Atazanavir Accord

Package Leaflet: Information for the Patient

Atazanavir Accord, 150 mg, hard capsules

Atazanavir Accord, 200 mg, hard capsules

Atazanavir Accord, 300 mg, hard capsules

atazanavir

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

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Atazanavir Accord is and what it is used for
• 2. Before you take Atazanavir Accord
• 3. How to take Atazanavir Accord
• 4. Possible side effects
• 5. How to store Atazanavir Accord
• 6. Contents of the pack and other information

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

Atazanavir Accord is an antiviral medicine (antiretroviral).It belongs to a group of medicines called protease inhibitors. These medicines control HIV infection by inhibiting a protein that the HIV virus needs to replicate. They work by reducing the amount of HIV in the body, which helps to strengthen the immune system. This reduces the risk of developing diseases associated with HIV infection.

Atazanavir Accord capsules can be used in adults and children from 6 years of age. Your doctor has prescribed Atazanavir Accord because you have HIV and are at risk of developing acquired immune deficiency syndrome (AIDS). Atazanavir Accord is usually used in combination with other anti-HIV medicines. Your doctor will discuss which of these medicines are best to use with Atazanavir Accord.

2. Before you take Atazanavir Accord

Do not take Atazanavir Accord:

• if you are allergic to atazanavir or any of the other ingredients of this medicine (listed in section 6)
• if you have moderate or severe liver problems. Your doctor will assess the severity of your liver disease before you take Atazanavir Accord
• if you are taking any of the following medicines (see also "Atazanavir Accord with other medicines"):
• rifampicin (an antibiotic used to treat tuberculosis)
• astemizole or terfenadine (medicines often used to treat allergy symptoms, which may also be available without a prescription); cisapride (a medicine used to treat heartburn, which is sometimes called acid reflux); pimozide (a medicine used to treat schizophrenia); quinidine or bepridil (medicines used to regulate heart rhythm)

ergotamine, dihydroergotamine, ergometrine, methylergometrine (medicines used to treat headache) and alfuzosin (a medicine used to treat enlarged prostate)

• quetiapine (a medicine used to treat schizophrenia, bipolar disorder, and severe depression); lurasidone (a medicine used to treat schizophrenia)
• herbal medicines containing St. John's Wort (Hypericum perforatum)
• triazolam and oral midazolam (medicines used to help you sleep or relieve anxiety)
• lomitapide, simvastatin, and lovastatin (medicines used to lower cholesterol levels in the blood)
• medicines containing grazoprevir, including combination products containing elbasvir and grazoprevir in a fixed dose and glecaprevir and pibrentasvir in a fixed dose (used to treat chronic hepatitis C virus infection)

Do not take Atazanavir Accord with sildenafil used to treat pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. If you are taking sildenafil to treat erectile dysfunction, tell your doctor. If any of the above applies to you, tell your doctor immediately.

Warnings and precautions

Atazanavir Accord does not cure HIV infection. You can still develop infections or other diseases associated with HIV.

Some people need special care when taking Atazanavir Accord. Before you start taking Atazanavir Accord, discuss this with your doctor and pharmacist.

Tell your doctor if you:

• have viral hepatitis B or C
• have symptoms of gallstones (pain on the right side of the abdomen)
• have hemophilia A or B
• need hemodialysis

Atazanavir Accord may affect kidney function.

Kidney stones have been reported in patients taking atazanavir. If you experience symptoms of kidney stones (pain in the side, blood in the urine, pain when urinating), tell your doctor immediately.

In some patients with advanced HIV infection (with AIDS) and a history of opportunistic infections, signs of inflammation from previous infections may occur soon after antiretroviral therapy is started. It is believed that these symptoms are due to the improvement in the body's immune response, enabling it to fight infections that may have been present without symptoms. If you notice any symptoms of infection, tell your doctor immediately. In addition to opportunistic infections, autoimmune diseases (diseases where the immune system attacks healthy tissues) may also occur after starting medicines for HIV infection. Autoimmune diseases may occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, tingling or numbness in hands and feet, heart palpitations, tremors, or hyperactivity, tell your doctor immediately so that they can provide the necessary treatment.

In some patients taking combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply) has developed. The risk factors for developing this disease include long-term use of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune system suppression, increased body mass index, and other factors. Symptoms of osteonecrosis are joint stiffness and pain (especially in the hips, knees, and shoulders) and difficulty walking. If you experience any of these symptoms, tell your doctor.

Hyperbilirubinemia (increased bilirubin levels in the blood) has been reported in patients taking atazanavir. A symptom may be a slight yellowing of the skin or eyes. If you experience any of these symptoms, tell your doctor.

Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking atazanavir. If a rash occurs, contact your doctor immediately.

If you experience heart rhythm disturbances (changes in heart rhythm), tell your doctor. In children taking Atazanavir Accord, it may be necessary to monitor heart function. The decision to monitor heart function is made by the doctor treating the child.

Children

Do not give this medicine to children under 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 side effects.

Atazanavir Accord with other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, or plan to take.

Some medicines must not be taken with Atazanavir Accord.These are listed at the beginning of section 2 in "Do not take Atazanavir Accord".

There are also other medicines that must not be taken with Atazanavir Accord. Tell your doctor about all the medicines you are taking, or have recently taken, or plan to take. It is especially important to tell your doctor if you are taking:

• other medicines used to treat HIV infection (e.g., indinavir, nevirapine, and efavirenz)
• sofosbuvir with velpatasvir and voxilaprevir (medicines used to treat hepatitis C virus infection)
• sildenafil, vardenafil, or tadalafil (medicines used to treat erectile dysfunction)
• oral contraceptives ("the pill"): if you are taking oral contraceptives while taking Atazanavir Accord, you should strictly follow your doctor's instructions and not miss any doses
• any medicines used to treat acid-related diseases (e.g., antacids [which should be taken 1 hour before or 2 hours after Atazanavir Accord], H2 receptor antagonists [such as famotidine], and proton pump inhibitors [such as omeprazole])
• medicines used to lower blood pressure, slow heart rate, or regulate heart rhythm (amiodarone, diltiazem, intravenous lidocaine, verapamil)
• atorvastatin, pravastatin, and fluvastatin (medicines used to lower cholesterol levels in the blood)
• salmeterol (a medicine used to treat asthma)
• cyclosporine, tacrolimus, and sirolimus (medicines used to reduce the effects of the immune system)
• certain antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole, and voriconazole (antifungal medicines)
• apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin (anticoagulant medicines used to prevent blood clots)
• carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptic medicines)
• irinotecan (a medicine used to treat cancer)
• sedatives (e.g., midazolam injection)
• buprenorphine (a medicine used to treat opioid addiction and pain)

Some medicines may interact with ritonavir used with Atazanavir Accord. It is important to tell your doctor if you are taking fluticasone or beclomethasone (medicines used in nasal or inhaled forms to treat allergy or asthma symptoms).

Atazanavir Accord with food and drink

It is important to take Atazanavir Accord with food (a full meal or a substantial snack) as this helps the absorption of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 in Atazanavir Accord, passes into breast milk. Women taking this medicine must not breastfeed.

It is not recommended that HIV-infected women breastfeed their babies because of the risk of transmitting the virus through breast milk.

If you are breastfeeding or plan to breastfeed, discuss this with your doctor as soon as possible.

Driving and using machines

If you experience dizziness or drowsiness after taking Atazanavir Accord, do not drive or operate machinery, but consult your doctor immediately.

Atazanavir Accord contains lactose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Atazanavir Accord, 200 mg, hard capsules, and Atazanavir Accord, 300 mg, hard capsules contain sunset yellow FCF (E 110). May cause allergic reactions.

3. How to take Atazanavir Accord

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This will help you get the most out of your medicine and reduce the risk of developing resistance to treatment.

The recommended dose of Atazanavir Accord for adults is 300 mg once daily with ritonavir 100 mg once daily, taken with food

and in combination with other anti-HIV medicines.Your doctor may adjust the dose of Atazanavir Accord according to the treatment regimen used.

The dose of Atazanavir Accord for children and adolescents (from 6 to less than 18 years of age) is determined by the doctor

based on the child's body weight.The dose calculated based on body weight is taken once daily with ritonavir 100 mg, as shown in the following table:

Check the availability of other pharmaceutical forms suitable for use in children from 3 months of age and weighing at least 5 kg. It is recommended to switch to Atazanavir Accord capsules when the patient is able to swallow capsules consistently.

Switching from the oral powder to capsules may require a dose adjustment. The doctor will determine the appropriate dose based on the child's body weight.

There are no recommendations for dosing atazanavir in children under 3 months of age.

Atazanavir Accord should be taken with food(a full meal or a substantial snack). The capsules should be swallowed whole. The capsules should not be opened.

If you take more Atazanavir Accord than you should

Taking too much Atazanavir Accord may cause yellowing of the skin and/or eyes (jaundice) and irregular heart rhythm (prolonged QTc interval).

If you have taken more Atazanavir Accord capsules than your doctor prescribed, contact your doctor or pharmacist immediately, or go to the nearest hospital.

If you forget to take Atazanavir Accord

If you miss a dose, take it as soon as you remember, with food. Take the next dose at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atazanavir Accord

Do not stop taking Atazanavir Accord without consulting your doctor.

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

4. Possible side effects

Like all medicines, Atazanavir Accord can cause side effects, although not everybody gets them.

During HIV treatment, it may not always be possible to determine whether a side effect is due to Atazanavir Accord or other medicines you are taking, or to the HIV disease itself.

Tell your doctor about any changes in your health.

During HIV treatment, you may experience an increase in body weight and levels of lipids and glucose in the blood. This is partly due to the improvement in your health and lifestyle, and in the case of lipids, sometimes due to the HIV medicines themselves. Your doctor will perform tests to monitor these changes.

If you experience any of the following serious side effects, tell your doctor immediately.

• Severe skin rash, itching, which can be severe. The rash usually goes away within 2 weeks without changing the dose of Atazanavir Accord. Severe rash can occur with other symptoms, which can be severe. If you experience a severe rash or a rash with symptoms similar to flu, blisters, fever, mouth sores, muscle or joint pain, swelling of the face, eye inflammation causing redness, or painful, warm, or red lumps, stop taking Atazanavir Accord and contact your doctor immediately.
• Frequent yellowing of the skin or eyes due to high bilirubin levels in the blood. This side effect is usually not serious in adults and children over 3 months of age, but it can be a sign of serious liver problems. If your skin or eyes turn yellow, contact your doctor immediately.
• Rarely, changes in heart rhythm have been reported. If you experience dizziness, drowsiness, or fainting, contact your doctor immediately. These may be symptoms of serious heart problems.
• Uncommonly, liver problems have been reported. Your doctor should perform blood tests before you start taking Atazanavir Accord and during treatment. In patients with liver problems, including hepatitis B and C, liver disease may worsen. If you experience dark urine (tea-colored), itching, yellowing of the skin or eyes, stomach pain, pale stools, or nausea, contact your doctor immediately.
• During treatment with atazanavir, gallbladder problems have been uncommonly reported. Symptoms may include pain in the right or middle upper abdomen, nausea, vomiting, fever, or yellowing of the skin or eyes.
• Atazanavir Accord may affect kidney function.
• Kidney stones have been uncommonly reported in patients taking atazanavir. If you experience symptoms of kidney stones, such as pain in the lower back or abdomen, blood in the urine, or pain when urinating, contact your doctor immediately.

Other side effects reported in patients taking atazanavir:

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

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

Uncommon (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 or gain, loss of appetite, increased appetite
• depression, anxiety, sleep disorders
• disorientation, memory loss, dizziness, drowsiness, unusual dreams
• fainting, high blood pressure
• shortness of breath
• pancreatitis, stomach inflammation, mouth sores, taste disorders, gas, dry mouth, abdominal bloating
• angioedema (severe swelling of the skin and other tissues, usually around the lips and eyes)
• hair loss (unusual hair loss or thinning), itching
• muscle atrophy (muscle wasting), joint pain, muscle pain
• kidney problems, blood in the urine, protein in the urine, frequent urination
• gynecomastia (breast enlargement in men)
• chest pain, malaise, fever
• insomnia (difficulty sleeping)

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

• gait disturbances (abnormal gait)
• edema
• liver and spleen enlargement
• myopathy (muscle pain, tenderness, and weakness not caused by physical exertion)
• kidney pain

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atazanavir Accord

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

No special precautions for storage are necessary.

Do not use this medicine after the expiry date which is stated on the carton, bottle, and blister after EXP. The expiry date refers to the last day of that month.

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 protect the environment.

6. Contents of the pack and other information

What Atazanavir Accord contains

Atazanavir Accord, 150 mg, hard capsules

• The active substance is atazanavir. Each hard capsule contains 150 mg of atazanavir (as atazanavir sulfate).
• The other ingredients are:
• capsule content:lactose monohydrate, crospovidone type B, magnesium stearate
• capsule shell:gelatin, brilliant blue FCF (E 133), iron oxide black (E 172), iron oxide yellow (E 172), titanium dioxide (E 171)
• black ink:shellac, iron oxide black (E 172), potassium hydroxide

Atazanavir Accord, 200 mg, hard capsules

• The active substance is atazanavir. Each hard capsule contains 200 mg of atazanavir (as atazanavir sulfate).
• The other ingredients are:
• capsule content:lactose monohydrate, crospovidone type B, magnesium stearate
• capsule shell:gelatin, brilliant blue FCF (E 133), iron oxide yellow (E 172), titanium dioxide (E 171), sunset yellow FCF (E 110)
• black ink:shellac, iron oxide black (E 172), potassium hydroxide

Atazanavir Accord, 300 mg, hard capsules

• The active substance is atazanavir. Each hard capsule contains 300 mg of atazanavir (as atazanavir sulfate).
• The other ingredients are:
• capsule content:lactose monohydrate, crospovidone type B, magnesium stearate
• capsule shell:gelatin, brilliant blue FCF (E 133), iron oxide yellow (E 172), titanium dioxide (E 171), erythrosine (E 127), sunset yellow FCF (E 110)
• black ink:shellac, iron oxide black (E 172), potassium hydroxide

What Atazanavir Accord looks like and contents of the pack

Atazanavir Accord, 150 mg, hard capsules are white to light yellow granular powder in hard gelatin capsules, approximately 19.3 mm in length, with a green opaque cap with a black inscription "H" and a light green opaque body with a black inscription "A6".

Available in OPA/Aluminum/PVC/Aluminum blisters containing 30, 60, and 90 hard capsules, in a cardboard box. Also available in a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) cap, containing 60 hard capsules, in a cardboard box.

Atazanavir Accord, 200 mg, hard capsules are white to light yellow granular powder in hard gelatin capsules, approximately 21.4 mm in length, with a green opaque cap with a black inscription "H" and a light green opaque body with a black inscription "A7".

Available in OPA/Aluminum/PVC/Aluminum blisters containing 30, 60, and 90 hard capsules, in a cardboard box. Also available in a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) cap, containing 60 hard capsules, in a cardboard box.

Atazanavir Accord, 300 mg, hard capsules are white to light yellow granular powder in hard gelatin capsules, approximately 23.5 mm in length, with an orange opaque cap with a black inscription "H" and a green opaque body with a black inscription "A8".

Available in OPA/Aluminum/PVC/Aluminum blisters containing 30, 60, and 90 hard capsules, in a cardboard box. Also available in a high-density polyethylene (HDPE) bottle with a child-resistant polypropylene (PP) cap, containing 30 hard capsules, in a cardboard box.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.

ul. Taśmowa 7

02-677 Warszawa

Polska

Tel: +48 22 577 28 00

Manufacturer/Importer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp. z o.o.

ul. Lutomierska 50

96-200 Pabianice

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Member State

Marketing authorization name

Bulgaria

Atazanavir Accord 150 mg hard capsules

Croatia

Atazanavir Accord

Cyprus

Atazanavir Accord 150 mg/300 mg σκληρά καψάκια

Czech Republic

Atazanavir Accord

Denmark

Atazanavir Accord

Spain

Atazanavir Accord 150 mg/200 mg/300 mg capsulas duras

Netherlands

Atazanavir Accord 150 mg/200 mg/300 mg harde capsule

Ireland

Atazanavir Accord 200 mg/300 mg hard capsules

Finland

Atazanavir Accord 200 mg/300 mg kapselit, kovat

Germany

Atazanavir Accord 150 mg/200 mg/300 mg Hartkapseln

Norway

Atazanavir Accord

Poland

Atazanavir Accord

Portugal

Atazanavir Accord

Romania

Atazanavir Accord 150 mg/200 mg/300 mg hard capsules

Slovenia

Atazanavir Accord 150 mg/200 mg/300 mg trde kapsule

Sweden

Atazanavir Accord 200 mg/300 mg hårda kapslar

Hungary

Atazanavir Accord Accord 150 mg/200 mg/300 mg tvrde kapsule

United Kingdom (Northern Ireland)

Atazanavir Accord 150 mg/200 mg/300 mg hard capsules

Italy

Atazanavir Accord

Date of last revision of the leaflet: September 2023