EMTRICITABINA 200 mg/245 mg Film-Coated Tablet

Зміст інструкції

1. Emtricitabina/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets
   1. What is Emtricitabina/Tenofovir disoproxil Zentiva and what is it used for
   2. What you need to know before taking Emtricitabina/Tenofovir disoproxil Zentiva
   3. How to take Emtricitabina/Tenofovir disoproxil Zentiva
   4. Possible side effects
   5. How to store Emtricitabina/Tenofovir disoproxil Zentiva
   6. Package contents and other information

Emtricitabina/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets

emtricitabina/tenofovir disoproxil

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Emtricitabina/Tenofovir disoproxil Zentiva and what is it used for

Emtricitabina/Tenofovir disoproxil Zentivacontains two active ingredients,emtricitabineand tenofovir

disoproxil. Both of these active ingredients are antiretroviralmedicines that are used for the
treatment of 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 work by interfering with the normal activity of an enzyme
(reverse transcriptase) which is essential for the virus to reproduce.

• Emtricitabina/Tenofovir disoproxil Zentiva is used to treat infection with humanimmunodeficiency virus 1 (HIV-1) in adults.
• It is also used to treat HIV in adolescents aged 12 to 18 years weighing at least 35 kgand who have already been treated with other HIV medicines that are no longer effective or have caused side effects.
• Emtricitabina/Tenofovir disoproxil Zentiva must always be used in combination with other medicines for the treatment of HIV infection.
• Emtricitabina/Tenofovir disoproxil Zentiva can be administered as a replacement for emtricitabine and tenofovir disoproxil used separately at the same doses.

This medicine is not a cure for HIV infection.While taking Emtricitabina/Tenofovir
disoproxil Zentiva you may still develop infections or other diseases associated with HIV
infection.

• Emtricitabina/Tenofovir disoproxil Zentiva is also used to reduce the risk ofcontracting HIV-1 infection in adults and adolescents aged 12 toless than 18 years weighing at least 35 kg, when taken daily, together with safe sex practices: See section 2 for a list of precautions to take against HIV infection.

2. What you need to know before taking Emtricitabina/Tenofovir disoproxil Zentiva

Do not take Emtricitabina/Tenofovir disoproxil Zentiva to treat HIV or to reduce the
risk of contracting HIV
if you are allergicto emtricitabine, tenofovir, tenofovir disoproxil or to any of the other
ingredients of this medicine (listed in section 6).

→If this applies to you, tell your doctor immediately.
Before taking Emtricitabina/Tenofovir disoproxil Zentiva to reduce the risk of contracting
HIV:
Emtricitabina/Tenofovir disoproxil Zentiva can only help to reduce the risk of contracting HIV
before you are infected.

• To start taking Emtricitabina/Tenofovir disoproxil Zentiva to reduce the riskof contracting HIV you must be HIV negative.You must have a test to make sure you do not already have an HIV infection. Do not take Emtricitabina/Tenofovir disoproxil Zentiva to reduce the risk unless you have been confirmed to be HIV negative. People who have HIV must take Emtricitabina/Tenofovir disoproxil Zentiva in combination with other medicines.
• Many tests for HIV may not detect a recent infection. Should you develop a flu-like illness, it could mean that you have recently been infected with HIV. Possible signs of HIV infection include:
• fatigue
• fever
• joint or muscle pain
• headache
• vomiting or diarrhea
• rash
• night sweats
• swollen lymph nodes in the neck or groin Tell your doctor if you have a flu-like illness -within the month before starting Emtricitabina/Tenofovir disoproxil Zentiva or at any time during taking Emtricitabina/Tenofovir disoproxil Zentiva.

Warnings and precautions
While taking Emtricitabina/Tenofovir disoproxil Zentiva to reduce the risk of contracting
HIV:

• Take Emtricitabina/Tenofovir disoproxil Zentiva every day to reduce the risk, not justwhen you think you have been at risk of contracting HIV. Do not miss any doses of Emtricitabina/Tenofovir disoproxil Zentiva and do not stop taking it. Missing doses may increase your risk of contracting HIV.
• Get tested for HIV regularly.
• If you think you may have been infected with HIV, tell your doctor immediately. They may give you further tests to make sure you are still HIV negative.

Simply taking Emtricitabina/Tenofovir disoproxil Zentiva may not prevent you from
contracting HIV.

