Rosuvastatin + acetylsalicylic acid rafarm: detailed information

Package leaflet: Information for the patient

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
Please read this leaflet carefully before using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Rosuvastatin + Acetylsalicylic acid Rafarm is and what it is used for
Important information before taking Rosuvastatin + Acetylsalicylic acid Rafarm
How to take Rosuvastatin + Acetylsalicylic acid Rafarm
Possible side effects
How to store Rosuvastatin + Acetylsalicylic acid Rafarm
Contents of the pack and other information
What Rosuvastatin + Acetylsalicylic acid Rafarm is and what it is 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 blood levels of lipids (fats), such as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone are insufficient. Cholesterol is a fatty substance (lipid) that can cause narrowing of blood vessels in the heart, leading to coronary heart disease. If you are at risk of a further heart attack, rosuvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, you should follow a standard cholesterol-lowering diet.
Acetylsalicylic acid, in low doses, belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off oxygen supply. If this occurs in the heart, it may cause a heart attack or angina. These two active substances, taken together, reduce the risk of a further heart attack in patients who have already had a heart attack or who experience chest pain attacks (unstable angina).

Rosuvastatin + Acetylsalicylic acid Rafarm is indicated for patients already taking rosuvastatin and acetylsalicylic acid at these doses. Instead of taking rosuvastatin and acetylsalicylic acid as separate tablets, the patient receives one capsule of Rosuvastatin + Acetylsalicylic acid Rafarm containing both components at the same strength as previously used.

2. Important information before taking Rosuvastatin + Acetylsalicylic acid Rafarm

Do not take Rosuvastatin + Acetylsalicylic acid Rafarm:

if you are allergic to rosuvastatin, acetylsalicylic acid, any other salicylates, non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breastfeeding, or if you become pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm, you must stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm by using appropriate contraceptive methods.
if you have liver disease.
if you have severe kidney disease.
if you have recurrent or unexplained muscle pain.
if you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
if you have previously experienced an asthma attack or swelling of certain body parts (e.g. face, lips, throat, or tongue) (angioedema) after taking salicylates or NSAIDs.
if you currently have or have previously had stomach or small intestine ulcers or any other bleeding, such as stroke.
if you have ever had blood clotting disorders.
if you suffer from gout.
if you have uncontrolled heart failure.
if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses higher than 15 mg per week.

Warnings and precautions
Before starting treatment with Rosuvastatin + Acetylsalicylic acid Rafarm, discuss this with your doctor or pharmacist:

if you have kidney function disorders.
if you have liver disease.
if you have previously experienced recurrent or unexplained muscle pain, muscle problems in yourself or family members, or muscle problems while taking other cholesterol-lowering medicines in the past. You must inform your doctor immediately if you experience unexplained muscle pain, especially if you feel unwell or have a fever. You should also inform your doctor or pharmacist if you experience persistent muscle weakness.
if you regularly consume large amounts of alcohol.
if your thyroid gland does not function properly.
if you are taking other medicines called fibrates to lower cholesterol levels. Please read this leaflet carefully, even if you have previously taken other cholesterol-lowering medicines.
if you are taking antiviral medicines for HIV infection, e.g. ritonavir with lopinavir and/or atazanavir; see section “Rosuvastatin + Acetylsalicylic acid Rafarm and other medicines”.
if you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used for bacterial infections); taking Rosuvastatin + Acetylsalicylic acid Rafarm with fusidic acid may lead to severe muscle problems (rhabdomyolysis); see section “Rosuvastatin + Acetylsalicylic acid Rafarm and other medicines”.
if you have severe respiratory failure.
if you are over 70 years old.
if you are of Asian descent (i.e. Japan, China, Philippines, Vietnam, Korea, and India). Your doctor must select an appropriate starting dose of Rosuvastatin + Acetylsalicylic acid Rafarm suitable for you.
if you currently have or have previously had stomach or small intestine problems (ulcers or gastrointestinal bleeding).
if you have hypertension.
if you suffer from asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack.
if you have hypersensitivity (allergy) to other painkillers and anti-inflammatory medicines, other anti-rheumatic medicines, or other allergy-inducing agents.
if you have other allergies (e.g. with skin reactions, itching).
if you are taking other anticoagulant medicines (e.g. coumarins, heparin – except low-dose heparin).
in case of impaired kidney function or reduced blood flow to the heart and blood vessels (e.g. kidney vessel disease, heart muscle weakness, reduced blood volume, major surgery, blood infection, or significant bleeding): acetylsalicylic acid may further increase the risk of kidney function disorders and acute kidney failure.
if you have heavy menstrual periods.

You must seek immediate medical advice if your symptoms worsen or if you experience severe or unexpected side effects, such as unusual bleeding, severe skin reactions, or any other symptoms of severe allergy (see section “Possible side effects”).
In a small number of people, statins may affect the liver. This is identified by a simple blood test that detects elevated liver enzyme activity in the blood. For this reason, your doctor will usually recommend this blood test (liver function test) before starting and during treatment with Rosuvastatin + Acetylsalicylic acid Rafarm.
Your doctor will closely monitor your condition while you are taking this medicine if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher if you have high blood sugar and fat levels, are overweight, and have high blood pressure.
You must take care to avoid dehydration (you may feel thirsty with a dry mouth), as concomitant use of acetylsalicylic acid may lead to worsening kidney function.
Inform your doctor if you are planning a surgical procedure (even a minor one, such as tooth extraction), as acetylsalicylic acid thins the blood and may increase the risk of bleeding.
Acetylsalicylic acid may cause Reye's syndrome when given to children. Reye's syndrome is a very rare disease affecting the brain and liver, which may lead to death. For this reason, Rosuvastatin + Acetylsalicylic acid Rafarm must not be given to children and adolescents under 18 years of age.
In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid may cause accelerated or severe breakdown of red blood cells or a certain form of anaemia. This risk may be caused by factors such as high doses, fever, or acute infections.
Low doses of acetylsalicylic acid may reduce uric acid excretion. This may trigger a gout attack in patients at risk.
In case of cuts or injuries, bleeding may last slightly longer than usual. This is related to the action of acetylsalicylic acid. Minor cuts and injuries (e.g. during shaving) are usually not significant. If you experience unusual bleeding (in an unusual location or of unusual duration), you should contact your doctor.

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

Rosuvastatin + Acetylsalicylic acid Rafarm and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Rosuvastatin + Acetylsalicylic acid Rafarm may affect the following medicines, or the following medicines may affect it:

fibrates (such as gemfibrozil, fenofibrate) or other medicines used to lower cholesterol levels (such as ezetimibe).
antacids (used to neutralise stomach acid).
oral contraceptives ("the pill").
hormone replacement therapy.
regorafenib (used in cancer treatment).
any of the following medicines used to treat viral infections, including HIV or hepatitis C virus, administered alone or in combination with other medicines (see: Warnings and precautions): ritonavir, lopinavir, atazanavir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
ketoconazole, 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. Therefore, if such treatment is to be used, be alert for signs of external or internal bleeding (e.g. bruising).
organ transplant rejection (cyclosporine, tacrolimus).
hypertension (e.g. diuretics and ACE inhibitors).
heart rhythm regulation (digoxin).
bipolar disorder (lithium).
pain and inflammation (e.g. non-steroidal anti-inflammatory drugs such as ibuprofen, naproxen, or steroid medicines).
gout (e.g. probenecid, benzbromarone).
glaucoma (acetazolamide).
cancer or rheumatoid arthritis (methotrexate; at doses lower than 15 mg per week).
medicines that lower blood sugar levels (antidiabetic medicines) (e.g. glibenclamide) – may lead to reduced 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 skin products or cortisone replacement therapy for Addison's disease) or in the treatment of inflammatory conditions, including rheumatic diseases and inflammatory bowel disease (corticosteroids). Concomitant use increases the risk of gastrointestinal side effects.
epileptic seizures (valproic acid).
medicines causing increased urine production (diuretics: so-called aldosterone antagonists, e.g. spironolactone and canrenoate, loop diuretics, e.g. furosemide).
Alcohol: increases the risk of gastrointestinal ulcers and bleeding.

If you need to take fusidic acid orally to treat a bacterial infection, temporary discontinuation of Rosuvastatin + Acetylsalicylic acid Rafarm will be necessary. Your doctor will inform you when it is safe to resume taking this medicine.
Taking Rosuvastatin + Acetylsalicylic acid Rafarm with fusidic acid may, in rare cases, 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 you are taking other medicines used to treat high blood pressure.

Taking Rosuvastatin + Acetylsalicylic acid Rafarm with food and drink
Rosuvastatin + Acetylsalicylic acid Rafarm should be taken with food.
During treatment with Rosuvastatin + Acetylsalicylic acid Rafarm, you should avoid drinking grapefruit juice.
Alcohol consumption may potentially increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding
Do not take Rosuvastatin + Acetylsalicylic acid Rafarm if you are pregnant or breastfeeding. If you become pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm, you must stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking Rosuvastatin + Acetylsalicylic acid Rafarm by using appropriate contraceptive methods.

Driving and using machines
Most people can drive cars and operate machinery while taking Rosuvastatin + Acetylsalicylic acid Rafarm – it will not affect their ability to drive motor vehicles. However, some people may experience dizziness while taking Rosuvastatin + Acetylsalicylic acid Rafarm. If the capsules cause nausea, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.

Rosuvastatin + Acetylsalicylic acid Rafarm contains lactose
If you have previously been diagnosed with an intolerance to certain sugars, you should contact your doctor before taking this medicine.

3. How to take Rosuvastatin + Acetylsalicylic acid Rafarm

This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Adults
The doctor will determine the appropriate dose for the patient, depending on their health status, current
treatment, and individual risk factors.
This medicine is not suitable for initiating treatment. Treatment should be started with separate
administration of the active substances; after appropriate doses have been established, a switch to
Rosuvastatin + Acetylsalicylic acid Rafarm at the appropriate strength may be made.
The recommended dose is one capsule daily.
This medicine should be taken with food. The medicine should be taken every day at the same time.
Capsules should be swallowed whole with plenty of fluid; they must not be crushed or chewed.
Rosuvastatin + Acetylsalicylic acid Rafarm must not be taken with grapefruit juice.
If the patient is admitted to hospital or is being treated for another illness, medical staff should be
informed that the patient is taking Rosuvastatin + Acetylsalicylic acid Rafarm.
Use in elderly patients
Dose adjustment is not necessary in elderly patients.
Use in children and adolescents
Rosuvastatin + Acetylsalicylic acid Rafarm must not be used in children and adolescents.
Patients with renal impairment
Dose adjustment is not required in patients with mild or moderate renal impairment.
Rosuvastatin + Acetylsalicylic acid Rafarm is contraindicated in patients with severe renal impairment.
Patients with hepatic impairment
Dose adjustment is not required in patients with mild or moderate hepatic impairment.
Rosuvastatin + Acetylsalicylic acid Rafarm is contraindicated in patients with severe hepatic impairment.
Taking more than the recommended dose of Rosuvastatin + Acetylsalicylic acid Rafarm
In case of overdose, contact your doctor or the nearest hospital immediately for advice.
Missed dose of Rosuvastatin + Acetylsalicylic acid Rafarm
Do not be concerned. If a capsule is missed, skip that dose completely. Take the next dose at the
regularly scheduled time. Do not take a double dose to make up for a missed dose.
Stopping treatment with Rosuvastatin + Acetylsalicylic acid Rafarm
Your doctor will inform you how long you should continue taking the medicine. After stopping
Rosuvastatin + Acetylsalicylic acid Rafarm, cholesterol levels may rise again. If treatment is stopped
before receiving appropriate advice, the condition may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.

You must stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and seek immediate medical help if any of the following very rare, serious side effects occur 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 difficulty in breathing and/or swallowing
Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions
If black stools or vomiting blood occur (signs of severe bleeding from the stomach)

You should also stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and
immediately contact your doctor:

If you experience unusual muscle pain that persists longer than expected. As with other statins, in a very small number of patients, adverse effects affecting muscles have occurred, which in rare cases led to potentially life-threatening muscle damage known as rhabdomyolysis.
If you experience muscle tearing.
If you develop a lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

The following side effects have been reported. If any of them cause discomfort to the patient or persist for longer than one week, you should contact your doctor.

ROSUVASTATIN

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

Headache
Abdominal pain
Constipation
Nausea
Muscle pain
Feeling of weakness
Dizziness
Diabetes. The occurrence of diabetes is more likely if the patient has high levels of sugar and fats in the blood, is overweight, and has high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

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

Rash, itching, hives, or other skin reactions
Increased protein in urine – usually resolves spontaneously without the need to discontinue Rosuvastatin + Acetylsalicylic acid Rafarm capsules (only at 5-20 mg dose)

Rare (occurring in more 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 skin itching (with raised bumps). If an allergic reaction is suspected, stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and seek immediate medical help.
Muscle damage in adults – as a precaution, you must stop taking Rosuvastatin + Acetylsalicylic acid Rafarm and immediately contact your doctor if you experience unusual muscle pain that persists longer than expected.
Severe abdominal pain (pancreatitis)
Increased liver enzymes in blood
Decreased platelet count, increasing the risk of bleeding or bruising (thrombocytopenia)
Lupus-like syndrome (including rash, joint disorders, and effects on blood cells)

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

Jaundice (yellowing of the skin and eyes)
Inflammation of the liver
Blood in the urine
Damage to nerves of the upper and lower limbs (e.g., tingling)
Joint pain
Memory loss
Gynaecomastia (enlargement of breasts in men)

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

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

ACETYLSALICYLIC ACID

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

Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain, and diarrhoea
Minor gastrointestinal bleeding (microbleeding)
Bleeding, such as nosebleeds, bleeding gums, skin bleeding, or bleeding from the urinary tract and genital organs, possibly with prolonged bleeding time. This effect may last 4 to 8 days after taking the medicine.

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

Bleeding from the stomach or intestines. With long-term use of acetylsalicylic acid, anaemia (iron deficiency anaemia) may occur due to occult blood loss from the stomach or intestines.
Intracranial bleeding, blood in the urine
Ulcers of the stomach or intestines, which very rarely may lead to perforation
Inflammation of the gastrointestinal tract
Skin reactions

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

Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal tract, and cardiovascular system, especially in patients with asthma. Symptoms may include: drop in blood pressure, shortness of breath, inflammation of the nasal mucosa, nasal congestion, anaphylactic shock, swelling of the face, tongue, and larynx (Quincke's oedema).
Severe bleeding, such as brain haemorrhage, especially in patients with uncontrolled hypertension and/or those concurrently taking anticoagulant medicines, which in individual cases may be life-threatening.
Confusion (state of disorientation)
Dizziness, headache
Hearing loss or ringing in the ears (tinnitus), particularly in children and elderly patients, which may be signs of overdose (see also section “Taking more than the recommended dose of Rosuvastatin + Acetylsalicylic acid Rafarm”)

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

Increased liver function test results
Kidney function disorders and acute kidney failure
Decreased blood sugar levels (hypoglycaemia)
Low doses of acetylsalicylic acid reduce the excretion of uric acid. This may trigger an attack of gout in patients at risk.
Fever-related rash with mucosal involvement (erythema multiforme)

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

In patients with severe glucose-6-phosphate dehydrogenase deficiency, accelerated breakdown or destruction of red blood cells and a certain form of anaemia have been observed.

If any of these side effects become severe, or if the patient experiences any side effects not listed in this leaflet, you should inform your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to:

Department of Monitoring of Adverse Drug Reactions
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 directly to the responsible entity.

By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store Rosuvastatin + Acetylsalicylic acid Rafarm

Keep this medicine out of 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 stated month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Rosuvastatin + Acetylsalicylic acid Rafarm contains
The active substances 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 (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
Rosuvastatin + Acetylsalicylic acid Rafarm 10 mg + 100 mg: each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
Rosuvastatin + Acetylsalicylic acid Rafarm 20 mg + 100 mg: each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

Other components are:
Tablet containing rosuvastatin:
Tablet core
Lactose monohydrate
Microcrystalline cellulose
Magnesium oxide, heavy
Crospovidone (type A)
Anhydrous colloidal silicon dioxide
Magnesium stearate
Coating
Polyvinyl alcohol, partially hydrolyzed
Titanium dioxide (E 171)
Talc
Iron oxide yellow (E 172)
Lecithin (soy)
Iron oxide red (E 172)
Xanthan gum
Iron oxide black (E 172)

Tablet containing acetylsalicylic acid:
Microcrystalline cellulose
Corn starch
Anhydrous colloidal silicon dioxide
Stearic acid

Capsule shell:
Gelatin
Titanium dioxide (E 171)
Indigo carmine (E 132)
Iron oxide yellow (E 172)

Black ink:
Shellac
Propylene glycol
Dehydrated alcohol
Butyl alcohol
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 of size 2, with a white opaque body and a dark green opaque cap. Each capsule contains one white or almost white, oval, biconvex, uncoated tablet of acetylsalicylic acid and one coated, brown, round, biconvex tablet of rosuvastatin 5 mg.

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

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

Rosuvastatin + Acetylsalicylic acid Rafarm is available in blister packs containing 28, 30, 56, and 90 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
Poland

This medicinal product is authorised in the EEA Member States 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