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TENOFOVIR DISOPROXIL LUPIN 163 MG FILM COATED TABLETS

Active substance(s): TENOFOVIR DISOPROXIL FUMARATE

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Package leaflet: Information for the patient

Tenofovir disoproxil Lupin 163 mg 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 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

1. What Tenofovir disoproxil is and what it is used for
Tenofovir disoproxil contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral
medicine which is used to treat HIV infection. Tenofovir is a nucleotide reverse transcriptase inhibitor, generally known as an
NRTI and works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the virus to
reproduce itself. Tenofovir disoproxil should always be used combined with other medicines to treat HIV infection.
Tenofovir disoproxil 163 mg tablets are a treatment for HIV (Human Immunodeficiency Virus) infection.
Tenofovir disoproxil 163 mg tablets are for use in children. They are only suitable for:
Ÿ children aged 6 to less than 12 years
Ÿ who weigh from 22 kg to less than 28 kg
Ÿ 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 Lupin
163 mg film-coated tablets

This medicine is not a cure for HIV infection. While taking tenofovir disoproxil your child may still develop infections or other
illnesses associated with HIV infection. Your child can also pass on HIV 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 give Tenofovir disoproxil
Ÿ If your child is allergic to tenofovir, tenofovir disoproxil fumarate or any of the other ingredients of this medicine listed in
section 6.
If this applies to your child, tell their doctor immediately and don't give Tenofovir disoproxil.
Warnings and precautions
Ÿ Tenofovir disoproxil 163 mg tablets are only suitable for children 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.
Ÿ Check your child's age and weight to see if these tablets are suitable, see Children and adolescents.
Talk to your child's doctor or pharmacist before giving Tenofovir disoproxil.

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Ÿ Take care not to infect other people. Your child can still pass on HIV when taking this medicine, although the risk is
lowered by effective antiretroviral therapy. Discuss with your child's doctor the precautions needed to avoid infecting
other people.
Ÿ Talk to your child's doctor or pharmacist if your child has had kidney disease or if tests have shown problems with their
kidneys. Tenofovir disoproxil should not be given to children with existing kidney problems. Tenofovir disoproxil may
affect your child's kidneys during treatment. Before starting treatment, your child's doctor may order blood tests to
assess your child's kidney function. Your child's doctor may also order blood tests during treatment to monitor how
your child's kidneys work.
Tenofovir disoproxil is not usually taken with other medicines that can damage your child's kidneys (see Other
medicines and Tenofovir disoproxil). If this is unavoidable, your child's doctor will monitor your child's kidney function
once a week.
Ÿ 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 child's doctor.
Bone problems (sometimes resulting in fractures) may also occur due to damage to kidney tubule cells (see section 4,
Possible side effects).
Ÿ Talk to your child's doctor if your child has 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 your child has hepatitis B infection, your child's doctor will carefully consider the best treatment

for them. If your child has a history of liver disease or chronic hepatitis B infection your child's doctor may conduct
blood tests to monitor their liver function.
Ÿ Look out for infections. If your child has advanced HIV infection (AIDS) and has an infection, they 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 child's body's improved immune system is
fighting infection. Look out for signs of inflammation or infection soon after your child starts taking tenofovir disoproxil.
If you notice signs of inflammation or infection, tell your child's 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 your child starts taking medicines for the treatment of their HIV
infection. Autoimmune disorders may occur many months after the start of treatment. If you notice that your child has
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 child's doctor
immediately to seek necessary treatment.
Children and adolescents
Tenofovir disoproxil 163 mg tablets are only suitable for:
Ÿ children aged 6 to less than 12 years
Ÿ who weigh from 22 kg to less than 28 kg
Ÿ 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 163 mg tablets are not suitable for the following groups:
Ÿ Not for children who weigh under 22 kg or 28 kg and over. Contact your child's doctor if your child is outside the
permitted weight.
Ÿ Not for children and adolescents under 6 years or 12 years and over.
Ÿ Not for HBV (Hepatitis B virus) infected children and adolescents of any age.
For dosage see section 3, How to take Tenofovir disoproxil.
Other medicines and Tenofovir disoproxil
Tell your child's doctor or pharmacist if they are taking, have recently taken or might take any other medicines.
Ÿ Do not give Tenofovir disoproxil if your child is already taking other medicines containing tenofovir disoproxil or
tenofovir alafenamide. Do not give Tenofovir disoproxil together with medicines containing adefovir dipivoxil (a
medicine used to treat chronic hepatitis B).
Ÿ It is very important to tell your child's doctor if your child is taking other medicines that may damage their kidneys.
These include:
Ÿ aminoglycosides, pentamidine or vancomycin (for bacterial infection),
Ÿ amphotericin B (for fungal infection),
Ÿ foscarnet, ganciclovir, or cidofovir (for viral infection),
Ÿ interleukin-2 (to treat cancer),
Ÿ adefovir dipivoxil (for HBV),
Ÿ tacrolimus (for suppression of the immune system),
Ÿ non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains).
Ÿ Other medicines containing didanosine (for HIV infection): Taking tenofovir disoproxil with other antiviral medicines
that contain didanosine can raise the levels of didanosine in the 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
child's doctor will carefully consider whether to treat your child with combinations of tenofovir and didanosine.
Ÿ 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
Give Tenofovir disoproxil with food (for example, a meal or a snack).
Pregnancy and breast-feeding
If your child is pregnant or breast-feeding, or they think they may be pregnant, ask your child's doctor or pharmacist for advice
before they take this medicine.
Ÿ Your child must not take Tenofovir disoproxil during pregnancy unless specifically discussed with your child's doctor.
Although there are limited clinical data on the use of tenofovir disoproxil in pregnant women, it is not usually used
unless absolutely necessary.
Ÿ Your child should try to avoid getting pregnant during treatment with Tenofovir disoproxil. Your child must use an
effective method of contraception to avoid becoming pregnant if they are sexually active.
Ÿ If your child becomes pregnant, ask your child's doctor about the potential benefits and risks of the antiretroviral
therapy to your child and your child's baby.
Ÿ If your child has taken Tenofovir disoproxil during their pregnancy, your child's doctor may request regular blood tests
and other diagnostic tests to monitor the development of the baby. 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.
Ÿ Your child must not breast-feed during treatment with Tenofovir disoproxil. This is because the active substance in this
medicine passes into human breast milk.
Ÿ Your child must not breast-feed, to avoid passing the virus to the baby in breast milk.
Driving and using machines
Tenofovir disoproxil can cause dizziness. If your child feels dizzy while taking Tenofovir disoproxil, they must not drive or ride a
bicycle and must not use any tools or machines.
Tenofovir disoproxil contains lactose
Tell your child's doctor before giving Tenofovir disoproxil if your child cannot tolerate lactose or if they have an intolerance to any
other sugars.

3. How to take Tenofovir disoproxil
Your child must always take this medicine exactly as their doctor or pharmacist has told you. Check with your child's doctor or
pharmacist if you are not sure.

The recommended dose is:
Ÿ Children aged 6 to less than 12 years who weigh from 22 kg to less than 28 kg:
1 tablet each day with food (for example, a meal or a snack).
Your child's doctor will monitor their weight.
Your child must always take the dose recommended by their doctor. This is to make sure that their medicine is fully effective, and
to reduce the risk of developing resistance to the treatment. Do not change the dose unless your child's doctor tells you to.
Your child's doctor will prescribe tenofovir disoproxil with other antiretroviral medicines.

Tests may also show:
Ÿ liver problems
The following side effects are uncommon (these can affect up to 1 in every 100 patients):
Ÿ breakdown of muscle, muscle pain or weakness
Tests may also show:
Ÿ decreases in potassium in the blood
Ÿ increased creatinine in your child's blood
Ÿ pancreas problems

Refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
If your child takes more Tenofovir disoproxil than they should
If your child accidentally takes too many tablets, they may be at increased risk of experiencing possible side effects with this
medicine (see section 4, Possible side effects). Contact your child's doctor or nearest emergency department for advice. Keep
the tablet bottle with you so that you can easily describe what your child has taken.
If your child forgets to take Tenofovir disoproxil
It is important not to miss a dose of Tenofovir disoproxil. If your child misses a dose, work out how long since they should have
taken it.
Ÿ If it is less than 12 hours after it is usually taken, they should take it as soon as they can, and then take their next dose at
its regular time.
Ÿ If it is more than 12 hours since your child should have taken it, forget about the missed dose. Wait and give the next
dose at the regular time. Do not give a double dose to make up for a forgotten tablet.

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):
Ÿ pain in the tummy (abdomen) caused by inflammation of the liver
Ÿ swelling of the face, lips, tongue or throat
Combination antiretroviral therapy may also cause increased fats in the blood (hyperlipaemia) and resistance to insulin. Your
child's doctor will test for these changes.
Reporting of side effects
If your child gets any side effects, talk to your child's 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.

If your child throws up less than 1 hour after taking Tenofovir disoproxil, give your child another tablet. Your child does not
need to take another tablet if they were sick more than 1 hour after taking Tenofovir disoproxil.
If your child stops taking Tenofovir disoproxil
Your child must not stop taking this medicine without their doctor's advice. Stopping treatment with tenofovir disoproxil may
reduce the effectiveness of the treatment recommended by your child's doctor.
If your child has HIV and hepatitis B it is very important not to stop their tenofovir disoproxil treatment without talking to your
child's doctor first. Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping
tenofovir disoproxil. Your child 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 child's
hepatitis.
Ÿ Talk to your child's doctor before your child stops taking Tenofovir disoproxil for any reason, particularly if your child is
experiencing any side effects or they have another illness.
Ÿ Tell your child's doctor immediately about new or unusual symptoms after your child stops treatment, particularly
symptoms you associate with hepatitis B infection.
Ÿ Contact your child's doctor before your child restarts taking Tenofovir disoproxil tablets.
If you have any further questions on the use of this medicine, ask your child's 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 child's 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 child's doctor immediately
Ÿ 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 your child may have lactic acidosis, contact your child's doctor immediately.
Other possible serious side effects
The following side effect is uncommon (this can affect up to 1 in every 100 patients):
Ÿ pain in the tummy (abdomen) caused by inflammation of the pancreas
Ÿ damage to kidney tubule cells
The following side effects are rare (these can affect up to 1 in every 1,000 patients):
Ÿ inflammation of the kidney, passing a lot of urine and feeling thirsty
Ÿ changes to your child's urine and back pain caused by kidney problems, including kidney failure
Ÿ softening of the bones (with bone pain and sometimes resulting in fractures), which may occur due to damage to kidney
tubule cells
Ÿ fatty liver
If you think that your child may have any of these serious side effects, talk to your child's doctor.
Most frequent side effects
The following side effects are very common (these can affect at least 10 in every 100 patients):
Ÿ diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, rash, feeling weak
Tests may also show:
Ÿ 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):
Ÿ flatulence

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 163 mg of tenofovir disoproxil (as fumarate).
- The other ingredients are microcrystalline cellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate,
hypromellose (E464), titanium dioxide (E171), triacetin.
What Tenofovir disoproxil looks like and contents of the pack
Tenofovir disoproxil 163 mg tablets are white to off-white, round, biconvex, film-coated tablets debossed with “200” 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 163 mg Film-coated Tablets
This leaflet was last revised in June 2017
Code No.: GO/DRUGS/654

ID#: 247371

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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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