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TENOFOVIR ZENTIVA 245 MG FILM COATED TABLETS

Active substance(s): TENOFOVIR DISOPROXIL FUMARATE

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EPAR + PRAC Update – Approved on 22/10/2014

PACKAGE LEAFLET: INFORMATION FOR THE USER
Tenofovir 245 mg film-coated tablets

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

The name of your medicine is Tenofovir 245 mg film-coated tablets (called tenofovir
throughout this leaflet). Tenofovir 245 mg film-coated tablets contain 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:

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EPAR + PRAC Update – Approved on 22/10/2014




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 fumarate or any of the other
ingredients of this medicine listed in section 6. If this applies to you, tell your doctor
immediately and do not 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

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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.

In the treatment of HIV, combination antiretroviral therapies (including tenofovir) may raise
blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to
insulin (see section 4, Possible side effects).
If you are diabetic, overweight or have high cholesterol, talk to your doctor.
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 have 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.

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EPAR + PRAC Update – Approved on 22/10/2014



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.


Do not 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 fumarate. 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 fumarate and didanosine were
taken together. Your doctor will carefully consider whether to treat you with
combinations of tenofovir and didanosine.

Pregnancy, breast-feeding and fertility
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

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benefits and risks of your antiretroviral therapy to you and your child.


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 medicines like tenofovir (NRTIs) during pregnancy, the
benefit from the protection against the virus 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 245 mg film-coated tablets contain lactose monohydrate
Tenofovir 245 mg film-coated tablets contain lactose monohydrate. If you have been told by
your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.

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: One 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: one 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

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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 tablet bottle 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 of tenofovir, 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


Do not 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 tenofovir. 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

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible serious side effects: tell your doctor immediately

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EPAR + PRAC Update – Approved on 22/10/2014

Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 people)
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
Uncommon (may affect up to 1 in 100 people):

pain in the tummy (abdomen) caused by inflammation of the pancreas
Rare (may affect up to 1 in 1,000 people):

inflammation of the kidney, passing a lot of urine and feeling thirsty, damage to kidney
tubule cells

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

Change in body shape
In the treatment of HIV, combination antiretroviral therapy (including tenofovir) may change
your body shape, by changing the way body fat is distributed. You may lose fat from your legs,
arms and face; gain fat around the tummy (abdomen) and internal organs; get larger breasts or
fatty lumps on the back of the neck (‘buffalo hump’). The cause and the long-term effects of
these changes are not yet known.
If you think that you may have any of these serious side effects, talk to your doctor.
Most frequent side effects
Very common (may affect more than 1 in 10 people):

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
Common (may affect up to 1 in 10 people):

headache, stomach pain, feeling tired, feeling bloated, flatulence
Tests may also show:

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EPAR + PRAC Update – Approved on 22/10/2014



liver problems

Uncommon (may affect up to 1 in 100 people):

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.
Rare (may affect up to 1 in 1,000 people):

pain in the tummy (abdomen) caused by inflammation of the liver

swelling of the face, lips, tongue or throat
In the treatment of HIV, combination antiretroviral therapy may also cause increased fats in the
blood (hyperlipaemia) and resistance to insulin. Your doctor will test for these changes.
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 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

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 and carton after
EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After first opening use the product 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 245 mg film-coated tablets contain
The active substance is tenofovir. Each Tenofovir 245 mg film-coated tablet contains 245 mg

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of tenofovir disoproxil (in the form of 300 mg tenofovir disoproxil fumarate).
The other ingredients are: Lactose monohydrate, Povidone K-25, Croscarmellose sodium,
Microcrystalline cellulose (E-460), Magnesium stearate, Hypromellose (E-464), Titanium
dioxide (E-171), Triacetin (E-1518), Indigo Carmine Aluminum Lake (E-132).
What Tenofovir 245 mg film-coated tablets look like and contents of the pack
Tenofovir 245 mg film-coated tablets are light blue, oblong biconvex-shaped, film-coated
tablets.
Contents of the pack:
Outer cartons contain 1 x 30 film-coated tablets in a bottle or 3 x 10 film-coated tablets in
blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS
Manufacturer: ZENTIVA, k.s, U kabelovny 130, Prague 10, Dolní Měcholupy, Zip code 102 37,
Czech Republic

This leaflet was last revised in August 2015.
© 2015 Zentiva

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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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