• Always practice safe sex. Use condoms to reduce contact with semen, vaginal fluid, or blood.
• Do not share personal items that may have blood or body fluids on them, such as

toothbrushes or razors.

• Do not share or reuse needles or other injection equipment 'or for administering drugs.
• Get tested for other sexually transmitted infections such as syphilis and gonorrhea. These infections make HIV infection easier.

Talk to your doctor if you have any other questions about how not to contract HIV or not to spread HIV to other
people.

While taking Emtricitabina/Tenofovir disoproxil Zentiva to treat HIVor to
reduce the risk of contracting HIV:

• Emtricitabina/Tenofovir disoproxil Zentiva can have effects on the kidneys.Before and during treatment, your doctor may prescribe blood tests to assess proper kidney function. Tell your doctor if you have had kidney disease, or if the tests have shown kidney problems. Emtricitabina/Tenofovir disoproxil Zentiva should not be given to adolescents who have kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabina/Tenofovir disoproxil Zentiva or, if you already have HIV, to take Emtricitabina/Tenofovir disoproxil Zentiva less frequently. Emtricitabina/Tenofovir disoproxil Zentiva is not recommended if you have severe kidney disease or are on dialysis.
• Tell your doctor if you suffer from osteoporosis. Patients with osteoporosis are at higherrisk of fractures.

Bone problems(which manifest as persistent or worsening bone pain and
sometimes resulting in fractures) can also occur due to damage to the cells of the renal
tubules (see section 4, Possible side effects). Tell your
doctor if you have bone pain or fractures.
Tenofovir disoproxil can also cause loss of bone mass. The most
pronounced loss of bone mass was observed in clinical studies in which patients were treated for HIV
with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the effects of tenofovir disoproxil on bone health in the long term and the future risk
of fractures in adult and pediatric patients are uncertain.

• Tell your doctor if you have had liver problems in the past, including hepatitis.Patients infected with HIV with liver problems (including chronic hepatitis B or C) treated with antiretrovirals have a higher risk of serious liver complications that can be life-threatening. If you have hepatitis B or C, your doctor will carefully evaluate the best treatment regimen for you.
• Find out your status ofinfection with the hepatitis B virus (HBV)before starting to take Emtricitabina/Tenofovir disoproxil Zentiva. If you have an HBV infection, there is a serious risk of liver problems if you stop taking Emtricitabina/Tenofovir disoproxil Zentiva, whether or not you have HIV. It is important that you do not stop taking Emtricitabina/Tenofovir disoproxil Zentiva without talking to your doctor: see section 3, Do not stop taking Emtricitabina/Tenofovir disoproxil Zentiva.
• Tell your doctor if you are over 65 years of age.The combination of emtricitabine and tenofovir disoproxil has not been studied in patients over 65 years of age.

Children and adolescents
Emtricitabina/Tenofovir disoproxil Zentiva is not indicated in children under 12 years of age.

Other medicines and Emtricitabina/Tenofovir disoproxil Zentiva
Do not take Emtricitabina/Tenofovir disoproxil Zentivaif you are already taking other medicines that
contain the ingredients of Emtricitabina/Tenofovir disoproxil Zentiva (emtricitabine and tenofovir
disoproxil) or any other antiviral medicine containing tenofovir alafenamide, lamivudine or
adefovir dipivoxil.

Taking Emtricitabina/Tenofovir disoproxil Zentiva with other medicines that can
damage the kidneys:it is particularly 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).
• vancomycin (for bacterial infection).
• interleukin-2 (to treat cancer).
• cidofovir (for viral infection).
• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).

If you are taking another antiviral medicine called a protease inhibitor to treat HIV, your
doctor may prescribe blood tests to better check your kidney function.

It is also important to tell your doctorif you are taking ledipasvir/sofosbuvir,
sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir to treat a hepatitis C infection.

Taking Emtricitabina/Tenofovir disoproxil Zentiva with other medicines that contain
didanosine (for the treatment of HIV infection):Taking Emtricitabina/Tenofovir
disoproxil Zentiva with other antiviral medicines containing didanosine may increase the level of
didanosine in the blood and may reduce the CD4 cell count. Rarely, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), which sometimes cause death, have been reported when medicines containing tenofovir
disoproxil and didanosine have been taken together. Your doctor will carefully consider whether to treat you with tenofovir and didanosine in combination.

Tell your doctorif 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.

Emtricitabina/Tenofovir disoproxil Zentiva with food and drink
Whenever possible, Emtricitabina/Tenofovir disoproxil Zentiva should be taken with food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
If you have already taken Emtricitabina/Tenofovir disoproxil Zentiva during pregnancy, your doctor may
request regular blood tests and other diagnostic tests to monitor the development of
the child. In children whose mothers took NRTIs during pregnancy, the benefit of
protection against HIV outweighed the risk of side effects.

• Do not breastfeed during treatment with Emtricitabina/Tenofovirdisoproxil Zentiva.The reason is that the active ingredients of this medicine are excreted in breast milk.
• Breastfeeding is not recommended for HIV-positive women as HIV infection can be transmitted to the baby with breast milk.
• If you are breastfeeding or planning to breastfeed, you should talk to your doctor as soon aspossible.

Driving and using machines
Emtricitabina/Tenofovir disoproxil Zentiva can cause dizziness. If you experience dizziness while
taking Emtricitabina/Tenofovir disoproxil Zentiva, do not driveand do not use tools or
machinery.

Emtricitabina/Tenofovir disoproxil Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially
“sodium-free”.

3. How to take Emtricitabina/Tenofovir disoproxil Zentiva

• Take this medicine exactly as your doctor has told you.If you have any doubts, ask your doctor or pharmacist.

The recommended dose of Emtricitabina/Tenofovir disoproxil Zentiva for treating HIV is:

• Adults:one tablet each day, when possible, Emtricitabina/Tenofovir disoproxil Zentiva should be taken with food.
• Adolescents aged between 12 and 18 years weighing at least 35 kg:one tablet each day, when possible, taken with food.

The recommended dose of Emtricitabina/Tenofovir disoproxil Zentiva to reduce the risk of
contracting HIV is:

• Adults: one tablet each day, when possible taken with food.
• Adolescents aged between 12 and less than 18 years weighing at least 35 kg: one tablet each day, when possible taken with food.

If you have difficulty swallowing, you can use the end of a spoon to crush the tablet. Then
mix the powder in 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 your medicine is fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.
• If you are being treated for HIV infection ,your doctor will prescribe Emtricitabina/Tenofovir disoproxil Zentiva with other antiretroviral medicines. Read the package leaflets of the other antiretrovirals as a guide to taking these medicines.
• If you are taking Emtricitabina/Tenofovir disoproxil Zentiva to reduce the risk of contracting HIV, take Emtricitabina/Tenofovir disoproxil Zentiva every day, not just when you think you have been at risk of HIV infection.

Talk to your doctor if you have questions about how not to contract HIV or prevent the spread of HIV to
others.

If you take more Emtricitabina/Tenofovir disoproxil Zentiva than you should
If you accidentally take a dose of Emtricitabina/Tenofovir disoproxil Zentiva higher than that
recommended, contact your doctor or the nearest emergency center. Bring the pack of
tablets with you so you can easily describe what you have taken.

If you forget to take Emtricitabina/Tenofovir disoproxil Zentiva
It is important not to miss a dose of Emtricitabina/Tenofovir disoproxil Zentiva.

• If you remember within 12 hoursof the usual time of taking Emtricitabina/Tenofovir disoproxil Zentiva, take the tablet, preferably with food, as soon as possible. Then take the next dose at the scheduled time.
• If you remember 12 hours or moreafterthe usual time of taking Emtricitabina/Tenofovir disoproxil Zentiva, do not take the missed dose. Wait and take the next dose, preferably with food, at the scheduled time. If vomiting occurs within 1 hour of taking Emtricitabina/Tenofovir disoproxilZentiva,take another tablet. You should not take another tablet if you have vomited more than 1 hour after taking Emtricitabina/Tenofovir disoproxil Zentiva.

Do not stop taking Emtricitabina/Tenofovir disoproxil Zentiva

• If you are taking Emtricitabina/Tenofovir disoproxil Zentiva for the treatment of HIV infection, stopping the tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
• If you are taking Emtricitabina/Tenofovir disoproxil Zentiva to reduce the risk of contracting HIV, do not stop taking Emtricitabina/Tenofovir disoproxil Zentiva and do not miss doses. If you stop using Emtricitabina/Tenofovir disoproxil Zentiva, or miss doses, the risk of contracting HIV infection may increase. Do not stop treatment with Emtricitabina/Tenofovir disoproxil Zentiva withoutcontacting your doctor.
• If you have hepatitis B, it is particularly important not to stop treatment with Emtricitabina/Tenofovir disoproxil Zentiva without contacting your doctor first. You may need to repeat blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as it may lead to a worsening of hepatitis, which can be potentially fatal.

