Rosuvastatin + Acetilsalicilic acid Rafarm

Leaflet included in the packaging: Patient Information

Rosuvastatin + Acetylsalicylic acid Rafarm, 5 mg + 100 mg, hard capsules

Rosuvastatin + Acetylsalicylic acid Rafarm, 10 mg + 100 mg, hard capsules

Rosuvastatin + Acetylsalicylic acid Rafarm, 20 mg + 100 mg, hard capsules

Rosuvastatin + Acetylsalicylic acid
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Rosuvastatin + Acetylsalicylic acid Rafarm and what is it used for
• 2. Important information before taking Rosuvastatin + Acetylsalicylic acid Rafarm
• 3. How to take Rosuvastatin + Acetylsalicylic acid Rafarm
• 4. Possible undesirable effects
• 5. How to store Rosuvastatin + Acetylsalicylic acid Rafarm
• 6. Contents of the packaging and other information

1. What is Rosuvastatin + Acetylsalicylic acid Rafarm and what is it used for

Rosuvastatin + Acetylsalicylic acid Rafarm contains two active substances: rosuvastatin and acetylsalicylic acid.

• Rosuvastatin belongs to a group of substances called statins, which are lipid-regulating medicines used to lower lipid levels (fats) in the blood when a low-fat diet and lifestyle changes are not sufficient. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels in the heart, leading to coronary artery disease. If the patient is at risk of another heart attack, rosuvastatin can also be used to reduce this risk, even if the cholesterol level is normal. During treatment, a standard cholesterol-lowering diet should be followed.
• Acetylsalicylic acid in small doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood to clot and participate in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off oxygen supply. If this happens in the heart, it can cause a heart attack or angina pectoris. These two active substances taken together reduce the risk of another heart attack if the patient has had a heart attack or if the patient experiences chest pain (unstable angina).

Rosuvastatin + Acetylsalicylic acid Rafarm is indicated for patients who are already taking rosuvastatin and acetylsalicylic acid in these doses. Instead of taking rosuvastatin and acetylsalicylic acid in the form of separate tablets, the patient receives one capsule of Rosuvastatin + Acetylsalicylic acid Rafarm, which contains both ingredients of the same strength as previously used.

2. Important information before taking Rosuvastatin + Acetylsalicylic acid Rafarm

When not to take Rosuvastatin + Acetylsalicylic acid Rafarm:

• if the patient is allergic to rosuvastatin, acetylsalicylic acid, or any other salicylates or nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• if the patient is pregnant or breastfeeding, or if they become pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm, they should stop taking it immediately and inform their doctor. Women should avoid becoming pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm, using appropriate methods of contraception.
• if the patient has liver disease.
• if the patient has severe kidney disease.
• if the patient has recurring or unexplained muscle pain.
• if the patient is taking a medicine called cyclosporin (e.g., after organ transplantation).
• if the patient has had an asthma attack or swelling of certain parts of the body (e.g., face, lips, throat, or tongue) after taking salicylates or NSAIDs.
• if the patient has had stomach or duodenal ulcers or any other bleeding, such as a stroke.
• if the patient has had blood clotting disorders.
• if the patient has gout.
• if the patient has uncontrolled heart failure.
• if the patient is taking a medicine called methotrexate (e.g., for cancer or rheumatoid arthritis) in doses higher than 15 mg per week.

Warnings and precautions

Before starting treatment with Rosuvastatin + Acetylsalicylic acid Rafarm, the patient should discuss it with their doctor or pharmacist.

• if the patient has kidney problems.
• if the patient has liver disease.
• if the patient has had recurring or unexplained muscle pain, muscle problems, or muscle problems in the family, or muscle problems while taking other cholesterol-lowering medicines in the past. The patient should inform their doctor immediately if they experience unexplained muscle pain, especially if they feel unwell or have a fever. The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness.
• if the patient regularly consumes large amounts of alcohol.
• if the patient has thyroid problems.
• if the patient is taking other medicines called fibrates to lower cholesterol levels. The patient should carefully read the leaflet, even if they have taken other cholesterol-lowering medicines before.
• if the patient is taking medicines for HIV infection, such as ritonavir with lopinavir and/or atazanavir; see "Rosuvastatin + Acetylsalicylic acid Rafarm and other medicines".
• if the patient is taking or has taken a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection in the last 7 days; taking Rosuvastatin + Acetylsalicylic acid Rafarm with fusidic acid can lead to serious muscle problems (rhabdomyolysis); see "Rosuvastatin + Acetylsalicylic acid Rafarm and other medicines".
• if the patient has severe respiratory failure.
• if the patient is over 70 years old.
• if the patient is of Asian origin (i.e., Japan, China, Philippines, Vietnam, Korea, and India). The doctor will choose the appropriate starting dose of Rosuvastatin + Acetylsalicylic acid Rafarm for the patient.
• if the patient currently has or has had stomach or duodenal problems (ulcers or bleeding from the gastrointestinal tract).
• if the patient has high blood pressure.
• if the patient has asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid can cause an asthma attack.
• in case of hypersensitivity (allergy) to other painkillers and anti-inflammatory drugs, other anti-rheumatic drugs, or other factors that cause allergy.
• if the patient has other allergies (e.g., skin reactions, itching).
• if the patient is taking other anticoagulant medicines (e.g., coumarin derivatives, heparin, except for low-dose heparin).
• in case of impaired kidney function or reduced blood flow to the heart and blood vessels (e.g., kidney artery disease, heart failure, decreased blood volume, major surgery, sepsis, or increased bleeding); acetylsalicylic acid can further increase the risk of kidney function disorders and acute kidney failure.
• if the patient has heavy menstrual bleeding.

The patient should immediately consult a doctor if their symptoms worsen or if they experience serious or unexpected undesirable effects, such as unusual bleeding symptoms, severe skin reactions, or any symptoms of a severe allergic reaction (see "Possible undesirable effects").

Statins can affect the liver in a small number of people. This is identified by a simple blood test that detects elevated liver enzyme activity. For this reason, the doctor will usually recommend a blood test (liver function test) before and during treatment with Rosuvastatin + Acetylsalicylic acid Rafarm.

During treatment with this medicine, the doctor will closely monitor the patient's condition if they have diabetes or are at risk of developing diabetes. The risk of developing diabetes is likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure.

The patient should be cautious not to become dehydrated (feeling thirsty with dry mouth) because taking acetylsalicylic acid can worsen kidney function.

The patient should inform their doctor if they plan to have surgery (even minor, e.g., tooth extraction), as acetylsalicylic acid can increase the risk of bleeding.

Acetylsalicylic acid can cause Reye's syndrome in children. Reye's syndrome is a very rare disease that affects the brain and liver and can be fatal. Therefore, Rosuvastatin + Acetylsalicylic acid Rafarm should not be given to children and adolescents under 18 years of age.

In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause accelerated breakdown or breakdown of red blood cells or a certain form of anemia. This risk may be caused by factors such as high doses, fever, or acute infections.

Small doses of acetylsalicylic acid can reduce uric acid excretion. This can cause a gout attack in patients at risk.

In case of injury or trauma, bleeding may take a little longer than usual. This is due to the effect of acetylsalicylic acid. Minor injuries and traumas (e.g., during shaving) are usually not significant. If the patient experiences unusual bleeding (in an unusual location or lasting longer than usual), they should contact their doctor.

Children and adolescents

Rosuvastatin + Acetylsalicylic acid Rafarm should not be used in children and adolescents.

Rosuvastatin + Acetylsalicylic acid Rafarm and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Rosuvastatin + Acetylsalicylic acid Rafarm may affect or be affected by the following medicines:

• fibrates (such as gemfibrozil, fenofibrate) or other medicines used to lower cholesterol levels (such as ezetimibe).
• antacids (used to neutralize stomach acid).
• oral contraceptives ("the pill").
• hormone replacement therapy.
• regorafenib (used to treat cancer).
• any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, alone or in combination with other medicines (see "Warnings and precautions"): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
• ketokonazole, itraconazole (antifungal medicines).
• rifampicin, erythromycin, clarithromycin (antibiotics).
• medicines that reduce blood clotting and prevent blood clots (e.g., warfarin, heparin, coumarin, clopidogrel, ticlopidine): acetylsalicylic acid can increase the risk of bleeding if taken before medicines that dissolve blood clots or thin the blood. In this regard, if such treatment is to be used, attention should be paid to signs of external or internal bleeding (e.g., bruising).
• organ rejection after transplantation (cyclosporin, tacrolimus).
• high blood pressure (e.g., diuretics, ACE inhibitors).
• heart rate regulation (digoxin).
• manic-depressive illness (lithium).
• pain and inflammation (e.g., nonsteroidal anti-inflammatory drugs, such as ibuprofen, naproxen, or corticosteroids).
• gout (e.g., probenecid, benzbromarone).
• glaucoma (acetazolamide).
• cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week).
• medicines that lower blood sugar levels (e.g., glibenclamide) - may cause a decrease in blood sugar levels.
• depression (selective serotonin reuptake inhibitors (SSRIs), such as sertraline or paroxetine).
• medicines used as hormone replacement therapy in case of adrenal or pituitary gland damage or removal (except for products used on the skin or cortisol replacement therapy for Addison's disease) or for the treatment of inflammatory conditions, including rheumatic diseases and inflammatory bowel disease (corticosteroids). Concomitant use increases the risk of undesirable effects on the gastrointestinal tract.
• seizures (valproic acid).
• medicines that increase urine production (diuretics: e.g., aldosterone antagonists, such as spironolactone and canrenone, loop diuretics, e.g., furosemide).
• Alcohol: increases the risk of stomach ulcers and bleeding.

If the patient needs to take oral fusidic acid to treat a bacterial infection, they will need to temporarily stop taking Rosuvastatin + Acetylsalicylic acid Rafarm. The doctor will inform the patient when it is safe to resume taking this medicine.

Taking Rosuvastatin + Acetylsalicylic acid Rafarm with fusidic acid can rarely lead to weakness, tenderness, or muscle pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.

Rosuvastatin + Acetylsalicylic acid Rafarm can further lower blood pressure if the patient is taking other medicines for high blood pressure.

Taking Rosuvastatin + Acetylsalicylic acid Rafarm with food and drink

Rosuvastatin + Acetylsalicylic acid Rafarm should be taken with a meal.

During treatment with Rosuvastatin + Acetylsalicylic acid Rafarm, the patient should avoid drinking grapefruit juice.

Consuming alcohol can potentially increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding

Rosuvastatin + Acetylsalicylic acid Rafarm should not be taken if the patient is pregnant or breastfeeding.

If the patient becomes pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm, they should stop taking it immediately and inform their doctor. Women should avoid becoming pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm, using appropriate methods of contraception.

Driving and using machines

Most people can drive and use machines while taking Rosuvastatin + Acetylsalicylic acid Rafarm - it will not affect their ability to drive vehicles or operate machinery. However, some people may experience dizziness while taking Rosuvastatin + Acetylsalicylic acid Rafarm. If the capsules cause nausea, dizziness, or fatigue, or if the patient experiences headache, they should not drive or operate machinery and should contact their doctor immediately.

Rosuvastatin + Acetylsalicylic acid Rafarm contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Rosuvastatin + Acetylsalicylic acid Rafarm

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Adults

The doctor will determine the appropriate dose for the patient, depending on their health, current treatment, and individual risk.

This medicine is not suitable for starting treatment. Treatment should be started with separate administration of the active substances; after determining the appropriate doses, it is possible to switch to Rosuvastatin + Acetylsalicylic acid Rafarm with the corresponding strength.

The recommended dose is one capsule per day.

The medicine should be taken with meals. The medicine should be taken every day at the same time.

The capsules should be swallowed whole, with a large amount of liquid; they should not be crushed or chewed.

Rosuvastatin + Acetylsalicylic acid Rafarm should not be taken with grapefruit juice.

If the patient is hospitalized or treated for another disease, they should inform the medical staff that they are taking Rosuvastatin + Acetylsalicylic acid Rafarm.

Taking Rosuvastatin + Acetylsalicylic acid Rafarm in elderly patients

No dose adjustment is necessary in elderly patients.

Taking Rosuvastatin + Acetylsalicylic acid Rafarm in children and adolescents

Rosuvastatin + Acetylsalicylic acid Rafarm should not be used in children and adolescents.

Patients with kidney problems

No dose adjustment is necessary in patients with mild or moderate kidney problems.

Taking Rosuvastatin + Acetylsalicylic acid Rafarm is contraindicated in patients with severe kidney problems.

Patients with liver problems

No dose adjustment is necessary in patients with mild or moderate liver problems.

Taking Rosuvastatin + Acetylsalicylic acid Rafarm is contraindicated in patients with severe liver problems.

Taking a higher dose of Rosuvastatin + Acetylsalicylic acid Rafarm than recommended

In case of an overdose, the patient should contact their doctor or the nearest hospital.

Missing a dose of Rosuvastatin + Acetylsalicylic acid Rafarm

The patient should not worry. If they miss a capsule, they should skip the missed dose and take the next dose at the right time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Rosuvastatin + Acetylsalicylic acid Rafarm

The doctor will inform the patient how long they should take the medicine. After stopping treatment with Rosuvastatin + Acetylsalicylic acid Rafarm, cholesterol levels may rise again. If the patient stops taking the medicine before receiving the doctor's advice, their condition may worsen.

In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Rosuvastatin + Acetylsalicylic acid Rafarm can cause undesirable effects, although not everybody gets them.

The patient should stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and seek medical help immediately if they experience any of the following very rare, serious undesirable effects after taking this medicine:

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat, causing significant breathing or swallowing problems.
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, and peeling of the skin, or other allergic reactions.
• If the patient experiences black stools or vomits blood (signs of severe stomach bleeding).

The patient should also stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and contact their doctor immediately:

• if they experience unusual muscle painthat lasts longer than expected. Like other statins, rosuvastatin has caused unpleasant muscle effects in a very small number of patients, which in rare cases have led to potentially life-threatening muscle damage, known as rhabdomyolysis.
• if they experience muscle rupture.
• if they experience a lupus-like syndrome(including rash, joint disorders, and effects on blood cells).

The following undesirable effects have been reported. If any of these effects cause the patient trouble or last longer than a week, they should contact their doctor.

ROSUVASTATIN

Common(occurring in less than 1 in 10 patients):

• Headache.
• Abdominal pain.
• Constipation.
• Nausea.
• Muscle pain.
• Feeling weak.
• Dizziness.
• Diabetes. Its occurrence is more likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. During treatment with this medicine, the doctor will monitor the patient's condition.

Uncommon(occurring in less than 1 in 100 patients):

• Rash, itching, or other skin reactions.
• Increased urine protein levels - usually resolves on its own without the need to stop taking the capsules (only doses of 5-20 mg).

Rare(occurring in less than 1 in 1,000 patients):

• Severe allergic reaction - characterized by swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, and severe itching of the skin (anaphylaxis). If an allergic reaction is suspected, the patient should stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and seek medical help immediately.
• Muscle damage in adults - as a precaution, the patient should stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and contact their doctor immediately if they experience unexplained muscle pain, especially if they feel unwell or have a fever.
• Severe abdominal pain (pancreatitis).
• Elevated liver enzyme levels in the blood.
• Decreased platelet count, which can increase the risk of bleeding or bruising (thrombocytopenia).
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare(occurring in less than 1 in 10,000 patients):

• Jaundice (yellowing of the skin and eyes).
• Liver inflammation.
• Blood in the urine.
• Nerve damage (e.g., numbness or tingling).
• Joint pain.
• Memory loss.
• Gynecomastia (breast enlargement in men).

Frequency not known(cannot be estimated from the available data):

• Diarrhea (loose stools).
• Stevens-Johnson syndrome (a severe condition with blistering of the skin, mouth, and eyes, and genital areas).
• Cough.
• Shortness of breath.
• Swelling (edema).
• Sleep disorders, including insomnia and nightmares.
• Sexual problems.
• Depression.
• Breathing problems, including persistent cough and/or shortness of breath or fever.
• Nerve damage that can cause weakness, numbness, or tingling.
• Persistent muscle weakness.

If the patient experiences any of these undesirable effects or any other undesirable effects not mentioned in this leaflet, they should tell their doctor or pharmacist.

Reporting undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not mentioned in the leaflet, they should tell their doctor, pharmacist, or nurse. Undesirable effects can be reported directly to:

Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides

Al. Jerozolimskie 181 C

02-222 Warsaw

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

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

Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Rosuvastatin + Acetylsalicylic acid Rafarm

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

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month stated.

Store at a temperature below 30°C. Store in the original packaging to protect from moisture.

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. Contents of the packaging and other information

What Rosuvastatin + Acetylsalicylic acid Rafarm contains

The active substances of the medicine are rosuvastatin (in the form of rosuvastatin calcium) and acetylsalicylic acid.

Rosuvastatin + Acetylsalicylic acid Rafarm 5 mg + 100 mg: each hard capsule contains 5 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Rosuvastatin + Acetylsalicylic acid Rafarm 10 mg + 100 mg: each hard capsule contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Rosuvastatin + Acetylsalicylic acid Rafarm 20 mg + 100 mg: each hard capsule contains 20 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

The other ingredients are:

The film-coated tablet containing rosuvastatincontainsthe followingingredientsin the core:

lactose monohydrate

microcrystalline cellulose

heavy magnesium oxide

crospovidone (type A)

silica, colloidal anhydrous

magnesium stearate

Coating:

hypromellose (partial hydroxypropyl)

titanium dioxide (E 171)

talc

iron oxide, yellow (E 172)

soybean lecithin

iron oxide, red (E 172)

xanthan gum

iron oxide, black (E 172)

The tablet containing acetylsalicylic acidcontainsthe followingingredients:

microcrystalline cellulose

corn starch

silica, colloidal anhydrous

stearic acid

Capsule shell:

gelatin

titanium dioxide (E 171)

indigo carmine (E 132)

iron oxide, yellow (E 172)

Black ink:

shellac

propylene glycol

anhydrous ethanol

isopropyl alcohol

ammonium hydroxide, solution

iron oxide, black (E 172)

potassium hydroxide

purified water

What Rosuvastatin + Acetylsalicylic acid Rafarm looks like and contents of the pack

Rosuvastatin + Acetylsalicylic acid Rafarm 5 mg + 100 mg: hard gelatin capsules, size 2, with a white opaque body and dark green opaque cap. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one brown, biconvex, round, film-coated tablet of rosuvastatin 5 mg.

Rosuvastatin + Acetylsalicylic acid Rafarm 10 mg + 100 mg: hard gelatin capsules, size 1, with a white opaque body with black printing "ASA 100" and light green opaque cap with black printing "RSV 10". Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one brown, biconvex, round, film-coated tablet of rosuvastatin 10 mg.

Rosuvastatin + Acetylsalicylic acid Rafarm 20 mg + 100 mg: hard gelatin capsules, size 0, with a white opaque body with black printing "ASA 100" and green opaque cap with black printing "RSV 20". Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and two brown, biconvex, round, film-coated tablets of rosuvastatin 10 mg.

Rosuvastatin + Acetylsalicylic acid Rafarm is available in blisters of 28, 30, 56, and 90 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

RAFARM S.A.

12 Korinthou str.

15451 N. Psihiko, Athens

Greece

Manufacturer

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

This medicinal product is authorized in the Member States of the EEA under the following names:

Poland:

Rosuvastatin + Acetylsalicylic acid Rafarm

Austria:

Rosuvastatin/Acetylsalicylsäure Rafarm 5 mg/100 mg Hartkapseln

Rosuvastatin/Acetylsalicylsäure Rafarm 10 mg/100 mg Hartkapseln

Rosuvastatin/Acetylsalicylsäure Rafarm 20 mg/100 mg Hartkapseln

Bulgaria:

Розувастатин / Ацетилсалицилова киселина Rafarm

Croatia:

ROSIX DUO 5 mg/100 mg tvrde kapsule

ROSIX DUO 10 mg/100 mg tvrde kapsule

ROSIX DUO 20 mg/100 mg tvrde kapsule

Germany:

Rosuvastatin + Acetylsalicylic acid Rafarm

Italy:

Rosuvastatina e Acido Acetilsalicilico Rafarm

Portugal:

ESTASP

Slovenia:

BELOROSTIN 5 mg/100 mg trde kapsule

BELOROSTIN 10 mg/100 mg trde kapsule

BELOROSTIN 20 mg/100 mg trde kapsule

Spain:

Rosuvastatina/Ácido acetilsalicílico Rafarm 5 mg/100 mg cápsulas duras

Rosuvastatina/Ácido acetilsalicílico Rafarm 10 mg/100 mg cápsulas duras

Rosuvastatina/Ácido acetilsalicílico Rafarm 20 mg/100 mg cápsulas duras

Greece:

ROSU-ASA

Cyprus:

ROSU-ASA

Date of last revision of the leaflet: