Reyataz 150 mg Hard Capsules

• 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.

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

• 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 REYATAZ
• if you are taking any of these medicines: see also Other medicines and REYATAZ
  • 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)

Do not take sildenafil with REYATAZ 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.

REYATAZ is not a cure for HIV infection. You may continue to develop infections or other illnesses linked to HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.

Some people will need special care before or while taking REYATAZ. Talk to your doctor or pharmacist before taking REYATAZ 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

REYATAZ may affect how well your kidneys work.

Kidney stones have been reported in patients taking REYATAZ. 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 REYATAZ. 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 REYATAZ. 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 REYATAZ may require their heart to be monitored. Your child's doctor will decide this.

Do not give this medicine to children younger than 3 months of age and weighing less than 5 kg. The use of REYATAZ 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.

You must not take REYATAZ with certain medicines. These are listed under Do not take REYATAZ, at the start of Section 2.

There are other medicines that may not mix with REYATAZ. Tell your doctor 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 REYATAZ 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 REYATAZ or 2 hours after taking REYATAZ, 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)
• cyclosporin, 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, and warfarin (anticoagulants, used to reduce the blood clots)
• carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics)
• irinotecan (used to treat cancer)
• sedative agents (e.g. midazolam administered by injection)
• buprenorphine (used to treat opioid addiction and pain).

Some medicines may interact with ritonavir, a medicine that is taken with REYATAZ. It is important to tell your doctor if you are taking fluticasone or budesonide (given by nose or inhaled to treat allergic symptoms or asthma).

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

If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Atazanavir, the active substance of REYATAZ, is excreted in human milk. Patients should not breast-feed while taking REYATAZ. It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.

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

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.

Yellowing of the skin and/or eyes (jaundice) and irregular heart beat (QTc prolongation) may occur if you or your child take too much REYATAZ.

If you accidentally take more REYATAZ capsules than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.

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.

Do not stop taking REYATAZ before talking to your doctor.

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

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

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• The active substance is atazanavir. Each capsule contains 150 mg of atazanavir (as sulphate).
• The other ingredients are crospovidone, lactose monohydrate, and magnesium stearate. The capsule shell and printing ink contain gelatine, shellac, ammonium hydroxide, simethicone, propylene glycol, indigocarmin (E132) and titanium dioxide (E171).

Each capsule of REYATAZ 150 mg contains 150 mg atazanavir.

Opaque blue and powder blue capsule printed with white and blue inks, with "BMS 150 mg" on one half and with "3624" on the other half.

REYATAZ 150 mg hard capsules are supplied in bottles of 60 capsules.

REYATAZ 150 mg hard capsules are also supplied in blister strips in packs of 60 capsules.

Not all pack sizes may be marketed in all countries.

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