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EMTRICITABINE/TENOFOVIR DISOPROXIL KLINGE 200 MG/245 MG FILM-COATED TABLETS

Active substance(s): EMTRICITABINE / TENOFOVIR DISOPROXIL PHOSPHATE

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PACKAGE LEAFLET

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Package leaflet: Information for the user
Emtricitabine/Tenofovir disoproxil Klinge 200 mg/245 mg Film-coated Tablets
Emtricitabine
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 Emtricitabine/Tenofovir disoproxil Klinge is and what it is used for
2.
What you need to know before you take Emtricitabine/Tenofovir disoproxil Klinge
3.
How to take Emtricitabine/Tenofovir disoproxil Klinge
4.
Possible side effects
5.
How to store Emtricitabine/Tenofovir disoproxil Klinge
6.
Contents of the pack and other information

1.

What Emtricitabine/Tenofovir disoproxil Klinge is and what it is used for

This medicine is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 18 years
and over.
Emtricitabine/Tenofovir disoproxil Klinge contains two active substances, emtricitabine and tenofovir
disoproxil. Both of these active substances are antiretroviral medicines which are used to treat HIV
infection. Emtricitabine is a nucleoside reverse transcriptase inhibitor and tenofovir is a nucleotide reverse
transcriptase inhibitor. However, both are generally known as NRTIs and they work by interfering with the
normal working of an enzyme (reverse transcriptase) that is essential for the virus to reproduce itself.
 Emtricitabine/Tenofovir disoproxil Klinge is used to treat Human Immunodeficiency Virus
(HIV-1) infection, in adults aged 18 years and over.
o Emtricitabine/Tenofovir disoproxil Klinge should always be used combined with other
medicines to treat HIV infection.
o Emtricitabine/Tenofovir disoproxil Klinge can be administered in place of emtricitabine
and tenofovir disoproxil used separately at the same doses.
People who are HIV positive can still pass on HIV when taking this medicine, although this risk is
lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid
infecting other people.
This medicine is not a cure for HIV infection. While taking Emtricitabine/Tenofovir disoproxil Klinge
you may still develop infections or other illnesses associated with HIV infection.
 Emtricitabine/Tenofovir disoproxil Klinge is also used to reduce the risk of getting HIV-1
infection, when used as a daily treatment, together with safer sex practices.
See section 2 for a list of precautions to take against HIV infection.
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2.

What you need to know before you take Emtricitabine/Tenofovir disoproxil Klinge

Do not take Emtricitabine/Tenofovir disoproxil Klinge to treat HIV or to reduce the risk of getting
HIV if you are allergic to emtricitabine, 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.
Before taking Emtricitabine/Tenofovir disoproxil Klinge to reduce the risk of getting HIV:
Emtricitabine/Tenofovir disoproxil Klinge can only help reduce your risk of getting HIV before you are
infected.
 You must be HIV negative before you start to take Emtricitabine/Tenofovir disoproxil Klinge to
reduce the risk of getting HIV. You must get tested to make sure that you do not already have HIV
infection. Do not take Emtricitabine/Tenofovir disoproxil Klinge to reduce your risk unless you are
confirmed to be HIV negative. People who do have HIV must take Emtricitabine/Tenofovir
disoproxil Klinge in combination with other drugs.
 Many HIV tests can miss a recent infection. If you get a flu-like illness, it could mean you have
recently been infected with HIV.
These may be signs of HIV infection:
 tiredness
 fever
 joint or muscle aches
 headache
 vomiting or diarrhoea
 rash
 night sweats
 enlarged lymph nodes in the neck or groin
Tell your doctor about any flu-like illness – either in the month before starting
Emtricitabine/Tenofovir disoproxil Klinge, or at any time while taking Emtricitabine/Tenofovir
disoproxil Klinge.
Warnings and precautions
While taking Emtricitabine/Tenofovir disoproxil Klinge to reduce the risk of getting HIV:
 Take Emtricitabine/Tenofovir disoproxil Klinge every day to reduce your risk, not just when you
think you have been at risk of HIV infection. Do not miss any doses of Emtricitabine/Tenofovir
disoproxil Klinge, or stop taking it. Missing doses may increase your risk of getting HIV infection.
 Get tested for HIV regularly.
 If you think you were infected with HIV, tell your doctor straight away. They may want to do more
tests to make sure you are still HIV negative.
 Just taking Emtricitabine/Tenofovir disoproxil Klinge may not stop you getting HIV.
o Always practice safer sex. Use condoms to reduce contact with semen, vaginal fluids, or
blood.
o Do not share personal items that can have blood or body fluids on them, such as
toothbrushes and razor blades.
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o
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Do not share or re-use needles or other injection or drug equipment.
Get tested for other sexually transmitted infections such as syphilis and gonorrhoea. These
infections make it easier for HIV to infect you.