Immediately tell your doctor about any new or unusual symptoms you notice after
stopping treatment, especially symptoms that are associated with hepatitis B
infection.
If you have any questions about using 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 fatal side effect. Lactic acidosis occurs more often in women, especially if overweight, and in people with liver disease. The following may be signs of lactic acidosis:
• shortness of breath,
• drowsiness,
• feeling sick, vomiting,
• stomach pain. If you think you have lactic acidosis, seek immediate medical attention.
• Any sign 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 weakened immune system), signs and symptoms of inflammation due to previous infections may occur shortly after starting anti-HIV treatment. These symptoms are thought to be due to an improvement in the body's immune response, which allows the body to fight infections that may have been present without any noticeable symptoms.
• Autoimmune disorders, in which the immune system attacks healthy body tissue, can also occur after starting medication to treat HIV infection. The

autoimmune disorders can occur many months after starting treatment. Look for
any symptoms of infection or other symptoms such as:

• muscle weakness,
• weakness starting in the hands and feet and rising towards the body's trunk,
• palpitations, tremors or hyperactivity. If you notice these or other symptoms of inflammation or infection, seek immediate medical attention.

Possible side effects:
Very common side effects(may affect more than 1 in 10 people):

• diarrhoea, vomiting, feeling sick,
• dizziness, headache,
• skin rash,
• feeling weak.

Tests may also show:

• decreases in phosphate in the blood,
• elevated creatine kinase.

Common side effects(may affect up to 1 in 10 people):

• pain, stomach pain,
• difficulty sleeping, nightmares,
• digestive problems resulting from feeling unwell after meals, feeling full, intestinal gas,
• skin rashes (including red spots or pustules sometimes with blisters and swelling of the skin), which may be allergic reactions, burning, changes in skin color with the appearance of dark patches,
• other allergic reactions, such as shortness of breath, swelling or feeling lightheaded,
• loss of bone mass

Tests may also show:

• decreased white blood cell count (this may make you more susceptible to infection),
• increased triglycerides (fats), bile or sugar in the blood,
• problems with liver and pancreas.

Uncommon side effects(may affect up to 1 in 100 people):

• abdominal pain (stomach) caused by inflammation of the pancreas,
• swelling of the face, lips, tongue or throat,
• anemia (low red blood cell count).
• muscle weakness, muscle pain or muscle weakness, which may occur due to damage to the renal tubular cells.

Tests may also show:

• decreased potassium in the blood,
• increased creatinine in the blood,
• changes in urine.

Rare side effects(may affect up to 1 in 1,000 people):

• lactic acidosis (see “Possible serious side effects”)
• fatty liver,
• yellowing of the skin and eyes, itching or abdominal (stomach) pain caused by inflammation of the liver,
• inflammation of the kidneys, abundant urine and thirst, kidney failure, damage to the renal tubular cells,
• softening of the bones (with bone pain and sometimes fractures),
• back pain caused by kidney problems.

Damage to the renal tubular cells may be associated with muscle weakness, softening
of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness and decreased
potassium or phosphate in the blood.

If you notice any of the side effects listed above or if any of them becomes serious, tell your
doctor or pharmacist.
The frequency of the following side effects is not known.

• Bone problems. Some patients taking combination antiretroviral medicines such as Emtricitabine/Tenofovir disoproxil Zentiva may develop a bone disease called osteonecrosis (bone tissue death caused by loss of blood supply to the bone). Long-term use of this type of medicine, taking corticosteroids, alcohol, 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,
• discomfort and pain in the joints (especially hip, knee and shoulder),
• difficulty moving. If you notice any of these symptoms, see your doctor.

During treatment for HIV, weight and levels of lipids and glucose in the blood may increase. This is partly related to the restoration of health and lifestyle and, in
the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will check these
changes.

Other effects in children

• Children who have been given emtricitabine have very commonly shown changes in skin color including
• the appearance of dark patches on the skin.
• Children have commonly shown a low red blood cell count (anemia)
• which may cause fatigue or shortness of breath in the child. If you notice any of these symptoms, see your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system listed in Annex V. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Emtricitabina/Tenofovir disoproxil Zentiva

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 the pack after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage temperature. Store in the
original packaging to protect the medicine from humidity.
Do not store at a temperature above 30°C after first opening.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Emtricitabina/Tenofovir disoproxil Zentiva contains

• The active ingredients areemtricitabine and tenofovir disoproxil phosphate. Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 291.5 mg of tenofovir disoproxil phosphate or 136 mg of tenofovir).
• The other ingredients are:Tablet core: microcrystalline cellulose, sodium croscarmellose, talc, colloidal anhydrous silica, magnesium stearate. Film coating: polyvinyl alcohol, titanium dioxide, macrogol, talc, indigo carmine aluminum lake (E 132).

Description of the appearance of Emtricitabina/Tenofovir disoproxil Zentiva and contents of the pack
Emtricitabina/Tenofovir disoproxil Zentiva 200 mg/245 mg film-coated tablets are
blue, oval, biconvex, film-coated tablets with no score line, with approximate dimensions of
19.35 mm x 9.75 mm.
Pack contents:
Outer packs containing 1 bottle of 30 film-coated tablets and outer packs containing 3 bottles of
30 film-coated tablets.
Not all pack sizes may be marketed.
Open the bottles by pressing the child-resistant cap down and turning it counterclockwise.
Each bottle contains a silica gel desiccant, which must be kept in the bottle to
protect the tablets. The silica gel is contained in a separate container and must not be
ingested.

Marketing authorisation holder
Zentiva, k.s.
U Kabelovny 130
102 37 Prague 10
Czech Republic

Manufacturer
S.C. Zentiva S.A.
50 Theodor Pallady Blvd.
Bucharest 032266
Romania
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Zentiva, k.s.
Tél/Tel: +32 (78) 700 112
[email protected]

Lietuva
Zentiva, k.s.
Tel: +370 52152025
[email protected]

България
Zentiva, k.s.
Тел: +35924417136
[email protected]

Luxembourg/Luxemburg
Zentiva, k.s.
Tél/Tel: +352 208 82330
[email protected]

Česká republika
Zentiva, k.s.
Tel: +420 267 241 111
[email protected]

Magyarország
Zentiva Pharma Kft.
Tel.: +36 1 299 1058
[email protected]

Danmark
Zentiva Denmark ApS
Tlf.: +45 787 68 400
[email protected]

Malta
Zentiva, k.s.
Tel: +356 2034 1796
[email protected]

Deutschland
Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 010
[email protected]

Nederland
Zentiva, k.s.
Tel: +31 202 253 638
[email protected]

Eesti
Zentiva, k.s.
Tel: +372 52 70308
[email protected]

Norge
Zentiva Denmark ApS
Tlf: +45 787 68 400
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Ελλάδα
Zentiva, k.s.
Τηλ: +30 211 198 7510
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Österreich
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Tel: +43 720 778 877
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España
Zentiva Spain S.L.U.
Tel: +34 671 365 828
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Polska
Zentiva Polska Sp. z o.o.
Tel: + 48 22 375 92 00
[email protected]

France
Zentiva France
Tél: +33 (0) 800 089 219
[email protected]

Portugal
Zentiva Portugal, Lda
Tel: +351210601360
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Zentiva d.o.o.
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Tel: +353 818 882 243
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România
ZENTIVA S.A.
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Zentiva, k.s.
Tel: +386 360 00 408
[email protected]

Ísland
Zentiva Denmark ApS.
Sími: +354 539 5025
[email protected]

Slovenská republika
Zentiva, a.s.
Tel: +421 2 3918 3010
[email protected]

Italia
Zentiva Italia S.r.l.
Tel: +39 80081631
[email protected]

Suomi/Finland
Zentiva Denmark ApS.
Puh/Tel: +358 942 598 648
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Κύπρος
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Τηλ: +30 211 198 7510
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Sverige
Zentiva Denmark ApS
Tel: +46 840 838 822
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Latvija
Zentiva, k.s.
Tel: +371 67893939
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More detailed information about this medicinal product is available on the website of the European
Medicines Agency: https://www.ema.europa.eu .