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TENOFOVIR DISOPROXIL MILPHARM 245 MG FILM-COATED TABLETS

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

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Package leaflet: Information for the patient

Tenofovir disoproxil 245 mg film-coated tablets
Tenofovir disoproxil

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What is in this leaflet
1. What Tenofovir disoproxil is and what it is
used for
2. What you need to know before you take
Tenofovir disoproxil
3. How to take Tenofovir disoproxil
4. Possible side effects
5. How to store Tenofovir disoproxil
6. Contents of the pack and other information
If Tenofovir disoproxil 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 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 245 mg 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 245 mg 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
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.
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 with
your doctor the precautions needed to avoid
infecting other people. Tenofovir disoproxil
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 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 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.
• 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).

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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. 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, your doctor
will monitor you carefully.

Children and adolescents
Tenofovir disoproxil 245 mg 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 245 mg 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.
• Don't stop any anti-HIV medicines
prescribed by your doctor when you start
tenofovir disoproxil if you have both HBV
and HIV.
• Do not take Tenofovir disoproxil if you
are already taking other medicines
containing tenofovir disoproxil or
tenofovir alafenamide. Do not take
Tenofovir disoproxil together with
medicines containing adefovir dipivoxil
(a medicine used to treat chronic
hepatitis B).
• 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 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
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.

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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.





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. How to take 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:
• 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).
A granules formulation of tenofovir disoproxil
may be available for patients having difficulty in
swallowing film-coated tablets. However, in
exceptional circumstances, 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 an adult and have problems
with your kidneys, your doctor may advise
you to take Tenofovir disoproxil 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 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
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.
• 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, take another tablet. You
do not need to take another tablet if you were
sick more than 1 hour after taking Tenofovir
disoproxil.
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.
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.
• Talk to your doctor before you stop taking
Tenofovir disoproxil 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 tablets.
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 (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.
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.
Most frequent side effects
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
Tests may also show:
• decreases in phosphate in the blood
Other possible side effects
The following side effects are common (these
can affect up to 10 in every 100 patients):
• headache, stomach pain, feeling tired,
feeling bloated, flatulence
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
Tests may also show:
• decreases in potassium in the blood

increased creatinine in your blood

pancreas problems
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 (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
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
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
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, carton, bottle after
EXP. The expiry date refers to the last day of
that month.
Store below 300C.
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 Tenofovir disoproxil contains
- The active substance is tenofovir disoproxil.
Each film-coated tablet contains 245 mg of
tenofovir disoproxil (as fumarate).
- The other ingredients are
Tablet Core: Croscarmellose sodium, Lactose
monohydrate. Cellulose, Microcrystalline
Starch, Pregelatinized (Maize Starch),
Magnesium Stearate
Tablet coating: Hypromellose 2910, lactose
monohydrate, titanium dioxide (E 171), triacetin,
FD&C Blue 2 aluminum lake (3-5%) EHD (E
132) and FD&C Blue 2 aluminum lake (3-5%)
SEN (E 132).
What Tenofovir disoproxil looks like and
contents of the pack
Film- coated tablet.
Blue color, oval shaped, biconvex, film-coated
tablets debossed with '300' on one side and 'T'
on the other side.
Tenofovir disoproxil film-coated tablets are
available in blister packs and HDPE bottle
packs.
Packsizes:
Blister packs: 30 film-coated tablets.
HDPE packs: 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
or
Arrow Generiques - Lyon
26 avenue Tony Garnier
Lyon, 69007, France
This leaflet was last revised in 05/2017.

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• Try to avoid getting pregnant
during treatment with 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 your antiretroviral therapy to you
and your child.
If you have taken 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
tenofovir disoproxil. 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.

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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