АТАЗАНАВИР 200 мг Капсулы твердые

Содержание инструкции

1. Atazanavir Sandoz 200 mg hard capsules, 300 mg hard capsules
   1. What is Atazanavir Sandoz 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. Package contents and other information

Atazanavir Sandoz 200 mg hard capsules, 300 mg hard capsules

Generic medicine

Read this leaflet carefully before taking this medicine, as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Atazanavir Sandoz 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 the infection from the human immunodeficiency virus (HIV) by blocking a protein that HIV needs to replicate.
These medicines work by reducing the amount of HIV virus in the body, and this leads to a
strengthening of 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 6 years of age and older. Your doctor
has prescribed Atazanavir Sandoz because you are affected by the HIV virus that causes Acquired
Immunodeficiency Syndrome (AIDS). It is normally used in association with other anti-HIV medicines.
Your doctor will discuss with you which association of these medicines with Atazanavir Sandoz is
best in your case.

2. What you need to know before taking Atazanavir Sandoz

Do not take Atazanavir Sandoz

• - if you are allergicto 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 assess the severity of your liver condition before deciding if you can take Atazanavir Sandoz.
• - if you are taking any of these medicines:see also Other medicines and Atazanavir Sandoz
• - rifampicin (an antibiotic for the treatment of tuberculosis)
• - astemizole or terfenadine (commonly used to treat allergy symptoms, these medicines may be available without a prescription); cisapride (used to treat heartburn, sometimes called acid indigestion); 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 prostate).
• 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 medicinal product)
• 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 that contain 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 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.
Talk to your doctor immediately if you are in any of these conditions.

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 necessary to avoid transmitting the infection to others.
Some people may require special attention before or during taking Atazanavir
Sandoz. Ask your doctor or pharmacist before taking Atazanavir Sandoz and make sure that the
doctor knows:

• - if you suffer from hepatitis B or C
• - if you develop signs or symptoms of gallstones (pain in the upper right side of the stomach)
• - if you suffer from haemophilia A or B
• - if you are on haemodialysis

Atazanavir Sandoz can affect kidney function.
Kidney stones have been reported in patients taking atazanavir. If you develop signs or symptoms of
kidney stones (pain in the side, blood in the urine, pain when urinating), tell your doctor immediately.
In some patients with advanced HIV infection (AIDS) and with a history of opportunistic infection,
signs and symptoms of previous infections may occur shortly after starting anti-HIV treatment. These
symptoms are thought to be due to an improvement in the body's immune response, which allows the
body to fight infections that may have been present without clear symptoms. If you notice any
symptoms of infection, please inform your doctor immediately. In addition to opportunistic infections,
autoimmune disorders (a condition that occurs when the immune system attacks healthy tissue in the
body) may also occur after you have started taking medicines to treat HIV infection. Autoimmune
disorders can occur many months after starting treatment. If you notice any
symptoms of infection or other symptoms such as muscle weakness, initial weakness in the hands and feet
that rises towards the trunk of the body, palpitations, tremor or hyperactivity, tell your doctor
immediately to request the necessary treatment.
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood
supply to the bone). The duration of combination antiretroviral therapy, the use of corticosteroids, the
consumption of alcohol, severe immunosuppression, a higher body mass index, among
others, may be some of the numerous risk factors for the development of this disease. Signs of
osteonecrosis are joint stiffness, discomfort and pain (especially in the hips, knees
and shoulders) and difficulty moving. See your doctor if you notice any of
these symptoms.
In patients taking atazanavir, hyperbilirubinemia (an increase in bilirubin levels in the blood) has occurred. The signs may be a slight yellowing of the skin or eyes. See
your doctor if you notice any of these symptoms.
Severe skin rash, including Stevens-Johnson syndrome, has been reported in patients taking atazanavir. If you develop a rash, tell your doctor immediately.
See your doctor if you notice a change in your heartbeat (changes in heart rhythm).
Children receiving Atazanavir Sandoz may need cardiac monitoring and this will be
established by the pediatrician.

Children
Do not give this medicine to childrenunder 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 some medicines.These medicines are listed in
the section Do not take Atazanavir Sandoz, at the beginning of section 2.
There are other medicines that you must not take with Atazanavir Sandoz. Tell your doctor if you
are taking, have recently taken or might take any other medicines. Especially, 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))

pregnancy, be sure to take them exactly as directed by your doctor and do not miss any
dose

• - any medicine used to treat acid-related disorders (e.g.: antacids to be taken 1 hour before taking Atazanavir Sandoz or 2 hours after taking Atazanavir Sandoz, H2-receptor blockers such as famotidine and proton pump inhibitors such as omeprazole)
• - medicines to lower blood pressure, decrease 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 lower the activity of the immune system)
• - some antibiotics (rifabutin, clarithromycin)
• - ketoconazole, itraconazole and voriconazole (antifungals)
• - warfarin (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 can interact with ritonavir, a medicine that is taken with Atazanavir
Sandoz. It is important that you tell your doctor if you are taking fluticasone or budesonide (administered
by nasal or inhaled route for the treatment of allergic symptoms or asthma).

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor for advice before taking this medicine.
Atazanavir, the active ingredient of Atazanavir Sandoz, is excreted in breast milk. Patients should
not breastfeed while taking Atazanavir Sandoz. It is recommended that HIV-infected women do not
breastfeed as the virus can be transmitted through breast milk.

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

Atazanavir Sandoz contains lactose.
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking
this medicine

3. How to take Atazanavir Sandoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask 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.

For adults, the recommended dose of Atazanavir Sandoz capsules is 300 mg once a
day with 100 mg of ritonavir, once a day, taken with food,in association with other
anti-HIV medicines. Your doctor may adjust the dose of Atazanavir Sandoz based on your anti-HIV
therapy.

For children (from 6 years to less than 18 years of age), the pediatrician will establish the right dose based on the
child's weight.The dose of Atazanavir Sandoz capsules in children is calculated based on body
weight and is taken once a day with food and 100 mg of ritonavir, as indicated below:
Other formulations of this medicine may be available for use in children who are at
least 3 months of age and weigh at least 5 kg. It is suggested to switch from other formulations to capsules
as soon as patients are able to swallow capsules regularly.
When switching between other formulations and capsules, a change in dosage may occur. The
doctor will decide the right dose based on the child's weight.
There are no recommended dosages of Atazanavir Sandoz for pediatric patients under 3 months
of age.

Take Atazanavir Sandoz capsules with food(a meal or a 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 and then take the next dose at the scheduled time. However, if the time of the next dose is near,
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 a missed dose.
If you stop taking Atazanavir Sandoz
Do not stop treatment with Atazanavir Sandoz before talking to your doctor.
If you have any questions about using this medicine, ask your doctor

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
When being treated for HIV infection, it is not always easy to tell which side effects are caused by Atazanavir Sandoz, by other medicines you are taking, or by the HIV infection itself. Tell your doctor if you notice anything unusual regarding your health.
During therapy for HIV, you may experience an increase in weight and levels of lipids and glucose in the blood. This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will check these changes.
Tell your doctor immediately if you develop any of the following serious side effects:
The redness usually disappears within 2 weeks without any modification to treatment with Atazanavir Sandoz. Severe redness may develop in association with other symptoms that may be serious. Stop taking Atazanavir Sandoz and tell your doctor immediately if you develop severe redness or redness with flu-like symptoms, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), painful, warm or red lumps (nodules).
 Yellowing of the skin or the white of the eyes caused by 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; but it can be a symptom of a serious problem. Tell your doctor immediately if your skin or the white of your eyes become yellow.
 Changes in the way your heart beats (changes in heart rhythm) can occur occasionally. Tell your doctor immediately if you feel dizzy, lightheaded, or faint suddenly. These may be symptoms of a serious heart problem.
 Liver problems can occur infrequently. Your doctor should perform blood tests before and during treatment with Atazanavir Sandoz. If you have liver problems, including hepatitis B or C infection, you may experience a worsening of your liver problems. Tell your doctor immediately if you notice dark urine (tea-colored), itching, yellowing of the skin or the white of your eyes, pain around the stomach, pale stools, or nausea.
 Gallbladder problems, such as gallstones, occur infrequently in people taking atazanavir. Symptoms of gallstones may include pain in the upper right or middle of the stomach, nausea, vomiting, fever, or yellowing of the skin or the white of the eyes.
 Atazanavir Sandoz can affect kidney function.
 Kidney stones occur infrequently in people taking atazanavir. Tell your doctor immediately if you notice symptoms of kidney stones, including pain in the lower back or stomach, blood in the urine, or pain when urinating.
Other side effects reported for patients treated with Atazanavir Sandoz are as follows:
Common (may affect up to 1 in 10 people):

• - headache
• - vomiting, diarrhea, 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 the 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, drowsiness, altered dream activity
• - syncope (fainting), hypertension (high blood pressure)
• - dyspnea (shortness of breath)
• - pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and inflammation of the oral cavity), dysgeusia (altered taste), flatulence (gas), dry mouth, abdominal distension
• - angioedema (severe swelling of the skin and other tissues, most frequently lips and eyes)
• - alopecia (unusual hair loss or thinning), itching
• - muscle atrophy (reduction of muscle mass), arthralgia (joint pain), myalgia (muscle pain)
• - interstitial nephritis (kidney inflammation), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination)
• - gynecomastia (enlargement of the breasts in men)
• - chest pain, malaise (general feeling of discomfort), fever
• - insomnia (difficulty falling asleep)

Rare (may affect up to 1 in 1000 people):

• - gait disturbance (abnormal way of walking)
• - edema (swelling)
• - hepato-splenomegaly (enlargement of the liver and spleen)
• - myopathy (muscle pain, muscle weakness from fatigue 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 through the national reporting system at 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 box, 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 at a temperature 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 in waste water 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 ingredient 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:
Lactose monohydrate, 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:
Lactose monohydrate, crospovidone (Type A) (E1202), anhydrous colloidal silica (E551), magnesium
stearate (E470b). The capsule shell and printing ink contain gelatin, titanium
dioxide (E171), indigotine (E132), iron oxide red (E172), shellac, propylene glycol

Description of the appearance of Atazanavir Sandoz and package contents

Atazanavir Sandoz 200 mg hard capsules:
Opaque, blue, size 0 capsule, with “200” printed on the cap with white ink

Atazanavir Sandoz 300 mg hard capsules:
Opaque, blue and red, size 00 capsule, with “300” printed on the cap with white ink

Atazanavir Sandoz 200 mg hard capsules:
Atazanavir Sandoz is available in aluminum-OPA/Alu/PVC blister packs divisible for single doses
containing 60 x 1 hard capsule
Atazanavir Sandoz is available in HDPE bottles with a child-resistant closure containing 60 hard capsules

Atazanavir Sandoz 300 mg hard capsules:
Atazanavir Sandoz is available in aluminum-OPA/Alu/PVC blister packs divisible for single doses
containing 30 x 1 hard capsule
Atazanavir Sandoz is available in a multi-pack containing 90 x 1 hard capsules (3
packs of 30 x 1) in aluminum-OPA/Alu/PVC blister packs divisible for single doses
Atazanavir Sandoz is available in HDPE bottles with a child-resistant closure containing 30 hard capsules and a multi-pack containing 90
hard capsules (3 packs of 30)
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area under the
following denominations:
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, hard capsules
Atazanavir Sandoz 200 mg, hard capsules
Atazanavir Sandoz 300 mg, hard capsules
.