Package Insert: Information for the User

Atazanavir Stada 300 mg Hard Capsules EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as 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 package insert. See section 4.

1.What isAtazanavir Stadaand for what it is used

2.What you need to know before starting to takeAtazanavir Stada

3.How to takeAtazanavir Stada

4.Possible side effects

5.Storage ofAtazanavir Stada

6.Contents of the package and additional informationl

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

Atazanavir capsules can be used by adults and children aged 6 years and older.Your doctor has prescribed atazanavir because you are infected with HIV, which causes Acquired Immune Deficiency Syndrome (AIDS).It is normally used in combination with other anti-HIV medications.Your doctor will determine the best combination of these medications with atazanavir for you.

DO NOT TAKE Atazanavir Stada

• 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 whether you can takeatazanavir.
• if you are taking any of the following medicines:see also “Other medicines and Atazanavir Stada”.

• rifampicin (an antibiotic used to treat tuberculosis)
• astemizol or terfenadine (often used to treat allergic symptoms, these medicines may be available without a prescription); cisaprida (used to treat gastroesophageal reflux, sometimes called heartburn); pimozida (used to treat schizophrenia); quinidina or bepridilo (used to correct heart rhythm); ergotamina, dihidroergotamina, ergonovina, metilergonovina (used to treat headaches); and alfuzosina (used to treat an enlarged prostate)
• quetiapina (used to treat schizophrenia, bipolar disorder, and major depressive disorder)
• lurasidona (used to treat schizophrenia)
• medicines containing 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).
• products containing 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)

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

Inform your doctor immediately if you are in any of these situations.

Warnings and precautions

Atazanavir is 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 with atazanavir. Consult your doctor or pharmacist before starting to take atazanavir and make sure to inform your doctor:

• 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 may affect kidney function.

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, symptoms and signs of inflammatory reactions may appear shortly after starting antiretroviral therapy. 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 but did not produce any obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (diseases in which 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 starting 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, please inform your doctor immediately to receive 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 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, please inform your doctor.

There have been cases of hyperbilirubinemia (elevated bilirubin levels in the blood) in patients receiving atazanavir. The signs may be a slightly yellowish discoloration of the skin or eyes. 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 may require their heart to be monitored. Your child's doctor will decide this.

Children

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

Other medicines and Atazanavir Stada

You should not take atazanavir with certain medicines.These are listed under the title “Do not take Atazanavir Stada”, at the beginning of Section 2.

There are other medicines that cannot be taken with atazanavir. Inform your doctor or pharmacist 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)
• sildenafilo, vardenafilo, or tadalafilo (used by men to treat erectile dysfunction)
• if you are taking an oral contraceptive ("the pill") with atazanavir, to avoid pregnancy, make sure to 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 taken 1 hour before taking atazanavir or 2 hours after taking atazanavir, H2 blockers such as famotidina, and proton pump inhibitors such as omeprazol)
• medicines to lower blood pressure, slow heart rate, or correct heart rhythm (amiodarona, diltiazem, lidocaína sistémica, verapamilo)
• atorvastatina, pravastatina, and fluvastatina (used to lower cholesterol in the blood)
• salmeterol (used to treat asthma)
• ciclosporina, tacrólimus, and sirólimus (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)
• carbamazepina, fenitoína, fenobarbital, and lamotrigina (antiepileptics)
• encorafenib, ivosidenib, and irinotecán (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 with atazanavir. It is essential to inform your doctor if you are using an inhaled or nasal corticosteroid (administered via the nose), fluticasona, or budesonida (administered to treat allergic symptoms or asthma).

Taking Atazanavir Stada with food and drinks

It is essential to take atazanavir with food (a meal or snack) as this helps the medicine to be absorbed.

Pregnancy and breastfeeding

If you are pregnant or think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine.

Atazanavir, the active ingredient of atazanavir, is excreted in breast milk. Patients should not breastfeed while taking atazanavir.

It is not recommendedfor women with HIV to breastfeed because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or plan to breastfeed,you should consult withyour doctoras 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 Stada contains lactose.

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist 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 once a day with 100 mg of ritonavir and with food, in combination with other anti-HIV medications. Your doctor may adjust the dose of atazanavir according to your anti-HIV treatment.Your doctor may adjust the dose of atazanavir according to your anti-HIV treatment.

Your doctor will decide the correct dose for your child 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:

* Ritonavir capsules, tablets, or oral solution can be used.

Other forms of atazanavir may be available for use in children at least 3 months old and at least 5 kg in weight. It is recommended to switch to capsules as soon as patients are able to swallow the capsules properly.

When switching between other pharmaceutical forms and capsules, it may be necessary to adjust the dose. Your doctor will decide the correct dose based on your child's weight.

