ATAZANAVIR 300 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Atazanavir Zentiva, 150 mg, hard capsules
3. Atazanavir Zentiva, 200 mg, hard capsules
4. Atazanavir Zentiva, 300 mg, hard capsules
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Atazanavir Zentiva and what is it used for
   1. Atazanavir Zentiva is an antiviral medicine (more specifically, an antiretroviral).
6. Important information before taking Atazanavir Zentiva
   1. When not to take Atazanavir Zentiva:
   2. Warnings and precautions
   3. Children
   4. Atazanavir Zentiva and other medicines
   5. Taking Atazanavir Zentiva with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Atazanavir Zentiva contains lactose
7. How to take Atazanavir Zentiva
   1. The recommended dose of Atazanavir Zentiva in capsules is 300 mg once daily
   2. In children (from 6 to 18 years of age), the appropriate dose will be determined by the doctor, based on the child's body weight
   3. Do not open the capsules.
   4. Taking a higher dose of Atazanavir Zentiva than recommended
   5. Missing a dose of Atazanavir Zentiva
   6. Stopping treatment with Atazanavir Zentiva
8. Possible side effects
   1. Reporting side effects
9. How to store Atazanavir Zentiva
10. Contents of the pack and other information
    1. What Atazanavir Zentiva contains
    2. What Atazanavir Zentiva looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Leaflet accompanying the packaging: information for the user

Atazanavir Zentiva, 150 mg, hard capsules

Atazanavir Zentiva, 200 mg, hard capsules

Atazanavir Zentiva, 300 mg, hard capsules

Atazanavir

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

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

Atazanavir Zentiva is an antiviral medicine (more specifically, an 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 strengthens the immune system. In this way, the medicine reduces the risk of developing diseases related to HIV infection.
Atazanavir Zentiva capsules can be used in adults and children over 6 years of age. The doctor has prescribed this medicine because the patient is infected with the HIV virus, which causes acquired immunodeficiency syndrome (AIDS). This medicine is used in combination with other medicines used to treat HIV. The doctor will discuss with the patient which combination of these medicines with Atazanavir Zentiva is most beneficial for the patient.

2. Important information before taking Atazanavir Zentiva

When not to take Atazanavir Zentiva:

• If the patient is allergicto atazanavir or any of the other ingredients of this medicine (listed in section 6)
• If the patient has moderate to severe liver function disorders.The doctor will assess the severity of the liver disease before deciding to use this medicine.
• If the patient is taking any of the following medicines:see also: Atazanavir Zentivaand other medicines
• rifampicin (an antibiotic used to treat tuberculosis);
• astemizole or terfenadine (these medicines used to treat allergy symptoms may also be available without a prescription); cisapride (used to treat gastroesophageal reflux disease, sometimes called heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to treat heart rhythm disorders); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headache); and alfuzosin (used to treat prostate enlargement);

quetiapine (used to treat schizophrenia, bipolar disorder, and severe depression);
products containing St. John's wort (Hypericum perforatum, herbal medicine);
triazolam and oral midazolam (used to facilitate sleep and to remove anxiety);
simvastatin and lovastatin (used to lower blood cholesterol levels);
drugs containing grazoprevir, including combination products containing elbasvir and grazoprevir in a fixed dose (used to treat chronic hepatitis C infection).

• Do not take this medicine with sildenafil when sildenafil is used to treat pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. You should tell your doctor if you are taking sildenafil to treat erectile dysfunction.
  You should immediately inform your doctor if you are taking any of the above medicines.

Warnings and precautions

This medicine will not cure HIV infection.The patient may still develop infections or other diseases related to HIV infection. While taking this medicine, the patient may still transmit HIV to others, although effective antiretroviral therapy reduces this risk. The patient should discuss with the doctor what precautions to take to avoid infecting others.
Some patients may require special care before or during treatment with this medicine. Before starting treatment with Atazanavir Zentiva, you should tell your doctor or pharmacist and inform your doctor about:

• existing hepatitis B or C;
• occurrence of symptoms of gallstones (pain in the right side of the abdomen);
• presence of hemophilia A or B;
• need for hemodialysis.

Atazanavir Zentiva may affect kidney function.
Patients taking atazanavir have reported kidney stones. If the patient experiences symptoms of kidney stones (side pain, blood in the urine, pain while urinating), they should immediately inform their doctor.
In some patients with advanced HIV infection (AIDS), who have previously had opportunistic infections, symptoms of inflammation caused by a previous infection may appear soon after starting antiretroviral treatment. It is believed that these symptoms are due to the improvement in the body's ability to respond to the infection, allowing it to fight off infections that may not have caused symptoms. If symptoms of infection are observed, you should immediately contact your doctor. In addition to opportunistic infections, autoimmune diseases (in which the immune system attacks healthy tissues) may also occur after starting antiretroviral treatment. These diseases can develop many months after starting treatment. If the patient notices symptoms of infection or other symptoms such as muscle weakness, weakness starting from the hands and feet and progressing towards the torso, heart palpitations, tremors, or hyperactivity, they should seek medical help as soon as possible.
In some patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone) may develop. The duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and increased body mass index may be some of the many risk factors for the development of the disease. Symptoms of osteonecrosis are joint stiffness, pain (especially in the hips, knees, and shoulders), and difficulty moving. If the patient notices any of these symptoms, they should contact their doctor.
Patients taking atazanavir have reported hyperbilirubinemia (increased bilirubin levels in the blood). A symptom may be mild yellowing of the skin or eyes. If the patient notices any of these symptoms, they should contact their doctor.
Patients taking atazanavir have reported severe skin rash, including Stevens-Johnson syndrome. If a rash appears, the patient should immediately inform their doctor.
If the patient notices changes in their heart rhythm (changes in heart rate), they should inform their doctor. Children taking this medicine may need to have their heart function monitored. The doctor will decide on this.

Children

This medicine should not be given to children under 3 months of age and weighing less than 5 kg. Due to the risk of severe complications, studies on the use of this medicine in children under 3 months of age and weighing less than 5 kg have not been conducted.

Atazanavir Zentiva and other medicines

Do not take Atazanavir Zentiva with certain medicines.They have been listed in the "When not to take Atazanavir Zentiva" section at the beginning of section 2.
There are also other medicines that should not be taken with Atazanavir Zentiva. You should tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take. It is especially important to inform your doctor about:

• other medicines used to treat HIV infection (e.g., indinavir, nevirapine, and efavirenz);
• boceprevir and sofosbuvir with velpatasvir and voxilaprevir (used to treat hepatitis C);
• sildenafil, vardenafil, or tadalafil [used to treat impotence (erectile dysfunction)];
• oral contraceptives ("the pill") - if you are taking them to prevent pregnancy along with this medicine, you must ensure that you strictly follow your doctor's instructions and do not miss any dose;
• any medicines used to treat diseases related to stomach acid production (e.g., antacids taken 1 hour before taking this medicine or 2 hours after taking this medicine, H2 receptor blockers such as famotidine, and proton pump inhibitors such as omeprazol);
• blood pressure-lowering medicines, heart rate-slowing medicines, or medicines that improve heart rhythm (amiodarone, diltiazem, lidocaine used systemically, verapamil);
• atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol levels);
• salmeterol (used to treat asthma);
• cyclosporine, tacrolimus, and sirolimus (medicines used to reduce the reactivity of the immune system in the body)
• certain antibiotics (rifabutin, clarithromycin);
• ketoconazole, itraconazole, and voriconazole (antifungal medicines);
• warfarin (an anticoagulant medicine);
• carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptic medicines);
• irinotecan (used to treat cancer);
• sedatives (e.g., midazolam given by injection);
• buprenorphine (used to treat opioid addiction and pain).

Some medicines may interact with ritonavir, a medicine that is taken with Atazanavir Zentiva. It is important to inform your doctor about taking medicines such as fluticasone or beclomethasone (given intranasally or inhaled to treat allergy symptoms or asthma).

Taking Atazanavir Zentiva with food and drink

It is important to take this medicine with food (a meal or a large snack), as this helps the medicine to be absorbed into the body.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor for advice before taking this medicine. Atazanavir, the active substance of this medicine, passes into human milk. You should not breastfeed while taking this medicine. To avoid transmitting HIV through breast milk, HIV-infected women should not breastfeed under any circumstances.

Driving and using machines

You should not drive or operate machines if you experience dizziness or a feeling of emptiness in the head. You should immediately contact your doctor.

