Atazanavir Teva 300 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atazanavir Teva 300 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Atazanavir is an antiviral (or antiretroviral) medicine. It belongs to a group of medicines called protease inhibitors. These medicines control Human Immunodeficiency Virus (HIV) infection by inhibiting a protein that the virus needs to multiply. It works by reducing the amount of HIV in your body, thereby strengthening your immune system. This way, atazanavir reduces the risk of developing diseases associated with HIV infection.

Atazanavir capsules can be used in adults and in children six years of age and older. Your doctor has prescribed atazanavir for you because of an infection caused by HIV, the virus that causes Acquired Immunodeficiency Syndrome (AIDS). It is usually used in combination with other antiretroviral medicines. Your doctor will determine the best combination of atazanavir with these medicines for you.

2. What you need to know before taking Atazanavir Teva

Do not take Atazanavir Teva:

• 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 disease before deciding whether you can take atazanavir.

• if you are taking any of the following medicines: see also Taking Atazanavir Teva with other medicines

  • rifampicin (an antibiotic used to treat tuberculosis).

• astemizole or terfenadine (commonly used to treat allergic symptoms; these medicines may be available without a 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 prostate gland).

• quetiapine (used to treat schizophrenia, bipolar disorder, and major depressive disorder), lurasidone (used in the treatment of schizophrenia).

• medicines containing St. John's wort (Hypericum perforatum, a herbal remedy).

• triazolam and oral midazolam (administered by mouth) (used to induce sleep and/or relieve anxiety).

• lomitapide, simvastatin, and lovastatin (used to lower blood cholesterol).

• medicines containing grazoprevir, including the fixed-dose combination of elbasvir/grazoprevir and the fixed-dose combination of glecaprevir/pibrentasvir (used to treat chronic hepatitis C infection).

• apalutamide (used to treat prostate cancer), encorafenib (used to treat cancer), and ivosidenib (used to treat cancer).

• carbamazepine, phenobarbital, and phenytoin (used to treat seizures).

Do not take sildenafil with atazanavir 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.

Tell your doctor if you are in any of these situations.

Warnings and precautions

Atazanavir is not a cure for HIV infection. You may continue to develop infections or other illnesses associated with HIV infection.

Some people may need special monitoring before or during treatment with atazanavir. Consult your doctor or pharmacist before starting atazanavir, and make sure your doctor knows:

• if you have hepatitis B or C
• if you develop signs or symptoms of gallstones (pain on the right side of your stomach)
• if you have haemophilia type A or B
• if you require haemodialysis

Atazanavir Teva may affect how your kidneys work.

Kidney stones have been reported in patients treated with atazanavir. If you experience signs or symptoms of kidney stones (side pain, blood in urine, pain when urinating), please inform your doctor immediately.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, allowing the body to fight infections that were previously present without noticeable symptoms. If you notice any signs of infection, please inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you start taking medicines for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up toward the trunk, palpitations, tremors, or hyperactivity, inform 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). Numerous risk factors for developing this condition include duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort (particularly in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, please inform your doctor.

Hyperbilirubinaemia (increased levels of bilirubin in the blood) has occurred in patients receiving atazanavir. Signs may include a slightly yellowish tint to the skin or eyes. If you notice any of these symptoms, please inform your doctor.

Severe skin rash, including Stevens-Johnson syndrome, has been observed in patients treated with atazanavir. Inform your doctor immediately if you develop a rash.

If you notice a change in your heartbeat (changes in heart rhythm), please inform your doctor.

Children receiving Atazanavir Teva may require heart monitoring. Your doctor will decide this.

Children

Do not give this medicine to children under 3 months of age and weighing less than 5 kg. The use of Atazanavir Teva has not been studied in children under 3 months of age and weighing less than 5 kg due to the risk of serious complications.

Taking Atazanavir Teva with other medicines

You must not take atazanavir with certain medicines. These are listed under the heading Do not take Atazanavir Teva, at the beginning of section 2.

There are other medicines that should not be taken with atazanavir. Inform your doctor if you are taking, have recently taken, or might need to take any other medicines. It is especially important that you mention the use of the following:

• 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 atazanavir to prevent pregnancy, ensure you take it exactly as directed by your doctor and do not miss any doses
• some medicines used to treat acid-related stomach conditions (e.g. antacids, which should be taken 1 hour before or 2 hours after taking atazanavir; H2-blockers such as famotidine; and proton pump inhibitors such as omeprazole)
• medicines to lower blood pressure, slow heart rate, or correct heart rhythm (amiodarone, diltiazem, systemic lidocaine, verapamil)
• atorvastatin, pravastatin, and fluvastatin (used to lower blood cholesterol)
• salmeterol (used to treat asthma)
• cyclosporine, tacrolimus, and sirolimus (medicines to reduce the effects of the body's immune system)
• certain antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole, and voriconazole (antifungals)
• apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel, and ticagrelor (used to reduce blood clots)
• lamotrigine (an antiepileptic)
• irinotecan (used to treat cancer)
• elagolix (gonadotropin-releasing hormone receptor antagonists, used to treat severe endometriosis pain)
• fostamatinib (used to treat chronic immune thrombocytopenia)
• sedative agents (e.g. midazolam administered by injection)
• buprenorphine (used to treat opioid addiction and pain)
• corticosteroids (all routes of administration; including dexamethasone).

Some medicines may interact with ritonavir, a medicine taken together with atazanavir. It is important that you inform your doctor if you are using an inhaled or nasal corticosteroid (administered through the nose), including fluticasone or budesonide (used to treat asthma or allergic symptoms).

Taking Atazanavir Teva with food and drink

It is important that you take atazanavir with food (a meal or snack), as this helps the medicine to be absorbed.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Atazanavir, the active substance in Atazanavir Teva, is excreted in human breast milk. Patients should not breastfeed while taking atazanavir.

Breastfeeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or considering breastfeeding, you should consult your doctor as soon as possible.

Driving and using machines

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

Atazanavir Teva contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Atazanavir Teva

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor again. This way, you can be sure that the treatment is fully effective and reduces the risk of the virus developing resistance to the treatment.

The recommended dose of atazanavir capsules for adults is 300 mg together with 100 mg of ritonavir once daily with food, in combination with other anti-HIV medicines. Your doctor will adjust the dose of atazanavir according to your antiretroviral therapy.

For children (from 6 to under 18 years of age), your doctor will determine the correct dose based on your child's weight. The dose of atazanavir capsules for children is calculated according to body weight and is taken once daily with food and 100 mg of ritonavir as shown below:

Atazanavir is also available as an oral powder for use in children at least 3 months of age and weighing at least 5 kg. It is recommended to switch from atazanavir oral powder to atazanavir capsules as soon as patients are able to swallow the capsules properly.

When switching between the oral powder and capsules, a dosage adjustment may be necessary. Your doctor will determine the correct dose based on your child's weight.

There are no dosage recommendations for atazanavir in pediatric patients under 3 months of age.

Take Atazanavir Teva capsules with food (a meal or snack). The capsules must be swallowed whole. Do not open the capsules.

If you take more Atazanavir Teva than you should

If you or your child take too much atazanavir, the skin and/or eyes may become yellowish (jaundice), and irregular heartbeats (QTc prolongation) may occur.

If you have accidentally taken more atazanavir capsules than prescribed by your doctor, contact your doctor immediately, go to the nearest hospital, or call the Toxicology Information Service at 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Atazanavir Teva

If you forget to take a dose, take it as soon as possible with food, then continue your treatment as normal. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Atazanavir Teva

Do not stop treatment with atazanavir without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. During treatment for HIV infection, it is not always easy to identify whether adverse effects are due to atazanavir, to any other medicine you may be taking at the same time, or to the HIV infection itself. For this reason, inform your doctor of any changes you notice in your health.

During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health, lifestyle, and, in the case of blood lipids, sometimes to HIV medicines themselves. Your doctor will monitor these changes.

Immediately inform your doctor if you develop any of the following serious adverse effects:

• Skin rash and itching have been reported, occasionally severe. The rash usually disappears within 2 weeks without changing treatment with atazanavir. A severe rash associated with other symptoms, which may be serious, can occur. Stop treatment with atazanavir and inform your doctor immediately if you develop a severe rash or a rash accompanied by flu-like symptoms, blisters, fever, mouth sores, muscle or joint pain, facial swelling, eye inflammation causing redness (conjunctivitis), or painful, hot, or red lumps (nodules).
• Yellowing of the skin or the whites of the eyes due to high levels of bilirubin in the blood has been frequently reported. This adverse effect is usually not harmful in adults and children over 3 months of age; however, it may be a sign of a serious condition. If your skin or the whites of your eyes turn yellow, inform your doctor immediately.
• Occasionally, changes in heart rhythm (changes in heartbeat) may occur. Inform your doctor immediately if you feel dizzy, lightheaded, or suddenly faint. These may be symptoms of a serious heart problem.
• Liver problems may occur infrequently. Your doctor should perform blood tests before starting treatment with atazanavir and during treatment. If you have liver problems, including hepatitis B or C infection, your liver condition may worsen. Inform your doctor immediately if your urine becomes dark (tea-colored), you experience itching, your skin or the whites of your eyes turn yellow, you have stomach pain, pale stools, or nausea.
• Gallbladder problems occur infrequently in people taking atazanavir. Symptoms of gallbladder problems may include pain in the right or upper middle part of the stomach, nausea, vomiting, fever, or yellowing of the skin or the whites of the eyes.
• Atazanavir Teva may affect how your kidneys function.
• Kidney stones occur infrequently in people taking atazanavir. Inform your doctor immediately if you experience symptoms of kidney stones, which may include pain in the lower back or lower abdomen, blood in the urine, or pain when urinating.

Other adverse effects reported in patients treated with atazanavir are as follows:

Common (may affect up to 1 in 10 people)

• headache
• vomiting, diarrhea, abdominal pain (stomach pain or 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 loss, weight gain, anorexia (loss of appetite), increased appetite
• depression, anxiety, sleep disturbance
• disorientation, amnesia (memory loss), dizziness, somnolence (drowsiness), abnormal dreams
• syncope (fainting), hypertension (high blood pressure)
• dyspnea (difficulty breathing)
• pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), aphthous stomatitis (mouth ulcers and cold sores), dysgeusia (altered sense of taste), flatulence (gas), dry mouth, abdominal distension
• angioedema (severe swelling of the skin and other tissues, usually lips or eyes)
• urticaria (hives), alopecia (abnormal hair loss or thinning), pruritus (itching)
• muscle atrophy (muscle wasting), arthralgia (joint pain), myalgia (muscle pain)
• interstitial nephritis (inflammation of the kidney), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination)
• gynecomastia (enlargement of breasts in men)
• chest pain, malaise (feeling unwell), fever
• insomnia (difficulty sleeping)

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

• gait disturbance (abnormal walking pattern)
• edema (swelling)
• hepatosplenomegaly (enlargement of the liver and spleen)
• myopathy (muscle pain, muscle weakness, loss of muscle tone not caused by exercise)
• kidney pain

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Atazanavir Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the outer packaging, bottle or blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atazanavir Teva

• The active substance is atazanavir.

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

• The other components of the capsule filling are crospovidone, lactose monohydrate, and magnesium stearate.
• The other components of the capsule shell are gelatin, indigo carmine (E132), titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172).
• The other components of the printing ink are shellac, iron oxide black (E172), propylene glycol (E1520), and 28% concentrated ammonium solution.

Appearance of the product and contents of the pack

Atazanavir Teva 300 mg hard capsules are opaque size 00 capsules with a total length of 23.3±0.3 mm, closed, with a blue cap and the marking "300" in black on the blue body. The capsule contents consist of light yellow powder.

Atazanavir Teva 300 mg in blisters is available in pack sizes of 30, 30x1, 60, and 90 capsules.

Atazanavir Teva 300 mg in bottles is available in pack sizes of 30, 90 (3x30) capsules, and in multiple packs containing 3 boxes, each containing 30 capsules.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid, Spain

Manufacturer

TEVA Gyógyszergyár Zrt. (TEVA Pharmaceutical Works Private Limited Company)
Pallagi út 13, Debrecen
H-4042, Hungary

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, Kraków
31-546, Poland

TEVA PHARMA S.L.U.
C/C, n. 4, Poligono Industrial Malpica, Zaragoza
50016, Spain

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, Zagreb
10000, Croatia

Date of the most recent revision of this summary: November 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).