Skip to Content

TENOFOVIRDISOPROXIL MILPHARM 163 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 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

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