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

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

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Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Emtricitabine-Tenofovir-200-245 mg

Market

UK-IE

Language

English

Size

500 x 400 mm (PIL)

Min. Font Size

9

Version No.

1 (Page 1 of 2)

Date

28.03.17 (Emtricitabine-Tenofovir-200-245 mg (ACC-UK-IE) PIL)

Prepared By
Regulatory Affairs

Package leaflet: Information for the user

Emtricitabine/Tenofovir disoproxil 200
mg/245 mg film-coated tablets
Emtricitabine/tenofovir disoproxil

Keyline
Checked By
Regulatory Affairs

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

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 or nurse.
- 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 or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.

Tell your doctor about any flu-like illness – either in the month before starting
Emtricitabine/Tenofovir disoproxil tablets, or at any time while taking
Emtricitabine/Tenofovir disoproxil tablets.

What is in this leaflet

• Take Emtricitabine/Tenofovir disoproxil tablets 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 tablets, or stop taking it. Missing doses may
increase your risk of getting HIV infection.

1. What Emtricitabine/Tenofovir disoproxil tablets is and what it is used for
2. What you need to know before you take Emtricitabine/Tenofovir disoproxil tablets
3. How to take Emtricitabine/Tenofovir disoproxil tablets
4. Possible side effects
5. How to store Emtricitabine/Tenofovir disoproxil tablets
6. Contents of the pack and other information

1. What Emtricitabine/Tenofovir disoproxil tablets is and
what it is used for
Emtricitabine/Tenofovir disoproxil tablets 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 tablets is used to treat Human Immunodeficiency
Virus 1 (HIV-1) infection, in adults aged 18 years and over.
• Emtricitabine/Tenofovir disoproxil tablets should always be used combined with
other medicines to treat HIV infection.
• Emtricitabine/Tenofovir disoproxil tablets 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 the 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 tablets you may still develop infections or other illnesses associated with
HIV infection.
• Emtricitabine/Tenofovir disoproxil tablets 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.

2. What you need to know before you take
Emtricitabine/Tenofovir disoproxil tablets
Do not take Emtricitabine/Tenofovir disoproxil tablets to treat HIV or to reduce
the risk of getting HIV
• If you are allergic (hypersensitive) to emtricitabine, tenofovir, tenofovir disoproxil 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 tablets to reduce the risk of
getting HIV:
Emtricitabine/Tenofovir disoproxil tablets 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
tablets 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
tablets to reduce your risk unless you are confirmed to be HIV negative. People
who do have HIV must take Emtricitabine/Tenofovir disoproxil tablets 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.

Warnings and precautions
While taking Emtricitabine/Tenofovir disoproxil tablets to reduce the risk of
getting HIV:

Approved By
Quality Assurance

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)
• 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.

• Get tested for HIV regularly.

Taking Emtricitabine/Tenofovir disoproxil tablets with other medicines containing
didanosine (for treatment of HIV infection): Taking Emtricitabine/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
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.

• 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.

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.

• Just taking Emtricitabine/Tenofovir disoproxil tablets may not stop you getting HIV.
• Always practice safer sex. Use condoms to reduce contact with semen, vaginal
fluids, or blood.
• Do not share personal items that can have blood or body fluids on them, such as
toothbrushes and razor blades.
• 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.

Emtricitabine/Tenofovir disoproxil tablets with food and drink
Whenever possible, Emtricitabine/Tenofovir disoproxil tablets should be taken with food.

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 tablets to treat HIV or to reduce
the risk of getting HIV:
• Emtricitabine/Tenofovir disoproxil tablets 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 tablets or, if you already have HIV, to take
Emtricitabine/Tenofovir disoproxil tablets less frequently. Emtricitabine/Tenofovir
disoproxil tablets 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 tablets . If you have HBV, there is a serious risk of
liver problems when you stop taking Emtricitabine/Tenofovir disoproxil tablets ,
whether or not you also have HIV. It is important not to stop taking
Emtricitabine/Tenofovir disoproxil tablets without talking to your doctor : see section
3, Do not stop taking Emtricitabine/Tenofovir disoproxil tablets .
• Talk to your doctor if you are over 65. Emtricitabine/Tenofovir disoproxil tablets 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 tablets contains lactose later in this section).
Children and adolescents
Emtricitabine/Tenofovir disoproxil tablets is not for use in children and adolescents
under 18 years of age.

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/Tenofovir
disoproxil tablets in pregnant women, it is not usually used unless absolutely
necessary.
• If you are a woman who could get pregnant during treatment with
Emtricitabine/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 therapy with Emtricitabine/Tenofovir disoproxil tablets
to you and your child.

