Atazanavir Sandoz

Package leaflet: Information for the patient

Atazanavir Sandoz 200 mg hard capsules, 300 mg hard capsules

Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Atazanavir Sandoz 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 Sandoz reduces the risk of developing diseases associated with HIV infection.
Atazanavir Sandoz capsules can be used by both adults and children aged 6 years and older. Your doctor
has prescribed Atazanavir Sandoz 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 Sandoz is best for your case.

2. What you need to know before taking Atazanavir Sandoz

Do not take Atazanavir Sandoz

• • 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 Sandoz.
• • if you are taking any of the following medicines: see also Other medicines and Atazanavir Sandoz
• • 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 benign prostatic hyperplasia).
• 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 midazolam (to be taken by mouth) (used to help you sleep and/or reduce anxiety)
• simvastatin and lovastatin (used to lower cholesterol levels in the blood)
• medicines containing grazoprevir, including the fixed-dose combination of elbasvir/grazoprevir (used to treat chronic hepatitis C infection)

Do not take sildenafil with Atazanavir Sandoz 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 Sandoz is not a cure for HIV infection. You may continue to develop infections or
other illnesses associated with HIV infection. You may still transmit HIV while taking
this medicine, although the risk is reduced by the effect of antiretroviral therapy. Discuss with your
doctor the precautions needed to avoid transmitting the infection to others.
Some people may require special attention before or during treatment with Atazanavir
Sandoz. Consult your doctor or pharmacist before taking Atazanavir Sandoz and ensure that 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 undergoing haemodialysis

Atazanavir Sandoz may affect kidney function.
Kidney stones have been reported in patients taking atazanavir. If you develop signs or symptoms of
kidney stones (side pain, blood in urine, pain when urinating), inform your doctor immediately.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections,
inflammatory signs and symptoms of previous infections may occur shortly after starting anti-HIV treatment.
These symptoms are believed to be due to an improved immune response, allowing the body to fight infections that may have been present without clear symptoms. If you notice any signs of infection, inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition occurring when the immune system attacks healthy body tissue) may also occur after starting treatment for HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading toward 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 (especially in 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 occurred in patients taking atazanavir. Signs may include slight yellowing of the skin or 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. If a rash develops, inform your doctor immediately.
Consult your doctor if you notice changes in your heartbeat (changes in heart rhythm). Children receiving Atazanavir Sandoz 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 Sandoz
You must not take Atazanavir Sandoz with certain medicines. These medicines are listed in the section Do not take Atazanavir Sandoz, at the beginning of section 2.
There are other medicines you must not take with Atazanavir Sandoz. Inform your doctor if you are taking, have recently taken, or might take any other medicines. In particular, it is important to mention the following:

• • other medicines for the treatment of 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 oral contraceptives ("the pill") with Atazanavir Sandoz to prevent pregnancy, be sure to 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 1 hour before or 2 hours after taking Atazanavir Sandoz, histamine-2 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 cholesterol levels in the blood)
• • salmeterol (used to treat asthma)
• • cyclosporine, tacrolimus, and sirolimus (medicines to reduce immune system activity)
• • some antibiotics (rifabutin, clarithromycin)
• • ketoconazole, itraconazole, and voriconazole (antifungals)
• • warfarin (an anticoagulant, used to reduce blood clot formation)
• • carbamazepine, phenytoin, phenobarbital, lamotrigine (antiepileptics)
• • irinotecan (used in cancer treatment)
• • sedatives (e.g.: injectable midazolam)
• • buprenorphine (used to treat opioid dependence and pain)

Some medicines may interact with ritonavir, a medicine taken with Atazanavir
Sandoz. It is important that you inform your doctor if you are taking fluticasone or budesonide (administered nasally or inhaled to treat allergic symptoms or asthma).
Atazanavir Sandoz with food and drinks
It is important that you take Atazanavir Sandoz with food (a meal or substantial snack), as this helps the absorption of the medicine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Atazanavir, the active substance in Atazanavir Sandoz, is excreted in breast milk. Patients should not breastfeed while taking Atazanavir Sandoz. Women infected with HIV are advised not to breastfeed, as the virus can be transmitted through breast milk.
Driving and using machines
If you feel dizzy or lightheaded, do not drive or operate machinery and contact your doctor immediately.
Atazanavir Sandoz contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Atazanavir Sandoz

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor.
This way, you can be sure that the medicine will be fully effective and will reduce the risk of the virus
developing resistance to treatment.
The recommended dose of Atazanavir Sandoz 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 Sandoz depending on your anti-HIV therapy.
For children (from 6 years up to but less than 18 years of age), the paediatrician will determine the
correct dose based on the child's body weight. The dose of Atazanavir Sandoz capsules in children is calculated according to body weight and is taken once daily with food and 100 mg of ritonavir, as indicated below:

Other forms of this medicine may be available for use in children who are at least 3 months old and weigh at least 5 kg. It is recommended to switch from other formulations to the capsules as soon as patients are able to swallow capsules regularly.
When switching from other formulations to capsules, a change in dosage may be necessary. Your doctor will determine the appropriate dose based on the child's weight.
There are no recommended doses of Atazanavir Sandoz for pediatric patients under 3 months of age.
Take Atazanavir Sandoz capsules with food (a meal or substantial snack). Swallow the capsules whole. Do not open the capsules.
If you take more Atazanavir Sandoz than you should
If you or the child takes too high a dose of Atazanavir Sandoz, yellowing of the skin and/or eyes (jaundice) and irregular heartbeat (prolongation of the QTc interval) may occur.
If you accidentally take more Atazanavir Sandoz capsules than prescribed by your doctor, contact your doctor or the nearest hospital immediately for advice.
If you forget to take Atazanavir Sandoz
If you forget to take a dose, take the missed dose as soon as possible with food, then continue with 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 the missed dose.
If you stop taking Atazanavir Sandoz
Do not stop treatment with Atazanavir Sandoz without first talking to your doctor.
If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. When you are being treated for HIV infection, it is not always easy to determine whether side effects are caused by Atazanavir Sandoz, by other medicines you are taking, or by the HIV infection itself. Inform your doctor if you notice any unusual symptoms regarding your health.

During HIV treatment, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to the improvement in 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. The rash usually disappears within 2 weeks without any change in treatment with Atazanavir Sandoz. However, severe rash may develop in association with other symptoms that could be serious. Stop taking Atazanavir Sandoz and inform your doctor immediately if you develop severe rash or rash accompanied by flu-like symptoms, blisters, fever, mouth ulcers, 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 (jaundice) due to high levels of bilirubin in the blood has been commonly reported. This side effect is usually not dangerous in adults and infants over 3 months of age; however, it may be a sign of a serious problem. Inform your doctor immediately if your skin or the whites of your eyes turn yellow.

• Changes in heart rhythm (alterations in heartbeat) may occasionally occur. Inform your doctor immediately if you experience dizziness, feel lightheaded, or faint suddenly. These may be symptoms of a serious heart problem.

• Liver problems have been reported uncommonly in people taking atazanavir. Your doctor should perform blood tests before and during treatment with Atazanavir Sandoz. 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 have been reported uncommonly in people taking atazanavir. Symptoms of gallstones may include pain in the upper right or central part of the stomach, nausea, vomiting, fever, or yellowing of the skin or whites of the eyes.

• Atazanavir Sandoz may affect kidney function.

• Kidney stones have been reported uncommonly in people taking atazanavir. Inform your doctor immediately if you notice symptoms of kidney stones, including pain in the lower back or stomach, blood in the urine, or pain during urination.

Other side effects reported in patients treated with Atazanavir Sandoz include:

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, changes in dream activity
• • 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 commonly 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 falling asleep)

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

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Atazanavir Sandoz

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 carton, on the label of the
bottle, or on the blister after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
For bottles:
For 200 mg:
Use within 2 months after first opening
For 300 mg:
Use within 1 month after first opening
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Atazanavir Sandoz contains

• The active substance is atazanavir
  Atazanavir Sandoz 200 mg hard capsules: Each capsule contains 200 mg of atazanavir (as sulfate)
  Atazanavir Sandoz 300 mg hard capsules: Each capsule contains 300 mg of atazanavir (as sulfate)
• The other ingredients are:

Atazanavir Sandoz 200 mg hard capsules:
Monohydrate lactose, crospovidone (type A) (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b). The capsule shell and printing ink contain gelatin, titanium dioxide (E171), indigotine (E132), shellac, propylene glycol (E1520).
Atazanavir Sandoz 300 mg hard capsules:
Monohydrate lactose, crospovidone (type A) (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b). The capsule shell and printing ink contain gelatin, titanium dioxide (E171), indigotine (E132), red iron oxide (E172), shellac, propylene glycol (E1520).

Description of the appearance of Atazanavir Sandoz and contents of the pack
Atazanavir Sandoz 200 mg hard capsules:
Opaque blue hard capsule, size 0, with "200" printed in white ink on the cap.
Atazanavir Sandoz 300 mg hard capsules:
Opaque blue and red hard capsule, size 00, with "300" printed in white ink on the cap.

Atazanavir Sandoz 200 mg hard capsules:
Atazanavir Sandoz is available in aluminium-OPA/Alu/PVC unit-dose divisible blisters containing 60 x 1 hard capsules.
Atazanavir Sandoz is also available in HDPE bottles with polypropylene child-resistant closure containing 60 hard capsules.

Atazanavir Sandoz 300 mg hard capsules:
Atazanavir Sandoz is available in aluminium-OPA/Alu/PVC unit-dose divisible blisters containing 30 x 1 hard capsules.
Atazanavir Sandoz is available in multi-pack cartons containing 90 x 1 hard capsules (3 packs of 30 x 1) in aluminium-OPA/Alu/PVC unit-dose divisible blisters.
Atazanavir Sandoz is also available in HDPE bottles with polypropylene child-resistant closure containing 30 hard capsules, and in a multi-pack carton containing 90 hard capsules (3 packs of 30).

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturers
Remedica Ltd
Aharnon Street, Limassol Industrial Estate,
3056 Limassol
Cyprus

Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Germany: Atazanavir HEXAL 150 mg Hard capsules
Atazanavir HEXAL 200 mg Hard capsules
Atazanavir HEXAL 300 mg Hard capsules
Italy: Atazanavir Sandoz
Netherlands: Atazanavir Sandoz 150 mg, harde capsules
Atazanavir Sandoz 200 mg, harde capsules
Atazanavir Sandoz 300 mg, harde capsules