Patient Information Leaflet

Aporoza 5 mg, film-coated tablets
Aporoza 10 mg, film-coated tablets
Aporoza 20 mg, film-coated tablets
Aporoza 40 mg, film-coated tablets
Rosuvastatin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet so that you can read it again if needed.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents:

What Aporoza is and what it is used for
Important information before taking Aporoza
How to take Aporoza
Possible side effects
How to store Aporoza
Contents of the pack and other information

1. What Aporoza is and what it is used for

Aporoza belongs to a group of medicines called statins.
Aporoza has been prescribed because:

You have high cholesterol levels. This means you are at risk of heart attack or stroke. Aporoza is used in adults, adolescents, and children aged 6 years and older to treat high cholesterol levels.
A statin has been recommended because changes in diet and increased physical activity have not sufficiently reduced your cholesterol levels. While taking Aporoza, you should continue a cholesterol-lowering diet and engage in regular physical exercise. Or
You have other risk factors increasing your chance of heart attack, stroke, or other similar health problems. Heart attack, stroke, or other health issues may be caused by a condition called atherosclerosis. Atherosclerosis results from the buildup of fatty deposits (plaques) in the arteries.

Why it is important to take Aporoza continuously
Aporoza is used to achieve normal blood levels of fatty substances called lipids, particularly cholesterol.
There are different types of cholesterol in the blood: so-called "bad" cholesterol (LDL-C) and "good" cholesterol (HDL-C).

Aporoza can reduce levels of bad cholesterol and increase levels of good cholesterol.
Aporoza inhibits the production of bad cholesterol in the body and improves the body's ability to remove cholesterol from the blood.

In most people, high cholesterol does not affect how they feel, as it causes no symptoms. However, if left untreated, fatty deposits can build up in the walls of blood vessels, causing them to narrow.
In some cases, narrowed blood vessels may become completely blocked, interrupting blood flow to the heart or brain, leading to a heart attack or stroke. By lowering cholesterol levels, the risk of heart attack, stroke, or other similar health problems associated with high cholesterol can be reduced.
You should continue taking Aporoza even if your cholesterol levels have returned to normal, because the medicine prevents cholesterol levels from rising again, which could lead to further fatty deposits.
Treatment should be discontinued if your doctor advises or if you become pregnant.

2. Important information before using Aporoza

When not to use Aporoza:

if the patient is allergic to rosuvastatin or any of the other ingredients of this medicine (listed in section 6),
during pregnancy or while breastfeeding. If pregnancy occurs during treatment with Aporoza, the medicine must be stopped immediately and the doctor contacted. Women of childbearing age taking Aporoza should use effective contraceptive methods,
if the patient has liver disease,
if the patient has severe kidney disease,
if the patient experiences recurrent or unexplained muscle pain,
if the patient is taking the combination sofosbuvir/velpatasvir/voxilaprevir (used in viral hepatitis infection known as hepatitis C),
if the patient is taking cyclosporine (a medicine used, for example, after organ transplantation).

If any of the above situations apply to the patient (or in case of doubt),
consult a doctor.
Additionally, do not take Aporoza at a dose of 40 mg (the highest dose):

if the patient has moderate kidney disease (in case of doubt, contact a doctor),
if the patient has thyroid dysfunction,
if the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in family members, or muscle problems during previous use of other cholesterol-lowering medicines,
if the patient regularly consumes large amounts of alcohol,
if the patient is of Asian origin (Japan, China, Philippines, Vietnam, Korea, and India),
if the patient is taking other medicines called fibrates, used to lower cholesterol.

If any of the above situations apply to the patient (or in case of doubt),
consult a doctor.
Warnings and precautions
Consult a doctor or pharmacist before starting treatment with Aporoza if:

the patient has kidney problems,
the patient has liver problems,
the patient has previously experienced recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in family members, or muscle problems during previous use of other cholesterol-lowering medicines. In case of unexplained muscle pain, especially if accompanied by malaise or fever, contact a doctor immediately. Also inform the doctor or pharmacist about persistent muscle weakness.
the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).
the patient has ever had a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking Aporoza or similar medicines.
if the patient regularly consumes large amounts of alcohol,
if the patient has thyroid dysfunction,
if the patient is taking other medicines called fibrates, used to lower cholesterol. Read the package leaflet carefully, even if other cholesterol-lowering medicines have been taken previously.
taking medicines used to treat HIV infection, e.g. ritonavir, lopinavir or atazanavir – see "Aporoza and other medicines".
the patient is taking or has taken within the last 7 days a medicine called fusidic acid (used for bacterial infections) orally or by injection. Combining fusidic acid and Aporoza may lead to serious muscle problems (rhabdomyolysis) – see also "Aporoza and other medicines".
patients over 70 years of age (because the doctor must select the appropriate dose of Aporoza).
patients who have developed severe respiratory failure.
patients of Asian race (Japan, China, Philippines, Vietnam, Korea, and India). The doctor will select the appropriate starting dose of Aporoza.

If any of the above situations apply to the patient (or in case of doubt):

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

Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with Aporoza. If any of the symptoms described in section 4 occur, stop taking Aporoza and contact a doctor immediately.

In a small number of patients, statins may affect liver function. This effect can be detected by a simple blood test checking for increased liver enzyme activity. Therefore, the doctor will usually recommend blood tests (liver enzyme activity) before starting and during treatment with Aporoza.

While taking this medicine, the doctor will closely monitor patients with diabetes and patients at risk of developing diabetes. Patients at risk of developing diabetes are those with high fasting blood glucose, obese patients, and patients with high blood pressure.

Children and adolescents

patients under 6 years of age. Aporoza must not be used in children under 6 years of age.
patients under 18 years of age. Aporoza 40 mg is not suitable for use in children and adolescents under 18 years of age.

Aporoza and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription.

Inform your doctor if the patient is taking any of the following medicines:

cyclosporine (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 (e.g. ezetimibe),
antacids (used to neutralize stomach acid),
erythromycin (an antibiotic), fusidic acid (an antibiotic – see below and Warnings and precautions),
oral contraceptive (pill),
regorafenib (used in cancer treatment),
darolutamide (used in cancer treatment),
capmatinib (used in cancer treatment),
hormone replacement therapy,
fostamatinib (used in the treatment of low platelet count),
febuxostat (used in the treatment and prevention of high blood uric acid levels),
teriflunomide (used in the treatment of multiple sclerosis),
any of the following medicines used to treat viral infections, including HIV infection or hepatitis C virus infection, 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 anaemia in patients with chronic kidney disease),
tafamidis (used to treat a disease called transthyretin amyloidosis).

Aporoza may alter the effect of these medicines or these medicines may alter the effect of Aporoza.

If oral fusidic acid must be taken to treat a bacterial infection, Aporoza should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Aporoza. Taking Aporoza with fusidic acid may 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
Do not take Aporoza during pregnancy or while breastfeeding. If the patient becomes pregnant while taking Aporoza, she should stop taking the medicine immediately and contact her doctor. Women of childbearing age should use effective contraceptive methods while taking Aporoza.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines
For most patients, Aporoza does not affect the ability to drive or operate machinery. However, some patients may experience dizziness. If dizziness occurs, contact a doctor before attempting to drive or operate machinery.

Aporoza contains lactose
If the patient has been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

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

A complete list of ingredients is given in section Contents of the pack and other information.

3. How to take Aporoza

Aporoza should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Usual doses in adult patients
Use of Aporoza to reduce high cholesterol levels:
Starting dose
Treatment with Aporoza should be started at a dose of 5 mg or 10 mg, even if the patient has previously taken other statins at higher doses. The starting dose depends on:

cholesterol levels,
the level of risk for heart attack or stroke,
the presence of any factor that may increase the risk of side effects.

You should contact your doctor or pharmacist to determine the appropriate starting dose. Your doctor may prescribe the lowest dose (5 mg) if:

the patient is of Asian race (Japan, China, Philippines, Vietnam, Korea, and India),
the patient is over 70 years of age,
there is moderate kidney impairment,
there is a risk of muscle pain or muscle problems (myopathy).

Dose increase and maximum daily dose
To achieve the desired cholesterol level, your doctor may decide to gradually increase the dose to the level appropriate for the patient. If treatment is started at 5 mg, your doctor may decide to increase it to 10 mg, then to 20 mg, and then to 40 mg, if necessary.
If treatment is started at 10 mg, your doctor may decide to double the dose to 20 mg, and then, if necessary, to 40 mg. There will be a four-week interval between each dose adjustment.
The maximum daily dose of Aporoza is 40 mg. This applies only to patients with high cholesterol levels and high risk of heart attack or stroke whose cholesterol levels are not sufficiently reduced with a 20 mg dose.

Use of Aporoza to reduce the risk of heart attack, stroke, or other related health problems:
The recommended starting dose is 20 mg once daily. However, your doctor may prescribe a lower dose if any of the factors mentioned above are present.

Use 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 starting dose is 5 mg once daily. Your doctor may gradually increase the dose until the appropriate dose for the individual patient is reached. The maximum daily dose of Aporoza is 10 mg or 20 mg in children and adolescents aged 6 to 17 years, depending on the patient's health status. The dose should be taken once daily. Aporoza 40 mg should not be used in 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 you remember to take your medicine, take it at the same time each day.

Regular medical check-ups to monitor cholesterol levels
It is important to attend regular check-ups to monitor whether your cholesterol levels remain at an appropriate level.
Your doctor may increase the dose of Aporoza to the level appropriate for you.

Taking more Aporoza than you should
Contact your doctor or the nearest hospital immediately.
If you go to a hospital or are treated for other conditions, inform the medical staff that you are taking Aporoza.

If you forget to take Aporoza
Do not worry if you miss a dose. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Aporoza
Before stopping Aporoza, speak to your doctor. Stopping Aporoza may cause cholesterol levels to rise again.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
It is important for the patient to be aware of which adverse reactions may occur with this medicine.
Adverse reactions are generally mild and transient.
If any of the following adverse reactions occur, stop taking
the medicine Aporoza and contact your 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, disc-shaped or round spots on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, throat, nose, genital organs and around the eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome),
Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

You should also stop taking Aporoza and contact your doctor immediately:

If you experience unusual muscle pain or muscle problems lasting longer than expected. Muscle-related symptoms occur more frequently in children and adolescents than in adults. As with other statins, muscle-related adverse reactions occur in a small number of patients and may rarely develop into potentially life-threatening muscle damage called rhabdomyolysis.
If a muscle tear occurs.
If a lupus-like syndrome occurs (including rash, joint disorders and effects on blood cells).

Common adverse reactions: may occur in 1 out of 10 people

Headache.
Abdominal pain.
Constipation.
Nausea.
Muscle pain.
Weakness.
Dizziness.
Increased protein level in urine – this parameter usually returns to normal on its own without the need to discontinue Aporoza (only at the 40 mg dose).
Diabetes. The likelihood of developing diabetes is higher if the patient has high levels of blood sugar and lipids, is overweight, and has high blood pressure. Your doctor will monitor you during treatment with this medicine.

Uncommon adverse reactions: may occur in 1 out of 100 people

Rash, itching or other skin reactions.
Increased protein level in urine – this parameter usually returns to normal on its own without the need to discontinue Aporoza (only at doses of 5 mg, 10 mg and 20 mg).

Rare adverse reactions: may occur in 1 out of 1,000 people

Severe allergic reaction, including swelling of the face, tongue and (or) throat, which may cause difficulty swallowing and breathing, severe itching of the skin (with lumps). If an allergic reaction occurs, stop taking Aporoza and contact your doctor immediately.
Muscle damage in adults. If unusual muscle pain or muscle problems lasting longer than expected occur, as a precaution stop taking Aporoza and contact your doctor immediately.
Severe abdominal pain (pancreatitis).
Increased liver enzyme activity in blood.
Greater than usual tendency to bleed or bruise due to low platelet count.
Symptoms of lupus-like syndrome (such as rash, joint disorders and hematological changes).

Very rare adverse reactions: (may occur in less than 1 out of 10,000 people)

Jaundice (yellowing of the skin and eyes).
Hepatitis (liver inflammation).
Trace amounts of blood in urine.
Nerve damage in the lower and upper limbs (numbness).
Joint pain.
Memory loss.
Gynaecomastia (enlargement of breast tissue in males).

Adverse reactions with unknown frequency include:

Diarrhea (loose stools).
Cough.
Shortness of breath (dyspnea).
Swelling (edema).
Sleep disorders, including insomnia and nightmares.
Sexual dysfunction.
Depression.
Breathing problems, including persistent cough and (or) shortness of breath or fever.
Tendon damage.
Persistent muscle weakness.
Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing). Ocular myasthenia (a disease causing weakness of eye muscles).

You should talk to your doctor if you experience weakness in your arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Aporoza

Keep this medicine out of the sight and reach of children.
There are no special requirements regarding storage temperature. Store in the original
packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry
date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Aporoza contains

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

What Aporoza looks like and contents of the pack
Aporoza 5 mg tablets:
Pink, oval, biconvex film-coated tablets, embossed with the code 'J' on one side and '53' on the other side.
Aporoza 10 mg tablets:
Pink, round, biconvex film-coated tablets, embossed with the code 'J' on one side and '54' on the other side.
Aporoza 20 mg tablets:
Pink, round, biconvex film-coated tablets, embossed with the code 'J' on one side and '55' on the other side.
Aporoza 40 mg tablets:
Pink, oval, biconvex film-coated tablets, embossed with the code 'J' on one side and '56' on the other side.

Film-coated tablets are available in blisters made of PA/Aluminium/PVC/Aluminium foil, packed in cardboard boxes.
Pack 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 pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
Poland

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 authorised in 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 film-coated tablets EFG