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

Take Atazanavir Stada capsules with food (a meal or snack). Swallow the capsules whole.Do not open the capsules.

If you take more Atazanavir Stada than 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 take Atazanavir Stada

If you have forgotten a dose, take it as soon as possible with some food and then take the next scheduled dose at the usual time. If it is almost time for the 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 the missed doses.

If you interrupt treatment with Atazanavir Stada

Do not stop treatment with atazanavir without consulting your doctor.

If you have any other questions 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 HIV infection treatment, it may not be easy to identify side effects caused by atazanavir, any other medicine you are taking, or the HIV infection itself. Inform your doctor of any changes 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 increased blood lipids, it may be due to the same HIV medicines. Your doctor will analyze these changes.

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

• Rash and occasional severe itching (both have been reported). The rash usually disappears in 2 weeks without changing the atazanavir treatment. The appearance of severe skin rashes may be associated with other potentially severe symptoms. 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 causing redness (conjunctivitis), painful, hot, or red nodules.
• Yellow discoloration of the skin or the white part of the eyes caused by high levels of bilirubin in the blood (has been reported frequently). This side effect is usually not hazardous in adults and children over 3 months of age; however, 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.
• Changes in the way your heart beats - changes in heart rhythm - may occur occasionally. Inform your doctor immediately if you feel dizzy, lightheaded, or suddenly faint. These may be symptoms of a serious heart problem.
• Liver problems (occur infrequently). Your doctor should perform blood tests before starting treatment with this medicine 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 turns dark (tea color), you experience itching, your skin or the white part of your eyes turns yellow, you have stomach pain, nausea, white or light yellow-pale stools.
• Biliary tract problems in people taking atazanavir (occur infrequently). Symptoms related to biliary tract problems may include pain in the upper right or middle part of the stomach, nausea, vomiting, fever, or yellow discoloration of the skin or the white part of the eyes.
• Atazanavir may affect kidney function.
• Kidney stones in people taking atazanavir (occur infrequently). Inform your doctor immediately if you experience 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 as follows:

Frequent (may affect up to 1 in 10 people):

• Headache
• Vomiting, diarrhea, abdominal pain (stomach discomfort), nausea, 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 fatigue 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 (elevated blood pressure)
• Dyspnea (difficulty breathing)
• Pancreatitis (pancreas inflammation), gastritis (stomach inflammation), aphthous stomatitis (mouth ulcers and herpes labialis), dysgeusia (alteration of the sense of taste), flatulence (gas), dry mouth, abdominal distension
• Angioedema (severe skin and tissue swelling, usually the lips or eyes)
• Alopecia (abnormal hair loss or weakening), pruritus (itching)
• Muscle atrophy (muscle contraction), arthralgia (joint pain), myalgia (muscle pain)
• Interstitial nephritis (kidney inflammation), 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 pattern)
• 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 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 the Spanish System for the Vigilance of Medicinal Products 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.

Do not store above 30 °C.

For bottles:

Use within 2 months after the first opening.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Atazanavir Stada

-The active ingredient is atazanavir. Each capsule contains 300 mg of atazanavir (assulfate).

-The other componentsare lactose monohydrate, crospovidone (type A) (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b). The capsule coating and printing ink contain gelatin, titanium dioxide (E171), indigotin (E132), iron oxide red (E172), lacquer and propylene glycol (E1520).

Appearance of the product and contents of the package

Atazanavir Stada 300 mg hard capsules are opaque, red and blue, size 00 capsules printed with white ink, with "300 mg" on the cap.

Atazanavir Stada 300 mg is available in:

• Pre-cut and single-dose blisters of Al-OPA/Al/PVC containing 30 x 1 hard capsules.
• Al-OPA/Al/PVC blisters containing 30 hard capsules.
• Multiple packaging containing 90 x 1 (3 packs of 30 x 1) hard capsules in pre-cut and single-dose blisters of Al-OPA/Al/PVC.
• Multiple packaging containing 90 (3 packs of 30) hard capsules in Aluminio-OPA/Alu/PVC blisters.
• High-density polyethylene (HDPE) bottles closed with a child-resistant polypropylene closure containing 30 hard capsules.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA Laboratorios, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Germany:Atazanavir AL 300 mg Hartkapseln

Denmark:Atazanavir STADA

Spain:Atazanavir STADA 300 mg hard capsules EFG

Finland:Atazanavir STADA 300 mg kovat kapselit

Netherlands:Atazanavir STADA 300 mg harde capsules

Iceland:Atazanavir STADA 300 mg hörð hylki

Italy:Atazanavir EG

Sweden:Atazanavir STADA 300 mg kapsel, hård

Last review date of this leaflet:February 2024

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