Package leaflet: Information for the user

Atazanavir Teva 150 mg hard capsules

Atazanavir Teva 200 mg hard capsules

Atazanavir Teva 300 mg hard capsules

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.

What is in this leaflet

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

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

3. How to take Atazanavir Teva

4. Possible side effects

6. Contents of the pack and other information

Atazanavir Teva 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 Teva reduces the risk of developing illnesses linked to HIV infection.

Atazanavir Teva capsules may be used by adults and children 6 years of age and older. Your doctor has prescribed Atazanavir Teva 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 Teva is best for you.

Atazanavir Teva 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.

Do not take Atazanavir Teva

• 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 Teva

Do not take sildenafil with Atazanavir Teva 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 the above apply to you.

Warnings and precautions

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

• if you have hepatitis B or C

• if you have type A or B haemophilia

• if you have diabetes

• if you require haemodialysis

• if you are taking oral contraceptives ("the Pill") to prevent pregnancy

• if you are taking omeprazole or other proton pump inhibitors; or famotidine or other H₂-receptor

antagonists (used to treat diseases related to the acid in the stomach)

patients receiving antiretroviral therapy

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 the 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 and adolescents

Atazanavir Teva capsules can be taken by children at least 6 years of age and older and weighing at least

15 kg who are able to swallow the capsules (see How to take Atazanavir Teva).

Children receiving Atazanavir Teva may require their heart to be monitored. Your child's doctor will decide

this.

Other medicines and Atazanavir Teva

You must not take Atazanavir Teva with certain medicines. These are listed under Do not take

Atazanavir Teva, at the start of section 2.

There are other medicines that may not mix with Atazanavir Teva. 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

• boceprevir (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 Teva, 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, H₂-blockers and proton pump inhibitors)

• medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm

• atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol)

• salmeterol (used to treat asthma)

• nevirapine and efavirenz (used to treat HIV)

• cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune

system)

• certain antibiotics (rifabutin, clarithromycin)

• ketoconazole, itraconazole, and voriconazole (antifungals)

• warfarin (anticoagulant, 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 Atazanavir Teva. 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).

Atazanavir Teva with food and drink

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

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or planning to become pregnant. Also be sure to talk to your doctor about breast-feeding. Patients should not breast-feed while taking Atazanavir Teva. It is recommended that women infected with HIV do not breast-feed because the virus might be transmitted through the breast milk.

Driving and using machines

If you feel dizzy or lightheaded, contact your doctor immediately.

Atazanavir Teva 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 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 adult dose of Atazanavir Teva capsules is 300 mg once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines. Your doctor may adjust thedose of Atazanavir Teva 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 Teva capsules for children is calculated by body weightand is taken once daily with food and 100 mg ritonavir as shown below:

Body Weight (kg)	Atazanavir Teva Dose once daily (mg)	Ritonavir Dose* once daily (mg)
15 to less than 20	150	100
20 to less than 40	200	100
At least 40	300	100
*Ritonavir capsules, tablets or oral solution may be used.

There are no dosing recommendations for Atazanavir Teva in paediatric patients less than 6 years of age or weighting less than 15 kg.

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

If you take more Atazanavir Teva than you should

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

If you forget to take Atazanavir Teva

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 aforgotten dose.

If you stop taking Atazanavir Teva

Do not stop taking Atazanavir Teva before talking to your doctor.

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

4. Possible side effects

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 Teva, by the other medicines you are taking, or by the HIV infection itself. Tell your doctor if you notice anything unusual about your health.

Patients treated with atazanavir have reported the following side effects:

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

• headache

• ocular icterus (presence of jaundice seen in the white part of the eyes)

• vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion)

• jaundice (yellowing of the skin and/or eyes)

• rash

• lipodistrophy syndrome (body changes due to fat redistribution, accumulation, or loss of body fat), fatigue (extreme tiredness)

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

• torsades de pointes (life threatening irregular heart beat)

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

• hypersensitivity (allergic reaction)

• diabetes mellitus (body cannot remove sugar from the blood normally)

• hyperglycaemia (high sugar levels in the blood)

• 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

• hepatitis (inflammation of the liver)

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

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

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

• nephrolithiasis (formation of kidney stones), interstitial nephritis (kidney inflamation), hematuria (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)

• serious skin rashes (allergic reactions including rash, a high temperature, increased levels of liver enzymes seen in blood tests, an increase in a type of white blood cell [esosinophilia], and/or enlarged lymph nodes) (see section 2)

• gallbladder disorders (gallstones and gallbladder inflammation)

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

• QTc prolongation (irregular heart beat)

• gait disturbance (abnormal manner of walking)

• oedema (swelling), palpitation (fast or irregular heart beat)

• hepatosplenomegaly (enlargement of the liver and spleen)

• vesiculobullous rash (visible accumulation of fluid under the skin), eczema (skin rash),

vasodilatation (widening of blood vessels)

• Stevens-Johnson syndrome (allergic reactions including serious skin rash, a high temperature and enlarged lymph nodes) (see section 2).

• myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise)

• kidney pain

People who already have type A or B haemophilia may notice increased bleeding.

There have been reports of raised blood sugar and developing or worsening of diabetes in people using protease inhibitors. Also, there have been reports of unusual heart beat in both adult and paediatric patients using atazanavir.

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes include increased amounts of fat in the upper back and neck ("buffalo hump"), breast, and around the abdomen ("belly"). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effects of these conditions are not known at this time.

Reporting of side effects

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

5. How to store Atazanavir Teva

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 outer carton, bottle or blister foil after EXP. The expiry date refers to the last day of that month.

Store below 30°C.

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.

6. Contents of the pack and other information

What Atazanavir Teva contains

Each hard capsule contains atazanavir sulfate corresponding to 150 mg of atazanavir.

Each hard capsule contains atazanavir sulfate corresponding to 200 mg of atazanavir.

Each hard capsule contains atazanavir sulfate corresponding to 300 mg of atazanavir.

magnesium stearate.

titanium dioxide (E171)

(300 mg) gelatine, indigotine (E132), titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172)

What Atazanavir Teva looks like and contents of the pack

Atazanavir Teva 150 mg hard capsules are non transparent size 1 capsules with overall closed length 19.4 ± 0.3 mm, with dark blue cap, and black mark 150 on light blue body. The content of the capsule is light yellow powder

Atazanavir Teva 200 mg hard capsules are non transparent size 0 capsules with overall closed length 21.7 ± 0.3 mm with blue cap, and black mark 200 on blue body. The content of the capsule is light yellow powder

Atazanavir Teva 300 mg hard capsules are non transparent size 00 capsules with overall closed length 23.3 ± 0.3 mm with red cap, and black mark 300 on blue body. The content of the capsule is light yellow powder

(150 mg and 200 mg) Atazanavir Teva stored in blisters is available in a pack size of 60 and 60 x 1 capsules.

(150 mg and 200 mg) Atazanavir Teva stored in bottles is available in a pack size of 60 capsules.

(300 mg) Atazanavir Teva stored in blisters are available in pack sizes of 30, 30 x 1, 60 and 90 capsules.

(300 mg) Atazanavir Teva stored in bottles is available in a pack size of 30 and 3 x 30 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This leaflet was last revised in 2016-04-08