300 mg / 150 mg film-coated tablets 
atazanavir / cobicistat

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What EVOTAZ is and what it is used for 
2. What you need to know before taking EVOTAZ 
3. How to take EVOTAZ 
4. Possible side effects 
5. How to store EVOTAZ 
6. Contents of the packaging and other information 

1. What EVOTAZ is and what it is used for

EVOTAZ contains two active substances:

  • atazanavir, an antiviral (or antiretroviral) medicine. It belongs to a group called protease inhibitors. This drug controls the Human Immunodeficiency Virus ( HIV ) – infection, by stopping the production of a protein that HIV – the virus et needs to multiply. It works by reducing the number of HIV – the virus in the blood and this, in turn, strengthens your immune system. This reduces EVOTAZ’s risk of diseases associated with HIV, which will be developed.
  • cobicistat, an enhancer ( pharmacokinetic enhancer) that helps to improve the effects of atazanavir. Cobicistat, do not treat your HIV – infection, but enhances the levels of atazanavir in the blood, by atazanavir is broken down more slowly and therefore stays in the body longer.

EVOTAZ can be used by adults over 18 who are infected with HIV – the virus that can cause acquired immunodeficiency syndrome ( AIDS ). It is used in combination with other anti- HIV medicines to help control your HIV infection. Your doctor will discuss with you which combinations of these medicines together with EVOTAZ are best for you.

2. What you need to know before taking EVOTAZ

Do not take EVOTAZ:

  • if you are allergic to atazanavir, cobicistat, or any of the other ingredients of this medicine (listed in section 6).
  • if you have moderate to severe liver problems
  • if you are taking any of these medicines: see also Using other medicines with EVOTAZ
    • rifampicin (an antibiotic used to treat tuberculosis )
    • carbamazepine, phenobarbital, and phenytoin ( antiepileptic drugs used to prevent seizures)
    • astemizole or terfenadine (often used to treat allergic symptoms, these medications may be over-the-counter); cisapride (used to treat acid reflux (heartburn)); pimozide (used to treat schizophrenia); amiodarone, dronedarone, quinidine, lidocaine (for injection ), or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, ergometrine and methylergonovine (used to treat headaches) and alfuzosin (used to treat prostate enlargement).
    • quetiapine (used to treat schizophrenia, bipolar disorder, and major depression); lurasidone (used to treat schizophrenia).
    • medicines containing St. John’s wort ( Hypericum perforatum, a herbal medicine).
    • triazolam and orally (taken by mouth) midazolam (used as a sleeping pill and/or to reduce anxiety).
    • simvastatin, lovastatin, and lomitapide (used to lower blood cholesterol).
    • avanafil (used to treat erectile dysfunction )
    • colchicine (used to treat gout ), if you have kidney and/or liver problems
    • dabigatran and ticagrelor (used to prevent and prevent blood clots)
    • grazoprevir-containing products, including fixed-dose combinations of elbasvir and grazoprevir, as well as fixed-dose combinations of glekaprevir and pibrentasvir (used to treat chronic hepatitis C infection )

Do not take sildenafil with EVOTAZ when sildenafil is used to treat pulmonary arterialhypertension. Sildenafil is also used to treat erectile dysfunction. Tell your doctor if you are using sildenafil to treat erectile dysfunction.

Tell your doctor immediately if this applies to you.

Warnings and cautions

For some people, special consideration may need to be given before or when taking EVOTAZ. Talk to your doctor or pharmacist before taking EVOTAZ.

EVOTAZ is not a cure for HIV – infection. You can continue to develop infections or diseases associated with HIV. You can still transmit HIV to other people when you take this medicine, even though the risk of effective antiviral treatment is reduced. Discuss with your doctor the necessary steps to avoid infecting others.

Make sure your doctor knows the following:

  • if you have liver problems
  • if you develop signs or symptoms of gallstones (pain in the right side). Gallstones have been reported in patients taking atazanavir, one of the substances in EVOTAZ.
  • if you have hemophilia A or B. You may notice increased bleeding.
  • if you have kidney problems or need hemodialysis. Kidney stones have been reported in patients taking atazanavir, a substance in EVOTAZ. Tell your doctor immediately if you develop signs and symptoms of kidney stones (pain in the side, blood in the urine, pain when urinating).
  • if you are taking contraceptives ( birth control pills ) to prevent pregnancy. If you are currently using birth control pills or hormone patches to prevent pregnancy, you should use another type of contraceptive (such as a condom).

In some patients with advanced HIV – infection ( AIDS ) and a history of opportunistic infection, you ( the infection that occurs due to the immune system is impaired), signs and symptoms of inflammation from previous infections may occur soon after anti- HIV started. These symptoms are probably due to an improvement in the body’s immune response, which enables the body to fight infections that may have been present without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection. In addition to opportunistic infection, you can autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines to treat your HIV – infection. Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, a weakness that starts in the hands or feet and moves to the torso, palpitations, tremors, or hyperactivity, inform your doctor immediately for the necessary treatment.

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue dies due to lost blood supply to the bone). Some of the many risk factors for developing the disease are long-term antiretroviral combination therapy, use of corticosteroids, alcohol consumption, a severe weakening of the immune system, and higher body mass index. Signs of osteonecrosis are stiffness in the joints and pain (especially in the hip, knee, and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.

Increased levels of bile dye in the blood (hyperbilirubinemia) have occurred in patients receiving EVOTAZ. Signs of this may be a mild yellowing of the skin or eyes. Tell your doctor if you experience any of these symptoms.

Severe rash including Stevens-Johnson syndrome has been reported in patients taking EVOTAZ. Tell your doctor immediately if you develop a skin rash.

EVOTAZ can affect how well your kidneys work.

If you find that your heart beats differently (changes in your heart rhythm), tell your doctor.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age. The use of EVOTAZ has not been studied in children and adolescents.

Other medicines and EVOTAZ

You must not take EVOTAZ with certain medicines. These are listed under Do not take EVOTAZ, at the beginning of section 2.

Other medicines may not be taken together or may require a change in their route of administration when taken with EVOTAZ. Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important to mention these:

  • medicines containing ritonavir or cobicistat (enhancer)
  • other medications for treating HIV – infection (for example, indinavir, didanosine, tenofovir disoproxil, tenofoviralafenamid, efavirenz, etravirine, nevirapine, and maraviroc)
  • sofosbuvir / velpatasvir / voxilaprevir (used to treat hepatitis C)
  • sildenafil, vardenafil, and tadalafil (used by men to treat impotence [erectile dysfunction])
  • if you are taking contraceptives ( birth control pills ). You should also use another type of contraceptive (such as a condom).
  • medicines used to treat diseases related to stomach acid (“heartburn”) (eg antacids, H 2 blockers like famotidine, and proton pump inhibitors like omeprazole)
  • disopyramide, flecainide, mexiletine, propafenone, digoxin, bosentan, amlodipine, felodipine, nicardipine, nifedipine, verapamil, diltiazem, metoprolol, and timolol (medicines that lower blood pressure, lower or correct heart rhythm)
  • atorvastatin, pravastatin, fluvastatin, pitavastatin and rosuvastatin (used to lower blood cholesterol)
  • salmeterol (used to treat asthma )
  • ciclosporin, tacrolimus, and sirolimus (medicines that reduce the effects of the body’s immune system)
  • certain antibiotics (rifabutin, clarithromycin)
  • ketoconazole , itraconazole, voriconazole and fluconazole (antifungals)
  • metformin (used to treat type 2 diabetes )
  • warfarin , apixaban, edoxaban and rivaroxaban (used to prevent blood clots)
  • irinotecan, dasatinib, nilotinib, vinblastine and vincristine (used to treat cancer)
  • trazodone (used to treat depression)
  • perphenazine, risperidone, thioridazine, midazolam (given as an injection ), buspirone, clorazepate, diazepam, estazolam, flurazepam, and zolpidem (used to treat diseases of the nervous system)
  • buprenorphine (used to treat opioid dependence and as an analgesic)

It is important to tell your doctor if you are taking: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone. These medicines are used to treat allergies, asthma, inflammatory bowel diseases, inflammation of the eyes, joints, and muscles, and other inflammatory diseases. If there are no alternatives, the drug should be used only after a doctor’s evaluation and under the close supervision of your doctor for side effects caused by corticosteroids.

Pregnancy and breastfeeding

EVOTAZ should not be used during pregnancy, as the drug level in your blood may be lower during pregnancy and may not be high enough to control HIV. Your doctor may prescribe other medicines if you become pregnant while taking EVOTAZ.

Atazanavir, an active substance in EVOTAZ, passes into breast milk. It is not known whether cobicistat, the other active substance in EVOTAZ, passes into breast milk, but it has been shown to pass into the milk of animals. Tell your doctor that you are breastfeeding if you are taking EVOTAZ. Patients should not breast-feed while taking EVOTAZ. It is recommended that women infected with HIV do not breast-feed as the virus can be transmitted through breast milk.

Driving and using machines

Some patients have reported dizziness after taking atazanavir and cobicistat, the active substances of EVOTAZ. Do not drive or use machines if you feel dizzy or dizzy. Contact your doctor immediately.

3. How to take EVOTAZ

Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure. In this way, you can be sure that you get the full effect of your medication and reduce the risk of HIV – the virus et develop resistance to the treatment.

The recommended dose for adults of EVOTAZ is one tablet daily with food, in combination with other anti- HIV medicines. The tablets have a bad taste, so swallow the tablet whole; do not crush or chew the tablets. This will help you make sure you get the full dose.

If you take more EVOTAZ than you should

If you accidentally take more EVOTAZ than your doctor has recommended, contact your HIV doctor immediately or contact your nearest hospital for advice.

If you forget to take EVOTAZ

If you forget to take a dose of EVOTAZ and discover it within 12 hours, take it with food as soon as possible and then take the next dose at the usual time. If you miss a dose and it is more than 12 hours since you should take EVOTAZ, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose the next time. It is important not to forget to take any dose of EVOTAZ or your other anti- HIV medicine.

If you stop taking EVOTAZ

Do not stop taking EVOTAZ before talking to your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you notice anything unusual about your health.

The following side effects may occur with EVOTAZ

Very common (may affect more than 1 user in 10)

  • yellowing of the skin or whites of the eyes
  • nausea

Common (may affect up to 1 in 10 users)

  • increased levels of bilirubin in the blood
  • vomiting, diarrhea, stomach pain or discomfort, regurgitation, distended abdomen, gas ( flatulence )
  • headache, dizziness
  • extreme fatigue
  • increased appetite, impaired sense of taste, dry mouth
  • difficulty sleeping, abnormal dreams, fatigue
  • rash

Uncommon (may affect up to 1 in 100 people)

  • life-threatening irregular heartbeat ( torsade de pointes )
  • allergic reaction (hypersensitivity)
  • inflammation of the liver
  • pancreatitis, gastritis
  • allergic reactions with rash, high fever, increased levels of liver enzymes in blood samples, increased levels of white blood cells ( eosinophilia ) and/or enlarged lymph nodes ) (see section 2)
  • severe swelling of the skin and other tissues usually your lips or eyes
  • fainting, high blood pressure
  • chest pain, malaise, fever
  • respiratory distress
  • kidney stone disease, kidney inflammation, blood in the urine, increased amount of protein in the urine, more frequent urination, chronic kidney disease (how well your kidneys are working)
  • gallstones ar
  • muscle wasting, joint pain, muscle pain
  • breast augmentation in men
  • depression, anxiety, sleep disturbance
  • abnormal fatigue or weakness
  • loss of appetite, weight loss, weight gain
  • disorientation, memory loss
  • numbness, weakness, tingling, or pain in the arms and legs
  • cold sores and colds
  • itchy rash, abnormal hair loss or thinning, itching

Rare (may affect up to 1 in 1,000 users)

  • allergic reactions with severe skin rash, high fever, and enlarged lymph nodes(Stevens-Johnson syndrome, see section 2).
  • fast or irregular heartbeat (QTc prolongation)
  • enlargement of the liver and spleen
  • gallbladder inflammation
  • kidney pain
  • swelling
  • visible accumulation of fluid under the skin, rash, vasodilation
  • abnormal gait
  • muscle pain, muscle weakness not caused by exercise

During HIV treatment, weight gain and increased levels of fats and sugar in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood fats, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

5. How to store EVOTAZ

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substances are atazanavir and cobicistat. Each film-coated tablet contains 300 mg of atazanavir (as sulfate) and 150 mg of cobicistat.
  • Other ingredients are:
    • Tablet core – microcrystalline cellulose (E460 (i)), croscarmellose sodium (E468), sodium starch glycolate, crospovidone (E1202), stearic acid (E570), magnesium stearate (E470b), hydroxypropylcellulose (E463), silica (E463)
    • Film coating – hypromellose (hydroxypropyl methylcellulose, E464), titanium dioxide (E171), talc (E553b), triacetin (E1518), red iron oxide (E172)

What the medicine looks like and the contents of the pack

EVOTAZ film-coated tablets are pink, oval, biconvex, measuring 19 mm x 10.4 mm, debossed with “3641” on one side, and flat on the other side of the tablet.

EVOTAZ film-coated tablets are packaged in bottles of 30 tablets. The following pack sizes are available: an outer carton of 1 bottle of 30 film-coated tablets and an outer carton of 90 (3 bottles of 30) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bristol-Myers Squibb Pharma EEIG

Plaza 254 
Blanchardstown Corporate Park 2 
Dublin 15, D15 T867

Ireland

Manufacturer

CATALENT ANAGNI SRL

Loc. Fontana del Ceraso snc

Provincial Street 12 Casilina, 41

03012 Anagni (FR)

Italy

Swords Laboratories T / A Bristol-Myers Squibb Pharmaceutical Operations,

External Manufacturing

Plaza 254

Blanchardstown Corporate Park 2

Dublin 15, D15 T867

Ireland

Contact the representative of the marketing authorization holder to find out more about this medicine.

Belgique / België / BelgienNV Bristol ‑ Myers Squibb Belgium SATel: + 32 2 352 76 11 LithuaniaBristol-Myers Squibb Kft.Tel: + 370 5 236 9140
BulgariaBristol ‑ Myers Squibb Kft.Tel: + 359 2 4942 480 Luxembourg / LuxemburgNV Bristol ‑ Myers Squibb Belgium SATel: + 32 2 352 76 11
Czech RepublicBristol ‑ Myers Squibb spol. s roTel: + 420 221 016 111 HungaryBristol-Myers Squibb Kft.Tel: + 36 1 9206 550
DenmarkBristol ‑ Myers SquibbTel: + 45 45 93 05 06 MaltaBristol ‑ Myers Squibb SrlTel: + 356 23976333
GermanyBristol ‑ Myers Squibb GmbH & Co. KGaATel: 0800 0752002 (+49 (0) 89 121 42 350) The NetherlandsBristol ‑ Myers Squibb BVTel: + 31 (0) 30 300 2222
EestiBristol-Myers Squibb Kft.Tel: + 372 6401030 NorwayBristol ‑ Myers Squibb Norway LtdTel: + 47 67 55 53 50
GreeceBristol ‑ Myers Squibb AE:Ηλ: + 30 210 6074300 AustriaBristol ‑ Myers Squibb GesmbHTel: + 43 1 60 14 30
SpainBristol ‑ Myers Squibb, SATel: + 34 91 456 53 00 PolandBristol ‑ Myers Squibb Polska Sp. z ooTel .: + 48 22 2606400
FranceBristol ‑ Myers Squibb SARLTel: + 33 (0) 810 410 500 PortugalBristol ‑ Myers Squibb Pharmacêutica Portuguesa, SATel: + 351 21 440 70 00
CroatiaBristol ‑ Myers Squibb spol. s Rotel: +385 1 2078‑508 RomaniaBristol ‑ Myers Squibb Kft.Tel: + 40 (0) 21 272 16 00
IrelandBristol ‑ Myers Squibb Pharmaceuticals ucTel: + 353 (0) 1 483 3625 SloveniaBristol ‑ Myers Squibb spol. s roTel: + 386 1 2355 100
IcelandBristol-Myers Squibb AB at Visitor hf.Phone: + 354 535 7000 Slovak RepublicBristol ‑ Myers Squibb spol. s roTel: + 421 2 20833 600
ItalyBristol ‑ Myers Squibb SrlTel: + 39 06 50 39 61 Finland / FinlandOy Bristol ‑ Myers Squibb (Finland) AbPuh / Tel: + 358 9 251 21 230
LatviaBristol-Myers Squibb Kft.Tel: + 371 66164750 United KingdomBristol ‑ Myers Squibb Pharmaceuticals LtdTel: + 44 (0800) 731 1736

Muhammad Nadeem

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