Ask your doctor if you have any more questions about how to prevent getting HIV or spreading HIV
to other people.
While taking Emtricitabine/Tenofovir disoproxil Klinge to treat HIV or to reduce the risk of getting
HIV:
 Emtricitabine/Tenofovir disoproxil Klinge may affect your kidneys. Before and during treatment,
your doctor may order blood tests to measure kidney function. Tell your doctor if you have had
kidney disease, or if tests have shown kidney problems. If you have kidney problems, your doctor may
advise you to stop taking Emtricitabine/Tenofovir disoproxil Klinge or, if you already have HIV, to
take Emtricitabine/Tenofovir disoproxil Klinge less frequently. Emtricitabine/Tenofovir disoproxil
Klinge is not recommended if you have severe kidney disease or are on dialysis.
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 infected
with HIV who also have 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 or C, your doctor will carefully consider the best treatment regimen for you.
 Know your hepatitis B virus (HBV) infection status before starting Emtricitabine/Tenofovir
disoproxil Klinge. If you have HBV, there is a serious risk of liver problems when you stop taking
Emtricitabine/Tenofovir disoproxil Klinge, whether or not you also have HIV. It is important not to
stop taking Emtricitabine/Tenofovir disoproxil Klinge without talking to your doctor: see section 3,
Do not stop taking Emtricitabine/Tenofovir disoproxil Klinge.
 Talk to your doctor if you are over 65. Emtricitabine and tenofovir disoproxil has not been studied
in patients over 65 years of age.
 Talk to your doctor if you are intolerant to lactose (see Emtricitabine/Tenofovir disoproxil Klinge
contains lactose later in this section).
Children and adolescents
Emtricitabine/Tenofovir disoproxil Klinge is not for use in children and adolescents under 18 years of age.
Other medicines and Emtricitabine/Tenofovir disoproxil Klinge
Do not take Emtricitabine/Tenofovir disoproxil Klinge if you are already taking other medicines that
contain the components of Emtricitabine/Tenofovir disoproxil Klinge (emtricitabine and tenofovir
disoproxil) or any other antiviral medicines that contain tenofovir alafenamide, lamivudine or adefovir
dipivoxil.
Taking Emtricitabine/Tenofovir disoproxil Klinge with other medicines that can damage your
kidneys: it is especially important to tell your doctor if you are taking any of these medicines, including:
 aminoglycosides (for bacterial infection)
 amphotericin B (for fungal infection)
 foscarnet (for viral infection)
 ganciclovir (for viral infection)
 pentamidine (for infections)
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 vancomycin (for bacterial infection)
 interleukin-2 (to treat cancer)
 cidofovir (for viral infection)
 non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pains)
If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your doctor may order
blood tests to closely monitor your kidney function.
It is also important to tell your doctor if you are taking ledipasvir/sofosbuvir to treat hepatitis C infection.
Taking Emtricitabine/Tenofovir disoproxil Klinge with other medicines containing didanosine (for
treatment of HIV infection): Taking emtricitabine and 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
causes 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.
Tell your doctor if you are taking any of these medicines. Tell your doctor or pharmacist if you are
taking, have recently taken or might take any other medicines.
Emtricitabine/Tenofovir disoproxil Klinge with food and drink
 Whenever possible, Emtricitabine/Tenofovir disoproxil Klinge should be taken with food.
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.
 Although there are limited clinical data on the use of emtricitabine and tenofovir disoproxil in
pregnant women, it is not usually used unless absolutely necessary.
 If you are a woman who could get pregnant during treatment with emtricitabine and 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 therapy with emtricitabine and tenofovir disoproxil to you and your child.
If you have taken Emtricitabine/Tenofovir disoproxil 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 NRTIs during pregnancy, the benefit from the protection against HIV outweighed the
risk of side effects.
 Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Klinge. This is
because the active substances in this medicine pass into human breast milk.
 If you are a woman with HIV it is recommended that you do not breast-feed, to avoid passing the
virus to the baby in breast milk.
Driving and using machines
Emtricitabine and tenofovir disoproxil can cause dizziness. If you feel dizzy while taking this medicine, do
not drive and do not use any tools or machines.
Emtriciabine/Tenofovir disproxil Klinge contains lactose
Tell your doctor if you are lactose-intolerant or intolerant to other sugars.
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Emtricitabine/Tenofovir disoproxil Klinge contains phosphate
Tell your doctor if you cannot take phosphates or if you are on a reduced phosphate diet.

