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TENOFOVIR DISOPROXIL 245 MG FILM-COATED TABLETS

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

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Cutter guidelines for
Tenofovir 245 mg
Leaflet

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Package leaflet: Information for the user

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 tablet is and what it is used for
2. What you need to know before you take Tenofovir disoproxil tablets
3. How to take Tenofovir disoproxil tablets
4. Possible side effects
5. How to store Tenofovir disoproxil tablets
6. Contents of the pack and other information
If Tenofovir disoproxil tablets 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 tablet is and what it is
used for
Tenofovir disoproxil tablets 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 tablets
should always be used combined with other medicines to treat HIV
infection.
Tenofovir disoproxil 245 mg film-coated 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 film-coated 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 tablets
for HBV.
This medicine is not a cure for HIV infection. While taking Tenofovir
disoproxil tablets 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 tablets
Do not take Tenofovir disoproxil tablets:
- if you are allergic to active substance 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 tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenofovir disoproxil tablets.
• 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 tablets 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
tablets 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 tablets 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 tablet is not usually taken with other medicines that
can damage your kidneys (see Other medicines and Tenofovir disoproxil
tablets). 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

Leaflet Size: 220 x 440 mm

treatment with Tenofovir disoproxil tablets 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 tablets. 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 tablets has not been studied in patients over 65 years of age.
If you are older than this and are prescribed Tenofovir disoproxil tablets,
your doctor will monitor you carefully.
Children and adolescents
Tenofovir disoproxil 245 mg film-coated 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 film-coated 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 tablets.
Other medicines and Tenofovir disoproxil tablets
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 tablets if you have both HBV and HIV.
• Do not take Tenofovir disoproxil tablets if you are already taking other
medicines containing tenofovir disoproxil. Do not take Tenofovir
disoproxil tablets 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 tablets 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 tablets with food and drink
Take Tenofovir disoproxil tablets 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 tablets during pregnancy
unless specifically discussed with your doctor. Although there are limited
clinical data on the use of Tenofovir disoproxil tablets in pregnant
women, it is not usually used unless absolutely necessary.
• Try to avoid getting pregnant during treatment with Tenofovir disoproxil
tablets. 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 tablets 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 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
tablets. 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 tablets can cause dizziness. If you feel dizzy while
taking Tenofovir disoproxil tablets, do not drive or ride a bicycle and do not
use any tools or machines.
Tenofovir disoproxil tablets contains lactose
Tell your doctor before taking Tenofovir disoproxil tablets if you cannot
tolerate lactose or if you have an intolerance to any other sugars.

3. How to take Tenofovir disoproxil tablets
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.

PHARMA CODE

PHARMA CODE

tenofovir disoproxil

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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).

Tests may also show:
• decreases in potassium in the blood
• increased creatinine in your blood
• pancreas problems.

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.

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.

Refer to the patient information leaflets of the other antiretrovirals for
guidance on how to take those medicines.
If you take more Tenofovir disoproxil tablets 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 or blister with
you so that you can easily describe what you have taken.
If you forget to take Tenofovir disoproxil tablets
It is important not to miss a dose of Tenofovir disoproxil tablets. 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
tablets, take another tablet. You do not need to take another tablet if you
were sick more than 1 hour after taking Tenofovir disoproxil tablets.
If you stop taking Tenofovir disoproxil tablets
Don’t stop taking Tenofovir disoproxil tablets without your doctor’s advice.
Stopping treatment with Tenofovir disoproxil tablets 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 tablets 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 tablets. 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 tablets 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:
• deep, rapid breathing
• drowsiness
• feeling sick (nausea), being sick (vomiting) and stomach pain.

PHARMA CODE

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.
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.

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
For UK
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
For Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie.
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Tenofovir disoproxil tablets
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 after {EXP}. The expiry date refers to the last day of that month.
This medicine 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 tablets contains
- The active substance is tenofovir. Each Tenofovir disoproxil tablet
contains 245 mg of tenofovir disoproxil.
- The other ingredients are cellulose microcrystalline (E460), lactose
monohydrate, maize starch pregelatinised, crospovidone type B (E1202)
and magnesium stearate (E470b) which make up the tablet core, and
hypromellose (E464), titanium dioxide (E171), macrogol 400 and
polysorbate 80 (E433) which make up the tablet coating. Refer to section
2 “Tenofovir disoproxil tablets contains lactose”.
What Tenofovir disoproxil tablets looks like and contents of the pack
Tenofovir disoproxil 245 mg film-coated tablets are white coloured,
almond-shaped, biconvex film-coated tablets debossed with “H” on one
side and “T11” on the other side.
Tenofovir disoproxil 245 mg film-coated tablets are supplied in
Aluminium/PVC/Aluminium/OPA unit-dose blister packs containing 30x1
film-coated tablets.
Tenofovir disoproxil 245 mg film-coated tablets are also supplied in bottles
containing 30 tablets. Each bottle contains a silica gel desiccant and
purified rayon that must be kept in the bottle to help protect your tablets.
The silica gel desiccant should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder :
Accord Healthcare Limited
Sage house, 319 Pinner road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer :
Pharmadox HeaIthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
This medicinal product is authorised in the Member States of the
EEA under the following names:
Austria
Denmark
Finland

Tenofovir disoproxil Accord 245 mg Filmtabletten
Tenofovir disoproxil Accord
Tenofovir disoproxil Accord 245 mg kalvopäällysteiset
tabletit
Ireland
Tenofovir disoproxil 245 mg film coated tablets
Italy
Tenofovir disoproxil Accord
The Netherlands Tenofovir disoproxil Accord 245 mg filmomhulde tabletten
Poland
Tenofovir disoproxil Accord
Romania
Tenofovir disoproxil Accord 245 mg comprimate filmate
Sweden
Tenofovir disoproxil Accord 245 mg filmdragerad tablet
United Kingdom Tenofovir disoproxil 245 mg film-coated tablets
Spain
Tenofovir disoproxil Accord 245 mg comprimidos
recubiertos con película EFG
This leaflet was last revised in 03/2017.

PHARMA CODE

• 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 tablets less frequently.
• If you have HBV your doctor may offer you an HIV test to see if you have
both HBV and HIV.

Expand Transcript

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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