Skip to Content

TENOFOVIR DISOPROXIL MILPHARM 245 MG FILM-COATED TABLETS

Active substance(s): TENOFOVIR DISOPROXIL FUMARATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user

Tenofovir disoproxil 123 mg film-coated tablets
Tenofovir disoproxil

-

-

What is in this leaflet
1. What Tenofovir disoproxil is and what
it is used for
2. What you need to know before your
child takes 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
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
infection. Tenofovir is a nucleotide reverse
transcriptase inhibitor, generally known as
an NRTI and works by interfering with the
normal working of an enzyme (reverse
transcriptase) that is essential for the virus
to reproduce itself. Tenofovir disoproxil
should always be used combined with
other medicines to treat HIV infection.
Tenofovir disoproxil 123 mg tablets are
a treatment for HIV (Human
Immunodeficiency Virus) infection.
Tenofovir disoproxil 123 mg tablets are for
use in children. They are only suitable for:
• children aged 6 to less than 12
years
• who weigh from 17 kg to less than
22 kg
• 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.
This medicine is not a cure for HIV
infection. While taking Tenofovir disoproxil
your child may still develop infections or
other illnesses associated with HIV
infection. Your child can also pass on HIV
to others, so it is important to take
precautions to avoid infecting other
people.
2. What you need to know before your
child takes Tenofovir disoproxil
Do not give Tenofovir disoproxil
• If your child is allergic to tenofovir,
tenofovir disoproxil or any of the other
ingredients of this medicine listed in
section 6.
If this applies to your child, tell their
doctor immediately and don't give
Tenofovir disoproxil .
Warnings and precautions
• Tenofovir disoproxil 123 mg
tablets are only suitable for children
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.
• Check your child's age and weight
to see if Tenofovir disoproxil 123 mg
tablets are suitable, see Children and
adolescents.
Talk to your child's doctor or pharmacist
before giving Tenofovir disoproxil .
• Take care not to infect other people.
Your child can still pass on HIV when
taking this medicine, although the risk
is lowered by effective antiretroviral
therapy. Discuss with your child's
doctor the precautions needed to avoid
infecting other people.
• Talk to your child's doctor or
pharmacist if your child has had kidney
disease or if tests have shown
problems with their kidneys. Tenofovir
disoproxil should not be given to
children with existing kidney problems.
Tenofovir disoproxil may affect your
child's kidneys during treatment.
Before starting treatment, your child's
doctor may order blood tests to assess
your child's kidney function. Your
child's doctor may also order blood
tests during treatment to monitor how
your child's kidneys work.
Tenofovir disoproxil is not usually taken
with other medicines that can damage
your child's kidneys (see Other medicines
and Tenofovir disoproxil ). If this is
unavoidable, your child's doctor will
monitor your child's 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 child's doctor.
Bone problems (sometimes resulting in
fractures) may also occur due to
damage to kidney tubule cells (see
section 4, Possible side effects).

Black



Talk to your child's doctor if your
child has 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
your child has hepatitis B infection,
your child's doctor will carefully
consider the best treatment for them. If
your child has a history of liver disease
or chronic hepatitis B infection your
child's doctor may conduct blood tests
to monitor their liver function.


Look out for infections. If your
child has advanced HIV infection
(AIDS) and has an infection, they
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 child's body's improved
immune system is fighting
infection. Look out for signs of
inflammation or infection soon after
your child starts taking tenofovir
disoproxil . If you notice signs of
inflammation or infection, tell your
child's 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
your child starts taking medicines for the
treatment of their HIV infection.
Autoimmune disorders may occur many
months after the start of treatment. If you
notice that your child has 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
child's doctor immediately to seek
necessary treatment.
Children and adolescents
Tenofovir disoproxil 123 mg tablets are
only suitable for:
• children aged 6 to less than 12
years
• who weigh from 17 kg to less than
22 kg
• 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 123 mg tablets are
not suitable for the following groups:
• Not for children who weigh under 17
kg or 22 kg and over. Contact your
child's doctor if your
child is outside the permitted weight.
• Not for children and adolescents
under 6 years or 12 years and over.
• Not for HBV (Hepatitis B virus)
infected children and adolescents of
any age.
For dosage see section 3, How to take
Tenofovir disoproxil .
Other medicines and Tenofovir
disoproxil
Tell your child's doctor or pharmacist if
they are taking, have recently taken or
might take any other
medicines.
• Do not give Tenofovir disoproxil
if your child is already taking other
medicines containing tenofovir
disoproxil or tenofovir alafenamide.
Do not give Tenofovir disoproxil
together with medicines containing
adefovir dipivoxil (a medicine used
to treat chronic hepatitis B).
• It is very important to tell your
child's doctor if your child is taking
other medicines that may damage
their 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 the 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 child's doctor will
carefully consider whether to treat your
child with combinations of tenofovir
and didanosine.
• It is also important to tell your
doctor if your child is taking
ledipasvir/sofosbuvir to treat hepatitis
C infection.
Tenofovir disoproxil with food and
drink
Give tenofovir disoproxil with food (for
example, a meal or a snack).
Pregnancy and breast-feeding
If your child is pregnant or breast-feeding,
or they think they may be pregnant, ask
your child's doctor or pharmacist for
advice before they take this medicine.
• Your child must not take tenofovir
disoproxil during pregnancy unless
specifically discussed with your child's
doctor. Although there are limited
clinical data on the use of tenofovir
disoproxil in pregnant women, it is not
usually used unless absolutely
necessary.
• Your child should try to avoid
getting pregnant during treatment
with tenofovir disoproxil . Your child
must use an effective method of
contraception to avoid becoming
pregnant if they are sexually
active.

P15xxxxx

-

Read all of this leaflet carefully
before your child starts 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 child's doctor or pharmacist.
This medicine has been prescribed for
your child only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as your
child's.
If your child gets any side effects, talk
to your child's doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See
section 4.

3. How to take Tenofovir disoproxil
Your child must always take this
medicine exactly as their doctor or
pharmacist has told you. Check with
your child's doctor or pharmacist if you are
not sure.
The recommended dose is:
• Children aged 6 to less than 12
years who weigh from 17 kg to less
than 22 kg:
1 tablet each day with food (for example, a
meal or a snack).
Your child's doctor will monitor their
weight.
Your child must always take the dose
recommended by their doctor. This is to
make sure that their medicine is fully
effective, and to reduce the risk of
developing resistance to the treatment. Do
not change the dose unless your child's
doctor tells you to.
Your child's doctor will prescribe Tenofovir
disoproxil with other antiretroviral
medicines.
Refer to the patient information leaflets of
the other antiretrovirals for guidance on
how to take those
medicines.
If your child takes more Tenofovir
disoproxil than they should
If your child accidentally takes too many
Tenofovir disoproxil tablets, they may be
at increased risk of experiencing possible
side effects with this medicine (see section
4, Possible side effects). Contact your
child's doctor or nearest emergency
department for advice. Keep the tablet
bottle with you so that you can easily
describe what your child has taken.
If your child forgets to take Tenofovir
disoproxil
It is important not to miss a dose of
Tenofovir disoproxil . If your child misses a
dose, work out how long since they should
have taken it.
• If it is less than 12 hours after it is
usually taken, they should take it as
soon as they can, and then take their
next dose at its regular time.
• If it is more than 12 hours since your
child should have taken it, forget about
the missed dose. Wait and give the
next dose at the regular time. Do not
give a double dose to make up for a
forgotten tablet.
If your child throws up less than 1 hour
after taking Tenofovir disoproxil , give
your child another tablet. Your child does
not need to take another tablet if they
were sick more than 1 hour after taking
Tenofovir disoproxil.
If your child stops taking Tenofovir
disoproxil
Your child must not stop taking Tenofovir
disoproxil without their doctor's advice.
Stopping treatment with Tenofovir
disoproxil may reduce the effectiveness of
the treatment recommended by your
child's doctor.
If your child has HIV and hepatitis B it is
very important not to stop their Tenofovir
disoproxil treatment without talking to
your child's doctor first. Some patients
have had blood tests or symptoms
indicating that their hepatitis has got
worse after stopping Tenofovir disoproxil .
Your child 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 child's hepatitis.
• Talk to your child's doctor before your
child stops taking Tenofovir disoproxil
for any reason, particularly if your child
is experiencing any side effects or they
have another illness.
• Tell your child's doctor immediately
about new or unusual symptoms after
your child stops treatment, particularly
symptoms you associate with hepatitis
B infection.
• Contact your child's doctor before your
child restarts taking Tenofovir
disoproxil tablets.
If you have any further questions on the
use of this medicine, ask your child's
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 child's 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
child's 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 your child may have lactic
acidosis, contact your child's 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 child's 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 your child may have
any of these serious side effects, talk to
your child's 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):
• 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 child's
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 your child gets any side effects, talk
to your child's 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 123 mg of
tenofovir disoproxil (as fumarate).
- The other ingredients are
Tablet Core: Croscarmellose sodium,
lactose monohydrate, cellulose,
microcrystalline,
Starch, pregelatinized (Maize Starch) and
magnesium stearate
Tablet coating: Hypromellose 2910,
lactose monohydrate, titanium dioxide (E
171), triacetin.
What Tenofovir disoproxil looks like
and contents of the pack
Film- coated tablet.
White to off white, capsule shaped,
biconvex film-coated tablets debossed
with '150' 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

P15xxxxx

• If your child becomes
pregnant, ask your child's
doctor about the potential
benefits and risks of the
antiretroviral therapy to your
child and your child's
baby.
• If your child has taken
tenofovir disoproxil during
their pregnancy, your child's
doctor may request regular
blood tests and other diagnostic
tests to monitor the
development of the baby. In
children whose mothers took
medicines like tenofovir
disoproxil (NRTIs) during
pregnancy, the benefit from the
protection against the virus
outweighed the risk of side
effects.
• Your child must not breast-feed
during treatment with tenofovir
disoproxil . This is because the active
substance in this medicine passes into
human breast milk.
• Your child must not breast-feed, to
avoid passing the virus to the baby in
breast milk.
Driving and using machines
Tenofovir disoproxil can cause dizziness.
If your child feels dizzy while taking
tenofovir disoproxil , they must not drive
or ride a bicycle and must not use any
tools or machines.
Tenofovir disoproxil contains lactose
Tell your child's doctor before giving
Tenofovir disoproxil if your child cannot
tolerate lactose or if they have an
intolerance to any other sugars.

This leaflet was last revised in 05/2017.

Package leaflet: Information for the user

Tenofovir disoproxil 163 mg film-coated tablets
Tenofovir disoproxil

-

-

Read all of this leaflet carefully
before your child starts 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
child's doctor or pharmacist.
This medicine has been prescribed for your
child only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as your child's.
If your child gets any side effects, talk to
your child's 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 is and what it is
used for
2. What you need to know before your child
takes 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
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 infection.
Tenofovir is a nucleotide reverse transcriptase
inhibitor, generally known as an NRTI and
works by interfering with the normal working of
an enzyme (reverse transcriptase) that is
essential for the virus to reproduce itself.
Tenofovir disoproxil should always be used
combined with other medicines to treat HIV
infection.
Tenofovir disoproxil 163 mg tablets are a
treatment for HIV (Human Immunodeficiency
Virus) infection.
Tenofovir disoproxil 163 mg tablets are for use
in children. They are only suitable for:
• children aged 6 to less than 12 years
• who weigh from 22 kg to less than 28 kg
• 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.
This medicine is not a cure for HIV infection.
While taking Tenofovir disoproxil your child may
still develop infections or other illnesses
associated with HIV infection. Your child can
also pass on HIV to others, so it is important to
take precautions to avoid infecting other people.
2. What you need to know before your child
takes Tenofovir disoproxil
Do not give Tenofovir disoproxil
• If your child is allergic to tenofovir,
tenofovir disoproxil or any of the other
ingredients of this medicine listed in section
6.
If this applies to your child, tell their doctor
immediately and don't give Tenofovir
disoproxil.
Warnings and precautions
• Tenofovir disoproxil 163 mg tablets are only
suitable for children 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.
• Check your child's age and weight to see
if Tenofovir disoproxil 163 mg tablets are
suitable, see Children and adolescents.
Talk to your child's doctor or pharmacist before
giving Tenofovir disoproxil.
• Take care not to infect other people. Your
child can still pass on HIV when taking this
medicine, although the risk is lowered by
effective antiretroviral therapy. Discuss with
your child's doctor the precautions needed
to avoid infecting other people.
• Talk to your child's doctor or pharmacist if
your child has had kidney disease or if tests
have shown problems with their kidneys.
Tenofovir disoproxil should not be given to
children with existing kidney problems.
Tenofovir disoproxil may affect your child's
kidneys during treatment. Before starting
treatment, your child's doctor may order
blood tests to assess your child's kidney
function. Your child's doctor may also order
blood tests during treatment to monitor how
your child's kidneys work.
Tenofovir disoproxil is not usually taken with
other medicines that can damage your child's
kidneys (see Other medicines and Tenofovir
disoproxil). If this is unavoidable, your child's
doctor will monitor your child's 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 child's doctor.
Bone problems (sometimes resulting in
fractures) may also occur due to damage to
kidney tubule cells (see section 4, Possible
side effects).

Black



Talk to your child's doctor if your child
has 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 your child has hepatitis B
infection, your child's doctor will carefully
consider the best treatment for them. If your
child has a history of liver disease or chronic
hepatitis B infection your child's doctor may
conduct blood tests to monitor their liver
function.
• Look out for infections. If your child has
advanced HIV infection (AIDS) and has an
infection, they 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 child's body's improved immune
system is fighting infection. Look out for
signs of inflammation or infection soon after
your child starts taking tenofovir disoproxil. If
you notice signs of inflammation or infection,
tell your child's 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 your child starts
taking medicines for the treatment of their HIV
infection. Autoimmune disorders may occur
many months after the start of treatment. If you
notice that your child has 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 child's doctor immediately to
seek necessary treatment.
Children and adolescents
Tenofovir disoproxil 163 mg tablets are only
suitable for:
• children aged 6 to less than 12 years
• who weigh from 22 kg to less than 28 kg
• 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 163 mg tablets are not
suitable for the following groups:
• Not for children who weigh under 22 kg or
28 kg and over. Contact your child's doctor if
your child is outside the permitted weight.
• Not for children and adolescents under 6
years or 12 years and over.
• Not for HBV (Hepatitis B virus) infected
children and adolescents of any age.
For dosage see section 3, How to take
Tenofovir disoproxil.
Other medicines and Tenofovir disoproxil
Tell your child's doctor or pharmacist if they are
taking, have recently taken or might take any
other medicines.
• Do not give Tenofovir disoproxil if your
child is already taking other medicines
containing tenofovir disoproxil or tenofovir
alafenamide . Do not give Tenofovir
disoproxil together with medicines
containing adefovir dipivoxil (a medicine
used to treat chronic hepatitis B).
• It is very important to tell your child's
doctor if your child is taking other
medicines that may damage their
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 the
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
child's doctor will carefully consider
whether to treat your child with
combinations of tenofovir and
didanosine.
• It is also important to tell your doctor if
your child is taking ledipasvir/sofosbuvir to
treat hepatitis C infection.
Tenofovir disoproxil with food and drink
Give tenofovir disoproxil with food (for
example, a meal or a snack).
Pregnancy and breast-feeding
If your child is pregnant or breast-feeding, or
they think they may be pregnant, ask your
child's doctor or pharmacist for advice before
they take this medicine.
• Your child must not take tenofovir
disoproxil during pregnancy unless
specifically discussed with your child's
doctor. Although there are limited clinical
data on the use of tenofovir disoproxil in
pregnant women, it is not usually used
unless absolutely necessary.
• Your child should try to avoid getting
pregnant during treatment with tenofovir
disoproxil. Your child must use an effective
method of contraception to avoid becoming
pregnant if they are sexually active.
• If your child becomes pregnant, ask your
child's doctor about the potential benefits
and risks of the antiretroviral therapy to your
child and your child's baby.
P15xxxxx





• If your child has taken tenofovir
disoproxil during their pregnancy,
your child's doctor may request
regular blood tests and other
diagnostic tests to monitor the
development of the
baby. In children whose mothers took
medicines like tenofovir disoproxil
(NRTIs) during pregnancy, the benefit
from the protection against the virus
outweighed the risk of side effects.
Your child must not breast-feed
during treatment with tenofovir
disoproxil. This is because the active
substance in this medicine passes into
human breast milk.
Your child must not breast-feed, to avoid
passing the virus to the baby in breast milk.

Driving and using machines
Tenofovir disoproxil can cause dizziness. If your
child feels dizzy while taking tenofovir
disoproxil, they must not drive or ride a
bicycle and must not use any tools or
machines.
Tenofovir disoproxil contains lactose
Tell your child's doctor before giving
Tenofovir disoproxil if your child cannot
tolerate lactose or if they have an intolerance to
any other sugars.
3. How to take Tenofovir disoproxil
Your child must always take this medicine
exactly as their doctor or pharmacist has
told you. Check with your child's doctor or
pharmacist if you are not sure.
The recommended dose is:
• Children aged 6 to less than 12 years
who weigh from 22 kg to less than 28 kg:
1 tablet each day with food (for example, a
meal or a snack).
Your child's doctor will monitor their weight.
Your child must always take the dose
recommended by their doctor. This is to
make sure that their medicine is fully effective,
and to reduce the risk of developing resistance
to the treatment. Do not change the dose
unless your child's doctor tells you to.
Your child's doctor will prescribe Tenofovir
disoproxil with other antiretroviral medicines.
Refer to the patient information leaflets of the
other antiretrovirals for guidance on how to take
those medicines.
If your child takes more Tenofovir disoproxil
than they should
If your child accidentally takes too many
Tenofovir disoproxil tablets, they may be at
increased risk of experiencing possible side
effects with this medicine (see section 4,
Possible side effects). Contact your child's
doctor or nearest emergency department for
advice. Keep the tablet bottle with you so that
you can easily describe what your child has
taken.
If your child forgets to take Tenofovir
disoproxil
It is important not to miss a dose of Tenofovir
disoproxil. If your child misses a dose, work out
how long since they should have taken it.
• If it is less than 12 hours after it is
usually taken, they should take it as
soon as they can, and then take their next
dose at its regular time.
• If it is more than 12 hours since your child
should have taken it, forget about the
missed dose. Wait and give the next dose at
the regular time. Do not give a double dose
to make up for a forgotten tablet.
If your child throws up less than 1 hour after
taking Tenofovir disoproxil, give your child
another tablet. Your child does not need to take
another tablet if they were sick more than 1
hour after taking Tenofovir disoproxil.
If your child stops taking Tenofovir
disoproxil
Your child must not stop taking Tenofovir
disoproxil without their doctor's advice.
Stopping treatment with Tenofovir disoproxil
may reduce the effectiveness of the treatment
recommended by your child's doctor.
If your child has HIV and hepatitis B it is very
important not to stop their Tenofovir disoproxil
treatment without talking to your child's doctor
first. Some patients have had blood tests or
symptoms indicating that their hepatitis has got
worse after stopping Tenofovir disoproxil. Your
child 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 child's hepatitis.
• Talk to your child's doctor before your child
stops taking Tenofovir disoproxil for any
reason, particularly if your child is
experiencing any side effects or they have
another illness.
• Tell your child's doctor immediately about
new or unusual symptoms after your child
stops treatment, particularly symptoms you
associate with hepatitis B infection.
• Contact your child's doctor before your child
restarts taking Tenofovir disoproxil tablets.
If you have any further questions on the use
of this medicine, ask your child's 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 child's
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
child's 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 your child may have lactic
acidosis, contact your child's 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 child's 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 your child may have any of
these serious side effects, talk to your
child's 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):
• 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 child's 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 your child gets any side effects, talk to
your child's 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 163 mg of
tenofovir disoproxil (as fumarate).
- The other ingredients are
Tablet Core: Croscarmellose sodium, lactose
monohydrate, cellulose, microcrystalline,
Starch, pregelatinized (Maize Starch) and
magnesium stearate
Tablet coating: Hypromellose 2910, lactose
monohydrate, titanium dioxide (E 171), triacetin.
What Tenofovir disoproxil looks like and
contents of the pack
Film- coated tablet.
White to off white, round shaped, biconvex filmcoated tablets debossed with '200' 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.
P15xxxxx

Package leaflet: Information for the user

Tenofovir disoproxil 204 mg film-coated tablets
Tenofovir disoproxil

-

-

What is in this leaflet
1. What Tenofovir disoproxil is and what it is
used for
2. What you need to know before your child
takes 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
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 infection.
Tenofovir is a nucleotide reverse transcriptase
inhibitor, generally known as an NRTI and
works by interfering with the normal working of
an enzyme (reverse transcriptase) that is
essential for the virus to reproduce itself.
Tenofovir disoproxil should always be used
combined with other medicines to treat HIV
infection.
Tenofovir disoproxil 204 mg tablets are a
treatment for HIV (Human Immunodeficiency
Virus) infection.
Tenofovir disoproxil 204 mg tablets are for use
in children. They are only suitable for:
• children aged 6 to less than 12 years
• who weigh from 28 kg to less than 35 kg
• 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.
This medicine is not a cure for HIV infection.
While taking Tenofovir disoproxil your child may
still develop infections or other illnesses
associated with HIV infection. Your child can
also pass on HIV to others, so it is important to
take precautions to avoid infecting other people.
2. What you need to know before your child
takes Tenofovir disoproxil
Do not give Tenofovir disoproxil
• If your child is allergic to tenofovir,
tenofovir disoproxil or any of the other
ingredients of this medicine listed in section
6.
If this applies to your child, tell their doctor
immediately and don't give Tenofovir
disoproxil.
Warnings and precautions
• Tenofovir disoproxil 204 mg tablets are only
suitable for children 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.
• Check your child's age and weight to see
if Tenofovir disoproxil 204 mg tablets are
suitable, see Children and adolescents.
Talk to your child's doctor or pharmacist before
giving Tenofovir disoproxil.
• Take care not to infect other people. Your
child can still pass on HIV when taking this
medicine, although the risk is lowered by
effective antiretroviral therapy. Discuss with
your child's doctor the precautions needed
to avoid infecting other people.
• Talk to your child's doctor or pharmacist if
your child has had kidney disease or if tests
have shown problems with their kidneys.
Tenofovir disoproxil should not be given to
children with existing kidney problems.
Tenofovir disoproxil may affect your child's
kidneys during treatment. Before starting
treatment, your child's doctor may order
blood tests to assess your child's kidney
function. Your child's doctor may also order
blood tests during treatment to monitor how
your child's kidneys work.
Tenofovir disoproxil is not usually taken with
other medicines that can damage your child's
kidneys (see Other medicines and Tenofovir
disoproxil). If this is unavoidable, your child's
doctor will monitor your child's 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 child's doctor.
Bone problems (sometimes resulting in
fractures) may also occur due to damage to
kidney tubule cells (see section 4, Possible
side effects).

Black



Talk to your child's doctor if your child
has 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 your child has hepatitis B
infection, your child's doctor will carefully
consider the best treatment for them. If your
child has a history of liver disease or chronic
hepatitis B infection your child's doctor may
conduct blood tests to monitor their liver
function.
• Look out for infections. If your child has
advanced HIV infection (AIDS) and has an
infection, they 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
child's body's improved immune system is
fighting infection. Look out for signs of
inflammation or infection soon after your
child starts taking tenofovir disoproxil. If you
notice signs of inflammation or infection, tell
your child's 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 your child starts
taking medicines for the treatment of their HIV
infection. Autoimmune disorders may occur
many months after the start of treatment. If you
notice that your child has 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 child's doctor immediately to
seek necessary treatment.
Children and adolescents
Tenofovir disoproxil 204 mg tablets are only
suitable for:
• children aged 6 to less than 12 years
• who weigh from 28 kg to less than 35 kg
• 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 204 mg tablets are not
suitable for the following groups:
• Not for children who weigh under 28 kg or
35 kg and over. Contact your child's doctor if
your child is outside the permitted weight.
• Not for children and adolescents under 6
years or 12 years and over.
• Not for HBV (Hepatitis B virus) infected
children and adolescents of any age.
For dosage see section 3, How to take
Tenofovir disoproxil.
Other medicines and Tenofovir disoproxil
Tell your child's doctor or pharmacist if they are
taking, have recently taken or might take any
other medicines.
• Do not give Tenofovir disoproxil if your
child is already taking other medicines
containing tenofovir disoproxil or tenofovir
alafenamide. Do not give Tenofovir
disoproxil together with medicines
containing adefovir dipivoxil (a medicine
used to treat chronic hepatitis B).
• It is very important to tell your child's
doctor if your child is taking other
medicines that may damage their
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 the 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 child's
doctor will carefully consider whether to
treat your child with combinations of
tenofovir and didanosine.
• It is also important to tell your doctor if
your child is taking ledipasvir/sofosbuvir to
treat hepatitis C infection.
Tenofovir disoproxil with food and drink
Give tenofovir disoproxil with food (for
example, a meal or a snack).
Pregnancy and breast-feeding
If your child is pregnant or breast-feeding, or
they think they may be pregnant, ask your
child's doctor or pharmacist for advice before
they take this medicine.
• Your child must not take tenofovir
disoproxil during pregnancy unless
specifically discussed with your child's
doctor. Although there are limited clinical
data on the use of tenofovir disoproxil in
pregnant women, it is not usually used
unless absolutely necessary.
• Your child should try to avoid getting
pregnant during treatment with
tenofovir disoproxil. Your child must use
an effective method of contraception to
avoid becoming pregnant if they are
sexually active.

P15xxxxx

-

Read all of this leaflet carefully
before your child starts 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
child's doctor or pharmacist.
This medicine has been prescribed for your
child only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as your child's.
If your child gets any side effects, talk to
your child's doctor or pharmacist. This
includes any possible side effects not listed
in this leaflet. See section 4.

3. How to take Tenofovir disoproxil
Your child must always take this medicine
exactly as their doctor or pharmacist has
told you. Check with your child's doctor or
pharmacist if you are not sure.
The recommended dose is:
• Children aged 6 to less than 12 years
who weigh from 28 kg to less than 35 kg:
1 tablet each day with food (for example, a
meal or a snack).
Your child's doctor will monitor their weight.
Your child must always take the dose
recommended by their doctor. This is to
make sure that their medicine is fully effective,
and to reduce the risk of developing resistance
to the treatment. Do not change the dose
unless your child's doctor tells you to.
Your child's doctor will prescribe Tenofovir
disoproxil with other antiretroviral medicines.
Refer to the patient information leaflets of the
other antiretrovirals for guidance on how to take
those medicines.
If your child takes more Tenofovir disoproxil
than they should
If your child accidentally takes too many
Tenofovir disoproxil tablets, they may be at
increased risk of experiencing possible side
effects with this medicine (see section 4,
Possible side effects). Contact your child's
doctor or nearest emergency department for
advice. Keep the tablet bottle with you so that
you can easily describe what your child has
taken.
If your child forgets to take Tenofovir
disoproxil
It is important not to miss a dose of Tenofovir
disoproxil. If your child misses a dose, work out
how long since they should have taken it.
• If it is less than 12 hours after it is
usually taken, they should take it as
soon as they can, and then take their next
dose at its regular time.
• If it is more than 12 hours since your child
should have taken it, forget about the
missed dose.
Wait and give the next dose at the regular
time. Do not give a double dose to make up
for a forgotten tablet.
If your child throws up less than 1 hour after
taking Tenofovir disoproxil, give your child
another tablet. Your child does not need to take
another tablet if they were sick more than 1
hour after taking Tenofovir disoproxil.
If your child stops taking Tenofovir
disoproxil
Your child must not stop taking Tenofovir
disoproxil without their doctor's advice.
Stopping treatment with Tenofovir disoproxil
may reduce the effectiveness of the treatment
recommended by your child's doctor.
If your child has HIV and hepatitis B it is very
important not to stop their Tenofovir disoproxil
treatment without talking to your child's doctor
first. Some patients have had blood tests or
symptoms indicating that their hepatitis has got
worse after stopping Tenofovir disoproxil. Your
child 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 child's hepatitis.
• Talk to your child's doctor before your child
stops taking Tenofovir disoproxil for any
reason, particularly if your child is
experiencing any side effects or they have
another illness.
• Tell your child's doctor immediately about
new or unusual symptoms after your child
stops treatment, particularly symptoms you
associate with hepatitis B infection.
• Contact your child's doctor before your child
restarts taking Tenofovir disoproxil tablets.
If you have any further questions on the use of
this medicine, ask your child's 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 child's
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
child's 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 your child may have lactic
acidosis, contact your child's 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 child's 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 your child may have any of
these serious side effects, talk to your
child's 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):
• 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 child's 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 your child gets any side effects, talk to
your child's 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 204 mg of
tenofovir disoproxil (as fumarate).
- The other ingredients are
Tablet Core: Croscarmellose sodium, lactose
monohydrate, cellulose, microcrystalline,
Starch, pregelatinized (Maize Starch) and
magnesium stearate
Tablet coating: Hypromellose 2910, lactose
monohydrate, titanium dioxide (E 171), triacetin.
What Tenofovir disoproxil looks like and
contents of the pack
Film- coated tablet.
White to off white, capsule shaped, biconvex
film-coated tablets debossed with '250' 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.

P15xxxxx

• If your child becomes pregnant,
ask your child's doctor about the
potential benefits and risks of the
antiretroviral therapy to your child
and your child's baby.
• If your child has taken tenofovir
disoproxil during their pregnancy,
your child's doctor may request
regular blood tests and other
diagnostic tests to monitor the
development of the baby. In children
whose mothers took medicines like
tenofovir disoproxil (NRTIs) during
pregnancy, the benefit from the
protection against the virus
outweighed the risk of side effects.
• Your child must not breast-feed during
treatment with tenofovir disoproxil. This
is because the active substance in this
medicine passes into human breast milk.
• Your child must not breast-feed, to
avoid passing the virus to the baby in
breast milk.
Driving and using machines
Tenofovir disoproxil can cause dizziness. If your
child feels dizzy while taking tenofovir
disoproxil, they must not drive or ride a
bicycle and must not use any tools or
machines.
Tenofovir disoproxil contains lactose
Tell your child's doctor before giving
Tenofovir disoproxil if your child cannot
tolerate lactose or if they have an intolerance to
any other sugars.

Package leaflet: Information for the patient

Tenofovir disoproxil 245 mg film-coated tablets
Tenofovir disoproxil

-

-





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).
Black



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.

P15XXXXX

-

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.







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.

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, 90 and 90 (3x30) film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
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 07/2017.

P15XXXXX

+ 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.

Hide