EMTRICITABINA 200 mg/245 mg Film-Coated Tablets

Зміст інструкції

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

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

emtricitabina/tenofovir disoproxil

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

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

Emtricitabina/Tenofovir disoproxil Mylan contains two active substances,emtricitabinaand tenofovir

disoproxil. Both active substances are antiretroviralmedicines that are used for the
treatment of HIV infection. Emtricitabina is a nucleoside reverse transcriptase inhibitor
and tenofovir is a nucleotide reverse transcriptase inhibitor. However, they are generically
known as NRTIs and act by interfering with the normal activity of an enzyme (reverse transcriptase)
which is essential for the virus to reproduce.

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

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

• Emtricitabina/Tenofovir disoproxil Mylan is also used to reduce the risk of contracting HIV-1 infection in adults and adolescents aged 12 years and older with a weight of at least 35 kg,when used as daily treatment together with safe sex practices: For a list of precautions to take against HIV infection see paragraph 2.

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

Do not take Emtricitabina/Tenofovir disoproxil Mylan to treat HIV infection or to
reduce the risk of contracting HIV if you are allergicto emtricitabina, 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 Mylan to reduce the risk of contracting
HIV:
This medicine can only help to reduce the risk of contracting an HIV infection before
being infected.

• You must be HIV negative before starting to take this medicine to reduce therisk of contracting HIV.You will need to be tested to make sure you do not yet have an HIV infection. Do not take this medicine to reduce the risk unless it has been confirmed that you are HIV negative. People with HIV infection must take this medicine in combination with other medicines.
• Many HIV tests may not detect a recent infection.If you experience flu-like symptoms, it could mean that you have recently contracted HIV. The following can be signs of HIV infection:
• fatigue
• fever
• joint or muscle pain
• headache
• vomiting or diarrhea
• rash
• night sweats
• swollen lymph nodes in the neck or groin
• Tell your doctor about any flu-like illness -both in the month before taking this medicine and at any time during its intake.

Warnings and precautions
While takingEmtricitabina/Tenofovir disoproxil Mylan to reduce the risk of contracting
HIV:

• Take this medicine every day to reduce your risk, not just when you think youhave been at risk of HIV infection.Do not miss any dose of Emtricitabina/Tenofovir disoproxil Mylan, nor interrupt the intake of this medicine. Missed doses can increase the risk of contracting HIV infection.
• Get tested for HIV regularly.
• If you believe you have contracted an HIV infection, tell your doctor immediately, who may ask you to undergo further tests to verify that you are still HIV negative.
• Taking Emtricitabina/Tenofovir disoproxil Mylan alone may not prevent you fromcontracting HIV.
• Always practice safe sex. Use a condom to reduce contact with semen, vaginal fluids, or blood.
• Do not share personal items that may have traces of blood or body fluids, such as toothbrushes or razors.
• Do not share or reuse needles or other injection or medication devices.
• Get tested for other sexually transmitted infections, such as syphilis and gonorrhea. These infections make you more susceptible to contracting HIV.

Talk to your doctor if you have any other questions about how to avoid contracting HIV or
transmitting HIV to others.

While taking Emtricitabina/Tenofovir disoproxil Mylan to treat HIV infection or to
reduce the risk of contracting HIV infection:

• Emtricitabina/tenofovir disoproxil may have effects on the kidneys.Before and during treatment, your doctor may prescribe blood tests to measure proper kidney function. Tell your doctor if you have had kidney disease, or if the tests have shown kidney problems. This medicine should not be administered to adolescents who suffer from kidney problems. If you have kidney problems, your doctor may advise you to stop taking emtricitabina/tenofovir disoproxil or if you already have an HIV infection, your doctor may suggest you take emtricitabina/tenofovir disoproxil less frequently. Emtricitabina/tenofovir disoproxil is not recommended if you suffer from a severe kidney disease or are undergoing dialysis.
• 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 association with a boosted protease inhibitor.
In general, the effects of tenofovir disoproxil on long-term bone health and the future risk of
fractures in adult and pediatric patients are uncertain.
Tell your doctor if you suffer from osteoporosis. Patients with osteoporosis are at higher risk
of fractures.

• Tell your doctor if you have had liver problems in the past, including hepatitis.Patients infected with HIV with also liver problems (including chronic hepatitis B or C), treated with antiretrovirals, have a higher risk of serious liver complications and that can lead to death. If you have hepatitis B or C, your doctor will carefully evaluate the best treatment regimen for you.
• Find out about your status of infection by the hepatitis B virus (HBV)before starting to take Emtricitabina/Tenofovir disoproxil Mylan. If you have an HBV infection, there is a serious risk of liver problems when you stop taking emtricitabina/tenofovir disoproxil, regardless of whether you also have an HIV infection. It is important that you do not stop taking emtricitabina/tenofovir disoproxil without talking to your doctor: see section 3, Do not stop treatment with Emtricitabina/Tenofovirdisoproxil Mylan.
• Tell your doctor if you are over 65 years of age.Emtricitabina/tenofovir disoproxil has not been studied in patients over 65 years of age.
• Tell your doctor if you are lactose intolerant(see Emtricitabina/Tenofovir disoproxil Mylan contains lactose further on in this paragraph).

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

Other medicines and Emtricitabina/Tenofovir disoproxil Mylan
Do not take Emtricitabina/Tenofovir disoproxil Mylanif you are already taking other medicines that
contain the components of this medicine (i.e., emtricitabina and tenofovir disoproxil) or any
other antiviral medicine that contains tenofovir alafenamide, lamivudine or adefovir dipivoxil.

Taking Emtricitabina/Tenofovir disoproxil Mylan with othermedicines 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 monitor your kidney function.

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

Taking Emtricitabina/Tenofovir disoproxil Mylanwith other medicines that contain
didanosine (for the treatment of HIV infection):Taking emtricitabina/tenofovir
disoproxil with other antiviral medicines that contain didanosine may increase the level of
didanosine in the blood and may reduce the CD4 cell count. Rarely, cases of inflammation
of the pancreas and lactic acidosis (excess lactic acid in the blood) have been reported when medicines containing tenofovir
disoproxil and didanosine have been taken together. Your doctor will need to 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 Mylan with food and drink

• Whenever possible, Emtricitabina/Tenofovir disoproxil Mylan should be taken with food.

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

• Do not breastfeed during treatment with Emtricitabina/Tenofovirdisoproxil Mylan.The reason is that the active ingredient of this medicine is 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 assoon as possible.

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

Emtricitabina/Tenofovir disoproxil Mylan contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact them before
taking this medicine.

3. How to take Emtricitabina/Tenofovir disoproxil Mylan

• 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 Mylan for treating HIV is:

• Adults:one tablet every day, preferably with food.
• Adolescents aged 12 to < 18 years weighing at least 35 kg:one tablet every day, preferably with food.

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

• Adults:one tablet every day, preferably with food.
• Adolescents aged between 12 and less than 18 years weighing at least 35 kg:one tablet every day, preferably 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 ensure that your medicines are 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

antiretrovirals as a guide on taking these medicines.

• If you are an adult taking this medicine to reduce the risk of contractingan HIV infection,take this medicine every day and not only when you think you have been at risk of contracting HIV.

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

If you miss a dose
It is important not to miss doses of Emtricitabina/Tenofovir disoproxil Mylan.

• If you realize this within 12 hoursof the usual time of taking Emtricitabina/Tenofovir disoproxil Mylan, take the tablet, preferably with food, as soon as possible. Then take the next dose at the scheduled time.
• If you realize this 12 hours or more afterthe usual time of taking Emtricitabina/Tenofovir disoproxil Mylan, do not take the missed dose. Wait and take the next dose, preferably with food, at the scheduled time.

In case of vomiting occurring within 1 hour of taking Emtricitabina/Tenofovir disoproxil
Mylan,take another tablet. You should not take another tablet if you have vomited more than one hour
after taking this medicine.

Do not stop treatment with Emtricitabina/Tenofovir disoproxil Mylan

• If you are taking Emtricitabina/Tenofovir disoproxil Mylan for the treatment ofHIV infection,stopping taking the tablets may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
• If you are taking Emtricitabina/Tenofovir disoproxil Mylan to reduce the risk ofcontracting an HIV infection,do not stop taking this medicine and do not miss any doses. Stopping taking this medicine or missed doses may increase the risk of contracting HIV.
• Do not stop treatment with Emtricitabina/Tenofovir disoproxil Mylan withoutcontacting your doctor.
• If you have hepatitis B, it is particularly important not to stop treatment with Emtricitabina/Tenofovir disoproxil Mylanwithout first contacting your doctor. It may be necessary 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 may be potentially fatal.
• Immediately inform your doctorof any new or unusual symptoms observed after stopping treatment, especially symptoms that are normally associated with hepatitis B infection.

If you have any doubts about using this medicine, ask your doctor or pharmacist.

Other effects in children
Children who have been given emtricitabina 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)
• this can cause fatigue or shortness of breath in the child
• If you notice any of these symptoms, see your doctor.

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
• sleepiness
• feeling sick, vomiting
• stomach pain
• If you think you have lactic acidosis, seek medical attention immediately.
• 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 believed 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 obvious symptoms.
• Autoimmune disorders, in which the immune system attacks healthy tissue in the body, can also occur after starting to take medicines to treat HIV infection. 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 trunk
• palpitations, tremor 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, nausea
• dizziness, headache
• rash
• feeling weak, muscle weakness

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, flatulence
• rashes (including red spots or pustules sometimes with blisters and swelling of the skin), which may be an allergic reaction, burning, change in skin colour with the appearance of dark patches.
• other allergic reactions, such as shortness of breath, swelling or feeling lightheaded

Tests may also show:

• decreased white blood cell count (this may make you more prone to infection)
• increased triglycerides (fatty acids), bile or glucose in the blood
• problems with the liver and pancreas

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

• abdominal pain caused by inflammation of the pancreas
• swelling of the face, lips, tongue or throat
• anaemia (low red blood cell count)
• muscle breakdown, muscle pain or muscle weakness, which may occur due to damage to the kidney tubule 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 pain caused by inflammation of the liver
• inflammation of the kidneys, abundant urine and thirst, kidney failure, damage to the kidney tubule cells
• softening of the bones (with bone pain and sometimes fractures)
• back pain caused by kidney problems

Damage to the kidney tubule cells may be associated with muscle breakdown, 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 may develop a bone disease called osteonecrosis(bone 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
• joint pain (especially in the hip, knee and shoulder)
• difficulty moving
• If you notice any of these symptoms, tell your doctor.

During HIV treatment, 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 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 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 Mylan

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 carton after
{Scad.}. The expiry date refers to the last day of that month.

Bottles:use within 90 days of first opening
Do not store at a temperature above 25°C. Store in the original packaging to protect
the medicine from moisture.
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 Mylan contains

• The active ingredients areemtricitabine and tenofovir disoproxil. Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate).
• The other ingredients aremicrocrystalline cellulose, low-substituted hydroxypropylcellulose, red iron oxide (E172), anhydrous colloidal silicon dioxide, lactose monohydrate (see section 2, "Emtricitabina/Tenofovir disoproxil Mylan contains lactose"), magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, brilliant blue FCF aluminium lake (E133), yellow iron oxide (E172).

Description of the appearance of Emtricitabina/Tenofovir disoproxil Mylan and package contents
The film-coated tablets of Emtricitabina/Tenofovir disoproxil Mylan are light green
in colour, capsule-shaped, biconvex, with dimensions of 19.8 mm × 9.00 mm, imprinted with ‘M’ on one
side and ‘ETD’ on the other.
This medicine is available in bottles containing a desiccant (DO NOT INGEST THE DESICCANT)
that contain 30 or 90 film-coated tablets and in multipacks of 90 film-coated tablets
consisting of 3 bottles, each containing 30 film-coated tablets or blister packs with
integrated desiccant containing 30, 30 × 1, 90 × 1 or 100 × 1 film-coated tablets and blisters
containing 30, 30 × 1 or 90 × 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan Pharmaceuticals Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft
Mylan utca 1, H-2900 Komárom,
Hungary
McDermott Laboratories Limited trading as Gerard Laboratories trading as Mylan Dublin
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Medis International a.s
vyrobani zavod Bolatice, Prumyslova, -961/16, Bolatice
747 23, Czech Republic
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1
Bad Homburg v. d. Hoehe
Hessen, 61352,
Germany
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
Viatris
Tél/Tel: + 32 (0)2 658 61 00

Lietuva
Viatris UAB
Tel: +370 5 205 1288

България
Майлан ЕООД
Тел.: +359 2 44 55 400

Luxembourg/Luxemburg
Viatris
Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika
Viatris CZ s.r.o.
Tel: +420 222 004 400

Magyarország
Viatris Healthcare Kft.
Tel.: + 36 1 465 2100

Danmark
Viatris ApS
Tlf: +45 28 11 69 32

Malta
V.J. Salomone Pharma Ltd
Tel: + 356 21 22 01 74

Deutschland
Viatris Healthcare GmbH
Tel: + 49 800 0700 800

Nederland
Mylan BV
Tel: + 31 (0)20 426 3300

Eesti
Viatris OÜ
Tel: + 372 6363 052

Norge
Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα
Viatris Hellas Ltd
Τηλ: +30 2100 100 002

Österreich
Arcana Arzneimittel GmbH
Tel: +43 1 416 2418

España
Viatris Pharmaceuticals, S.L.U
Tel: + 34 900 102 712

Polska
Mylan Healthcare Sp. z o.o.
Tel.: + 48 22 546 64 00

France
Vatris Santé
Tél: +33 4 37 25 75 00

Portugal
Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska
Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 599

România
BGP Products SRL
Tel: +40 372 579 000

Ireland
Mylan Ireland Limited
Tel: +353 1 8711600

Slovenija
Viatris d.o.o.
Tel: + 386 1 236 31 80

Ísland
Icepharma hf
Sími: +354 540 8000

Slovenská republika
Viatris Slovakia s.r.o.
Tel: +421 2 32 199 100

Italia
Viatris Italia S.r.l.
Tel: + 39 (0) 2 612 46921

Suomi/Finland
Vatris Oy
Puh/Tel: + 358 20 720 9555

Κύπρος
Varnavas Hadjipanayis Ltd
Τηλ: +357 2220 7700

Sverige
Viatris AB
Tel: + 46 (0)8 630 19 00

Latvija
Viatris SIA
Tel: +371 676 055 80

United Kingdom (Northern Ireland)
Mylan IRE Healthcare Limited
Tel: +353 18711600
More detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .