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TENOFOVIR DISOPROXIL SANDOZ 245MG FILM-COATED TABLETS

Active substance(s): TENOFOVIR DISOPROXIL / TENOFOVIR DISOPROXIL

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Package leaflet: Information for the patient

SZ00000LT000

Tenofovir disoproxil 245mg Film-coated Tablets
Tenofovir disoproxil
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.
What is in this leaflet
1. What Tenofovir is and what it is used for
2. What you need to know before you take Tenofovir
3. How to take Tenofovir
4. Possible side effects
5. How to store Tenofovir
6. Contents of the pack and other information
If Tenofovir 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 is and what it is
used for

Tenofovir 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 should always
be used combined with other medicines to treat HIV
infection.
Tenofovir is 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 is 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 for HBV.
This medicine is not a cure for HIV infection. While
taking Tenofovir 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

Do not take Tenofovir
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenofovir.
• 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 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 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 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 is not usually taken with other medicines
that can damage your kidneys (see Other medicines
and Tenofovir). 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).
• 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 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. 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 has not been studied in patients
over 65 years of age. If you are older than this and
are prescribed Tenofovir, your doctor will monitor
you carefully.
Children and adolescents
Tenofovir is 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 is 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.
Other medicines and Tenofovir
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 if you have
both HBV and HIV.
• Do not take Tenofovir if you are already taking
other medicines containing tenofovir disoproxil or
tenofovir alafenamide. Do not take Tenofovir 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 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 with food and drink
Take Tenofovir 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 during pregnancy
unless specifically discussed with your doctor.
Although there are limited clinical data on the use of
Tenofovir in pregnant women, it is not usually used
unless absolutely necessary.
• Try to avoid getting pregnant during treatment
with Tenofovir. 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.
Continued on the next page >>

• If you have taken Tenofovir 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. 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 can cause dizziness. If you feel dizzy while
taking Tenofovir, do not drive or ride a bicycle and
do not use any tools or machines.
Tenofovir contains lactose
Tell your doctor before taking Tenofovir if you cannot
tolerate lactose or if you have an intolerance to any
other sugars.

3

How to take Tenofovir

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).
If you have particular difficulty swallowing, 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 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 than you should
If you accidentally take too many Tenofovir 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 pack with you so that
you can easily describe what you have taken.
If you forget to take Tenofovir
It is important not to miss a dose of Tenofovir. 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, take another tablet. You do not need to
take another tablet if you were sick more than 1 hour
after taking Tenofovir.
If you stop taking Tenofovir
Don’t stop taking Tenofovir without your doctor’s
advice. Stopping treatment with Tenofovir 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 treatment without talking to your doctor
first. Some patients have had blood tests or symptoms
indicating that their hepatitis has got worse after
stopping this medicine. 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
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 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 the Yellow Card Scheme (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

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 bottle, carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage
conditions.
After first opening of the bottle, please use within 30 days.
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 contains
• The active substance is tenofovir disoproxil. Each
film-coated tablet contains 245 mg of tenofovir
disoproxil.
• The other ingredients are:
Tablet core: microcrystalline cellulose, lactose
monohydrate, maize starch pregelatinised,
crospovidone (Type B), magnesium stearate
Film-coating: hypromellose, titanium dioxide (E171),
macrogol 400, polysorbate 80.
Refer to section 2 “Tenofovir contains lactose”.
What Tenofovir looks like and contents of the pack
White coloured, almond shaped, biconvex, film coated
tablets, of dimensions 16 mm x 10 mm, debossed with
‘H’ on one side and ‘T11’ on the other side.
Push-through OPA-Al-PVC/Al unit-dose blister
Pack sizes: 30 x 1, 60 x 1 and 90 x 1 film-coated tablets.
White opaque colour HDPE bottle, containing a silica
gel desiccant canister and purified rayon coils, with a
white opaque polypropylene child resistant screw cap.
Pack sizes: 30, 60 (2 x 30) and 90 (3 x 30) film-coated
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Sachsen-Anhalt, 39179
Barleben, Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park, Paola PLA 3000 Malta
This leaflet was last revised in 11/2016
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Source: Medicines and Healthcare Products Regulatory Agency

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

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