ATAZANAVIR 200 MG HARD CAPSULES - patient leaflet, side effects, dosage

amneal3

Package leaflet: Information for the user Atazanavir 150 mg hard capsules Atazanavir 200 mg hard capsules Atazanavir 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 is and what it is used for

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

• 3. How to take Atazanavir

• 4. Possible side effects

• 5. How to store Atazanavir

• 6. Contents of the pack and other information

1. what atazanavir is and what it is used for

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

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

2. what you need to know before you take atazanavir

Do not take Atazanavir:

• 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.
• if you are taking any of these medicines (see also “Other medicines and Atazanavir”):

• – 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);

• – 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);

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

Do not take sildenafil with Atazanavir 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

Talk to your doctor or pharmacist before taking Atazanavir.

Atazanavir 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. Ask your doctor the precautions needed to avoid infecting other people.

Some people will need special care before or while taking Atazanavir. Talk to your doctor or pharmacist before taking Atazanavir 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(a blood disorder in which the ability of the blood to clot is severely reduced)
• if you require haemodialysis (the process of purifying the blood when the kidneys are not working normally)

Kidney problems

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.

Infections

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.

Osteonecrosis

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.

High levels of bilirubin in the blood

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.

Severe allergic reactions

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

Heart problems

If you notice a change in the way your heart beats (heart rhythm changes), please inform your doctor. Children receiving Atazanavir 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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

There are other medicines that may not mix with Atazanavir. Tell your doctor if you are taking:

• other medicines to treat HIV infection (e.g. indinavir, nevirapine and efavirenz)
• 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 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 or 2 hours after taking Atazanavir, 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)
• 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. 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 with food

It is important that you take Atazanavir 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 for advice before taking this medicine.

Atazanavir, the active substance of Atazanavir, is excreted in human milk. Patients should not breast-feed while taking Atazanavir. 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, do not drive or use machines and contact your doctor immediately.

Atazanavir hard capsules contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take atazanavir

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 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 the dose of Atazanavir according to your anti-HIV therapy.

Use in children

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 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 Dose once daily (mg)	Ritonavir Dose* once daily (mg)
15 to less than 35	200	100
at least 35	300	100
* 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 in paediatric patients less than 3 months of age.

Take Atazanavir capsules with food (a meal or a substantial snack). Swallow the capsules whole.

Do not open the capsules.

If you take more Atazanavir than you should

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

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.

If you forget to take Atazanavir

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

Do not stop taking Atazanavir 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, 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 Atazanavir treatment. Severe rash may be developed in association with other symptoms which could be serious. Stop taking Atazanavir 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 bilirrubin 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 to you starting Atazanavir 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)
• 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 inflamation), 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)
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store atazanavir

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 pack after “EXP". The expiry date refers to the last day of the month.

For HDPE bottle pack:

This medicine does not require any special storage conditions.

For Alu/Alu blister pack:

Do not store above 30°C.

After first opening of the bottle use the medicinal product within 60 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 to protect the environment.

6. contents of the pack and other informationwhat atazanavir contains the active substance is atazanavir sulfate.

Each capsule contains 150 mg, 200 mg or 300 mg of atazanavir (as sulfate).

• The other ingredients are:

What Atazanavir looks like and contents of the pack

Atazanavir 150 mg hard capsules

Size ‘1 ’ hard gelatin capsules having imprinted ‘Amneal 150 mg’ on blue opaque cap with white ink and ‘1136’ on powder blue opaque body with blue ink, filled with off white to yellow granular powder.

Atazanavir 200 mg hard capsules

Size ‘0’ hard gelatin capsules having imprinted ‘Amneal 200 mg’ on blue opaque cap and ‘1137’ on blue opaque body with white ink, filled with off white to yellow granular powder.

Atazanavir 300 mg hard capsules

Size ‘00’ hard gelatin capsules having imprinted ‘Amneal 300 mg’ on red opaque cap and ‘1138’ on blue opaque body with white ink, filled with off white to yellow granular powder.

Atazanavir is available in:

Blister: Aluminium(OPA-Alu-PVC)/Aluminium blisters in packs containing 30, 60 and 90 hard capsules.

Bottle: HDPE container with child resistant Polypropylene closure containing 30 and 60 hard capsules.

Not all pack size may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder :

Amneal Pharma Europe Limited

70 Sir John Rogerson’s Quay, Dublin 2, Ireland

Manufacturer :

Amneal Netherlands BV

Emmaplein 4D

5211 VW

's-Hertogenbosch

The Netherlands

This leaflet was last revised in April 2018.

Size : 240 × 520 mm, Colour: M Black, Key line(Not to Print)

Back Side

NOTE: Actual Perforation require for Patient alert card

Minimum Font Size 9 pt

Date: 11/04/2018

Page 2 of 2