If you are being treated for HIV infection your doctor will prescribe
Emtricitabine/Tenofovir disoproxil tablets 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 tablets to reduce the risk of getting
HIV, take Emtricitabine/Tenofovir disoproxil tablets 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 tablets than you should
If you accidentally take more than the recommended dose of Emtricitabine/Tenofovir
disoproxil tablets, 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 Emtricitabine/Tenofovir disoproxil tablets
It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil tablets.
If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir
disoproxil tablets, 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 tablets, 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 tablets,
take another tablet. You do not need to take another tablet if you were sick more than
1 hour after taking Emtricitabine/Tenofovir disoproxil tablets.
Do not stop taking Emtricitabine/Tenofovir disoproxil tablets
If you take Emtricitabine/Tenofovir disoproxil tablets 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 tablets to reduce the risk of
getting HIV, do not stop taking Emtricitabine/Tenofovir disoproxil tablets or miss any
doses. Stopping use of Emtricitabine/Tenofovir disoproxil tablets, or missing doses,
may increase your risk of getting HIV infection.
Do not stop taking Emtricitabine/Tenofovir disoproxil tablets without contacting your
doctor.

If you have taken Emtricitabine/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 NRTIs during pregnancy,
the benefit from the protection against HIV outweighed the risk of side effects.

If you have hepatitis B, it is especially important not to stop your
Emtricitabine/Tenofovir disoproxil tablets 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.

• Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil tablets .
This is because the active substances in this medicine pass into human breast milk.

Tell your doctor immediately about new or unusual symptoms after you stop
treatment, particularly symptoms you associate with hepatitis B infection.

• 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.

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Driving and using machines
Emtricitabine/Tenofovir disoproxil tablets can cause dizziness. If you feel dizzy while
taking Emtricitabine/Tenofovir disoproxil tablets , do not drive and do not use any
tools or machines.
Emtricitabine/Tenofovir disoproxil tablets contains Lactose
Tell your doctor if you are lactose-intolerant or intolerant to other sugars.

3. How to take Emtricitabine/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.
The recommended dose of Emtricitabine/Tenofovir disoproxil tablets to treat HIV or to
reduce the risk of getting HIV is:
Adults: one tablet each day. Whenever possible, Emtricitabine/Tenofovir disoproxil
tablets should be taken with food.

Other medicines and Emtricitabine/Tenofovir disoproxil tablets
Do not take Emtricitabine/Tenofovir disoproxil tablets if you are already taking other
medicines that contain emtricitabine and tenofovir disoproxil, or any other antiviral
medicines that contain tenofovir alafenamide, lamivudine or adefovir dipivoxil.

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.

Taking Emtricitabine/Tenofovir disoproxil tablets with other medicines that can
damage your kidneys: It is especially important to tell your doctor if you are taking

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.

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:
• deep rapid breathing
• drowsiness
• feeling sick (nausea), being sick (vomiting)
• 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.

Artwork No.

-

Colours Used

Customer

Accord

Pantone Black

Description

Emtricitabine-Tenofovir-200-245 mg

Market

UK-IE

Language

English

Size

500 x 400 mm (PIL)

Min. Font Size

9

Version No.

1 (Page 2 of 2)

Date

28.03.17 (Emtricitabine-Tenofovir-200-245 mg (ACC-UK-IE) PIL)

Prepared By
Regulatory Affairs

• 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:
• muscle weakness
• weakness beginning in the hands and feet and moving up towards the trunk of the
body
• palpitations, tremor or hyperactivity
If you notice these or any symptoms of inflammation or infection, get medical help
immediately.
Possible side effects:
Very common side effects (may affect more than 1 in 10 people)
• diarrhoea, being sick (vomiting), feeling sick (nausea)
• dizziness, headache
• rash
• feeling weak
Tests may also show:
• decreases in phosphate in the blood
• increased creatine kinase
Common side effects (may affect up to 1 in 10 people)
• pain, stomach pain
• difficulty sleeping, abnormal dreams
• problems with digestion resulting in discomfort after meals, feeling bloated,
flatulence
• 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
• other allergic reactions, such as wheezing, swelling or feeling light-headed
Tests may also show:
• low white blood cell count (a reduced white blood cell count can make you more
prone to infection)
• increased triglycerides (fatty acids), bile or sugar in the blood
• liver and pancreas problems
Uncommon side effects (may affect up to 1 in 100 people)
• pain in the abdomen (tummy) caused by inflammation of the pancreas
• swelling of the face, lips, tongue or throat
• anaemia (low red blood cell count)
• breakdown of muscle, muscle pain or weakness which may occur due to damage to
the kidney tubule cells
Tests may also show:
• decreases in potassium in the blood
• increased creatinine in your blood
• changes to your urine
Rare side effects (may affect up to 1 in 1,000 people)
• Lactic acidosis (see Possible serious side effects)
• fatty liver
• yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by
inflammation of the liver
• inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure,
damage to kidney tubule cells
• softening of the bones (with bone pain and sometimes resulting in fractures)
• back pain caused by kidney problems

