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TENOFOVIR DISOPROXIL TEVA 245MG FILM-COATED TABLETS

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

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TEVA UK Ref:

EAS192 LEA TENOFOVIR DISOPROXIL 245mg FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
594 mm
140 mm
-

Colours Used:

Tenofovir Disoproxil 245 mg
Film-coated Tablets
Package leaflet: Information for the patient

Version:
Template

What Tenofovir Disoproxil is and
what it is used for

Tenofovir Disoproxil 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 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 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.

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.

• 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, your doctor will
monitor you carefully.
Children and adolescents
Tenofovir Disoproxil 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.
Tenofovir Disoproxil 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.
For dosage see section 3, “How to take
Tenofovir Disoproxil”.
Other medicines and Tenofovir Disoproxil
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.

You do not have to have HIV to be treated with • Don’t stop any anti-HIV medicines
prescribed by your doctor when you start
Tenofovir Disoproxil for HBV.
Tenofovir Disoproxil if you have both HBV
This medicine is not a cure for HIV infection.
and HIV.
While taking Tenofovir Disoproxil you may still • Do not take Tenofovir Disoproxil if you are
develop infections or other illnesses
already taking other medicines containing
associated with HIV infection. You can also
tenofovir disoproxil or tenofovir
pass on HIV or HBV to others, so it is
alafenamide. Do not take Tenofovir
important to take precautions to avoid
Disoproxil together with medicines
infecting other people.
containing adefovir dipivoxil (a medicine
used to treat chronic hepatitis B).

2

What you need to know before you • It is very important to tell your doctor if you
take Tenofovir Disoproxil
are taking other medicines that may

Do not take Tenofovir Disoproxil if you:
• are allergic to tenofovir, tenofovir disoproxil
or any of the other ingredients of this
medicine listed in section 6.
➔ If this applies to you, tell your doctor
immediately and don’t take Tenofovir
Disoproxil.

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).

Warnings and precautions
Talk to your doctor or pharmacist before
taking Tenofovir Disoproxil
• 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
• Other medicines containing didanosine (for
with your doctor the precautions needed to
HIV infection): Taking Tenofovir Disoproxil
avoid infecting other people. Tenofovir
with other antiviral medicines that contain
Disoproxil does not reduce the risk of
didanosine can raise the levels of
passing on HBV to others through sexual
didanosine in your blood and may reduce
contact or blood contamination. You must
CD4 cell counts. Rarely, inflammation of the
continue to take precautions to avoid this.
pancreas and lactic acidosis (excess lactic
acid in the blood), which sometimes caused
• Talk to your doctor or pharmacist if you
death, have been reported when medicines
have had kidney disease or if tests have
containing tenofovir disoproxil and
shown problems with your kidneys.
didanosine were taken together. Your
Tenofovir Disoproxil should not be given to
doctor will carefully consider whether to
adolescents with existing kidney problems.
treat you with combinations of tenofovir and
Before starting treatment, your doctor may
didanosine.
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 is not usually taken
with other medicines that can damage your
kidneys (see “Other medicines and
Tenofovir Disoproxil”). If this is unavoidable,
your doctor will monitor your kidney
function once a week.

28 March 2017
PANTONE® GREEN C
BLACK

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.
• Look out for infections. If you have
• If you have any further questions, ask your
advanced HIV infection (AIDS) and have an
doctor or pharmacist.
infection, you may develop symptoms of
• This medicine has been prescribed for you
infection and inflammation or worsening of
only. Do not pass it on to others. It may
the symptoms of an existing infection once
harm them, even if their signs of illness are
treatment with Tenofovir Disoproxil is
the same as yours.
started. These symptoms may indicate that
• If you get any side effects, talk to your
your body’s improved immune system is
doctor or pharmacist. This includes any
fighting infection. Look out for signs of
possible side effects not listed in this
inflammation or infection soon after you
leaflet. See section 4.
start taking Tenofovir Disoproxil. If you
notice signs of inflammation or infection,
What is in this leaflet:
tell your doctor at once.
1. What Tenofovir Disoproxil is and what it is
In addition to the opportunistic infections,
used for
autoimmune
disorders (a condition that
2. What you need to know before you take
occurs when the immune system attacks
Tenofovir Disoproxil
healthy body tissue) may also occur after
3. How to take Tenofovir Disoproxil
you start taking medicines for the treatment
4. Possible side effects
of your HIV infection. Autoimmune
5. How to store Tenofovir Disoproxil
disorders may occur many months after the
6. Contents of the pack and other information
start of treatment. If you notice any
symptoms of infection or other symptoms
If Tenofovir Disoproxil has been prescribed
such as muscle weakness, weakness
for your child, please note that all the
beginning in the hands and feet and moving
information in this leaflet is addressed to
up towards the trunk of the body,
your child (in this case please read “your
palpitations, tremor or hyperactivity, please
child” instead of “you”).
inform your doctor immediately to seek
necessary treatment.

