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TENOFOVIR DISOPROXIL KLINGE 245 MG FILM-COATED TABLETS

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

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Package leaflet: Information for the patient
Tenofovir disoproxil Klinge245 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 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 Klinge 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 Klinge 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 Klinge is and what it is used for

Tenofovir Klinge 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 Klinge 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 Klinge 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
1

Do not take Tenofovir disoproxil
• If you are allergic to tenofovir, tenofovir disoproxil phosphate 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 Klinge 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 Klinge 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
2

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 Klinge 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 Klinge 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
Klinge if you have both HBV and HIV.
-

Do not take Tenofovir Klinge if you are already taking other medicines containing tenofovir
disoproxil or tenofovir alafenamide. Do not take Tenofovir Klinge 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.

3

-

It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir to
treat hepatitis C infection.

Tenofovir Klinge with food and drink
Take Tenofovir Klingewith 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 Klinge 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 Klinge 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 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 Klinge contains lactose
Tell your doctor before taking Tenofovir Klingeif you cannot tolerate lactose or if you have an
intolerance to any other sugars.
Tenofovir Klinge contains phosphate
Tell your doctor if you cannot take phosphates or if you are on a reduced phosphate diet.
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).
4

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 Klinge 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 Klinge 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 Klingefor 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.
5

-

Contact your doctor before you restart taking Tenofovir Klinge 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
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
6

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 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 bottle and carton after EXP. The
expiry date refers to the last day of that month.
Store below 25 oC
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 Klingecontains
The active substance is tenofovir. Each Tenofovir Klinge tablet contains 245 mg of tenofovir
disoproxil (as phosphate).
The other ingredients are microcrystalline cellulose, croscarmellose sodium, stearic acid,
lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin and indigo
carmine aluminium lake (E132).
What Tenofovir Klinge looks like and contents of the pack
Tenofovir Klinge tablets are blue, oval, biconvex, film-coated tablets debossed with “T1” on one side
and plain on the other side.

7

Tenofovir Klinge is supplied in white plastic bottles. Each bottle contains two silica gel dessicant
sachets. The sachets must be kept in the bottle to help protect your tablets and should not be
swallowed.
The following pack sizes are available:
30 film-coated tablets
90 (3 packs of 30) film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Klinge Pharma GmbH
Arzbacher Str. 78
56130 Bad Ems
Germany
This leaflet was last revised in March 2017.

8

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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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