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
Please read 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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Atazanavir Accord is and what it is used for
2. What you need to know before taking 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 (antiretroviral) medicine. It belongs to a group of
medicines called protease inhibitors. These medicines control HIV infection by
inhibiting a protein that HIV virus needs to multiply. They work by reducing the
amount of HIV virus in the body, thereby strengthening the immune system. In this way, Atazanavir
Accord reduces the risk of developing HIV-related illnesses.
Atazanavir Accord capsules can be used in adults and children aged 6 years and older. Your doctor
has prescribed Atazanavir Accord because you have an HIV infection and are at risk of developing
acquired immunodeficiency syndrome (AIDS). Atazanavir Accord is usually used in combination with other
HIV medicines. Your doctor will discuss with you which of these medicines, used together with Atazanavir
Accord, are best for you.

2. Important information before using Atazanavir Accord

When not to use Atazanavir Accord:

• if the patient is allergic to atazanavir or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has moderate or severe liver function impairment. Before using Atazanavir Accord, the doctor will assess the severity of the patient's liver disease.
• if the patient is taking any of the following medicines (see also "Atazanavir Accord and other medicines"):
• rifampicin (an antibiotic used to treat tuberculosis)
• astemizole or terfenadine (medicines commonly used to treat allergy symptoms, which may also be available without a prescription); cisapride (a medicine used to treat gastro-oesophageal reflux, symptoms of which are sometimes called heartburn); pimozide (a medicine used to treat schizophrenia); quinidine or bepridil (medicines used to regulate heart rhythm)

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

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

Do not take Atazanavir Accord together with sildenafil used for the treatment of
pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. If
the patient is taking sildenafil for erectile dysfunction, inform the doctor.
If any of the above applies to the patient, inform the doctor immediately.
Warnings and precautions
Atazanavir Accord does not cure HIV infection. There is still a possibility that the patient may develop infections or other HIV-related illnesses.
Some patients require special care before and during treatment with Atazanavir Accord. Before starting treatment with Atazanavir Accord, discuss this with the doctor and pharmacist.
Inform the doctor if the patient:

• has hepatitis B or C virus infection;
• has symptoms of gallstones (pain on the right side of the abdomen);
• has haemophilia A or B;
• requires haemodialysis.

Atazanavir Accord may affect kidney function.
Kidney stones have been reported in patients taking atazanavir. If symptoms of kidney stones occur (pain in the side, blood in the urine, pain when passing urine), inform the doctor immediately.
In some patients with advanced HIV infection (with AIDS) and a history of opportunistic infections, inflammatory symptoms may occur shortly after starting antiretroviral therapy. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that previously had no obvious symptoms. If any signs of infection occur, seek medical advice immediately. In addition to opportunistic infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissues) may also occur after starting treatment with medicines for HIV infection.
Autoimmune disorders may occur many months after starting treatment. If any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and progressing towards the trunk, palpitations, tremor or hyperexcitability occur, inform the doctor immediately so that appropriate treatment can be initiated.
In some patients receiving combination antiretroviral therapy, bone disease, known as osteonecrosis (death of bone tissue due to inadequate blood supply), may develop. Risk factors for developing this condition include long-term use of combination antiretroviral therapy, corticosteroid use, alcohol consumption, significantly weakened immune system, high body mass index and others.
Symptoms of osteonecrosis include joint stiffness and pain (especially in the hips, knees and shoulders) and difficulty moving. If any of these symptoms occur, inform the doctor.
Hyperbilirubinaemia (increased blood bilirubin levels) has been observed in patients treated with atazanavir. This may manifest as slight yellowing of the skin or eyes. If any of these symptoms occur, inform the doctor.
Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking atazanavir. If a rash develops, contact the doctor immediately.
If the patient experiences heart rhythm disorders (changes in heart rhythm), inform the doctor. In children receiving Atazanavir Accord, heart function monitoring may be necessary. The decision on monitoring is made by the doctor treating the child.
Children
This medicine must not be given to children under 3 months of age or weighing less than 5 kg. Studies on the use of atazanavir in children under 3 months of age and weighing less than 5 kg have not been conducted due to the risk of serious complications.
Atazanavir Accord and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Some medicines must not be combined with Atazanavir Accord. These are listed at the beginning of section 2 under "When not to use Atazanavir Accord".
There are also other medicines that must not be combined with Atazanavir Accord. Inform the doctor about all medicines currently or recently taken, or those planned for use. It is especially important to inform the doctor about taking the following medicines:

• 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 impotence [erectile dysfunction])
• oral contraceptives ("the pill"): if the patient is taking oral contraceptives while using Atazanavir Accord, she should strictly follow the doctor's instructions and not miss any doses
• any medicines used to treat conditions related to gastric acid secretion (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 reduce cholesterol levels)
• salmeterol (a medicine used to treat asthma)
• cyclosporine, tacrolimus and sirolimus (medicines used to suppress immune system activity)
• certain antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole and voriconazole (antifungal medicines)
• apixaban, dabigatran, edoxaban, rivaroxaban and warfarin (anticoagulants used to prevent blood clots)
• carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptic medicines)
• irinotecan (a medicine used to treat cancer)
• sedatives (e.g. midazolam administered by injection)
• buprenorphine (a medicine used to treat opioid dependence and pain)

Some medicines may interact with ritonavir taken together with Atazanavir Accord.
It is important to inform the doctor if the patient is taking fluticasone or budesonide (medicines administered via nasal spray or inhalation for the treatment of allergy symptoms or asthma).
Atazanavir Accord with food and drink
It is important to take Atazanavir Accord with food (a full meal or substantial snack), as this helps the medicine to be absorbed.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to have a child, she should consult the doctor before using this medicine.
Atazanavir, the active substance in Atazanavir Accord, passes into breast milk. Patients taking this medicine should not breastfeed.
Breastfeeding is not recommended for women with HIV infection due to the risk of transmitting the virus to the infant through breast milk.
If the patient is breastfeeding or planning to breastfeed, she should discuss this with the doctor as soon as possible.
Driving and operating machinery
If the patient experiences dizziness or drowsiness after taking Atazanavir Accord, he or she should not drive or operate machinery, but should contact the doctor immediately.
Atazanavir Accord contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, consult the doctor before using this medicine.
Atazanavir Accord 200 mg, hard capsules and Atazanavir Accord 300 mg, hard capsules contain sunset yellow FCF (E110). This may cause allergic reactions.

3. How to use Atazanavir Accord

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
the doctor. This ensures that the medicine will be fully effective and reduces the
risk of the virus developing resistance to treatment.
The recommended dose of Atazanavir Accord for adults is 300 mg once daily, taken together
with ritonavir 100 mg once daily, with food, and in combination with other antiretroviral medicines used in the treatment of HIV infection. The doctor may adjust the dose of Atazanavir
Accord depending on the treatment regimen used.
The dose of Atazanavir Accord for children and adolescents (aged 6 to less than 18 years) is determined
by the doctor based on the patient's body weight. The weight-based dose should be taken once daily with food, together with ritonavir 100 mg, as shown in the table below:

Check the availability of other pharmaceutical forms suitable for use in children aged at least 3 months and weighing at least 5 kg. It is recommended to switch to Atazanavir Accord capsules as soon as the patient is able to consistently swallow capsules.
Changing the formulation from oral powder to capsules may require a dose adjustment. The appropriate dose will be determined by the physician based on the child's body weight.
Dosage recommendations for atazanavir in children under 3 months of age have not been established.
Atazanavir Accord must be taken with food (a full meal or substantial snack). Capsules should be swallowed whole. Do not open the capsules.
Taking more Atazanavir Accord than prescribed
Taking an overdose of Atazanavir Accord may cause yellowing of the skin and/or whites of the eyes (jaundice) and irregular heartbeat (QTc prolongation).
If you accidentally take more capsules than prescribed, contact your doctor immediately or go to the nearest hospital.
Missing a dose of Atazanavir Accord
If a dose is missed, take it as soon as you remember, together with a meal. 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 missed dose.
Stopping Atazanavir Accord treatment
Do not stop taking Atazanavir Accord without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
When treating HIV infection, it may not always be easy to determine whether a side effect
has been caused by the medicine Atazanavir Accord or by other medicines the patient is taking, or
by a disease associated with HIV infection. Any changes in health status should be reported to the doctor.
During treatment for HIV infection, patients may experience an increase in body weight and in blood levels
of lipids and glucose. This is partly related to improved health and lifestyle, and in the case of lipids, sometimes
to the use of anti-HIV medicines themselves. The doctor will arrange tests to monitor these changes.
If the patient experiences any of the serious side effects listed below, medical advice should be sought immediately.

• Skin rash and itching may occur, which may be severe. The rash usually resolves within 2 weeks without changing the treatment with Atazanavir Accord. However, severe rash together with other symptoms may occur, which may be serious. If the patient develops severe rash or rash accompanied by flu-like symptoms, blistering, fever, mouth ulcers, joint or muscle pain, facial swelling, eye inflammation causing redness (conjunctivitis), or painful, warm, or red nodules, the patient should stop taking Atazanavir Accord and seek immediate medical advice.
• Yellowing of the skin or whites of the eyes due to high levels of bilirubin in the blood has been frequently reported. This side effect is usually not harmful in adults and children over 3 months of age, but may be a sign of serious disorders. If the patient's skin or whites of the eyes turn yellow, immediate medical advice should be sought.
• Changes in heart rhythm may occur rarely. If the patient experiences dizziness, lightheadedness, or sudden fainting, immediate medical advice should be sought. These may be symptoms of serious heart problems.
• Liver function disorders may occur uncommonly. The doctor should arrange blood tests before starting treatment with Atazanavir Accord and during treatment. In patients with pre-existing liver disorders, including hepatitis B and C, liver disease may worsen. If the patient develops dark-coloured urine (tea-coloured), itching, yellowing of the skin or whites of the eyes, stomach pain, pale stools, or nausea, immediate medical advice should be sought.
• Gallbladder disorders have been reported uncommonly during treatment with atazanavir. Symptoms may include pain in the right or central upper abdomen, nausea, vomiting, fever, or yellowing of the skin or whites of the eyes.
• Atazanavir Accord may affect kidney function.
• Kidney stones have been reported uncommonly in patients treated with atazanavir. If the patient experiences symptoms of kidney stones, such as lower back pain or abdominal pain, blood in the urine, or pain when passing urine, immediate medical advice should be sought.

