Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - atazanavir

Document Subject

Generated Narrative: MedicinalProductDefinition mp975c71538de6c7ace8f1a35ed29b064a

identifier: http://ema.europa.eu/identifier/EU/1/16/1091/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Atazanavir Mylan 150 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-975c71538de6c7ace8f1a35ed29b064a

identifier: http://ema.europa.eu/identifier/EU/1/16/1091/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - atazanavir

Attesters

What is in this leaflet

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

Atazanavir Mylan is an antiviral (or antiretroviral) medicine. It is one of a group called protease inhibitors. These medicines control Human Immunodeficiency Virus (HIV) infection by stopping a protein that the HIV needs for its multiplication. They work by reducing the amount of HIV in your body and this in turn, strengthens your immune system. In this way Atazanavir Mylan reduces the risk of developing illnesses linked to HIV infection.

Atazanavir Mylan capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed Atazanavir Mylan for you because you are infected by the HIV that causes Acquired Immunodeficiency Syndrome (AIDS). It is normally used in combination with other anti-HIV medicines. Your doctor will discuss with you which combination of these medicines with Atazanavir Mylan is best for you.

Do not take Atazanavir Mylan

• if you are allergic to atazanavir or any of the other ingredients of this medicine (listed in section 6)
• if you have moderate to severe liver problems. Your doctor will evaluate how severe your liver disease is before deciding whether you can take Atazanavir Mylan
• if you are taking any of these medicines: see also Other medicines and Atazanavir Mylan

• 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 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 prostatic gland).

• quetiapine (used to treat schizophrenia, bipolar disorder and major depressive disorder).

• lurasidone (used to treat schizophrenia).

• medicines containing St. John s wort (Hypericum perforatum, a herbal preparation).

• triazolam and oral (taken by mouth) midazolam (used to help you sleep and/or to relieve anxiety).

• lomitapide, simvastatin and lovastatin (used to lower blood cholesterol).

• grazoprevir-containing products, including elbasvir/grazoprevir fixed-dose combination, and glecaprevir/pibrentasvir fixed-dose combination (used to treat chronic hepatitis C infection).

• apalutamide (used to treat prostate cancer).

Do not take sildenafil with Atazanavir Mylan when sildenafil is used for the treatment of pulmonary arterial hypertension. Sildenafil is also used for the treatment of erectile dysfunction. Tell your doctor if you are using sildenafil for the treatment of erectile dysfunction. Tell your doctor at once if any of these apply to you. Warnings and precautions

Atazanavir Mylan is not a cure for HIV infection. You may continue to develop infections or other illnesses linked to HIV infection.

Some people will need special care before or while taking Atazanavir Mylan. Talk to your doctor or pharmacist before taking Atazanavir Mylan and make sure your doctor knows:

• if you have hepatitis B or C
• if you develop signs or symptoms of gall stones (pain at the right side of your stomach)
• if you have type A or B haemophilia
• if you require haemodialysis

Atazanavir may affect how well your kidneys work.

Kidney stones have been reported in patients taking atazanavir. If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately. In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in hands and feet and moving up towards the trunk of the body, palpitations, tremor, or hyperactivity, please inform your doctor immediately to seek necessary treatment.

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches, and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Hyperbilirubinaemia (an increase in the level of bilirubin in the blood) has occurred in patients receiving atazanavir. The signs may be a mild yellowing of the skin or eyes. If you notice any of these symptoms please inform your doctor.

Serious skin rash, including Stevens-Johnson syndrome, has been reported in patients taking atazanavir. If you develop a rash inform your doctor immediately.

If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor. Children receiving Atazanavir Mylan may require their heart to be monitored. Your child s doctor will decide this.

Children Do not give this medicine to children younger than 3 months of age and weighing less than 5 kg. The use of atazanavir in children less than 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 Mylan You must not take Atazanavir Mylan with certain medicines. These are listed under Do not take Atazanavir Mylan, at the start of Section 2. There are other medicines that may not mix with Atazanavir Mylan. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to mention these:

• other medicines 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 an oral contraceptive ("the Pill") with Atazanavir Mylan to prevent pregnancy, be sure to take it exactly as instructed by your doctor and not miss any doses.
• any medicines used to treat diseases related to the acid in the stomach (e.g. antacids to be taken 1 hour before taking Atazanavir Mylan or 2 hours after taking Atazanavir Mylan, H2-blockers like famotidine and proton pump inhibitors like omeprazole)
• medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil)
• atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol)
• salmeterol (used to treat asthma)
• ciclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of 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)
• carbamazepine, phenytoin, phenobarbital, and lamotrigine (antiepileptics)
• encorafenib, ivosidenib, and irinotecan (used to treat cancer)
• elagolix (gonadotropin-releasing hormone receptor antagonists, used to treat severe 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 that is taken with Atazanavir Mylan. It is important to tell your doctor if you are taking an inhaled or nasal (given in the nose) corticosteroid, including fluticasone or budesonide (given to treat allergic symptoms or asthma).

Atazanavir Mylan with food and drink It is important that you take Atazanavir Mylan with food (a meal or a substantial snack) as this helps the body absorb the medicine.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think that 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 Mylan, is excreted in human milk. Patients should not breast-feed while taking Atazanavir Mylan.
Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as
soon as possible.

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

Atazanavir Mylan contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (e.g., lactose), contact your doctor before taking this medicinal product.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. This way, you can be sure your medicine is fully effective and you reduce the risk of the virus developing resistance to the treatment.

The recommended dose of Atazanavir Mylan capsules for adults is 300 mg once daily with 100 mg ritonavir once daily, taken with food, in combination with other anti-HIV medicines. Your doctor may adjust the dose of Atazanavir Mylan according to your anti-HIV therapy.

For children (6 to less than 18 years of age), your child s doctor will decide the right dose based on your child s weight. The dose of Atazanavir Mylan capsules for children is calculated by body weight and is taken once daily with food and 100 mg ritonavir as shown below:

Body Weight (kg) Atazanavir Mylan dose once daily (mg) Ritonavir Dose* once daily (mg) 15 to less than at least * Ritonavir capsules, tablets, or oral solution may be used.

Other forms of this medicine may be available for use in children at least 3 months old and weighing at least 5 kg. Switching to capsules from other formulations is encouraged as soon as patients are able to consistently swallow capsules.

A change in dose may occur when switching between other formulations and capsules. Your doctor will decide the right dose based on your child s weight.

There are no dosing recommendations for Atazanavir Mylan in paediatric patients less than 3 months of age.

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

If you take more Atazanavir Mylan than you should Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much Atazanavir Mylan. If you accidentally take more Atazanavir Mylan capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.

If you forget to take Atazanavir Mylan If you miss a dose, take the missed dose as soon as possible with food and then take your next scheduled dose at its regular time. If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at its regular time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Atazanavir Mylan Do not stop taking Atazanavir Mylan before talking to your doctor.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always easy to identify what side effects are caused by atazanavir, by the other medicines you are taking, or by the HIV infection itself. Tell your doctor if you notice anything unusual about your health.

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Tell your doctor immediately if you develop any of the following serious side effects:

• Skin rash, itching that may occasionally be severe has been reported. The rash usually disappears within 2 weeks without any change to your treatment. Severe rash may be developed in association with other symptoms which could be serious. Stop taking Atazanavir Mylan and talk to your doctor immediately if you develop a severe rash or a rash with flu-like illness symptoms, blisters, fever, mouth sores, muscle or joint pain, swelling in the face, inflammation of the eye which causes redness (conjunctivitis), painful, warm, or red lumps (nodules).
• Yellowing of your skin or the white part of your eyes caused by high levels of bilirubin in your blood has been commonly reported. This side effect is usually not dangerous in adults and infants older than 3 months of age; but it might be a symptom of a serious problem. If your skin or the white part of your eyes turns yellow, talk to your doctor immediately.
• Changes in the way your heart beats (heart rhythm change) may occasionally happen. Talk to your doctor immediately if you get dizzy, lightheaded or if you suddenly faint. These could be symptoms of a serious heart problem.
• Liver problems may uncommonly happen. Your doctor should do blood tests prior you starting to take 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. Talk to your doctor immediately if you get dark (tea-colored) urine, itching, yellowing of your skin or the white part of your eyes, pain around the stomach, pale-colored stools, or nausea.
• Gallbladder problems uncommonly happen in people taking atazanavir. Symptoms of gallbladder problems may include pain in the right or middle upper stomach area, nausea, vomiting, fever, or yellowing your skin or the white part of your eyes.
• Atazanavir may affect how well your kidneys work.
• Kidney stones uncommonly happen in people taking atazanavir. Talk to your doctor immediately if you get symptoms of kidney stones which may include, pain in your low back or low stomach-area, blood in your urine, or pain when you urinate.

