Atazanavir Stada 200 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Atazanavir Stada 200 mg hard capsules EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 others, 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.

Leaflet contents

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

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

Atazanavir Stada 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 blocking a protein that HIV needs in order 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 illnesses associated with HIV infection.

Atazanavir capsules can be used by adults and children aged 6 years and older. Your doctor has prescribed atazanavir 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 determine the best combination of medicines for you to take with atazanavir.

2. What you need to know before taking Atazanavir Stada

DO NOT TAKE Atazanavir Stada

• 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 "Other medicines and Atazanavir Stada".

• 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 (taken by mouth) (used to induce sleep and/or relieve anxiety)

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

• products 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)

Do not take sildenafil with atazanavir when sildenafil is used for the treatment of pulmonary arterial hypertension. Sildenafil is also used to treat erectile dysfunction. Inform your doctor if you are taking sildenafil for the treatment of erectile dysfunction.

Inform your doctor immediately 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 will need special monitoring before or during treatment with atazanavir. Consult your doctor or pharmacist before starting atazanavir and make sure to inform your doctor:

• 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 may affect kidney function.

Cases of 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, inflammatory signs and symptoms from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that were previously present but asymptomatic. If you notice any signs of infection, please inform your doctor immediately. In addition to opportunistic infections, autoimmune disorders (conditions in which the immune system attacks healthy body tissue) may also occur after you start taking medicines for 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 beginning in the hands and feet and moving upward toward the trunk, palpitations, tremors, or hyperactivity, please inform your doctor immediately to receive necessary treatment.

Some patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by 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 (especially in the hip, knee, and shoulder) and difficulty moving. If you notice any of these symptoms, please inform your doctor.

Hyperbilirubinemia (increased blood bilirubin levels) has occurred in patients receiving atazanavir. Signs may include a slightly yellowish discoloration of 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 may require heart monitoring. Your child's 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 has not been studied in children under 3 months of age and weighing less than 5 kg due to the risk of serious complications.

Other medicines and Atazanavir Stada

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

There are other medicines that should not be taken with atazanavir. Inform your doctor or pharmacist 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 for the treatment of 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 must 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, reduce 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)
• ciclosporin, tacrolimus, and sirolimus (medicines to reduce the body's immune system activity)
• certain antibiotics (rifabutin, clarithromycin)
• ketoconazole, itraconazole, and voriconazole (antifungals)
• apixaban, dabigatran, edoxaban, rivaroxaban, warfarin, clopidogrel, prasugrel, and ticagrelor (used to reduce blood clots)
• carbamazepine, phenytoin, phenobarbital, and lamotrigine (antiepileptics)
• encorafenib, ivosidenib, and 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 given together with atazanavir. It is important that you inform your doctor if you are using an inhaled or nasal corticosteroid (administered through the nose), fluticasone or budesonide (used to treat allergic symptoms or asthma).

Taking Atazanavir Stada 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, is excreted in 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 must consult your doctor as soon as possible.

Driving and using machines

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

Atazanavir Stada contains lactose.

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

3. How to take Atazanavir Stada

Follow exactly the instructions for taking this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. This way, you can be sure that the treatment is fully effective and reduces the risk of the virus developing resistance to 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 may adjust the dose of atazanavir according to your anti-HIV treatment.

For children (6 to 18 years of age), your child's doctor will determine the correct dose based on your child's body 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:

• Ritonavir capsules, tablets, or oral solution may be used.

Other formulations of atazanavir may be available for use in children at least 3 months of age and weighing at least 5 kg. It is recommended to switch from other formulations to capsules as soon as patients are able to swallow capsules appropriately.

When switching between other pharmaceutical forms and capsules, a dose 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 Stada capsules with food (a meal or snack). Swallow the capsules whole. Do not open the capsules.

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

If you forget to take Atazanavir Stada

If you missed a dose, take it as soon as possible with food, and then take the next scheduled dose at the regular time. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for missed doses.

If you stop taking Atazanavir Stada

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 may 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 caused by atazanavir, by any other medicine you are taking, or by the HIV infection itself. 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 and lifestyle, and in the case of increased blood lipids, sometimes due to the HIV medicines themselves. Your doctor will monitor these changes.

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

• Skin rash, and occasionally severe itching (both have been reported). The rash usually disappears within 2 weeks without any change in atazanavir treatment. The appearance of severe skin rashes may be associated with other potentially serious symptoms. 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), painful, hot or red lumps (nodules).
• Yellowing of the skin or whites of the eyes caused by high levels of bilirubin in the blood (frequently reported). This adverse effect is usually not dangerous in adults and children over 3 months of age; however, it may be a sign of a serious problem. If your skin or the whites of your eyes turn yellow, inform your doctor immediately.
• Changes in your heartbeat—changes in heart rhythm—may occur occasionally. Inform your doctor immediately if you feel dizzy, lightheaded, or if you suddenly faint. These may be symptoms of a serious heart problem.
• Liver problems (occur infrequently). Your doctor should perform blood tests before starting treatment with this medicine and during treatment. If you have liver problems, including hepatitis B or C infection, your liver problems 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, nausea, or pale or clay-colored stools.
• Gallbladder problems in people taking atazanavir (occur infrequently). Symptoms of gallbladder problems may include pain in the upper middle or right side of the stomach, nausea, vomiting, fever, or yellowing of the skin or whites of the eyes.
• Atazanavir may affect kidney function.
• Kidney stones in people taking atazanavir (occur infrequently). Inform your doctor immediately if you have 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:

Frequent (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 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 taste), flatulence (gas), dry mouth, abdominal distension
• angioedema (severe swelling of the skin and other tissues, usually lips or eyes)
• 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 type of 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 Stada

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 packaging, bottle, or blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C.

For bottles:

Use within 4 months after first opening.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Atazanavir Stada

• The active substance is atazanavir. Each capsule contains 200 mg of atazanavir (as sulfate).
• The other components are lactose monohydrate, crospovidone (type A) (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b). The capsule shell and printing ink contain gelatin, titanium dioxide (E171), indigotine (E132), lacquer and propylene glycol (E1520).

Appearance of the product and contents of the pack

Atazanavir Stada 200 mg hard capsules are opaque blue, size 0, printed in white ink with "200 mg" on the cap.

Atazanavir Stada 200 mg is available in:

• Pre-cut and single-dose Al-OPA/Al/PVC blisters containing 60 x 1 hard capsules.
• Al-OPA/Al/PVC blisters containing 60 hard capsules.
• HDPE bottles closed with a child-resistant polypropylene cap containing 60 hard capsules.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Remedica Ltd

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicinal product is authorised in the European Economic Area Member States under the following names:

Germany: Atazanavir AL 200 mg Hartkapseln
Denmark: Atazanavir STADA
Spain: Atazanavir STADA 200 mg hard capsules EFG
Finland: Atazanavir STADA 200 mg kovat kapselit
Netherlands: Atazanavir STADA 200 mg harde capsules
Iceland: Atazanavir STADA 200 mg hörð hylki
Italy: Atazanavir EG
Sweden: Atazanavir STADA 200 mg kapsel, hård

Date of the most recent revision of this leaflet: February 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).