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TENOFOVIR DISOPROXIL TEVA 245MG FILM-COATED TABLETS

Active substance(s): TENOFOVIR DISOPROXIL PHOSPHATE

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Tenofovir Disoproxil 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 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
This medicine 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 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 already have been treated with other HIV
medicines which are no longer fully effective due to development of resistance, or have caused side
effects.
Tenofovir Disoproxil tablets are also used to treat chronic hepatitis B, an infection with HBV
(hepatitis B virus). 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 do not 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 the 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”).



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 possible signs of lactic acidosis (excess of lactic acid in your blood) once you start
taking Tenofovir Disoproxil. Possible signs of lactic acidosis are:
 deep, rapid breathing
 drowsiness
 nausea, vomiting and stomach pain
This rare but serious side effect can cause enlargement of the liver and has occasionally been fatal.
Lactic acidosis occurs more often in women, particularly if they are very overweight. If you have
liver disease you may also be more at risk of getting this condition. While you are being treated with
Tenofovir Disoproxil, your doctor will monitor you closely for any signs that you may be developing
lactic acidosis.



In the treatment of HIV, combination antiretroviral therapies (including Tenofovir Disoproxil) 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 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 disorder 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 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 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.




Do not 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. 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.

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.



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 medicines like Tenofovir Disoproxil (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 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).

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 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
Do not 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.

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
 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 effect is uncommon (this can affect up to 1 in every 100 patients):
 pain in the tummy (abdomen) caused by inflammation of the pancreas
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, 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
 changes in body shape
In the treatment of HIV, combination antiretroviral therapy (including Tenofovir Disoproxil) 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
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.
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, pharmacist or nurse. 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 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 blister or 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.
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. Each tablet contains tenofovir disoproxil phosphate equivalent to
245 mg of tenofovir disoproxil.
 The other ingredients are:
 Tablet core: microcrystalline cellulose, lactose monohydrate, pregelatinised starch,
hydrogenated vegetable oil and sodium laurilsulfate.
 Film-coating: polyvinyl alcohol - partially hydrolysed (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b), indigo carmine aluminium lake (E132), carminic acid
(E120).
Refer to section 2 “Tenofovir Disoproxil contains lactose”.
What Tenofovir Disoproxil looks like and contents of the pack
Tenofovir Disoproxil are light blue to blue, film coated, oval shaped tablet, 16.6 mm long and 8.9 mm
wide, debossed with “T” on one side of the tablet and plain on the other side.
Tenofovir Disoproxil is available in blister packs containing 30 or 90 tablets, unit dose blister packs
containing 30x1 or 90x1 tablets, bottles containing 30 tablets or 90 tablets (3 x 30) .
The bottles contain one or two canister shaped silica gel desiccants. Please do not eat these.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Gyógyszergyár Zrt. (Teva Pharmaceutical Works Private Limited Company), Debrecen, Pallagi út
13, H-4042, Hungary
*OR
Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren, 89143, Germany
*OR
Teva Pharma B.V., Swensweg 5, Haarlem, 2031 GA, The Netherlands

This leaflet was last revised in 07/2015
PL 00289/1897
* Only the actual site of batch release will appear on the printed version of the leaflet

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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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