Aporoza

Leaflet accompanying the packaging: patient information

Aporoza, 5 mg, film-coated tablets

Aporoza, 10 mg, film-coated tablets

Aporoza, 20 mg, film-coated tablets

Aporoza, 40 mg, film-coated tablets

Rosuvastatinum

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Aporoza and what is it used for
• 2. Important information before taking Aporoza
• 3. How to take Aporoza
• 4. Possible side effects
• 5. How to store Aporoza
• 6. Package contents and other information

1. What is Aporoza and what is it used for

Aporoza belongs to a group of medicines called statins.

Aporoza has been prescribed because:

• The patient has high cholesterol levels. This means that the patient is at risk of a heart attack (myocardial infarction) or stroke. Aporoza is used in adults, adolescents, and children over 6 years of age to treat high cholesterol levels.
• A statin has been recommended because diet and increased physical activity have not been sufficient to adequately reduce cholesterol levels. While taking Aporoza, the patient should maintain a cholesterol-lowering diet and exercise regularly. Or
• The patient has other factors that increase the risk of a heart attack, stroke, or other similar health problems. A heart attack, stroke, or other health problems may be caused by a disease called atherosclerosis. Atherosclerosis is the result of the accumulation of lipid deposits in the arteries.

Why it is essential to continue taking Aporoza

Aporoza is used to achieve normal blood levels of fatty substances called lipids, most commonly cholesterol.

• Aporoza can lower the level of bad cholesterol and increase the level of good cholesterol.
• Aporoza inhibits the body's production of bad cholesterol and improves the ability to remove cholesterol from the blood.

Most people with high cholesterol do not feel unwell, as it does not cause any symptoms. However, if left untreated, lipid deposits can build up in the walls of blood vessels, causing them to narrow.

In some cases, narrowed blood vessels can become blocked, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of a heart attack, stroke, or other similar health problems associated with high cholesterol can be reduced.

The patient should continue taking Aporozaeven if they have achieved normal cholesterol levels, as the medicine prevents the cholesterol level from increasing againand causing lipid deposits to build up.

Treatment should be discontinued if the doctor advises it or if the patient becomes pregnant.

2. Important information before taking Aporoza

When not to take Aporoza:

• during pregnancyor while breastfeeding. If the patient becomes pregnant while taking Aporoza, they should stop taking the medicine immediately and consult a doctor. Women of childbearing age taking Aporoza should use effective methods of contraception.
• (a medicine used, for example, after organ transplants).

If any of the above situations apply to the patient (or if there are any doubts), they should consult a doctor.

In addition, Aporoza should not be taken at a dose of 40 mg (the highest dose):

• (if in doubt, the patient should consult a doctor),
thyroid function disorders,
• ,
• (Japan, China, Philippines, Vietnam, Korea, and India),
• , which lower cholesterol levels.

If any of the above situations apply to the patient (or if there are any doubts), they should consult a doctor.

Warnings and precautions

The patient should consult a doctor or pharmacist before starting Aporoza if:

• they have kidney problems,
• they have liver problems,
• they have a history of recurring or unexplained muscle pain or muscle problems, or similar problems in relatives, or muscle problems while taking other cholesterol-lowering medicines in the past. If the patient experiences unexplained muscle pain, especially if it is accompanied by a feeling of illness or fever, they should consult a doctor immediately. They should also inform their doctor or pharmacist about persistent muscle weakness.
• they have myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).
• they have ever had a severe skin rash or skin peeling, blisters, or ulcers in the mouth, throat, or eyes after taking Aporoza or other similar medicines.
• they regularly consume large amounts of alcohol,
• they have thyroid function disorders,
• they are taking other medicines called fibrates, which lower cholesterol levels. The patient should carefully read the leaflet, especially if they have taken other cholesterol-lowering medicines in the past.
• they are taking medicines used to treat HIV infection, such as ritonavir, lopinavir, or atazanavir (see "Aporoza and other medicines").
• they are taking or have taken within the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Aporoza can lead to serious muscle problems (rhabdomyolysis), see also Aporoza and other medicines.
• patients over 70 years old(as the doctor will need to choose a suitable dose of Aporoza for the patient).
• patients with severe respiratory failure.
• patients of Asian origin(Japan, China, Philippines, Vietnam, Korea, and India). The doctor will choose a suitable initial dose of Aporoza for the patient.

If any of the above situations apply to the patient (or if there are any doubts):

• they should not take Aporoza at a dose of 40 mg (the highest dose) and should consult a doctor or pharmacist before taking any dose of Aporoza

Aporoza.

Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with Aporoza. If the patient experiences any of the symptoms described in section 4, they should stop taking Aporoza and consult a doctor immediately.

A small number of patients taking statins may experience liver problems. This can be detected by a simple blood test that checks for increased liver enzyme activity. Therefore, the doctor will usually recommend a blood test (liver enzyme test) before and during treatment with Aporoza.

While taking this medicine, the doctor will closely monitor patients with diabetes and those at risk of developing diabetes. Patients at risk of developing diabetes include those with high blood sugar levels, obesity, and high blood pressure.

Children and adolescents

• patients under 6 years old.Aporoza should not be used in children under 6 years old.
• patients under 18 years old. Aporoza 40 mg should not be used in children and adolescents under 18 years old.

Aporoza and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription.

The patient should inform their doctor if they are taking any of the following medicines:

• cyclosporin (used, for example, after organ transplants),
• warfarin, clopidogrel, or ticagrelor (or any other medicine used to thin the blood),
• fibrates (such as gemfibrozil, fenofibrate) or other medicines used to lower cholesterol levels (e.g., ezetimibe),
• antacids (used to neutralize stomach acid),
• erythromycin (an antibiotic), fusidic acid (an antibiotic - see also Warnings and precautions),
• oral contraceptives (the pill),
• regorafenib (used to treat cancer),
• darolutamide (used to treat cancer),
• capmatinib (used to treat cancer),
• hormone replacement therapy,
• fostamatinib (used to treat low platelet count),
• febuxostat (used to treat and prevent high uric acid levels in the blood)
• teriflunomide (used to treat multiple sclerosis)
• any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir,
• roxadustat (used to treat anemia in patients with chronic kidney disease),
• tafamidis (used to treat a disease called transthyretin amyloidosis).

Aporoza may affect the way these medicines work, or these medicines may affect the way Aporoza works.

If it is necessary to take fusidic acid orally to treat a bacterial infection, the patient should temporarily stop taking Aporoza. The doctor will inform the patient when it is safe to start taking Aporoza again. Taking Aporoza with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Aporoza with food, drink, and alcohol

Aporoza can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Aporoza should not be takenduring pregnancy or while breastfeeding. If the patient becomes pregnant while taking Aporoza, they should stop taking the medicine immediatelyand consult a doctor. Women of childbearing age taking Aporoza should use effective methods of contraception.

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Aporoza does not usually affect the ability to drive or use machines. However, some patients may experience dizziness. If the patient experiences dizziness, they should consult a doctor before attempting to drive or use machines.

Aporoza contains lactose

If the patient has been told they have an intolerance to some sugars, they should consult a doctor before taking Aporoza.

Aporoza contains azo dyes, Allura Red AC (E129), lake, and Orange Yellow FCF (E110), lake, which may cause allergic reactions.

A full list of ingredients is provided in the section Package contents and other information.

3. How to take Aporoza

Aporoza should always be taken as directed by the doctor. If the patient has any doubts, they should consult a doctor or pharmacist.

Usual doses for adults

Taking Aporoza to lower high cholesterol levels:

Initial dose

Treatment with Aporoza should be started with a dose of 5 mg or 10 mg, even if the patient has taken other statins in higher doses in the past. The initial dose depends on:

• cholesterol levels,
• the risk of a heart attack or stroke,
• the presence of factors that may increase the risk of side effects.

The patient should consult a doctor or pharmacist to determine the appropriate initial dose.

The doctor may prescribe the lowest dose (5 mg) if:

• the patient is of Asian origin(Japan, China, Philippines, Vietnam, Korea, and India),
• the patient is over 70 years old,
• the patient has moderate kidney disease,
• there is a risk of muscle pain and muscle problems (myopathy).

Dose increase and maximum daily dose

To achieve normal cholesterol levels, the doctor may decide to gradually increase the dose of Aporoza until the patient reaches a dose that is suitable for them. If the patient starts with a dose of 5 mg, the doctor may decide to increase it to 10 mg, then 20 mg, and finally 40 mg if necessary.

If the patient starts with a dose of 10 mg, the doctor may decide to double the dose to 20 mg, and then to 40 mg if necessary. There will be a 4-week interval between each dose modification.

The maximum daily dose of Aporoza is 40 mg. This only applies to patients with very high cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels are not adequately lowered by a dose of 20 mg.

Taking Aporoza to reduce the risk of a heart attack, stroke, or other similar health problems:

The recommended initial dose is 20 mg per day. However, the doctor may prescribe a lower dose if the patient has any of the above-mentioned factors.

Taking Aporoza in children and adolescents aged 6 to 17 years

The dose range for children and adolescents aged 6 to 17 years is 5 mg to 20 mg once daily. The usual initial dose is 5 mg once daily. The doctor may gradually increase the dose until the patient reaches a dose that is suitable for them. The maximum daily dose of Aporoza is 10 mg or 20 mg in children aged 6 to 17 years, depending on the patient's condition.

The dose should be taken once daily. Aporoza 40 mg should not be usedin children.

How to take the tablets

The tablet should be swallowed whole with water.

Aporoza should be taken once daily. Aporoza can be taken at any time of day.

To help remember to take the medicine, it should be taken at the same time every day.

Regular medical check-ups to monitor cholesterol levels

It is essential to regularly visit the doctor to check if cholesterol levels are under control.

The doctor may increase the dose of Aporoza to a dose that is suitable for the patient.

Taking a higher dose of Aporoza than recommended

The patient should consult a doctor or the nearest hospital.

If the patient goes to the hospital or is treated for other illnesses, they should inform the medical staff that they are taking Aporoza.

If the patient forgets to take Aporoza

The patient should not worry if they miss a dose. The next dose should be taken at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping Aporoza

Before stopping Aporoza, the patient should consult a doctor. Stopping Aporoza may cause cholesterol levels to rise again.

If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aporoza can cause side effects, although not everybody gets them.

It is essential for the patient to be aware of the possible side effects of Aporoza.

Side effects are usually mild and temporary.

If the patient experiences any of the following side effects, they should stop taking Aporoza and consult a doctor immediately:

• difficulty breathing, with or without swelling of the face, lips, tongue, and/or throat,
• swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing,
• severe itching of the skin (with lumps),
• red, flat, round, or oval patches on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, or eyes. The development of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome),
• widespread rash, high fever, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

The patient should also stop taking Aporoza and consult a doctor immediately if they experience:

• unusual muscle pain or muscle problemsthat last longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, muscle problems can occur in a small number of patients and rarely may develop into a potentially life-threatening muscle injury called rhabdomyolysis.

If the patient experiences muscle weakness, they should consult a doctor.

• If the patient experiences muscle rupture.
• If the patient develops a lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Common side effects:may affect up to 1 in 10 people

• headache.
• stomach pain.
• constipation.
• nausea.
• muscle pain.
• weakness.
• dizziness.
• increased protein in the urine - this parameter usually returns to normal on its own without the need to stop Aporoza (only with a dose of 40 mg).
• diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient while they are taking this medicine.

Uncommon side effects:may affect up to 1 in 100 people

• skin rash, itching, or other skin reactions.
• increased protein in the urine - this parameter usually returns to normal on its own without the need to stop Aporoza (with doses of 5 mg, 10 mg, and 20 mg).

Rare side effects:may affect up to 1 in 1,000 people

• severe allergic reaction, including swelling of the face, lips, tongue, and/or throat, which may cause difficulty swallowing and breathing, severe itching of the skin (with lumps). If an allergic reaction occurs, the patient should stop taking Aporozaand consult a doctor immediately.
• muscle injury in adults. If the patient experiences unusual muscle pain or muscle problemsthat last longer than expected, as a precaution, they should stop taking Aporoza and consult a doctor immediately.
• severe stomach pain (pancreatitis).
• increased liver enzyme activity in the blood.
• increased tendency to bleed or bruise due to low platelet count.
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare side effects:may affect less than 1 in 10,000 people

• jaundice (yellowing of the skin and eyes).
• liver inflammation.
• trace amounts of blood in the urine.
• nerve damage in the arms and legs (numbness).
• joint pain.
• memory loss.
• gynecomastia (breast enlargement in men).

Side effects with unknown frequency:

• diarrhea (loose stools).
• cough.
• shortness of breath (dyspnea).
• swelling.
• sleep disorders, including insomnia and nightmares.
• sexual function disorders.
• depression.
• breathing problems, including persistent cough and/or shortness of breath or fever.
• tendon injury.
• persistent muscle weakness.
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing). Ocular myasthenia (a disease that causes muscle weakness in the eyes).

The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aporoza

The medicine should be stored out of sight and reach of children.

There are no special storage instructions.

The medicine should be stored in its original packaging to protect it from light.

The medicine should not be used after the expiration date stated on the carton after EXP. The expiration date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Aporoza contains

• The active substance of Aporoza is rosuvastatin. Each tablet contains 5 mg, 10 mg, 20 mg, or 40 mg of rosuvastatin (Rosuvastatinum) (as rosuvastatin calcium).
• The other ingredients are: tablet core: lactose monohydrate, calcium hydrogen phosphate, microcrystalline cellulose (PH 102), crospovidone type B, magnesium stearate. Tablet coating: lactose monohydrate, hypromellose 15cP, titanium dioxide (E 171), triacetin, Allura Red AC (E 129), lake, Orange Yellow FCF (E 110), lake, indigo carmine (E 132), lake.

What Aporoza looks like and package contents

Aporoza 5 mg tablets:

Pink, oval, biconvex, film-coated tablets with "J" engraved on one side and "53" on the other side.

Aporoza 10 mg tablets:

Pink, round, biconvex, film-coated tablets with "J" engraved on one side and "54" on the other side.

Aporoza 20 mg tablets:

Pink, round, biconvex, film-coated tablets with "J" engraved on one side and "55" on the other side.

Aporoza 40 mg tablets:

Pink, oval, biconvex, film-coated tablets with "J" engraved on one side and "56" on the other side.

Film-coated tablets are available in PA/Aluminum/PVC/Aluminum blisters in a cardboard box.

Package sizes:

5 mg and 10 mg:20, 28, 60 film-coated tablets

20 mg:28, 30 film-coated tablets

40 mg:28 film-coated tablets

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warszawa

Manufacturer/Importer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus, 19, Venda Nova

2700-487 Amadora

Portugal

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

Italy:

Rosuvastatina Aurobindo

Poland:

Aporoza

Portugal:

Rosuvastatina Aurovitas

Spain:

ROSUVASTATINA AUROVITAS 5 mg/10 mg/20 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 10/2024