristo contains lactose

Tenofovir disoproxil Aristo
245 mg film-coated tablets

Do not take Tenofovir disoproxil Aristo

Children and adolescents

• If you are allergic to tenofovir, tenofovir disoproxil phosphate or any of the
other ingredients of this medicine listed in section 6.

Tenofovir disoproxil Aristo tablets are suitable for:
• HIV-1 infected adolescents aged 12 to less than 18 years who
weigh at least 35 kg and who have already been treated with other
HIV medicines which are no longer fully effective due to development of
resistance, or have caused side effects
• HBV infected adolescents aged 12 to less than 18 years who weigh
at least 35 kg.

If this applies to you, tell your doctor immediately and don’t take
Tenofovir disoproxil Aristo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenofovir disoproxil Aristo.
• Take care not to infect other people. 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. Tenofovir disoproxil Aristo does not reduce the risk of passing
on HBV to others through sexual contact or blood contamination. You must
continue to take precautions to avoid this.
• Talk to your doctor or pharmacist if you have had kidney disease or
if tests have shown problems with your kidneys. Tenofovir disoproxil
Aristo should not be given to adolescents with existing kidney problems.
Before starting treatment, your doctor may order blood tests to assess
your kidney function. Tenofovir disoproxil may affect your kidneys during
treatment. Your doctor may order blood tests during treatment to monitor
how your kidneys work. If you are an adult, your doctor may advise you to
take the tablets less often. Do not reduce the prescribed dose, unless your
doctor has told you to do so.

Tenofovir disoproxil Aristo tablets are not suitable for the following groups:
• Not for HIV-1 infected children under 12 years of age
• Not for HBV infected children under 12 years of age.

Tell your doctor before taking Tenofovir disoproxil Aristo if you cannot
tolerate lactose or if you have an intolerance to any other sugars.
Tenofovir disoproxil Aristo contains phosphate
Tell your doctor if you cannot take phosphates or if you are on a reduced
phosphate diet.

3. How to take 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.

For dosage see section 3, “How to take Tenofovir disoproxil Aristo”.
Other medicines and Tenofovir disoproxil Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

The recommended dose is:
• Adults: 1 tablet each day with food (for example, a meal or a snack).
• Adolescents aged 12 to less than 18 years who weigh at least 35 kg:
1 tablet each day with food (for example, a meal or a snack).

• Don’t stop any anti-HIV medicines prescribed by your doctor when you
start Tenofovir disoproxil Aristo if you have both HBV and HIV.

If you have particular 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.

• Do not take Tenofovir disoproxil Aristo if you are already taking other
medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not
take Tenofovir disoproxil Aristo together with medicines containing adefovir
dipivoxil (a medicine used to treat chronic hepatitis B).

• 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 an adult and have problems with your kidneys, your doctor
may advise you to take Tenofovir disoproxil Aristo less frequently.
• If you have HBV your doctor may offer you an HIV test to see if you have
both HBV and HIV.
Refer to the patient information leaflets of the other antiretrovirals for
guidance on how to take those medicines.
If you take more Tenofovir disoproxil Aristo than you should
If you accidentally take too many 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.

Possible serious side effects: tell your doctor immediately

Reporting of side effects

• Lactic acidosis (excess lactic acid in the blood) is a rare (can 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 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.

If you think that you may have lactic acidosis, contact your doctor
immediately.

5. How to store Tenofovir disoproxil Aristo
Keep this medicine out of the sight and reach of children.

Other possible serious side effects
The following side effects are uncommon (this can affect up to 1 in every 100
patients):
• pain in the tummy (abdomen) caused by inflammation of the pancreas
• damage to kidney tubule cells

If you forget to take Tenofovir disoproxil Aristo
It is important not to miss a dose of Tenofovir disoproxil Aristo. If you miss a
dose, work out how long since you should have taken it.
• If it is less than 12 hours after it is usually taken, take it as soon as you
can, and then take your next dose at its regular time.
• If it is more than 12 hours since you should have taken it, forget about
the missed dose. Wait and take the next dose at the regular time. Do not
take a double dose to make up for a forgotten tablet.
If you throw up less than 1 hour after taking Tenofovir disoproxil
Aristo, take another tablet. You do not need to take another tablet if you
were sick more than 1 hour after taking Tenofovir disoproxil Aristo.
If you stop taking Tenofovir disoproxil Aristo
Don’t stop taking this medicine without your doctor’s advice. Stopping
treatment with tenofovir disoproxil may reduce the effectiveness of the
treatment recommended by your doctor.

The following side effects are rare (these can affect up to 1 in every 1,000
patients):
• inflammation of the kidney, passing a lot of urine and feeling thirsty
• changes to your urine and back pain caused by kidney problems,
including kidney failure
• softening of the bones (with bone pain and sometimes resulting in
fractures), which may occur due to damage to kidney tubule cells
• fatty liver
If you think that you may have any of these serious side effects, talk
to your doctor.

• Talk to your doctor before you stop taking Tenofovir disoproxil Aristo for
any reason, particularly if you are experiencing any side effects or you have
another illness.
• Tell your doctor immediately about new or unusual symptoms after you stop
treatment, particularly symptoms you associate with hepatitis B infection.
• Contact your doctor before you restart taking Tenofovir disoproxil Aristo
tablets.

The following side effects are very common (these can affect at least 10 in
every 100 patients):
• diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, rash,
feeling weak

6. Contents of the pack and other information
What Tenofovir disoproxil Aristo contains
• The active substance is tenofovir. Each Tenofovir disoproxil Aristo tablet
contains 245 mg of tenofovir disoproxil (as phosphate).
• The other ingredients are microcrystalline cellulose, croscarmellose sodium,
stearic acid, lactose monohydrate, hypromellose (E464), titanium dioxide
(E171), triacetin and indigo carmine aluminium lake (E132).
What Tenofovir disoproxil Aristo looks like and contents of the pack
Tenofovir disoproxil Aristo tablets are blue, oval, biconvex, film-coated tablets
debossed with “T1” on one side and plain on the other side.

• decreases in phosphate in the blood
Other possible side effects

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

The following side effects are common (these can affect up to 10 in every 100
patients):
• headache, stomach pain, feeling tired, feeling bloated, flatulence

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Tests may also show:
• liver problems
The following side effects are uncommon (these can affect up to 1 in every
100 patients):
• breakdown of muscle, muscle pain or weakness

Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany
This leaflet was last revised in March 2017.

Tests may also show:
• decreases in potassium in the blood
• increased creatinine in your blood
• pancreas problems

4. Possible side effects

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.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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.

Tenofovir disoproxil Aristo is supplied in white plastic bottles. Each bottle
contains two silica gel dessicant sachets. The sachets must be kept in the bottle
to help protect your tablets and should not be swallowed.

If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

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.

Store below 25 °C

Most frequent side effects

Tests may also show:
If you have hepatitis B or HIV and hepatitis B together (co-infection), it is very
important not to stop your 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 tenofovir disoproxil. You
may require blood tests for several months after stopping treatment. In some
patients with advanced liver disease or cirrhosis, stopping treatment is not
recommended as this may lead to worsening of your hepatitis.

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.

The following side effects are rare (these can affect up to 1 in every 1,000
patients):
• pain in the tummy (abdomen) caused by inflammation of the liver
• swelling of the face, lips, tongue or throat

GI178000-01/UK/0317

50000451/1

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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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