Other side effects reported for patients treated with atazanavir are the following:

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

• headache
• vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion)
• fatigue (extreme tiredness)

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

• peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs)

• hypersensitivity (allergic reaction)

• asthenia (unusual tiredness or weakness)

• weight decreased, weight gain, anorexia (loss of appetite), appetite increased

• depression, anxiety, sleep disorder

• disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream

• syncope (fainting), hypertension (high blood pressure)

• dyspnoea (shortness of breath)

• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension

• angioedema (severe swelling of the skin and other tissues most often the lips or the eyes)

• alopecia (unusual hair loss or thinning), pruritus (itching)

• muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles)

• interstitial nephritis (kidney inflammation), haematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination)

• gynaecomastia (breast enlargement in men)

• chest pain, malaise (generally feeling unwell), fever

• insomnia (difficulty sleeping)

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

• gait disturbance (abnormal manner of walking)
• oedema (swelling)
• hepatosplenomegaly (enlargement of the liver and spleen)
• myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise)
• kidney pain

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

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

Do not use this medicine after the expiry date which is stated on the label, carton or blister. The expiry date refers to the last day of that month. Store below 25 C. Store in the original package in order to protect from moisture.

For bottles: Once opened, use within 90 days.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Atazanavir Mylan contains

Atazanavir Mylan 150 mg hard capsules

• The active substance is atazanavir. Each capsule contains 150 mg or atazanavir (as sulphate).
• The other ingredients are lactose monohydrate (see section 2, Atazanavir Mylan contains lactose ), crospovidone, magnesium stearate. The capsule shell and printing ink contain iron oxide red (E172),

titanium dioxide (E171), patent blue V (E131), gelatin, shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide.

Atazanavir Mylan 200 mg hard capsules

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

Atazanavir Mylan 300 mg hard capsules

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

What Atazanavir Mylan looks like and contents of the pack

Atazanavir Mylan 150 mg hard capsules are greenish-blue and blue opaque capsules with MYLAN over AR150 printed in black ink on cap and body.

Atazanavir Mylan 200 mg hard capsules are blue and greenish-blue opaque capsules with MYLAN over AR200 printed in black ink on cap and body.

Atazanavir Mylan 300 mg hard capsules are red and greenish-blue opaque capsules with MYLAN over AR300 printed in black ink on cap and body.

Atazanavir Mylan 150 mg hard capsules This medicine comes in blister packs containing 60 or 60 x 1 (unit dose) capsules or in bottles containing hard capsules.

Atazanavir Mylan 200 mg hard capsules This medicine comes in blister packs containing 30, 60 or 60 x 1 (unit dose) capsules or in bottles containing 60 hard capsules.

Atazanavir 300 mg hard capsules This medicine comes in blister packs containing 30 or 30 x 1 (unit dose) capsules or in bottles containing or 90 hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Pharmaceuticals 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, Kom rom, H-2900 Hungary

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Viatris T l/Tel: + 32 (0)2 658 61 Lietuva Viatris UAB
Tel: +370 5 205 1

: +359 2 44 55 Luxembourg/Luxemburg Viatris T l/Tel: + 32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: + 420 222 004 Magyarorsz g Viatris Healthcare Kft. Tel.: + 36 1 465 2Danmark Viatris ApS Tlf: + 45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Viatris Healthcare GmbH
Tel: + 49 800 0700 Nederland Mylan B.V. Tel: + 31 (0)20 426 3Eesti Viatris O
Tel: + 372 6363 Norge Viatris AS Tlf: + 47 66 75 33
Viatris Hellas Ltd
: +30 2100 100 sterreich Arcana Arzneimittel GmbH Tel: + 43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel.: + 48 22 564 64 France Viatris Sant
T l: +33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 214 127 Hrvatska Viatris Hrvatska d.o.o.
Tel: +385 1 23 50 Rom nia BGP Products SRL Tel: + 40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Viatris d.o.o. Tel: +386 1 236 31 sland Icepharma hf. Slovensk republika Viatris Slovakia s.r.o.

S mi: +354 540 8Tel: +421 2 32 199 Italia Viatris Italia S.r.l. Tel: +39 02 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd : + 357 222 077 Sverige Viatris AB
Tel: + 46 (0) 8 630 19 Latvija Viatris SIA Tel: + 371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: + 353 18711This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: