Skip to Content

TENOFOVIR DISOPROXIL MILPHARM 123 MG FILM-COATED TABLETS

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

View full screen / Print PDF » 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.

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