Atazanavir Zentiva contains lactose

If you have been diagnosed with an intolerance to some sugars (e.g., lactose), you should contact your doctor before taking this medicine.

3. How to take Atazanavir Zentiva

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should ask your doctor. This will ensure that the medicine is fully effective and reduce the risk of developing resistance to the treatment.

The recommended dose of Atazanavir Zentiva in capsules is 300 mg once daily

with ritonavir at a dose of 100 mg once daily, with food, in combination with other medicines used to treat HIV. The doctor may adjust the dose of Atazanavir Zentiva depending on the HIV treatment being used.

In children (from 6 to 18 years of age), the appropriate dose will be determined by the doctor, based on the child's body weight

The dose of Atazanavir Zentiva capsules, calculated based on the child's body weight,should be taken once daily with food and 100 mg of ritonavir, as shown below:

You should 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 Zentiva capsules when the patient is able to consistently swallow capsules. Changing the pharmaceutical form from oral powder to capsules may require a dose change. The doctor will determine the appropriate dose based on the child's body weight.
There are no recommendations for dosing this medicine in children under 3 months of age.
Atazanavir Zentiva capsules should be taken with food(a meal or a large snack). The capsules should be swallowed whole.

Do not open the capsules.

Taking a higher dose of Atazanavir Zentiva than recommended

After taking an overdose of this medicine, jaundice (yellowing of the skin and/or eyes) and/or irregular heartbeat (prolonged QTc interval) may occur.
In case of accidental ingestion of too many Atazanavir Zentiva capsules, you should seek medical advice from your doctor or the nearest hospital.

Missing a dose of Atazanavir Zentiva

If a dose of the medicine is missed, it should be taken as soon as possible with food, and the next planned dose should be taken at the usual time. If this coincides with the time of the next dose, the missed dose should not be taken. You should wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping treatment with Atazanavir Zentiva

Do not stop taking this medicine without consulting your doctor.
If you have any further questions about taking this medicine, you should ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During HIV treatment, it is not always possible to distinguish between side effects caused by Atazanavir Zentiva and those caused by other medicines taken at the same time or by HIV infection itself. You should inform your doctor about any change in your health status.
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to the improvement in health and lifestyle, and in the case of lipid levels in the blood, sometimes to the HIV treatment itself. The doctor will monitor these changes.
You should immediately inform your doctor if you notice any of the following serious side effects:

• Reports of skin rash and itching have been received, which can sometimes be severe. The rash usually resolves within 2 weeks without changing the treatment regimen with Atazanavir Zentiva. Severe forms of rash may be accompanied by other symptoms, which can be serious. You should stop taking this medicine and immediately consult your doctor if you experience a severe rash or rash with flu-like symptoms, blisters, fever, mouth ulcers, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), or painful, warm, or red lumps (nodules).
• Reports of yellowing of the skin or eyes due to high bilirubin levels in the blood have been received. This side effect is usually not dangerous in adults and infants over 3 months of age, but it may be a sign of a serious health disorder. If you notice yellowing of the skin or eyes, you should immediately consult your doctor.
• Changes in heart rhythm (heart rhythm disorders) have sometimes been reported. You should immediately contact your doctor if you experience dizziness, a feeling of fainting, or sudden fainting. These may be symptoms of a serious heart condition.
• Not very often, liver disorders have been reported. Before and during treatment with this medicine, the doctor should perform blood tests on the patient. In patients with liver disease, including viral hepatitis B or C, worsening of existing liver disease may occur. If you notice dark urine (tea-colored), itching, yellowing of the skin or eyes, abdominal pain, pale stools, or nausea, you should immediately inform your doctor.
• In patients taking this medicine, not very often, gallbladder disorders have been reported. Symptoms of gallbladder disease may include pain in the right or middle upper abdomen, nausea, vomiting, fever, or yellowing of the skin or eyes.
• Atazanavir Zentiva may affect kidney function.
• In patients taking this medicine, not very often, kidney stones have been reported. You should immediately consult your doctor if you notice 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 by patients taking this medicine are as follows:
Frequently(may affect up to 1 in 10 people):

• headaches;
• vomiting, diarrhea, abdominal pain (stomach pain or discomfort), nausea, dyspepsia (indigestion);
• fatigue (extreme tiredness).

Not very often(may affect up to 1 in 100 people):

• peripheral nervous system disorders (numbness, weakness, tingling, or pain in the hands and feet);
• hypersensitivity (allergic reaction);
• asthenia (unusual tiredness or weakness);
• weight loss, weight gain, anorexia (loss of appetite), increased appetite;
• depression, anxiety, sleep disorders;
• disorientation, amnesia (memory loss), dizziness, somnolence (drowsiness), nightmares;
• fainting (syncope), hypertension (high blood pressure);
• shortness of breath (dyspnea);
• pancreatitis, gastritis, aphthous stomatitis (mouth ulcers and throat redness), taste disorders, bloating (gas), dry mouth, abdominal distension;
• angioedema (severe swelling of the skin and other tissues, most often of the lips or eyes);
• alopecia (unusual hair loss or thinning), pruritus;
• atrophy (muscle wasting), arthralgia (joint pain), myalgia (muscle pain);
• interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (protein in the urine), frequent urination;
• gynecomastia (breast enlargement);
• chest pain, malaise, fever;
• insomnia (difficulty sleeping);

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

• gait disturbances (unusual gait);
• edema (swelling);
• liver and spleen enlargement;
• myopathy (muscle pain, muscle tenderness, or weakness caused by exercise);
• kidney pain

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181C, 02-222 Warsaw.
Phone: +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 marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atazanavir Zentiva

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, or blister. The expiry date refers to the last day of the month.
Shelf life after first opening the bottle containing 30 capsules: 30 days.
Shelf life after first opening the bottle containing 60 capsules: 60 days.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Atazanavir Zentiva contains

Atazanavir Zentiva, 150 mg

• The active substance of the medicine is atazanavir. Each capsule contains 150 mg of atazanavir (in the form of atazanavir sulfate).
• The other ingredients are: lactose monohydrate, crospovidone (type B), and magnesium stearate. The capsule shell contains titanium dioxide (E 171), gelatin, and indigo carmine (E 132).

Atazanavir Zentiva, 200 mg

• The active substance of the medicine is atazanavir. Each capsule contains 200 mg of atazanavir (in the form of atazanavir sulfate).
• The other ingredients are: lactose monohydrate, crospovidone (type B), and magnesium stearate. The capsule shell contains titanium dioxide (E 171), gelatin, and indigo carmine (E 132).

Atazanavir Zentiva, 300 mg

• The active substance of the medicine is atazanavir. Each capsule contains 300 mg of atazanavir (in the form of atazanavir sulfate).
• The other ingredients are: lactose monohydrate, crospovidone (type B), and magnesium stearate. The capsule shell contains titanium dioxide (E 171), gelatin, indigo carmine (E 132), iron oxide red (E 172), iron oxide black (E 172), and iron oxide yellow (E 172).

What Atazanavir Zentiva looks like and contents of the pack

Atazanavir Zentiva, 150 mg:
Each capsule of the medicine contains 150 mg of atazanavir.
A granular powder with a light yellow to light brown color in hard gelatin capsules with a non-transparent blue cap and a greenish-blue body.
Atazanavir Zentiva, 200 mg:
Each capsule of the medicine contains 200 mg of atazanavir.
A granular powder with a light yellow to light brown color in hard gelatin capsules with a non-transparent blue cap and a non-transparent blue body.
Atazanavir Zentiva, 300 mg:
Each capsule of the medicine contains 300 mg of atazanavir.
A granular powder with a light yellow to light brown color in hard gelatin capsules with a non-transparent red cap and a non-transparent blue body.
Atazanavir Zentiva, 150 mg, hard capsules are available in bottles containing 60 capsules.
Atazanavir Zentiva, 150 mg, hard capsules are also available in blisters containing 60 capsules.
Atazanavir Zentiva, 200 mg, hard capsules are available in bottles containing 60 capsules.
Atazanavir Zentiva, 200 mg, hard capsules are also available in blisters containing 60 capsules.
Atazanavir Zentiva, 300 mg, hard capsules are available in bottles containing 30 or 60 capsules. One bottle containing 30 or 60 capsules, as well as three bottles containing 90 (3x30) capsules, are available in one carton.
Atazanavir Zentiva, 300 mg, hard capsules are also available in blisters containing 30 or 60 capsules.
Not all pack sizes may be marketed in all countries.

Marketing authorization holder and manufacturer

Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic