ATAZANAVIR STADA 300 mg HARD CAPSULES

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

DO NOT TAKE Atazanavir Stada

• 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 these medicines:see also “Other medicines and Atazanavir Stada”.

• rifampicin (an antibiotic used to treat tuberculosis)
• astemizole or terfenadine (frequently used to treat allergic symptoms, these medicines may be available without a prescription); cisapride (used to treat gastric 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 medicinal plant)
• triazolam and midazolam oral (given by mouth) (used to induce sleep and/or relieve anxiety)
• lomitapide. simvastatin and lovastatin (used to lower blood cholesterol)
• products 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)

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.

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 will 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 reports of kidney stones in patients treated with atazanavir. If you experience signs or symptoms of kidney stones (side pain, blood in the urine, pain when urinating), please inform your doctor immediately.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammatory reactions may appear as a result of previous infections, shortly after starting anti-HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, allowing it to fight infections that were present but not producing 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 medicines to treat your HIV infection. 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 moving up to the body, palpitations, tremors, or hyperactivity, please inform 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 immunosuppression, and high body mass index. The symptoms of osteonecrosis are stiffness in the joints, 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 occurred in patients receiving atazanavir. The signs may be a slightly yellowish color 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 your heart rhythm (changes in heart rate), please inform your doctor. Children who are taking atazanavir may require their heart to be monitored. Your child's doctor will decide this.

Children

Do not give this medicine to childrenunder 3 months of age and weighing less than 5 kg. The use of 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

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

There are other medicines that should not be taken with atazanavir. Inform your doctor or pharmacist 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))
• if you are taking an oral contraceptive ( "the pill") with atazanavir, to prevent pregnancy, make sure to take it exactly as your doctor has told you and do not miss any doses
• certain medicines used to treat diseases related to stomach acid (e.g., antacids that should be administered 1 hour before taking atazanavir 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, systemic lidocaine, 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 reduce blood clots)
• carbamazepine, phenytoin, phenobarbital, and lamotrigine (antiepileptics)
• encorafenib, ivosidenib, and irinotecan (used to treat cancer)
• elagolix (gonadotropin-releasing hormone receptor antagonists, used to treat severe pain from endometriosis)
• fostamatinib (used to treat chronic immune thrombocytopenia)
• sedative agents (e.g., midazolam administered 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 inform your doctor if you are using an inhaled or nasal corticosteroid (administered through the nose), fluticasone or budesonide (administered to treat allergic symptoms or asthma).

Taking Atazanavir Stada 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 breastfeeding

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

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

It is not recommendedthat HIV-positive women breastfeed their babies because HIV infection can be transmitted to the baby through breast milk.

If you are breastfeeding or thinking of breastfeeding, you must consultyour 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 Stada 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 Stada

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This way, you can be sure that the treatment is totally effective and reduces the risk of the virus developing resistance to the treatment.

The recommended dose of atazanavir capsules for adults is 300 mg together with 100 mg of ritonavir once a day and with food,in combination with other anti-HIV medicines. Your doctor may adjust the dose of atazanavir according to your anti-HIV treatment.

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

• Ritonavir capsules, tablets, or oral solution may be used.

Other forms of atazanavir may be available for use in children aged at least 3 months and weighing at least 5 kg. It is recommended to switch from other forms of administration 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 the child's weight.

There are no dose recommendations 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 (prolonged QTc) 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 medicine and the amount ingested.

If you forget to take Atazanavir Stada

If you have missed 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 missed doses.

If you stop taking Atazanavir Stada

Do not stop taking atazanavir before consulting your doctor.

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, by any other medicine that you are taking, or by the HIV infection itself. 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 increased blood lipids, it is sometimes due to the HIV medicines themselves. Your doctor will analyze these changes.

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

• Skin rash, and occasional itching (both have been reported). The rash usually disappears within 2 weeks without making any changes to the treatment with atazanavir. The appearance of severe skin rashes could be associated with other potentially serious symptoms. 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, mouth sores, muscle or joint pain, swelling in the face, eye inflammation that causes redness (conjunctivitis), painful, hot, or red bumps (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; however, 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 - can occur occasionally. Inform your doctor immediately if you feel dizzy, faint, or if you suddenly faint. These can be symptoms of a serious heart problem.
• Liver problems (occur infrequently). Your doctor must 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 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, nausea, white or pale-yellow stools.
• Gallbladder problems in people taking atazanavir (occur infrequently). 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 may affect kidney function.
• Kidney stones in people taking atazanavir (occur infrequently). 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 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 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 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 (breathing difficulties)
• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis (mouth ulcers and cold sores), dysgeusia (altered sense of taste), flatulence (gas), dry mouth, abdominal distension
• angioedema (severe swelling of the skin and other tissues, usually the lips or eyes)
• 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's 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 Stada

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

Do not use this medicine after the expiration date stated 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 first opening.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atazanavir Stada

• The active ingredient is atazanavir. Each capsule contains 300 mg of atazanavir (as sulfate).
• The other ingredients are lactose monohydrate, crospovidone (type A) (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b). The capsule shell and printing ink contain gelatin, titanium dioxide (E171), indigo carmine (E132), red iron oxide (E172), lacquer, and propylene glycol (E1520).

Appearance and Package Contents

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

Atazanavir Stada 300 mg is available in:

• Precut and unit-dose Al-OPA/Al/PVC blisters containing 30 x 1 hard capsules.
• Al-OPA/Al/PVC blisters containing 30 hard capsules.
• Multipack containing 90 x 1 (3 packs of 30 x 1) hard capsules in precut and unit-dose Al-OPA/Al/PVC blisters.
• Multipack containing 90 (3 packs of 30) hard capsules in Al-OPA/Al/PVC blisters.
• High-density polyethylene (HDPE) bottles closed with a child-resistant polypropylene cap containing 30 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicine is authorized in the Member States of the European Economic Area under 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 hard capsules

Netherlands: Atazanavir STADA 300 mg hard capsules

Iceland: Atazanavir STADA 300 mg hard capsules

Italy: Atazanavir EG

Sweden: Atazanavir STADA 300 mg hard capsules

Date of the last revision of this leaflet:February 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/).