3.

How to take Emtricitabine/Tenofovir disoproxil Klinge
 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 of Emtricitabine/Tenofovir disoproxil Klinge to treat HIV or to reduce the
risk of getting HIV is:
 Adults: one tablet each day. Whenever possible, Emtricitabine/Tenofovir disoproxil Klinge should be
taken with food.
If you have 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 being treated for HIV infection your doctor will prescribe Emtricitabine/Tenofovir
disoproxil Klinge with other antiretroviral medicines. Please refer to the patient information leaflets
of the other antiretrovirals for guidance on how to take those medicines.
 If you are taking Emtricitabine/Tenofovir disoproxil Klinge to reduce the risk of getting HIV,
take Emtricitabine/Tenofovir disoproxil Klinge every day, not just when you think you have been at
risk of HIV infection.
Ask your doctor if you have any questions about how to prevent getting HIV or prevent spreading HIV to
other people.
If you take more Emtricitabine/Tenofovir disoproxil Klinge than you should
If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir disoproxil Klinge,
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 miss a dose
It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Klinge.

 If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil
Klinge, take the tablet preferably with food as soon as possible. Then take the next dose at your usual
time.
 If you notice 12 hours or more after the time you usually take Emtricitabine/Tenofovir disoproxil
Klinge, forget about the missed dose. Wait and take the next dose, preferably with food, at your usual
time.
If you vomit less than 1 hour after taking Emtricitabine/Tenofovir disoproxil Klinge, take another
tablet. You do not need to take another tablet if you were sick more than 1 hour after taking
Emtricitabine/Tenofovir disoproxil Klinge.
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Do not stop taking Emtricitabine/Tenofovir disoproxil Klinge
 If you take Emtricitabine/Tenofovir disoproxil Klinge for treatment of HIV infection, stopping
tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
 If you are taking Emtricitabine/Tenofovir disoproxil Klinge to reduce the risk of getting HIV,
do not stop taking Emtricitabine/Tenofovir disoproxil Klinge or miss any doses. Stopping use of
Emtricitabine/Tenofovir disoproxil Klinge, or missing doses, may increase your risk of getting HIV
infection
Do not stop taking Emtricitabine/Tenofovir disoproxil Klinge without contacting your doctor.
 If you have hepatitis B, it is especially important not to stop your Emtricitabine/Tenofovir disoproxil
Klinge treatment without talking to your doctor first. 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, which may be life-threatening.
Tell your doctor immediately about new or unusual symptoms after you stop treatment,
particularly symptoms you associate with hepatitis B infection.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

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


Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect.
Lactic acidosis occurs more often in women, particularly if they are overweight, and in people with
liver disease. The following may be signs of lactic acidosis:
o deep rapid breathing
o drowsiness
o feeling sick (nausea), being sick (vomiting)
o stomach pain
If you think you may have lactic acidosis, get medical help immediately.



Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a
history of opportunistic infections (infections that occur in people with a weak immune system), signs
and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is
started. It is thought that these symptoms are due to an improvement in the body’s immune response,
enabling the body to fight infections that may have been present with no obvious symptoms.
 Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after
you start taking medicines to treat HIV infection. Autoimmune disorders may occur many months
after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
o muscle weakness
o weakness beginning in the hands and feet and moving up towards the trunk of the body
o palpitations, tremor or hyperactivity
If you notice these or any symptoms of inflammation or infection, get medical help
immediately.
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Possible side effects:
Very common side effects
(may affect more than 1 in 10 people)
o diarrhoea, being sick (vomiting), feeling sick (nausea)
o dizziness, headache
o rash
o feeling weak
Tests may also show:
o decreases in phosphate in the blood
o increased creatine kinase
Common side effects
(may affect up to 1 in 10 people)
o pain, stomach pain
o difficulty sleeping, abnormal dreams
o problems with digestion resulting in discomfort after meals, feeling bloated, flatulence
o rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may
be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
o other allergic reactions, such as wheezing, swelling or feeling light-headed
Tests may also show:
o low white blood cell count (a reduced white blood cell count can make you more prone to infection)
o increased triglycerides (fatty acids), bile or sugar in the blood
o liver and pancreas problems
Uncommon side effects
(may affect up to 1 in 100 people)
o pain in the abdomen (tummy) caused by inflammation of the pancreas
o swelling of the face, lips, tongue or throat
o anaemia (low red blood cell count)
o breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule
cells
Tests may also show:
o decreases in potassium in the blood
o increased creatinine in your blood
o changes to your urine
Rare side effects
(may affect up to 1 in 1,000 people)
o Lactic acidosis (see Possible serious side effects)
o fatty liver
o yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver
o inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney
tubule cells
o softening of the bones (with bone pain and sometimes resulting in fractures)
o back pain caused by kidney problems
Damage to kidney tubule cells may be associated with 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.
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If you notice any of the side effects listed above or if any of the side effects get serious, talk to your
doctor or pharmacist.
The frequency of the following side effects is not known.
o Bone problems. Some patients taking combination antiretroviral medicines such as
Emtricitabine/Tenofovir disoproxil Klinge may develop a bone disease called osteonecrosis (death of
bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time,
taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight,
may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
o joint stiffness
o joint aches and pains (especially of the hip, knee and shoulder)
o difficulty with movement
If you notice any of these symptoms tell your doctor.
During treatment for HIV 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.
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 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 Emtricitabine/Tenofovir disoproxil Klinge

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 label and carton 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 Emtricitabine/Tenofovir disoproxil Klinge contains
The active substances are emtricitabine and tenofovir disoproxil (as phosphate).
Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to
291 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).
The other ingredients are microcrystalline cellulose (E460), mannitol (E421), croscarmellose sodium, silica,
hydrophobic colloidal, stearic acid (E570), lactose monohydrate, hypromellose (E464), titanium dioxide
(E171),triacetin (E1518) and indigo carmoine aluminium lake (E132).
What Emtricitabine/Tenofovir disoproxil Klinge looks like and contents of the pack
Emtricitabine/Tenofovir disoproxil Klinge are blue coloured, oval shaped, biconvex, 18.6 mm x 9.5 mm
film-coated tablets plain on both sides.
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Emtricitabine/Tenofovir disoproxil Klinge is supplied in white plastic bottles. Each bottle contains one (in
30’s pack) or three (in 100’s pack) silica gel dessicant sachets depending on the pack size.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
Klinge Pharma GmbH
Arzbacher Str. 78
D-56130 Bad Ems
Germany]
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:
UK: Emtricitabine / Tenofovie 200mg / 245 mg Klinge film-coated tablets
DE: Emtricitabine / Tenofovir 200mg / 245 mg Klinge Filmtabletten
This leaflet was last revised in 04/2017

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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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