1

3

• It is also important to tell your doctor if you
are taking ledipasvir/sofosbuvir to treat
hepatitis C infection.
Tenofovir Disoproxil with food and drink
Take Tenofovir Disoproxil 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
• Bone problems. Some adult patients with
during pregnancy unless specifically
HIV taking combination antiretroviral
discussed with your doctor. Although there
therapy may develop a bone disease called
are limited clinical data on the use of
osteonecrosis (death of bone tissue caused
Tenofovir Disoproxil in pregnant women, it
by loss of blood supply to the bone). The
is not usually used unless absolutely
length of combination antiretroviral therapy,
necessary.
corticosteroid use, alcohol consumption,
severe immunosuppression, higher body
• Try to avoid getting pregnant during
mass index, among others, may be some of
treatment with Tenofovir Disoproxil. You
the many risk factors for developing this
must use an effective method of
disease. Signs of osteonecrosis are joint
contraception to avoid becoming pregnant.
stiffness, aches and pains (especially of the
• If you become pregnant, or plan to become
hip, knee and shoulder) and difficulty in
pregnant, ask your doctor about the
movement. If you notice any of these
potential benefits and risks of your
symptoms tell your doctor.
antiretroviral therapy to you and your child.
Bone problems (sometimes resulting in
fractures) may also occur due to damage to • If you have taken Tenofovir Disoproxil
during your pregnancy, your doctor may
kidney tubule cells (see section 4, “Possible
request regular blood tests and other
side effects”).
diagnostic tests to monitor the development
• Talk to your doctor if you have a history of
of your child. In children whose mothers
liver disease, including hepatitis. Patients
took NRTIs during pregnancy, the benefit
with liver disease including chronic
from the protection against HIV outweighed
hepatitis B or C, who are treated with
the risk of side effects.

TEVA UK Ref:

EAS192 LEA TENOFOVIR DISOPROXIL 245mg FC TAB TUK Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
594 mm
140 mm
-

• 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, do not drive or ride a bicycle and
do not use any tools or machines.
Tenofovir Disoproxil contains lactose
Tell your doctor before taking Tenofovir
Disoproxil if you cannot tolerate lactose or if
you have an intolerance to any other sugars.

3

Template

Colours Used:

• Do not breast-feed during treatment with
Tenofovir Disoproxil. This is because the
active substance in this medicine passes
into human breast milk.

How to take Tenofovir Disoproxil

Version:

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.
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.

The following side effects are uncommon
(these can affect up to 1 in every 100 patients):
• breakdown of muscle, muscle pain or
weakness.
Tests may also show:
• decreases in potassium in the blood
• increased creatinine in your blood
• pancreas problems.

• If you are an adult and have problems with
your kidneys, your doctor may advise you to
take Tenofovir Disoproxil less frequently.
The breakdown of muscle, softening of the
bones (with bone pain and sometimes
• If you have HBV your doctor may offer you resulting in fractures), muscle pain, muscle
an HIV test to see if you have both HBV and weakness and decreases in potassium or
HIV.
phosphate in the blood may occur due to
damage to kidney tubule cells.
Refer to the patient information leaflets of the
other antiretrovirals for guidance on how to
The following side effects are rare (these can
take those medicines.
affect up to 1 in every 1,000 patients):
If you take more Tenofovir Disoproxil than
you should
➔ If you accidentally take too many 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, blister or outer
carton with you so that you can easily
describe what you have taken.
If you forget to take Tenofovir Disoproxil
It is important not to miss a dose of Tenofovir
Disoproxil. If you miss a dose, work out how
long since you should have taken it.

• pain in the tummy (abdomen) caused by
inflammation of the liver
• swelling of the face, lips, tongue or throat.

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.

5

How to store Tenofovir Disoproxil

• 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.

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

If you throw up less than 1 hour after taking
Tenofovir Disoproxil, take another tablet. You
do not need to take another tablet if you were
sick more than 1 hour after taking Tenofovir
Disoproxil.

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.

Do not use this medicine after the expiry date
which is stated on the blister or bottle and
• If it is more than 12 hours since you should
carton after {EXP}. The expiry date refers to
have taken it, forget about the missed dose.
the last day of that month.
Wait and take the next dose at the regular
time. Do not take a double dose to make up This medicine does not require any special
for a forgotten tablet.
storage conditions.

If you stop taking Tenofovir Disoproxil
Don’t stop taking Tenofovir Disoproxil without
your doctor’s advice. Stopping treatment with
Tenofovir Disoproxil may reduce the
effectiveness of the treatment recommended
by your doctor.

6

Contents of the pack and other
information

What Tenofovir Disoproxil contains
• The active substance is tenofovir. Each
tablet contains tenofovir disoproxil
If you have hepatitis B or HIV and hepatitis B
phosphate equivalent to 245 mg of tenofovir
together (co-infection), it is very important not
disoproxil.
to stop your Tenofovir Disoproxil treatment
• The other ingredients are:
without talking to your doctor first. Some
• Tablet core: microcrystalline cellulose,
patients have had blood tests or symptoms
lactose monohydrate, pregelatinised
indicating that their hepatitis has got worse
starch, hydrogenated vegetable oil and
after stopping Tenofovir Disoproxil. You may
sodium laurilsulfate.
require blood tests for several months after
• Film-coating: polyvinyl alcohol - partially
stopping treatment. In some patients with
hydrolysed (E1203), titanium dioxide
advanced liver disease or cirrhosis, stopping
(E171), macrogol (E1521), talc (E553b),
treatment is not recommended as this may
indigo carmine aluminium lake (E132),
lead to worsening of your hepatitis.
carminic acid (E120).
Refer to section 2 “Tenofovir Disoproxil
• Talk to your doctor before you stop taking
contains lactose”.
Tenofovir Disoproxil for any reason,
particularly if you are experiencing any side What Tenofovir Disoproxil looks like and
effects or you have another illness.
contents of the pack
Tenofovir Disoproxil are light blue to blue, film
• Tell your doctor immediately about new or
coated, oval shaped tablet, 16.6 mm long and
unusual symptoms after you stop treatment, 8.9 mm wide, debossed with “T” on one side
particularly symptoms you associate with
of the tablet and plain on the other side.
hepatitis B infection.
Tenofovir Disoproxil is available in blister
• Contact your doctor before you restart
packs containing 30 or 90 tablets, unit dose
taking Tenofovir Disoproxil.
blister packs containing 30x1 or 90x1 tablets
and a hospital pack of 10x1 tablets, bottles
If you have any further questions on the use of
containing 30 tablets or 90 tablets (3 x 30) .
this medicine, ask your doctor or pharmacist.
The bottles contain one or two canister
shaped silica gel desiccants. Please do not
eat these.
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.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Teva Operations Poland Sp. z o.o., Ul.
Mogilska 80, 31-546 Kraków, Poland
This leaflet was last revised in 03/2017
PL 00289/1897

Possible serious side effects: tell your doctor
immediately
• 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 think that you may have lactic
acidosis, contact your doctor immediately.

28 March 2017
PANTONE® GREEN C
BLACK

Always take this medicine exactly as your
Most frequent side effects
doctor or pharmacist has told you. Check with The following side effects are very common
your doctor or pharmacist if you are not sure. (these can affect at least 10 in every 100
patients):
The recommended dose is:
• diarrhoea, being sick (vomiting), feeling sick
• Adults: 1 tablet each day with food (for
(nausea), dizziness, rash, feeling weak.
example, a meal or a snack).
Tests may also show:
• Adolescents aged 12 to less than 18 years • decreases in phosphate in the blood.
who weigh at least 35 kg: 1 tablet each day
with food (for example, a meal or a snack). Other possible side effects
The following side effects are common (these
➔ If you have particular difficulty swallowing, can affect up to 10 in every 100 patients):
you can use the tip of a spoon to crush the • headache, stomach pain, feeling tired,
tablet. Then mix the powder with about 100
feeling bloated, flatulence.
ml (half a glass) of water, orange juice or
Tests may also show:
grape juice and drink immediately.
• liver problems.
• 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.

3

EAS192
32165-A

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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