ATAZANAVIR MYLAN 300 mg HARD CAPSULES

Introduction

Package Leaflet: Information for theuser

Atazanavir Viatris 150 mg hard capsulesEFG

Atazanavir Viatris 200 mg hard capsulesEFG

Atazanavir Viatris 300 mg hard capsulesEFG

atazanavir

Read all of this leaflet carefully before you start 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 thepackage leaflet

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

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

3. How to take Atazanavir Viatris

4. Possible side effects

5. Storage of Atazanavir Viatris

6. Contents of the pack and further information

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

Atazanavir Viatris is an antiviral medicine (or antiretroviral).It belongs to a group of medicines called protease inhibitors.These medicines control HIV infection by blocking a protein that HIV needs to multiply. It works by reducing the amount of HIV in your body and thereby strengthening your immune system. This reduces the risk of developing diseases associated with HIV infection.

Atazanavir Viatris capsules can be used by adults and children from 6 years of age and older. Your doctor has prescribed Atazanavir Viatris because you are infected with HIV, which causes acquired immune deficiency syndrome (AIDS). It is usually used in combination with other anti-HIV medicines. Your doctor will decide which combination of these medicines is best for you with Atazanavir Viatris.

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

Do not take AtazanavirViatris

• to atazanavir or any of the other ingredients of this medicine

(see section 6)

• . Your doctor will assess the severity of your liver disease before deciding if you can take Atazanavir Viatris
• also see Taking Atazanavir Viatris with other medicines

• rifampicin (an antibiotic used to treat tuberculosis) –
• astemizole or terfenadine (used frequently to treat allergic symptoms, these medicines may be available without a prescription); cisapride (used to treat stomach 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 in the treatment of schizophrenia)
• medicines containing St. John's Wort (Hypericum perforatum, a medicinal plant)
• triazolam and oral midazolam (given by mouth) (used to induce sleep and/or relieve anxiety)
• lomitapide, simvastatin, and lovastatin (used to lower blood cholesterol)
• 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 infection).
• apalutamide (used to treat prostate cancer), encorafenib (used to treat cancer), and ivosidenib (used to treat cancer)
• carbamazepine, phenobarbital, and phenytoin (used to treat seizures)

Do not take sildenafil with Atazanavir Viatris 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 andprecautions

Atazanavir Viatris 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 Viatris. Consult your doctor or pharmacist before starting Atazanavir Viatris 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 inflammation of previous infections may appear soon after starting anti-HIV treatment. These symptoms are believed to be due to an improvement in the body's immune response, allowing it to fight infections that were present without apparent symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start 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 receiving 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 immunodepression, 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 tone 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 Viatris 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 AtazanavirViatris

You must not take Atazanavir Viatris with certain medicines. These are listed under the heading Do not take Atazanavir Viatris, at the beginning of Section 2.

There are other medicines that should not be taken with Atazanavir Viatris. 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 Viatris to prevent pregnancy, make sure to take it exactly as your doctor has indicated and do not miss any doses
• certain medicines used to treat diseases related to stomach acidity (e.g., antacids that should be administered 1 hour before taking Atazanavir Viatris or 2 hours after taking Atazanavir Viatris, H2 blockers such as famotidine, and proton pump inhibitors such as omeprazole)
• medicines to lower blood pressure, reduce 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)
• lamotrigine (antiepileptic)
• irinotecan (used to treat cancer)
• elagolix (antagonists of gonadotropin-releasing hormone receptors, used to treat intense 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 given with Atazanavir Viatris. It is important that you inform your doctor if you are using fluticasone or budesonide (administered by nasal or inhalation route, for the treatment of allergic symptoms or asthma).

Taking Atazanavir Viatris with food anddrinks

It is important that you take Atazanavir Viatris with food (a meal or snack) as this helps the absorption of the medicine.

Pregnancy andbreastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Atazanavir, the active substance of Atazanavir Viatris, is excreted in breast milk. You should also make sure to talk to your doctor about breastfeeding. Patients must not breastfeed while taking Atazanavir Viatris. It is recommended that HIV-infected women do not breastfeed their babies because the virus can be transmitted through breast milk.

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

If you are breastfeeding or thinking of breastfeeding, you must consult your doctoras soon as possible.

Driving and usingmachines

If you feel dizzy or drowsy, do not drive or use machines, and contact your doctor immediately.

Atazanavir Viatris containslactose.

If your doctor has told you that you have an intolerance to some sugars (e.g., lactose), consult your doctor before taking this medicine.

3. How to take Atazanavir Viatris

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor 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 Viatris capsules for adults is 300 mg together with 100mgof ritonavir once a day and with food,in combination with other anti-HIV medicines. Your doctor may adjust the dose of Atazanavir Viatris according to your anti-HIV treatment.

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

Other forms of this medicine may be available for use in children from 3 months of age and weighing at least 5 kg. It is recommended to switch to other formulations to capsules as soon as patients are able to swallow the capsules properly.

When switching between other formulations and capsules, a dose change may be necessary. Your doctor will decide the correct dose based on your child's weight. There are no dose recommendations for Atazanavir Viatris in pediatric patients under 3 months of age.

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

If you take more Atazanavir Viatris than youshould

If you or your child take too much Atazanavir Viatris, the skin and/or eyes may turn yellow (jaundice) and irregular heartbeats (prolonged QTc) may occur. If you have accidentally taken more Atazanavir Viatris capsules than your doctor recommended, contact your doctor immediately or go to the nearest hospital for consultation.

If you forget to take AtazanavirViatris

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 formisseddoses.

If you stop taking AtazanavirViatris

Do not stop taking Atazanavir Viatris before consulting your doctor.

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

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 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 blood lipids, sometimes to HIV medicines themselves. Your doctor will monitor these changes.

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

• Rash has been reported, itching that can occasionally be severe. The rash usually disappears within 2 weeks without changing your treatment with Atazanavir Viatris. Severe rash associated with other symptoms that can be severe may develop. Discontinue treatment with Atazanavir Mylan 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 lumps (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; but 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 occasionally occur. 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 can 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, pale-colored stools, or nausea.
• Bile duct problems can occur infrequently in people taking Atazanavir Viatris. Symptoms of bile duct 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 can occur infrequently in people taking Atazanavir Viatris.
• 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, 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 abnormal tiredness 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 (high blood pressure)
• dyspnea (difficulty breathing)
• 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, malaise (feeling unwell), fever
• insomnia (difficulty sleeping)

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

• gait disturbance (abnormal gait)
• 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, 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 national reporting system included in Appendix V.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atazanavir Viatris

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

Do not use this medicine after the expiration date that appears on the label, carton, or blister. The expiration date is the last day of the month indicated.

Store below 25°C. Store in the original packaging to protect it from moisture.

In the case of bottles: Once opened, use the medicine within 90 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Atazanavir Viatris

Atazanavir Viatris 150 mg hard capsules

• The active ingredient is atazanavir. Each capsule contains 150 mg of atazanavir (as sulfate).
• The other ingredients are lactose monohydrate (see section 2 "Atazanavir Viatris contains lactose"), crospovidone, and magnesium stearate. The capsule shell and printing ink contain iron oxide red (E172), titanium dioxide (E171), patented blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), and potassium hydroxide.

Atazanavir Viatris 200 mg hard capsules

• The active ingredient is atazanavir. Each capsule contains 200 mg of atazanavir (as sulfate).
• The other ingredients are lactose monohydrate (see section 2 "Atazanavir Viatris contains lactose"), crospovidone, and magnesium stearate. The capsule shell and printing ink contain titanium dioxide (E171), indigo carmine (E132), iron oxide red (E172), patented blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), and potassium hydroxide.

Atazanavir Viatris 300 mg hard capsules

• The active ingredient is atazanavir. Each capsule contains 300 mg of atazanavir (as sulfate).
• The other ingredients are lactose monohydrate, crospovidone, and magnesium stearate. The capsule shell and printing ink contain iron oxide yellow (E172), iron oxide red (E172), titanium dioxide (E171), patented blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), and potassium hydroxide.

Appearance of Atazanavir Viatris and Package Contents

Atazanavir Viatris 150 mg hard capsules are greenish-blue and blue opaque capsules with the imprint "MYLAN" over "AR150" in black ink on the cap and body.

Atazanavir Viatris 200 mg hard capsules are blue and greenish-blue opaque capsules with the imprint "MYLAN" over "AR200" in black ink on the cap and body.

Atazanavir Viatris 300 mg hard capsules are red and greenish-blue opaque capsules with the imprint "MYLAN" over "AR300" in black ink on the cap and body.

Atazanavir Viatris 150 mg hard capsules

This medicine is supplied in blisters containing 60 or 60 x 1 (single-dose) capsules or in bottles containing 60 hard capsules.

Atazanavir Viatris 200 mg hard capsules

This medicine is supplied in blisters containing 30, 60, or 60 x 1 (single-dose) capsules or in bottles containing 60 hard capsules.

Atazanavir Viatris 300 mg hard capsules

This medicine is supplied in blisters containing 30 or 30 x 1 (single-dose) capsules or in bottles containing 30 or 90 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturers

Mylan Hungary Kft, Mylan utca 1, Komárom, H-2900 Hungary

Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information about this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.