Package Leaflet: Information for the User

Atazanavir Teva 300 mg Hard Capsules EFG

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

• Keep this leaflet, as 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 give it to others even if they have similar symptoms to you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Atazanavir Teva and what it is used for

2.What you need to know before you start taking Atazanavir Teva

3.How to take Atazanavir Teva

4.Possible side effects

5.Storage of Atazanavir Teva

6. Contents of the pack and additional informationl

Atazanavir is an antiviral (or antiretroviral) medication.It belongs to a group of medications calledprotease inhibitors.These medications control the Human Immunodeficiency Virus (HIV) infection by paralyzing a protein that the virus needs to multiply. It acts by reducing the amount of HIV in your body and this in turn strengthens your immune system. In this way, atazanavir reduces the risk of developing diseases associated with HIV infection.

Atazanavir capsules can be used in adults and children six years of age and older. Your doctor has prescribed atazanavir due to the infection caused by the HIV virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is normally used in combination with other antiretroviral medications. Your doctor will determine the best combination for you of atazanavir with these medications.

Do not take Atazanavir Teva:

• if you are allergicto atazanavir or to any of the other ingredients of this medicine (listed in section 6).
• if you have moderate to severe liver problems.Your doctor will assess the severity of your liver disease before deciding if you can takeatazanavir.
• if you are taking any of the following medicines:see alsoTaking Atazanavir Teva with other medicines
• • rifampicin (an antibiotic used to treat tuberculosis).

• astemizol or terfenadine (used commonly to treat allergic symptoms, these medicines may be available without a prescription); cisaprida (used to treat gastroesophageal reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidina or bepridil (used to correct heart rhythm); ergotamine, dihidroergotamina, ergonovina, metilergonovina (used to treat headaches); and alfuzosina (used to treat benign prostatic hyperplasia).
• quetiapina (used to treat schizophrenia, bipolar disorder, and major depressive disorder), lurasidona (used to treat schizophrenia).
• medicines that contain St. John's Wort (Hypericum perforatum,a medicinal plant).
• triazolam and midazolam oral (administered by mouth) (used to induce sleep and/or relieve anxiety).
• lomitapida, simvastatina, and lovastatina (used to lower cholesterol in the blood).
• medicines that contain grazoprevir, including the fixed-dose combination of elbasvir/grazoprevir and the fixed-dose combination of glecaprevir/pibrentasvir (used to treat chronic hepatitis C).
• apalutamida (used to treat prostate cancer),encorafenib (used to treat cancer) and ivosidenib (used to treat cancer).
• carbamazepina, fenobarbital, and fenitoína (used to treat seizures).

• Do not take sildenafil withatazanavirwhen sildenafil is used to treat pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. Inform your doctor if you are taking sildenafil for erectile dysfunction.
• Inform your doctor if you are in any of these situations.
• Advertencias and precautions
• Atazanaviris not a cure for HIV infection.You may continue to develop infections or other diseases associated with HIV infection.
• Some people may need special monitoring before or during treatment withatazanavir. Consult your doctor or pharmacist before starting to takeatazanavir, ensure that your doctor knows:
• if you have hepatitis B or C
• if you develop signs or symptoms of gallstones (pain in the right side of your stomach)
• if you have hemophilia type A or B
• if you need to undergo hemodialysis
• Atazanavir Teva may affect the way your kidneys work.
• There have been cases of kidney stones in patients treated with atazanavir. If you experience signs or symptoms of kidney stones (side pain, blood in the urine, pain while urinating), please inform your doctor immediately.
• In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of previous infections may appear shortly after starting antiretroviral treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight off infections that were present without apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medications for HIV treatment. Autoimmune disorders may appear many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.
• Some patients receiving combined antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the numerous risk factors for developing this disease are the duration of combined antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. The symptoms of osteonecrosis are joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, please inform your doctor.
• Hyperbilirubinemia (elevated bilirubin levels in the blood) has been reported in patients receiving atazanavir. The signs may be a slightly yellowish skin or eye tone. If you notice any of these symptoms, please inform your doctor.
• Severe skin rash, including Stevens-Johnson syndrome, has been observed in patients treated with atazanavir. Inform your doctor immediately if you develop a rash.
• If you notice a change in the way your heart beats (changes in heart rhythm), please inform your doctor.
• Children receiving Atazanavir Teva may require their heart to be monitored. Your doctor will decide this.
• Children
• Do not administer this medicine to children under 3 months of age and weighing less than 5 kg. Atazanavir Teva has not been studied in children under 3 months of age and weighing less than 5 kg due to the risk of serious complications.
• Taking Atazanavir Teva with other medicines
• You should not take atazanavir with certain medicines.These are listed under the titleDo not take Atazanavir Tevaat the beginning of section 2.
• There are other medicines that cannot be mixed withatazanavir. Inform your doctor if you are taking, have taken recently, or may need to take any other medicine. It is especially important to mention the use of the following:
• other medicines for the treatment of HIV infection (e.g. indinavir, nevirapina, and efavirenz)
• sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C)
• sildenafil, vardenafilo, or tadalafilo (used by men to treat erectile dysfunction)
• if you are taking an oral contraceptive ("the pill") withatazanavir, to avoid pregnancy, ensure that you take it exactly as your doctor has instructed and do not miss any doses
• some medicines used to treat acid-related diseases (e.g. antacids that should be administered 1 hour before taking atazanavir or 2 hours after taking atazanavir, H2 blockers such as famotidina, or proton pump inhibitors such as omeprazol)
• medicines to lower blood pressure, slow heart rate, or correct heart rhythm (amiodarona, diltiazem, lidocaína systemic, verapamilo)
• atorvastatina, pravastatina, and fluvastatina (used to lower cholesterol in the blood)
• salmeterol (used to treat asthma)
• ciclosporina, tacrolimus, and sirolimus (medicines to reduce the effects of the body's immune system)
• certain antibiotics (rifabutina, claritromicina)
• ketoconazol, itraconazol, and voriconazol (antifungals)
• apixaban, dabigatran, edoxaban, rivaroxaban, warfarina, clopidogrel, prasugrel, and ticagrelor (used to reduce blood clots)
• lamotrigina (antiepileptic)
• irinotecan (used to treat cancer)
• elagolix (antagonists of the gonadotropin-releasing hormone receptor, used to treat intense endometriosis pain)
• fostamatinib (used to treat chronic immune thrombocytopenia)
• sedatives (e.g. midazolam administered by injection)
• buprenorfina (used to treat opioid addiction and pain)
• corticosteroids (all routes of administration; including dexametasona).
• Some medicines may interact with ritonavir, a medicine that is administered withatazanavir. It is essential to inform your doctor if you are using an inhaled or nasal corticosteroid (administered via the nose), including fluticasona or budesonida (administered to treat asthma or allergic symptoms).
• Taking Atazanavir Teva with food and drinks
• It is essential to takeatazanavirwith food (a meal or snack) as this helps the absorption of the medicine.
• Pregnancy and breastfeeding
• If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
• Atazanavir, the active ingredient of Atazanavir Teva, is excreted in human breast milk. Patients should not breastfeed while takingatazanavir.
• It is not recommended that women with HIV infection breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor as soon as possible.
• Driving and operating machines
• If you feel dizzy or disoriented, do not drive or operate machines, and contact your doctor immediately.
• Atazanavir Teva contains lactose.
• This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again. In this way, you can be sure that the treatment is completely effective and reduces the risk of the virus developing resistance to treatment.

The recommended dose of atazanavir capsules for adults is 300 mg along with 100 mg of ritonavir once a day and with food,in combination with other antiretroviral medications. Your doctor will adjust the dose of atazanavir according to your antiretroviral therapy.

For children (from 6 to under 18 years of age), your doctor will decide on the correct dose based on your child's weight.The dose of atazanavir capsules for children is calculated by body weight and is taken once a day with food and 100 mg of ritonavir as shown below:

Atazanavir is also available as an oral powder for use in children at least 3 months old and at least 5 kg in weight. It is recommended to switch from atazanavir oral powder to atazanavir capsules as soon as patients are able to swallow the capsules properly.

When switching between oral powder and capsules, a dose change may be necessary. Your doctor will decide on the correct dose based on your child's weight.

There are no recommended doses for atazanavir in pediatric patients under 3 months of age.

TakeAtazanavir Tevacapsules with food(a meal or snack). The capsules must be swallowed whole.Do not open the capsules.

If you take moreAtazanavir Tevathan you should

If you or your child take too much atazanavir, the skin and/or eyes may turn yellow (jaundice) and irregular heartbeats (QTc prolongation) may occur.

If you have accidentally taken more atazanavir capsules than your doctor prescribed, contact your doctor immediately or go to the nearest hospital for consultation or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forget to takeAtazanavir Teva

If you have forgotten to take a dose, try to take it as soon as possible with some food and then continue your treatment normally. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at your usual time.Do not take a double dose to make up for the missed doses.

If you interrupt treatment withAtazanavir Teva

Do not stop treatment with atazanavir before consulting your doctor.

If you have any other doubts about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.During treatment for HIV infection, it is not always easy to identify side effects caused by atazanavir, those caused by any other medicine you are taking at the same time, or those due to the HIV infection itself. For this reason, inform your doctor of any change you notice in your health status.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medicines themselves. Your doctor will monitor these changes.

Inform your doctor immediately if you develop any of the following severe side effects:

• There have been reports of skin rash, occasional itching that can be severe. The rash usually disappears in 2 weeks without changing your atazanavir treatment. A severe rash associated with other symptoms that can be severe may develop. Discontinue atazanavir treatment and inform your doctor immediately if you develop a severe rash or a rash with symptoms similar to the flu, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation that causes redness (conjunctivitis), painful, hot, or red nodules.
• There have been frequent reports of yellowing of the skin or the white part of the eyes caused by high levels of bilirubin in the blood. This side effect is usually not dangerous in adults and children over 3 months of age; but it may be a sign of a serious problem. If your skin or the white part of your eyes turns yellow, inform your doctor immediately.
• Occasionally, changes in the way your heart beats (cardiac rhythm changes) may occur. Inform your doctor immediately if you feel dizzy, lightheaded, or if you suddenly faint. These may be symptoms of a serious heart problem.
• Liver problems may occur occasionally. Your doctor should perform blood tests before starting atazanavir treatment and during treatment. If you have liver problems, including hepatitis B or C infection, you may experience worsening of your liver problems. Inform your doctor immediately if your urine becomes dark (tea-colored), you have itching, your skin or the white part of your eyes turns yellow, you have stomach pain, pale stools, or nausea.
• Occasionally, gallbladder problems occur in people taking atazanavir. Symptoms of gallbladder problems may include pain in the upper right or middle part of the stomach, nausea, vomiting, fever, or yellowing of the skin or the white part of the eyes.
• Atazanavir Teva may affect the way your kidneys work.
• Occasionally, kidney stones occur in people taking atazanavir. Inform your doctor immediately if you have symptoms of kidney stones, which may include pain in the lower back or lower abdomen, blood in the urine, or pain while urinating.

Other side effects reported in patients treated with atazanavir are the following:

Frequent (may affect up to 1 in 10 people)

• headache
• vomiting, diarrhea, abdominal pain (stomach pain or discomfort), nausea, indigestion
• fatigue (extreme tiredness)

Rare (may affect up to 1 in 100 people)

• peripheral neuropathy (numbness, weakness, tingling, or pain in the arms and legs)
• hypersensitivity (allergic reaction)
• asthenia (unusual tiredness or weakness)
• weight loss, weight gain, anorexia (loss of appetite), increased appetite
• depression, anxiety, sleep disturbance
• disorientation, amnesia (memory loss), dizziness, somnolence (drowsiness), abnormal dreams
• syncope (fainting), hypertension (high blood pressure)
• shortness of breath
• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and herpes labialis), dysgeusia (alteration of the sense of taste), flatulence, dry mouth, abdominal distension
• angioedema (severe swelling of the skin and other tissues, usually the lips or eyes)
• urticaria (hives), alopecia (abnormal hair loss or weakening), pruritus (itching)
• muscle atrophy (muscle contraction), arthralgia (joint pain), myalgia (muscle pain)
• interstitial nephritis (inflammation of the kidney), hematuria (blood in the urine), proteinuria (excess protein in the urine), polyuria (increased frequency of urination)
• gynecomastia (breast enlargement in men)
• chest pain, discomfort (feeling unwell), fever
• insomnia (difficulty sleeping)

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

• gait disturbance (abnormal walking)
• edema (swelling)
• hepatosplenomegaly (enlargement of the liver and spleen)
• myopathy (muscle pain, weakness, loss of muscle tone not caused by exercise)
• renal pain

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the outer packaging, bottle, or blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofAtazanavir Teva

• The active ingredient is atazanavir.

Each hard capsule contains atazanavir sulfate corresponding to 300 mg of atazanavir.

• The other components of the capsule filling are crospovidone, lactose monohydrate, and magnesium stearate.
• The other components of the capsule coating are gelatin, indigotin (E132), titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172)
• The other components of the printing ink are shellac, iron oxide black (E172), propylene glycol (E1520), and concentrated ammonium solution 28%.

Appearance of the product and contents of the package

Atazanavir Teva 300 mg hard capsules are non-transparent size 00 capsules with a total closed length of 23.3±0.3 mm with a blue cap and the mark 300 in black on the blue body. The capsule contents are light yellow powder.

Atazanavir Teva 300 mg in blisters is available in packaging sizes of 30, 30x1, 60, and 90 capsules.

Atazanavir Teva 300 mg in bottles is available in packaging sizes of 30, 90 (3x30) capsules and in multiple packaging containing 3 boxes each containing 30 capsules.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid.

Responsible manufacturer

TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company)

Debrecen, Pallagi út 13,

H-4042, Hungary

Teva Operations Poland Sp. z.o.o

ul. Mogilska 80. Cracow

31-546, Poland

TEVA PHARMA S.L.U.

C/C, n. 4, Poligono Industrial Malpica, Zaragoza

50016,Spain

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)

Prilaz baruna Filipovica 25, Zagreb

10000, Croatia

Last review date of this leaflet:November 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).