EMTRICITABINA 200 mg/245 mg Film-Coated Tablets

Зміст інструкції

1. Emtricitabina/tenofovir disoproxil Krka d.d. 200 mg/245 mg film-coated tablets
   1. What is Emtricitabina/tenofovir disoproxil Krka d.d. and what is it used for
   2. What you need to know before taking Emtricitabina/tenofovir disoproxil Krka d.d.
   3. How to take Emtricitabina/tenofovir disoproxil Krka d.d.
   4. Possible side effects
   5. How to store Emtricitabina/tenofovir disoproxil Krka d.d.
   6. Contents of the pack and other information

• B. PACKAGE LEAFLET

Emtricitabina/tenofovir disoproxil Krka d.d. 200 mg/245 mg film-coated tablets

emtricitabina/tenofovir disoproxil

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

1. What is Emtricitabina/tenofovir disoproxil Krka d.d. and what is it used for

Emtricitabina/tenofovir disoproxil Krka d.d. contains two active ingredients,emtricitabineand

tenofovir disoproxil. Both 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, they are generically
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 Krka d.d. is used to treat infection with humanimmunodeficiency virus 1 (HIV-1)in adults
• It is also used to treat HIV in adolescents aged between 12 and 18 years with aweight 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 Krka d.d. must always be used in combination with other medicines for the treatment of HIV infection.
• Emtricitabina/tenofovir disoproxil Krka d.d. can be given as a replacement for emtricitabine 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 Krka d.d. you can still develop infections or other illnesses associated with HIV infection.

2. What you need to know before taking Emtricitabina/tenofovir disoproxil Krka d.d.

Do not take Emtricitabina/tenofovir disoproxil Krka d.d. if you are allergic toemtricitabina, 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.
Warnings and precautions
During the taking of Emtricitabina/tenofovir disoproxil Krka d.d. to treat HIV

• Emtricitabina/tenofovir disoproxil Krka d.d. may have effects on the kidneys.Before and during treatment, your doctor may prescribe blood tests to measure your kidney function correctly. Tell your doctor if you have had kidney disease, or if tests have shown kidney problems. Emtricitabina/tenofovir disoproxil Krka d.d.should not be given to adolescents with kidney problems. If you have kidney problems, your doctor may advise you to stop taking Emtricitabina/tenofovir disoproxil Krka d.d. or, if you already have HIV, to take Emtricitabina/tenofovir disoproxil Krka d.d. less frequently. Emtricitabina/tenofovir disoproxil Krka d.d. is not recommended if you have severe kidney disease or are on dialysis.
• Tell your doctor if you suffer from osteoporosis, have had bone fractures in the past, or have problemswith your bones.
• Bone problems(which can 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 long-term bone health 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 who also suffer from liver problems (including chronic hepatitis B or C), treated with antiretrovirals, have a higher risk of severe and potentially life-threatening liver complications. If you have hepatitis B or C, your doctor will carefully evaluate the best treatment regimen for you.
• Find out your status for hepatitis B virus (HBV) infectionbefore starting to take Emtricitabina/tenofovir disoproxil Krka d.d.. If you have an HBV infection, there is a serious risk of liver problems if you stop taking Emtricitabina/tenofovir disoproxil Krka d.d., whether or not you have HIV. It is important that you do not stop taking Emtricitabina/tenofovir disoproxil Krka d.d. without talking to your doctor: see section 3, Do not stop taking Emtricitabina/tenofovir disoproxil Krka d.d..
• Tell your doctor if you are over 65 years of age.Emtricitabina/tenofovir disoproxil Krka d.d. has not been studied in patients over 65 years of age.
• Tell your doctor if you are lactose intolerant(see Emtricitabina/tenofovir disoproxil Krka d.d. contains lactose later in this section). Children and adolescentsEmtricitabina/tenofovir disoproxil Krka d.d. is not indicated in children under 12 years of age. Other medicines and Emtricitabina/tenofovir disoproxil Krka d.d.Do not take Emtricitabina/tenofovir disoproxil Krka d.d.if you are already taking other medicines that

contain the components of Emtricitabina/tenofovir disoproxil Krka d.d. (emtricitabina and tenofovir
disoproxil) or any other antiviral medicine that contains tenofovir alafenamide, lamivudine or
adefovir dipivoxil.

Taking Emtricitabina/tenofovir disoproxil Krka d.d. with other medicines that candamage 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 check your kidney function more closely. 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 Krka d.d. with other medicines that containdidanosine (for the treatment of HIV infection):Taking Emtricitabina/tenofovir disoproxil Krka d.d. with other antiviral medicines that contain didanosine may increase the level of didanosine in the blood and may reduce the CD4 cell count. Cases of pancreatitis and lactic acidosis (excess lactic acid in the blood), which sometimes cause death, have been rarely 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 Krka d.d. with food and drink

• Whenever possible, Emtricitabina/tenofovir disoproxil Krka d.d. should be taken with food .Pregnancy and breastfeedingIf you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.If you have already taken Emtricitabina/tenofovir disoproxil Krka d.d. during pregnancy, your doctor may require 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 outweighed the risk of side effects.
• Do not breastfeed while taking Emtricitabina/tenofovirdisoproxil Krka d.d..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 through breast milk.
• If you are breastfeeding or are thinking about breastfeeding, you should talk to your doctor assoon as possible.
• Driving and operating machineryEmtricitabina/tenofovir disoproxil Krka d.d. can cause dizziness. If you experience dizziness while taking Emtricitabina/tenofovir disoproxil Krka d.d., do not driveand do not use tools or machinery.

Emtricitabina/tenofovir disoproxil Krka d.d. contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact him before taking
this medicine.

Emtricitabina/tenofovir disoproxil Krka d.d. contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
sodium-free.

3. How to take Emtricitabina/tenofovir disoproxil Krka d.d.

• Take this medicine exactly as your doctor has told you.If you are unsure, ask your doctor or pharmacist.

The recommended dose of Emtricitabina/tenofovir disoproxil Krka d.d. is:

• Adults:one tablet each day, when possible taken with food.
• Adolescents aged between 12 and 18 years with a weight of 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 approximately 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 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.
• Your doctor will prescribe Emtricitabina/tenofovir disoproxil Krka d.d. with other medicines

to take these medicines.
Ask your doctor if you have questions about how to avoid contracting HIV or preventing the transmission
of HIV to others.

If you take more Emtricitabina/tenofovir disoproxil Krka d.d. than you should
If you accidentally take a dose of Emtricitabina/tenofovir disoproxil Krka d.d. higher than that
recommended, contact your doctor or the nearest emergency room. Bring the tablet bottle with you
so you can easily describe what you have taken.

If you forget to take Emtricitabina/tenofovir disoproxil Krka d.d.
It is important not to miss doses of Emtricitabina/tenofovir disoproxil Krka d.d..

• If you realise this within 12 hoursof the usual time of taking Emtricitabina/tenofovir disoproxil Krka d.d., take the tablet, preferably with food, as soon as possible.

Then take your next dose at the scheduled time.

• If you realise this 12 hours or more afterthe usual time of taking Emtricitabina/tenofovir disoproxil Krka d.d., do not take the missed dose. Wait and take your next dose, preferably with food, at the scheduled time. If vomiting occurs within 1 hour of taking Emtricitabina/tenofovir disoproxilKrka d.d.,take another tablet. You do not need to take another tablet if you have vomited more than one hour after taking Emtricitabina/tenofovir disoproxil Krka d.d.. If you stop taking Emtricitabina/tenofovir disoproxil Krka d.d.
• Stopping treatment may reduce the effects of the anti-HIV therapy prescribed by your doctor. → Do not stop treatment with Emtricitabina/tenofovir disoproxil Krka d.d. withoutcontacting your doctor.
• If you have hepatitis B, it is particularly important not to stop treatment with Emtricitabina/tenofovir disoproxil Krka d.d. 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 worsening of hepatitis, which can be potentially fatal.
• Tell your doctor immediatelyabout any new or unusual symptoms you experience after stopping treatment, particularly symptoms that are normally 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 of nausea, 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 body tissue, can also occur after starting to take medicines to treat HIV infection. The

autoimmune disorders can occur many months after starting treatment. Pay
attention to the appearance of 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)
• diarrhea, vomiting, nausea
• dizziness, headache
• skin rash
• feeling of weakness, muscle weakness Tests may also show:
• decreases in blood phosphate
• 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 of fullness, intestinal gas
• rashes (including red spots or pustules sometimes with blisters and swelling of the skin), which may be an allergic reaction, burning, change 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 prone to infection)
• increased triglycerides (fatty acids), bile or glucose in the blood
• problems with 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
• 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 or eyes, itching or abdominal pain caused by inflammation of the liver
• inflammation of the kidneys, abundant urine and feeling of 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 above side effects or if any of them becomes serious,see 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 tissue death caused by a lack of blood supply to the bone). Taking this type of medicine for a prolonged period, taking corticosteroids, alcohol, a severely weakened 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, see your doctor.

During treatment for HIV, weight and lipid and glucose levels 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 experienced changes in skin color including
• the appearance of dark patches on the skin
• Children have commonly experienced a low red blood cell count (anemia)
• this 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 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 Krka d.d.

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 pack after Exp. The expiry date refers to the last day of that month.

Blister
Do not store above 30°C. Store in the original blister pack to protect the
medicine from moisture and light.

Bottle
Do not store above 30°C. Keep the bottle tightly closed to protect the
medicine from moisture and light.
Shelf life after first opening of the bottle: 2 months.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Emtricitabina/tenofovir disoproxil Krka d.d. contains

• The active substances are emtricitabine and tenofovir disoproxil. Each tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300.7 mg of tenofovir disoproxil succinate or 136 mg of tenofovir).
• The other excipients are: Tablet core: pregelatinized starch, sodium croscarmellose, lactose monohydrate, microcrystalline cellulose, sodium stearyl fumarate, stearic acid. Film coating: hypromellose 5 cP, titanium dioxide (E171), macrogol, indigo carmine aluminum lake (E132). See section 2 "Emtricitabina/tenofovir disoproxil Krka d.d. contains lactose", see section 2 "Emtricitabina/tenofovir disoproxil Krka d.d. contains sodium".

Description of the appearance of Emtricitabina/tenofovir disoproxil Krka d.d. and contents of the pack
Emtricitabina/tenofovir disoproxil Krka d.d. film-coated tablets (tablets) are blue, oval, biconvex tablets with dimensions of 20 mm x 10 mm.
Emtricitabina/tenofovir disoproxil Krka d.d. is available in cartons containing blisters of 28 x 1 and 84
film-coated tablets.
Emtricitabina/tenofovir disoproxil Krka d.d. is also available in bottles of 30 tablets, with a
child-resistant tamper-evident closure in polypropylene with a silica gel desiccant,
which serves to protect the tablets. The following formats are available: a carton containing 1 bottle
of 30 film-coated tablets and 90 (3 bottles of 30) film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62

Lietuva
UAB KRKA Lietuva
Tel: + 370 5 236 27 40

България
КРКА България ЕООД
Teл.: + 359 (02) 962 34 50

Luxembourg/Luxemburg
KRKA Belgium, SA.
Tél/Tel: + 32 (0) 487 50 73 62 (BE)

Česká republika
KRKA ČR, s.r.o.
Tel: + 420 (0) 221 115 150

Magyarország
KRKA Magyarország Kereskedelmi Kft.
Tel.: + 36 (1) 355 8490

Danmark
KRKA Sverige AB
Tlf.: + 46 (0)8 643 67 66 (SE)

Malta

• E. J. Busuttil Ltd. Tel: + 356 21 445 885

Deutschland
TAD Pharma GmbH
Tel: + 49 (0) 4721 606-0

Nederland
KRKA Belgium, SA.
Tel: + 32 (0) 487 50 73 62 (BE)

Eesti
KRKA, d.d., Novo mesto Eesti filiaal
Tel: + 372 (0) 6 671 658

Norge
KRKA Sverige AB
Tlf: + 46 (0)8 643 67 66 (SE)

Ελλάδα
KRKA ΕΛΛΑΣ ΕΠΕ
Τηλ: + 30 2100101613

Österreich
KRKA Pharma GmbH, Wien
Tel: + 43 (0)1 66 24 300

España
KRKA Farmacéutica, S.L.
Tel: + 34 911 61 03 80

Polska
KRKA-POLSKA Sp. z o.o.
Tel.: + 48 (0)22 573 7500

France
KRKA France Eurl
Tél: + 33 (0)1 57 40 82 25

Portugal
KRKA Farmacêutica, Sociedade Unipessoal Lda.
Tel: + 351 (0)21 46 43 650

Hrvatska
KRKA - FARMA d.o.o.
Tel: + 385 1 6312 101

România
KRKA Romania S.R.L., Bucharest
Tel: + 4 021 310 66 05

Ireland
KRKA Pharma Dublin, Ltd.
Tel: + 353 1 413 3710

Slovenija
KRKA, d.d., Novo mesto
Tel: + 386 (0) 1 47 51 100

Ísland
LYFIS ehf.
Sími: + 354 534 3500

Slovenská republika
KRKA Slovensko, s.r.o.
Tel: + 421 (0) 2 571 04 501

Italia
KRKA Farmaceutici Milano S.r.l.
Tel: + 39 02 3300 8841

Suomi/Finland
KRKA Finland Oy
Puh/Tel: +358 20 754 5330

Κύπρος
KI.PA. (PHARMACAL) LIMITED
Τηλ: + 357 24 651 882

Sverige
KRKA Sverige AB
Tel: + 46 (0)8 643 67 66 (SE)

Latvija
KRKA Latvija SIA
Tel: + 371 6 733 86 10
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu .