Atazanavir Viatris

Package leaflet: Information for the user

Atazanavir Viatris 150 mg hard capsules, 200 mg hard capsules, 300 mg hard capsules

atazanavir
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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Atazanavir Viatris is an antiviral (or antiretroviral) medicine. It belongs to a group
called protease inhibitors. These medicines control human immunodeficiency virus (HIV) infection
by blocking a protein that HIV needs in order to replicate.
By reducing the amount of HIV virus in the body, these medicines help strengthen the immune system.
In this way, Atazanavir Viatris reduces the risk of developing diseases associated with HIV infection.
Atazanavir Viatris capsules can be used in both adults and children aged 6 years and older. Your doctor has prescribed Atazanavir Viatris because you are infected with HIV, the virus that causes Acquired Immunodeficiency Syndrome (AIDS). It is usually used in combination with other anti-HIV medicines. Your doctor will discuss with you which combination of these medicines with Atazanavir Viatris is best.

2. What you should know before taking Atazanavir Viatris

Do not take Atazanavir Viatris

• if you are allergic to atazanavir or to 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 condition before deciding whether you can take Atazanavir Viatris.
• if you are taking any of the following medicines: see also Other medicines and Atazanavir Viatris
• rifampicin, an antibiotic used to treat tuberculosis
• astemizole or terfenadine (commonly used to treat allergy symptoms; these medicines may be available without prescription); cisapride (used to treat gastric reflux, sometimes referred to as heartburn); pimozide (used to treat schizophrenia); quinidine or bepridil (used to correct heart rhythm); ergotamine, dihydroergotamine, ergonovine, methylergonovine (used to treat headaches); alfuzosin (used to treat benign prostatic hyperplasia).
• quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder)
• lurasidone (used to treat schizophrenia).
• medicinal products containing St. John’s Wort (Hypericum perforatum, a herbal preparation)
• triazolam and oral midazolam (to be taken by mouth) (used to help you sleep and/or reduce anxiety).
• lomitapide, simvastatin and lovastatin (used to lower blood cholesterol levels).
• medicines 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)

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 taking sildenafil for erectile
dysfunction.
Contact your doctor immediately if you are in any of these situations.
Warnings and precautions
Atazanavir Viatris is not a cure for HIV infection. You may continue to develop infections or
other illnesses associated with HIV infection.
Some people may require special attention before or during treatment with Atazanavir
Viatris. Talk to your doctor or pharmacist before taking Atazanavir Viatris and make sure your
doctor knows:

• if you have hepatitis B or C
• if you develop signs or symptoms of gallstones (pain in the right side of the abdomen)
• if you have haemophilia type A or B
• if you are on haemodialysis

Atazanavir may affect kidney function.
Kidney stones have been reported in patients taking Atazanavir Viatris. If you develop signs or
symptoms of kidney stones (flank pain, blood in the urine, pain when urinating), inform your
doctor immediately.
In some patients with advanced HIV infection (AIDS) and with a history of opportunistic infections,
inflammatory signs and symptoms of previous infections may occur shortly after starting
antiretroviral therapy. These symptoms are believed to be due to an improved immune response,
which enables the body to fight infections that may have occurred without obvious symptoms.
If you notice any signs of infection, inform your doctor immediately. In addition to opportunistic
infections, autoimmune diseases (a condition in which the immune system attacks healthy body
tissue) may also occur after starting antiretroviral therapy. Autoimmune diseases may occur
several months after starting treatment. If you notice any signs of infection or other symptoms
such as muscle weakness, initial weakness in hands and feet spreading upwards towards the trunk,
palpitations, tremor or hyperactivity, contact your doctor immediately to receive necessary
treatment.
Some patients receiving combination antiretroviral therapy may develop a bone disease called
osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration of
combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe
immunosuppression, higher body mass index, among others, may be some of the many risk factors
for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort and pain
(particularly in the hips, knees and shoulders) and difficulty moving. Consult your doctor if you
notice any of these symptoms.
Hyperbilirubinaemia (an increase in blood bilirubin levels) has been observed in patients taking
Atazanavir Viatris. Signs may include mild yellowing of the skin and eyes. Consult your doctor if
you notice any of these symptoms.
Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking
Atazanavir Viatris. If you develop a skin rash, inform your doctor immediately.
Consult your doctor if you notice changes in your heartbeat (changes in heart rhythm).
Children receiving Atazanavir Viatris may require cardiac monitoring, which will be determined by
the paediatrician.
Children
Do not give this medicine to children under 3 months of age and weighing less than 5 kg. The use of
atazanavir in children under 3 months of age and weighing less than 5 kg has not been studied due to
the risk of serious complications.
Other medicines and Atazanavir Viatris
You must not take Atazanavir Viatris with certain medicines. These medicines are listed in the
section Do not take Atazanavir Viatris at the beginning of section 2.
There are other medicines that you must not take with Atazanavir Viatris. Inform your doctor or pharmacist
if you are taking, have recently taken, or might take any other medicines.
In particular, it is important to mention the following:

• other medicines used to treat 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 oral contraceptives ("the pill") with Atazanavir Viatris to prevent pregnancy, make sure you take them exactly as directed by your doctor and do not miss any doses
• any medicine used to treat acid-related stomach disorders (e.g.: antacids taken one hour before or two hours after taking Atazanavir Viatris, histamine H2-receptor 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 levels)
• salmeterol (used to treat asthma)
• ciclosporin, tacrolimus and sirolimus (medicines to reduce immune system activity)
• some antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole and voriconazole (antifungals)
• apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel and ticagrelor (used to reduce blood clot formation)
• carbamazepine, phenytoin, phenobarbital and lamotrigine (antiepileptics)
• encorafenib, ivosidenib and irinotecan (used in cancer treatment)
• elagolix (gonadotropin-releasing hormone receptor antagonists, used to treat severe endometriosis pain)
• fostamatinib (used to treat chronic immune thrombocytopenia)
• sedatives (e.g., injectable midazolam)
• buprenorphine (used to treat opioid dependence and pain)
• corticosteroids (all routes of administration; including dexamethasone).

Some medicines may interact with ritonavir, a medicine taken with Atazanavir
Viatris. It is important that you inform your doctor if you are taking an inhaled or nasal
corticosteroid (including fluticasone or budesonide, used to treat allergic symptoms or asthma).
Atazanavir Viatris with food and drink
It is important that you take Atazanavir Viatris with food (a meal or substantial snack), as this helps the medicine to be absorbed.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Atazanavir, the active substance in Atazanavir Viatris, is excreted in breast milk. Patients should not breastfeed while taking Atazanavir Viatris.
Breastfeeding is not recommended for HIV-positive women because HIV infection can be transmitted to the infant through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.
Driving and using machines
If you feel dizzy or lightheaded, do not drive or operate machinery and contact your doctor immediately.
Atazanavir Viatris contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars (e.g. lactose), contact your doctor before taking this medicine.

3. How to take Atazanavir Viatris

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
By following these instructions, you can be sure that the medicine will be fully effective and the risk of the virus developing resistance to the treatment will be reduced.
The recommended dose of Atazanavir Viatris capsules for adults is 300 mg once daily with 100 mg of ritonavir, taken once daily with food, in combination with other anti-HIV medicines. Your doctor may adjust the dose of Atazanavir Viatris depending on your anti-HIV therapy.
For children (aged 6 to less than 18 years), the paediatrician will determine the correct dose based on the child's body weight. The dose of Atazanavir Viatris capsules in children is calculated according to body weight and is taken once daily with food and 100 mg of ritonavir, as indicated below:

Atazanavir is also available in other formulations for use in children who are at least 3 months old and weigh at least 5 kg. It is recommended to switch from the other atazanavir formulation to atazanavir capsules as soon as patients are able to swallow capsules regularly.
A dosage adjustment may occur when switching from the oral powder to the capsules. The doctor will determine the appropriate dose based on the child's weight.
There are no recommended doses of Atazanavir Viatris for pediatric patients under 3 months of age.
Take Atazanavir Viatris capsules with food (a meal or substantial snack). Swallow the capsules whole. Do not open the capsules.
If you take more Atazanavir Viatris than you should
If you or the child takes a higher dose of Atazanavir Viatris than prescribed, yellowing of the skin and/or eyes (jaundice) and irregular heartbeat (QTc interval prolongation) may occur.
If you accidentally take more Atazanavir Viatris capsules than prescribed by your doctor, contact your doctor or the nearest hospital immediately for advice.
If you forget to take Atazanavir Viatris
If you forget to take a dose, take the missed dose as soon as possible with food, then take the next dose at the scheduled time. However, if the time for the next dose is approaching, do not take the missed dose. Wait and take only the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Atazanavir Viatris
Do not stop treatment with Atazanavir Viatris before discussing it with your doctor.
If you have any doubts 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 everybody will experience them.
When being treated for HIV infection, it may not always be easy to determine whether side effects are
caused by atazanavir, by other medicines you are taking, or by the HIV infection itself.
Inform your doctor if you notice anything unusual about your health.
During HIV therapy, an increase in weight and in blood lipid and glucose levels may occur. This is partly
related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the
HIV medicines themselves. Your doctor will monitor these changes.
Inform your doctor immediately if you develop any of the following serious side effects:

• Skin rash and itching have been reported, which may occasionally be severe. Skin rash usually resolves within 2 weeks without any change in treatment with Atazanavir Viatris. Severe rash may develop in association with other symptoms that could be serious. Stop taking Atazanavir Viatris and inform your doctor immediately if you develop severe rash or rash accompanied by flu-like symptoms, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), or painful, warm, red lumps (nodules).
• Yellowing of the skin or whites of the eyes due to high levels of bilirubin in the blood has been commonly reported. This side effect is usually not harmful in adults and infants over 3 months of age; however, it may be a sign of a serious condition. Inform your doctor immediately if your skin or the whites of your eyes turn yellow.
• Changes in heart rhythm (alterations in heartbeat) may occur occasionally. Inform your doctor immediately if you feel dizzy, lightheaded, or experience sudden fainting. These may be symptoms of a serious heart problem.
• Liver problems may occur uncommonly. Your doctor should perform blood tests before and during treatment with this medicine. If you have liver problems, including hepatitis B or C infection, your liver condition may worsen.

Inform your doctor immediately if you notice dark urine (tea-colored), itching, yellowing of the skin or whites of the eyes, stomach pain, pale stools, or nausea.

• Gallstones may occur uncommonly in people taking Atazanavir Viatris. Symptoms of gallstones may include pain in the upper right or central abdomen, nausea, vomiting, fever, or yellowing of the skin or whites of the eyes.
• Atazanavir may affect kidney function.
• Kidney stones may occur uncommonly in people taking Atazanavir Viatris. Inform your doctor immediately if you notice symptoms of kidney stones, including pain in the lower back or abdomen, blood in the urine, or pain during urination.

Other side effects reported in patients treated with Atazanavir Viatris are listed below:
Common (may affect up to 1 in 10 people)

• headache
• vomiting, diarrhoea, abdominal pain (stomach discomfort), nausea, dyspepsia (indigestion)
• fatigue (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 (unusual tiredness or weakness)
• weight decrease, weight increase, anorexia (loss of appetite), increased appetite
• depression, anxiety, sleep disorders
• disorientation, amnesia (memory loss), dizziness, somnolence (drowsiness), abnormal dreams
• syncope (fainting), hypertension (high blood pressure)
• dyspnoea (shortness of breath)
• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and oral inflammation), dysgeusia (altered taste), flatulence (intestinal gas), dry mouth, abdominal distension
• angioedema (severe swelling of the skin and other tissues, most frequently lips and eyes)
• alopecia (unusual hair loss or thinning), pruritus (itching)
• muscle atrophy (reduction in muscle mass), arthralgia (joint pain), myalgia (muscle pain)
• interstitial nephritis (inflammation of the kidney), haematuria (blood in urine), proteinuria (excess protein in urine), pollakiuria (increased frequency of urination)
• gynaecomastia (enlargement of breasts in men)
• chest pain, malaise (general feeling of discomfort), fever
• insomnia (difficulty sleeping)

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

• gait disturbances (abnormal walking pattern)
• oedema (swelling)
• hepatosplenomegaly (enlargement of the liver and spleen)
• myopathy (muscle pain, muscle weakness with fatigue not caused by physical exercise)
• renal pain

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist,
or nurse. You can also report side effects directly via the national reporting system listed in Annex V.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Atazanavir Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton, or the
blister. The expiry date refers to the last day of that month.
Store below 25°C. Keep in the original packaging to protect the
medicine from moisture.
For bottles: once opened, use within 90 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Atazanavir Viatris contains
Atazanavir Viatris 150 mg hard capsules

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

Atazanavir Viatris 200 mg hard capsules

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

Atazanavir Viatris 300 mg hard capsules

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

Description of the appearance of Atazanavir Viatris and package contents
Atazanavir Viatris 150 mg hard capsules are opaque aquamarine and blue capsules, with the imprint "MYLAN" above "AR150" in black ink on both cap and body.
Atazanavir Viatris 200 mg hard capsules are opaque blue and aquamarine capsules, with the imprint "MYLAN" above "AR200" in black ink on both cap and body.
Atazanavir Viatris 300 mg hard capsules are opaque red and aquamarine capsules, with the imprint "MYLAN" above "AR300" in black ink on both cap and body.
Atazanavir Viatris 150 mg hard capsules
This medicinal product is supplied in blisters containing 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.
Atazanavir Viatris 200 mg hard capsules
This medicinal product is supplied in blisters containing 30, 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.
Atazanavir Viatris 300 mg hard capsules
This medicinal product is supplied in blisters containing 30 or 30 x 1 (unit dose) capsules or in bottles containing 30 or 90 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer
McDermott Laboratories trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: +359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan B.V.
Tel: + 49 800 0700 800 Tel: + 31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: +30 2100 100 002 Tel: + 43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: +48 22 564 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: +33 4 37 25 75 00 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 236 31 80

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: +39 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Τηλ: + 357 22863100 Viatris AB
Tel: + 46 (0) 8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: + 371 676 055 80 Tel: + 353 18711600

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu