ATAZANAVIR TEVA 300 mg HARD CAPSULES

2. What you need to know before you take Atazanavir Teva

Do not take Atazanavir Teva:

• if you are allergicto atazanavir or 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 take atazanavir.
• if you are taking any of the following medicines:also see Taking Atazanavir Teva with other medicines
• • rifampicin (an antibiotic used to treat tuberculosis).

• astemizole or terfenadine (commonly used to treat allergic symptoms, these medicines may be available without a prescription); cisapride (used to treat stomach reflux, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); and alfuzosin (used to treat enlarged prostate).
• quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder), lurasidone (used to treat schizophrenia).
• medicines that contain St. John's Wort (Hypericum perforatum, a herbal remedy).
• triazolam and midazolam oral (given by mouth) (used to induce sleep and/or relieve anxiety).
• lomitapide, simvastatin, and lovastatin (used to lower blood cholesterol).
• 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 infection).
• apalutamide (used to treat prostate cancer), encorafenib (used to treat cancer), and ivosidenib (used to treat cancer).
• carbamazepine, phenobarbital, and phenytoin (used to treat seizures).

Do not take sildenafil with atazanavir when sildenafil is used to treat pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. Inform your doctor if you are using sildenafil to treat erectile dysfunction.

Tell your doctor if you are in any of these situations.

Warnings and precautions

Atazanavir is not a cure for HIV infection. You may still develop infections or other illnesses associated with HIV infection.

Some people will need special checks before or during treatment with atazanavir. Tell your doctor or pharmacist before you start taking atazanavir, make sure 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 have hemodialysis

Atazanavir Teva may affect how your kidneys work.

There have been reports of kidney stones in patients treated with atazanavir. If you have signs or symptoms of kidney stones (side pain, blood in the urine, pain when urinating), tell your doctor immediately.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body's immune response, enabling it to fight infections that have been present without any obvious symptoms. If you notice any symptoms of infection, tell your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves up towards the trunk of the body, palpitations, tremor, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

Some patients who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunodepression, 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, tell your doctor.

Hyperbilirubinemia (increased bilirubin levels in the blood) has occurred in patients taking atazanavir. The signs may be a slightly yellowish tint to the skin or eyes. If you notice any of these symptoms, tell your doctor.

Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients treated with atazanavir. Tell your doctor immediately if you develop a rash.

If you notice a change in the way your heart beats (changes in heart rhythm), tell your doctor.

Children who are taking Atazanavir Teva may need to have their heart monitored. Your doctor will decide this.

Children

Do not give this medicine to children under 3 months of age and weighing less than 5 kg. The use of Atazanavir Teva in children under 3 months of age and weighing less than 5 kg has not been studied due to the risk of serious complications.

Taking Atazanavir Teva with other medicines

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

There are other medicines that must not be taken with atazanavir. Tell your doctor if you are taking, have recently taken, or might take any other medicines. It is especially important that you mention the use of the following:

• other medicines for the treatment of HIV infection (e.g., indinavir, nevirapine, and efavirenz)
• sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C)
• sildenafil, vardenafil, or tadalafil (used by men to treat impotence (erectile dysfunction))
• certain medicines used to treat acid-related diseases (e.g., antacids that should be taken 1 hour before or 2 hours after taking atazanavir, H2 blockers such as famotidine, and proton pump inhibitors such as omeprazole)
• medicines to lower blood pressure, slow heart rate, or correct heart rhythm (amiodarone, diltiazem, lidocaine systemic, verapamil)
• atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol)
• salmeterol (used to treat asthma)
• cyclosporine, tacrolimus, and sirolimus (medicines to reduce the effects of the body's immune system)
• certain antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole, and voriconazole (antifungals)
• apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel, and ticagrelor (used to prevent blood clots)
• lamotrigine (antiepileptic)
• irinotecan (used to treat cancer)
• elagolix (gonadotropin-releasing hormone receptor antagonists, used to treat endometriosis-related pain)
• fostamatinib (used to treat chronic immune thrombocytopenia)
• sedative agents (e.g., midazolam given by injection)
• buprenorphine (used to treat opioid addiction and pain)
• corticosteroids (all routes of administration; including dexamethasone).

Some medicines may interact with ritonavir, a medicine that is given with atazanavir. It is important that you tell your doctor if you are using an inhaled or nasal corticosteroid (given by inhalation or nasal spray), including fluticasone or budesonide (given to treat asthma or allergic symptoms).

Taking Atazanavir Teva with food and drinks

It is important that you take atazanavir with food (a meal or snack) as this helps the absorption of the medicine.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Atazanavir, the active ingredient in Atazanavir Teva, is excreted in human breast milk. Patients must not breast-feed while taking atazanavir.

It is recommended that HIV-infected women do not breast-feed their babies to avoid transmitting the virus. If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.

Driving and using machines

If you feel dizzy or drowsy, do not drive or use 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 some sugars, consult your doctor before taking this medicine.

3. How to take Atazanavir Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor. This will ensure that your treatment is effective and reduce the risk of the virus developing resistance to the treatment.

The recommended dose of atazanavir capsules for adults is 300 mg with 100 mg of ritonavir once daily and with food,in combination with other anti-HIV medicines. Your doctor will adjust the dose of atazanavir according to your antiretroviral therapy.

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

Atazanavir is also available as an oral powder for use in children aged 3 months or older and weighing 5 kg or more. It is recommended to switch from atazanavir oral powder to atazanavir capsules as soon as patients are able to swallow the capsules adequately.

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

There are no dose recommendations for atazanavir in pediatric patients less than 3 months of age.

Take Atazanavir Teva capsules with food(a meal or snack). The capsules should be swallowed whole. Do not open the capsules.

If you take more Atazanavir Teva than you should

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

If you or your child have taken more atazanavir capsules than you should, contact your doctor immediately or go to the nearest hospital for advice or call the Poison Information Service on 91.562.04.20, quoting the medicine and the amount taken.

If you forget to take Atazanavir Teva

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

If you stop taking Atazanavir Teva

Do not stop taking atazanavir without talking to your doctor first.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. During the treatment of HIV infection, it is not always easy to identify the adverse effects caused by atazanavir, those caused by any other medicine being used 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 state of health.

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

Inform your doctor immediately if you develop any of the following serious adverse effects:

• Rash has been reported, itching that can occasionally be severe. The rash usually disappears within 2 weeks without changing your treatment with atazanavir. Severe rash associated with other symptoms that can be serious may develop. Discontinue treatment with atazanavir and inform your doctor immediately if you develop a severe rash or a rash with symptoms similar to the flu, blisters, fever, sores in the mouth, muscle or joint pain, swelling in the face, eye inflammation that causes redness (conjunctivitis), painful, hot, or red lumps (nodules).
• Yellowing of the skin or the white part of the eyes caused by high bilirubin levels in the blood has been frequently reported. This adverse effect is usually not dangerous in adults and children over 3 months of age; but it can be a symptom of a serious problem. If your skin or the white part of your eyes turns yellow, inform your doctor immediately.
• Changes in the way your heart beats (changes in heart rhythm) may occasionally occur. Inform your doctor immediately if you feel dizzy, faint, or if you suddenly pass out. These can be symptoms of a serious heart problem.
• Liver problems may occur infrequently. Your doctor must perform blood tests before starting treatment with atazanavir and during treatment. If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems. Inform your doctor immediately if your urine turns dark (tea-colored), you have itching, your skin or the white part of your eyes turns yellow, you have pain around the stomach, pale stools, or nausea.
• Bile duct problems may occur infrequently in people taking atazanavir. Symptoms of bile duct problems may include pain in the right or upper 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 function.
• Kidney stones may occur infrequently 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 stomach, blood in the urine, or pain while urinating.

Other adverse 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, dyspepsia (indigestion)
• fatigue (extreme tiredness)

Infrequent (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 or excessive 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)
• dyspnea (difficulty breathing)
• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis (mouth ulcers and cold sores), dysgeusia (alteration 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 thinning), 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, muscle weakness, loss of muscle tone not caused by exercise)
• kidney pain

Reporting of Adverse Effects

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

5. Storage of Atazanavir Teva

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

Do not use this medicine 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 via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atazanavir Teva

• The active ingredient is atazanavir.

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

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

Appearance of the Product and Package Contents

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 pack sizes of 30, 30x1, 60, and 90 capsules.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta.

28108 Alcobendas. Madrid.

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

Date of the Last Revision of this Leaflet:November 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).