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

Rosuvastatinum + Acidum acetylsalicylicum
You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you 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 side effects, including any side effects not listed in this leaflet, they should tell 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 side 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 enough. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels in the heart, leading to coronary artery disease. If a 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 clotting and participate in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off oxygen supply. When 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, any other salicylan, or non-steroidal 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 salicylan or NSAIDs.
• if the patient has had stomach or duodenal ulcers or any other bleeding, such as a stroke.
• if the patient has had bleeding 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 immediately inform their doctor 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, e.g., ritonavir with lopinavir and/or atazanavir; see "Rosuvastatin + Acetylsalicylic acid Rafarm and other medicines".
• if the patient is taking or has taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection; 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 an appropriate starting dose of Rosuvastatin + Acetylsalicylic acid Rafarm for the patient.
• if the patient currently has or has had stomach or duodenal ulcers or bleeding (gastrointestinal bleeding).
• 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 allergic reactions.
• 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 renal function or reduced blood flow to the heart and blood vessels (e.g., kidney artery disease, heart failure, reduced blood volume, severe surgery, sepsis, or increased bleeding); acetylsalicylic acid may further increase the risk of kidney problems 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 side effects, such as unusual bleeding symptoms, severe skin reactions, or any symptoms of a severe allergic reaction (see "Possible side 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 are planning 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 rapid 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 trauma (e.g., during shaving) are usually not significant. If the patient experiences unusual bleeding (in an unusual location or duration), 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 other medicines:

• fibrates (e.g., gemfibrozil, fenofibrate) or other medicines used to lower cholesterol levels (e.g., 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, 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 may increase the risk of bleeding if taken before medicines that dissolve blood clots or thin the blood. In this case, if the patient is to receive such treatment, they should be monitored for 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., non-steroidal 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 corticosteroid replacement therapy for Addison's disease) or for the treatment of inflammatory conditions, including rheumatoid arthritis and inflammatory bowel disease (corticosteroids). Concomitant use increases the risk of gastrointestinal side effects.
• 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 gastrointestinal 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 restart the medicine.

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

Rosuvastatin + Acetylsalicylic acid Rafarm may 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 may 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 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.

If the patient has any doubts, they 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 condition, they should inform the medical staff that they are taking Rosuvastatin + Acetylsalicylic acid Rafarm.

Use in elderly patients

There is no need to modify the dose in elderly patients.

Use in children and adolescents

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

Patients with kidney problems

Dose adjustment is not necessary in patients with mild or moderate kidney problems.

The use of Rosuvastatin + Acetylsalicylic acid Rafarm is contraindicated in patients with severe kidney problems.

Patients with liver problems

Dose adjustment is not necessary in patients with mild or moderate liver problems.

The use of 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 a doctor or the nearest hospital for advice.

Missing a dose of Rosuvastatin + Acetylsalicylic acid Rafarm

The patient should not worry. If they miss a capsule, they should skip that dose and take the next dose at the usual time.

The patient 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.

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

4. Possible side effects

Like all medicines, Rosuvastatin + Acetylsalicylic acid Rafarm can cause side 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 side 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 severe breathing or swallowing difficulties.
• Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), 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 unexplained muscle pain that persists longer than expected.
• if they experience muscle rupture.
• if they experience a condition similar to lupus (including rash, joint problems, and effects on blood cells).

The following side effects have been reported:

ROSUVASTATIN

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

• 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 people):

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

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

• severe allergic reaction - symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, severe itching of the skin (with lumps). In case of suspected allergic reaction, 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 enzymes in the blood.
• reduced platelet count, which can increase the risk of bleeding or bruising (thrombocytopenia).
• condition similar to lupus (including rash, joint problems, and effects on blood cells).

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

• jaundice (yellowing of the skin and eyes).
• inflammation of the liver.
• blood in the urine.
• nerve damage (e.g., 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, eyes, and genitals).
• 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, tingling, or numbness.
• persistent muscle weakness.

ACETYLSALICYLIC ACID

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

• gastrointestinal disorders, such as heartburn, nausea, vomiting, abdominal pain, and diarrhea.
• minor gastrointestinal bleeding (microbleeding).
• bleeding, such as nosebleeds, bleeding gums, skin or urinary tract bleeding, or genital bleeding, which may prolong bleeding time. This effect may persist for 4 to 8 days after taking the medicine.

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

• gastrointestinal bleeding or ulcers. Long-term use of acetylsalicylic acid may cause hidden blood loss from the stomach or intestines, leading to iron deficiency anemia.
• bleeding in the brain or urine.
• stomach or duodenal ulcers, which can rarely lead to perforation.
• inflammation of the gastrointestinal tract.
• skin reactions.

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

• allergic reactions, including skin, respiratory, gastrointestinal, and cardiovascular reactions, especially in patients with asthma. Symptoms of the disease may include: decreased blood pressure, shortness of breath, nasal congestion, angioedema, or hives.
• severe bleeding, such as brain bleeding, especially in patients with uncontrolled hypertension and/or concomitant use of anticoagulant medicines, which can be life-threatening.
• confusion.
• dizziness, headache.
• hearing loss or ringing in the ears (tinnitus), especially in children and the elderly, may be signs of overdose (see also "Taking a higher dose of Rosuvastatin + Acetylsalicylic acid Rafarm than recommended").

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

• elevated liver enzyme activity.
• kidney problems and acute kidney failure.
• low blood sugar levels (hypoglycemia).
• small doses of acetylsalicylic acid can reduce uric acid excretion. This can cause a gout attack in patients at risk.

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

• in patients with severe glucose-6-phosphate dehydrogenase deficiency, acetylsalicylic acid can cause rapid breakdown or breakdown of red blood cells and a certain form of anemia.

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse.

Side effects can be reported directly to:

Department for Monitoring of Adverse Reactions to Medicinal Products

Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

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

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 Rosuvastatin + Acetylsalicylic acid Rafarm

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

The medicine should not be used after the expiry date stated on the packaging after EXP.

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

The medicine should be stored at a temperature below 30°C.

The medicine should be stored in its original packaging to protect it 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:

rosuvastatin tablet core:

lactose monohydrate

microcrystalline cellulose

heavy magnesium oxide

crospovidone (type A)

silica, colloidal, anhydrous

magnesium stearate

coating:

hypromellose

partially hydrogenated polyvinyl alcohol

titanium dioxide (E 171)

talc

iron oxide, yellow (E 172)

lecithin (soybean)

iron oxide, red (E 172)

xanthan gum

iron oxide, black (E 172)

acetylsalicylic acid tablet core:

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

butanol

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 a dark green, opaque cap. Each capsule contains one white or almost white, biconvex, oval, uncoated acetylsalicylic acid tablet and one brown, biconvex, round, coated rosuvastatin 5 mg tablet.

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

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

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: