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TENOFOVIR DISOPROXIL DR. REDDYS 245 MG FILM-COATED TABLETS

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

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157 mm

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Package leaflet: Information for the patient
Tenofovir disoproxil 245 mg Film-Coated Tablets

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Tenofovir disoproxil

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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 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
Tenofovir disoproxil tablets contain the active substance
tenofovir disoproxil succinate. 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.

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Tenofovir disoproxil 245 mg 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 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 245 mg tablets are 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
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
succinate 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 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 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 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 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 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 245 mg 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 245 mg 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.
• Don’t 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 or
tenofovir alafenamide. 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:
o aminoglycosides, pentamidine or vancomycin
(for bacterial infection),
o amphotericin B (for fungal infection),
o foscarnet, ganciclovir, or cidofovir (for viral infection),
o interleukin-2 (to treat cancer),
o adefovir dipivoxil (for HBV),
o tacrolimus (for suppression of the immune system),
o 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.
• It is also important to tell your doctor if you are taking
ledipasvir/sofosbuvir to treat hepatitis C infection.
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 NRTIs during
pregnancy, the benefit from the protection against HIV
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 tablets contain lactose
Tell your doctor before taking Tenofovir disoproxil if you
cannot tolerate lactose or if you have an intolerance to any
other sugars.

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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).
• 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
Don’t 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 tablets.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.
4. Possible side effects

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, website 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 bottle and carton after {EXP}. The expiry
date refers to the last day of that month.
- This medicine does not require any special storage
conditions.
- Use within 30 days after first opening; store below 25oC.
- 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 tablets contain
- The active substance is tenofovir.
Each Tenofovir disoproxil tablet contains 245 mg of tenofovir
disoproxil (as succinate).
- The other ingredients are:
lactose anhydrous, microcrystalline cellulose 112 (E460),
pregelatinised starch, croscarmellose sodium and magnesium
stearate (E470b) which make up the tablet core, and Indigo
Carmine Aluminium Lake (E132), Titanium dioxide (E171),
Poly(Vinyl Alcohol) (E1203), Macrogol 3350 (E1521) and
Talc (E553b) which make up the tablet coating. Refer to
section 2 “Tenofovir disoproxil tablets contain lactose”.
What Tenofovir disoproxil tablets look like and contents
of the pack
Tenofovir disoproxil 245 mg film-coated tablets are light
blue, almond-shaped, with dimensions of approximately
17.0 mm x 10.5 mm.
Tenofovir disoproxil 245 mg film-coated tablets are supplied
in bottles containing 30 tablets, packed in a carton. Each
bottle contains a silica gel desiccant that must be kept in the
bottle to help protect your tablets. The silica gel desiccant is
contained in a separate canister and should not be swallowed.
The following pack sizes are available:
30 (1 x 30) film-coated tablets
90 (3 x 30) film-coated tablets

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.

Not all pack sizes may be marketed.

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Manufacturer
Remedica Ltd, Aharnon Street, Limassol Industrial Estate,
Limassol, 3056 Cyprus

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:
o deep, rapid breathing
o drowsiness
o 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

Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom

This leaflet was last revised in 12/2016.

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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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