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TENOFOVIR DISOPROXIL LUPIN 245 MG FILM COATED TABLETS

Active substance(s): TENOFOVIR DISOPROXIL FUMARATE

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Package leaflet: Information for the patient

Tenofovir disoproxil Lupin 245 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 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 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
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

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.

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 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.

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 your child takes Tenofovir disoproxil
Do not take Tenofovir disoproxil
·
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 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.

Pharmacode Direction

·
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.

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.

You do not have to have HIV to be treated with tenofovir disoproxil for HBV.

3504

·
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.

Tenofovir disoproxil 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 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.

Tenofovir disoproxil Lupin
245 mg film-coated tablets

Bone problems (sometimes resulting in fractures) may also occur due to damage to
kidney tubule cells (see section 4, Possible side effects).

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:
·
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 fumarate 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 your child is 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 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 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 this medicine 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
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:
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 effect is 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 national reporting
system listed in 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 carton and bottle after EXP.
The expiry date refers to the last day of that month.
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 contains
- The active substance is tenofovir. Each tablet contains 245 mg of tenofovir disoproxil (as
fumarate).
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium
stearate, lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin and
indigo carmine aluminium lake (E132).
What Tenofovir disoproxil looks like and contents of the pack
Tenofovir disoproxil 245 mg tablets are blue, oval, biconvex, film-coated tablets debossed with
“300” on one side and plain on the other side.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets
and 3 bottles of 30 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court, Bexton Road
Knutsford, Cheshire, WA16 0PF
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom: Tenofovir disoproxil Lupin 245 mg Film-coated Tablets
Germany: Tenofovirdisoproxil-Hormosan 245 mg Filmtabletten
This leaflet was last revised in June 2017
Code No.: GO/DRUGS/654

ID#: 246733

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