Other side effects reported in patients treated with atazanavir:
Common (may affect up to 1 in 10 people):

• headache
• vomiting, diarrhoea, abdominal pain (stomach pain and discomfort), nausea, indigestion
• extreme tiredness

Uncommon (may affect up to 1 in 100 people):

• peripheral neuropathy (numbness, weakness, tingling or pain in arms and legs)
• hypersensitivity (allergic reaction)
• asthenia (feeling of unusual tiredness or weakness)
• decreased or increased body weight, anorexia (loss of appetite), increased appetite
• depression, anxiety, sleep disorders
• disorientation, amnesia (loss of memory), dizziness, drowsiness, unusual dreams
• fainting, hypertension (high blood pressure)
• shortness of breath
• pancreatitis, gastritis (inflammation of the stomach lining), aphthous stomatitis (mouth ulcers and herpes-like lesions), taste disturbances, flatulence, dry mouth, abdominal distension
• angioedema (serious swelling of the skin and other tissues, usually around the lips or eyes)
• alopecia (unusual hair loss or thinning), itching
• muscle atrophy (decrease in muscle mass), joint pain, muscle pain
• interstitial nephritis, haematuria (blood in urine), proteinuria (protein in urine), polyuria (increased frequency of urination)
• gynaecomastia (enlargement of breasts in men)
• chest pain, malaise, fever
• insomnia (difficulty sleeping)

Rare (may affect up to 1 in 1000 people):

• gait disturbances (abnormal walking pattern)
• swelling
• enlargement of the liver and spleen
• myopathy (muscle pain, tenderness and weakness not caused by physical exertion)
• kidney pain

Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform the doctor or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the responsible entity.
Reporting side effects helps 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 storage conditions are required for this medicinal product.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister after
EXP. The expiry date refers to the last day of the stated 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. One hard capsule contains 150 mg of atazanavir (as atazanavir sulfate).
• Other ingredients are:
• Capsule contents: monohydrate lactose, crospovidone type B, magnesium stearate
• Capsule shell: gelatin, brilliant blue FCF (E 133), black iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171)
• Black ink: shellac, black iron oxide (E 172), potassium hydroxide

Atazanavir Accord, 200 mg, hard capsules

• The active substance is atazanavir. One hard capsule contains 200 mg of atazanavir (as atazanavir sulfate).
• Other ingredients are:
• Capsule contents: monohydrate lactose, crospovidone type B, magnesium stearate
• Capsule shell: gelatin, brilliant blue FCF (E 133), yellow iron oxide (E 172), titanium dioxide (E 171), orange yellow (E 110)
• Black ink: shellac, black iron oxide (E172), potassium hydroxide

Atazanavir Accord, 300 mg, hard capsules

• The active substance is atazanavir. One hard capsule contains 300 mg of atazanavir (as atazanavir sulfate).
• Other ingredients are:
• Capsule contents: monohydrate lactose, crospovidone type B, magnesium stearate
• Capsule shell: gelatin, brilliant blue FCF (E 133), yellow iron oxide (E 172), titanium dioxide (E 171), erythrosine (E 127), orange yellow (E 110)
• Black ink: shellac, black iron oxide (E172), potassium hydroxide

What Atazanavir Accord looks like and contents of the pack
Atazanavir Accord, 150 mg, hard capsules contain a granular powder, white to slightly yellow, in hard gelatin capsules approximately 19.3 mm long, with a green opaque cap printed with "H" in black and a light green opaque body printed with "A6" in black.
Available in OPA/Aluminium/PVC/Aluminium 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 PP cap containing 60 hard capsules, in a cardboard box.

Atazanavir Accord, 200 mg, hard capsules contain a granular powder, white to slightly yellow, in hard gelatin capsules approximately 21.4 mm long, with a green opaque cap printed with "H" in black and a light green opaque body printed with "A7" in black.
Available in OPA/Aluminium/PVC/Aluminium 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 PP cap containing 60 hard capsules, in a cardboard box.

Atazanavir Accord, 300 mg, hard capsules contain a granular powder, white to slightly yellow, in hard gelatin capsules approximately 23.5 mm long, with an orange opaque cap printed with "H" in black and a green opaque body printed with "A8" in black.
Available in OPA/Aluminium/PVC/Aluminium 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 PP cap containing 30 hard capsules, in a cardboard box.

Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Poland
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.
Lutomierska 50 Street
96-200 Pabianice
Poland

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

| Member State | Name of the medicinal product | |------------------|-------------------------------------| | 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 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 |