Keyline
Checked By
Regulatory Affairs

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the national reporting system (see contact details below). By reporting
side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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

5. How to store Emtricitabine/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 bottle and carton
after EXP. The expiry date refers to the last day of that month.

Name of the
member state
Netherland
Austria
Denmark
Finland
Ireland
Italy
Norway
Poland
Portugal
Romania
Sweden
United kingdom

Name of the medicinal product
Emtricitabine/Tenofovir disoproxil Accord 200 mg/245 mg filmom
hulde tabletten
Emtricitabine/Tenofovir disoproxil Accord 200 mg/245 mg
Filmtabletten
Emtricitabine/Tenofovir disoproxil Accord 200 mg/245 mg
filmovertrukne tabletter
Emtricitabine/Tenofovir disoproxil Accord 200 mg/245 mg tabletti,
kalvopäällysteinen
Emtricitabine/Tenofovir disoproxil 200 mg/245 mg film-coated
tablets
Emtricitabina e Tenofovir Disoproxil Accord
Emtricitabine/Tenofovir disoproxil Accord
Emtricitabine + Tenofovir disoproxil Accord
Emtricitabina/Tenofovir Accord
Emtricitabina/Tenofovir disoproxil Accord 200 mg/245 mg
comprimate filmate
Emtricitabine/Tenofovir disoproxil Accord 200 mg/245 mg
filmdragerad tablet
Emtricitabine/Tenofovir disoproxil 200 mg/245 mg film-coated
tablets
Emtricitabine/Tenofovir disoproxil Accord 200 mg/245 mg
comprimidos recubiertos con película

Spain

HDPE Bottle: Store in the original package in order to protect from moisture. Keep
the bottle tightly closed. This product does not require any special temperature
storage conditions..

This leaflet was last revised in 03/2017

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 to protect the environment.

6. Contents of the pack and other information
What Emtricitabine/Tenofovir disoproxil tablets contains
• The active substances are emtricitabine and tenofovir disoproxil. Each
Emtricitabine/Tenofovir disoproxil tablets contains 200 mg of emtricitabine and 245
mg of tenofovir disoproxil (equivalent to 136 mg of tenofovir).
• The other ingredients are:
Tablet core: Croscarmellose sodium, Lactose monohydrate, Cellulose,
microcrystalline (PH 101 and PH 102), Magnesium stearate, Pregelatinised maize
starch
Tablet coating: Opadry blue contains Hypromellose 15 m.Pas, Lactose monohydrate,
Titanium dioxide (E171), Triacetin, Indigo carmine aluminium lake (E132)
What Emtricitabine/Tenofovir disoproxil tablets looks like and contents of the
pack
Emtricitabine/Tenofovir disoproxil tablets is Blue, capsule shaped, film-coated tablets
debossed with 'H' on one side and 'E29' on the other side.
Pack size of 30, 60, and 90 tablets in OPA-Al-PVC/Al blister pack. Also available in
pack size of 30x1, 60x1 and 90x1 tablets in OPA-Al-PVC/Al perforated unit dose
blister.
Pack size of 30 tablets and 90 tablets (3 bottles of 30 tablets) in white opaque high
density polyethylene (HDPE) bottle with white opaque polypropylene child-resistant
closure and silica gel desiccant filled in cylindrical canister. Each bottle contains a
silica gel desiccant filled in cylindrical canister that must be kept in the bottle to help
protect your tablets and it should not be swallowed.

The frequency of the following side effects is not known.
• Bone problems. Some patients taking combination antiretroviral medicines such as
Emtricitabine/Tenofovir disoproxil tablets 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:
• joint stiffness
• joint aches and pains (especially of the hip, knee and shoulder)
• difficulty with movement

Not all pack sizes may be marketed.

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.

This medicinal product is authorised in the Member States of the EEA under
the following names:

OPA-Al-PVC/Al Blister: Store in the original package in order to protect from
moisture. Store below 30°C.

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.
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.

If you notice any of these symptoms tell your doctor.

Approved By
Quality Assurance

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF
United Kingdom
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000, Malta

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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