Asadrox

Italy
Brand name Asadrox
Form capsules, hard gelatin
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 048829
Manufacturer ADAMED S.R.L.

Package leaflet: Information for the patient

ASADROX 5 mg/100 mg hard capsules, 10 mg/100 mg hard capsules, 20 mg/100 mg hard capsules

Rosuvastatin/Acetylsalicylic acid
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

  1. What ASADROX is and what it is used for
  2. What you need to know before taking ASADROX
  3. How to take ASADROX
  4. Possible side effects
  5. How to store ASADROX
  6. Contents of the pack and other information

1. What ASADROX is and what it is used for

ASADROX contains two active substances: rosuvastatin and acetylsalicylic acid.

  • Rosuvastatin belongs to a group of substances called statins, medicines that regulate lipids (fats), which are used to reduce levels of lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have not been effective. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels of the heart, leading to coronary heart disease. If you are at risk of another heart attack, rosuvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. During treatment, you must continue to follow a standard cholesterol-lowering diet.
  • Low-dose acetylsalicylic acid belongs to a group of medicines called antiplatelet agents. Platelets are tiny blood cells that cause blood clotting and are involved in thrombosis. When a clot forms in an artery, it blocks blood flow and interrupts the supply of oxygen. When this occurs in the heart, it can cause a heart attack or angina. These two active substances, taken together, reduce the likelihood of having another heart attack, if you have already had one, or if you suffer from episodes of chest pain (unstable angina pectoris). ASADROX is indicated for patients who are already taking rosuvastatin and acetylsalicylic acid at these dosages. Instead of taking rosuvastatin and acetylsalicylic acid separately, you will receive one capsule of ASADROX containing both substances at the same dosages.

2. What you need to know before taking ASADROX

Do not take ASADROX:

  • If you are allergic to rosuvastatin, acetylsalicylic acid, any other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this
    medicine (listed in section 6);
  • if you are allergic to peanuts or soy;
  • if you are pregnant or breastfeeding. If you become pregnant while being treated with ASADROX, stop taking it immediately and contact your doctor. Women must avoid pregnancy during treatment with ASADROX by using appropriate contraceptive measures;
  • if you have liver disease;
  • if you have severe kidney problems;
  • if you have repeated or unexplained muscle aches or pains;
  • if you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used for a viral liver infection called hepatitis C);
  • if you are taking a medicine called cyclosporine (used, for example, after organ transplant);
  • if you have previously experienced an asthma attack, or swelling of certain body parts, such as face, lips, throat or tongue (angioedema), after taking salicylates or NSAIDs;
  • if you currently suffer or have previously suffered from stomach or small intestine ulcer, or any type of bleeding, such as stroke;
  • if you have ever had problems with blood clotting;
  • if you suffer from gout;
  • if you suffer from uncompensated heart failure;
  • if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses exceeding 15 mg per week;
  • if you have ever developed a severe skin rash, skin peeling, blisters and/or mouth ulcers after taking rosuvastatin or related medicines.

Warnings and precautions
Talk to your doctor or pharmacist before taking ASADROX:

  • if you have kidney problems;
  • if you have liver problems;
  • if you have had repeated or unexplained muscle aches or pains, a personal or family history of muscle disorders, or if you previously experienced muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle aches or pains, especially if you feel unwell or have a fever. Also inform your doctor or pharmacist if you have persistent muscle weakness;
  • if you regularly consume large amounts of alcohol;
  • if your thyroid gland is not functioning properly;
  • if you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have previously taken other medicines for high cholesterol;
  • if you are taking medicines used to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir; see section “Other medicines and ASADROX”;
  • if you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). The combination of fusidic acid and ASADROX may lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and ASADROX”;
  • The risk of muscle-related side effects may be higher when daptomycin is taken during treatment with ASADROX. Your doctor may decide not to prescribe daptomycin or to temporarily discontinue ASADROX;
  • if you have severe respiratory insufficiency;
  • if you are over 70 years old;
  • if you are of Asian origin (i.e. Japanese, Chinese, Filipino, Vietnamese, Korean or Indian). Your doctor must choose the appropriate initial dose of ASADROX for you;
  • if you have or have had stomach or small intestine problems (ulcers or gastrointestinal bleeding);
  • if you are simultaneously taking non-steroidal anti-inflammatory drugs, such as ibuprofen and naproxen (medicines for pain, fever or inflammation);
  • if you have high blood pressure;
  • if you have 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 or anti-inflammatory medicines, or other rheumatism medicines, or other factors that may cause allergies;
  • if you have other allergies (e.g. skin reactions, itching);
  • if you are taking other medicines called anticoagulants (e.g. coumarin derivatives, heparin – except for low-dose heparin treatment);
  • if you have impaired kidney function or reduced cardiac or vascular blood flow (e.g. kidney vascular disease, weakened heart muscle, reduced blood volume, major surgery, blood poisoning or increased bleeding): acetylsalicylic acid may further increase the risk of kidney dysfunction and acute kidney failure;
  • if you have heavy menstrual bleeding;
  • if you have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), since statins may sometimes worsen myasthenia or cause its onset (see section 4).

You should seek immediate medical advice if your symptoms worsen or if you experience serious or unexpected side effects, such as unusual bleeding symptoms, severe skin reactions or any other signs of severe allergy (see section “Possible side effects”).
Metamizole (a substance used to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells that stick together and form a blood clot) when taken simultaneously. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.
In a small number of people, statins may affect liver function. This is detected by a simple blood test monitoring increased levels of liver enzymes. For this reason, your doctor will usually request this blood test (liver function test) before and during treatment with ASADROX.
During treatment with this medicine, your doctor will carefully monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight and have high blood pressure.
Be careful not to become dehydrated (you may feel thirsty with a dry mouth), as the concomitant use of acetylsalicylic acid may worsen kidney function.
Inform your doctor if you are planning to undergo surgery (even minor procedures 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 administered to children. Reye's syndrome is a very rare condition affecting the brain and liver and may be life-threatening. For this reason, ASADROX must not be administered to children and adolescents under 18 years of age.
In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid may cause destruction or accelerated destruction of red blood cells or a certain type of anaemia. This risk may be increased by factors such as high dosage; fever or acute infections may also increase the risk.
Low-dose acetylsalicylic acid reduces uric acid excretion. This may trigger a gout attack in at-risk patients.
If you cut yourself or sustain an injury, bleeding may take longer to stop. This is due to the effect of acetylsalicylic acid. Minor cuts or injuries (e.g. during shaving) usually are not significant. If unusual bleeding occurs (in an unusual location or of unusual duration), contact your doctor.
Serious skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin treatment.
Discontinue use of ASADROX and seek immediate medical attention if you notice any of the symptoms described in section 4.
Medicines containing acetylsalicylic acid should not be taken for long periods or at high doses without consulting a doctor.

Children and adolescents
ASADROX must not be used in children and adolescents.

Other medicines and ASADROX
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ASADROX may affect or be affected by other medicines such as:

  • fibrates (e.g. gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (e.g. ezetimibe);
  • antacids (used to neutralize stomach acid);
  • oral contraceptives (the pill);
  • hormone replacement therapy;
  • fostamatinib (used to treat low platelet count);
  • febuxostat (used to treat and prevent high blood levels of uric acid);
  • teriflunomide (used to treat multiple sclerosis);
  • regorafenib (used to treat tumours);
  • darolutamide (used to treat tumours);
  • capmatinib (used to treat tumours);
  • any of the following medicines used to treat viral infections, including HIV or hepatitis C, alone or in combination (see “Warnings and Precautions”): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, simeprevir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir;
  • roxadustat (used to treat anaemia in patients with chronic kidney disease);
  • daptomycin (antibiotic; see “Warnings and Precautions”);
  • tafamidis (used to treat a disease called transthyretin amyloidosis);
  • itraconazole (antifungal medicine);
  • erythromycin, clarithromycin (antibiotics);
  • blood thinners/clot prevention (e.g. warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding if taken before clot removal or blood-thinning treatment; therefore, if you are to undergo such treatment, be alert for signs of external or internal bleeding (e.g. bruising);
  • organ rejection after transplant (cyclosporine, tacrolimus);
  • hypertension (e.g. diuretics and ACE inhibitors);
  • heart rate regulation (digoxin);
  • treatment of manic-depressive disorders (lithium);
  • anti-inflammatory and pain medicines (non-steroidal analgesics/anti-inflammatory drugs) and rheumatism medicines containing salicylic acid: increased risk of gastrointestinal bleeding and ulcers;
  • gout (probenecid, benzbromarone);
  • glaucoma (acetazolamide);
  • cancer or rheumatoid arthritis (methotrexate at doses below 15 mg/week);
  • medicines to lower blood sugar (antidiabetics) such as insulin, tolbutamide, glibenclamide (so-called sulfonylureas) in combination with acetylsalicylic acid at higher doses – blood sugar levels may decrease;
  • depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline and
    paroxetine);
  • hormone replacement therapy when adrenal glands or pituitary gland have been destroyed or removed (except for skin-applied medicines or cortisone replacement therapy in Addison’s disease), or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids). Concomitant use increases the risk of intestinal side effects;
  • seizures (epilepsy) (valproic acid);
  • medicines that increase urinary excretion (diuretics: so-called aldosterone antagonists such as spironolactone and canrenoate, loop diuretics, e.g. furosemide);
  • alcohol: increases the risk of gastrointestinal ulcers and bleeding.

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking ASADROX. Your doctor will inform you when it is safe to restart ASADROX. Taking ASADROX with fusidic acid may rarely cause muscle weakness, soreness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

ASADROX with food and drinks
Alcohol consumption may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding
Do not take ASADROX if you are pregnant or breastfeeding with breast milk. If you become pregnant during treatment with ASADROX, stop taking it immediately and inform your doctor.
Women must avoid becoming pregnant during treatment with ASADROX by using adequate contraception.

Driving and using machines
Most people can drive and operate machinery while being treated with ASADROX, as it does not affect their abilities.
However, some people may experience dizziness during treatment with ASADROX.
If the capsules make you feel unwell, dizzy or tired, or cause headaches, do not drive or operate machinery and contact your doctor immediately.

ASADROX contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars (lactose or milk sugar), consult him before taking ASADROX.

ASADROX contains soybean oil
If you are allergic to peanuts or soy, do not use this medicine.

3. How to take ASADROX

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
Adults
Your doctor will determine the appropriate dose for you, based on your condition, ongoing treatment, and individual risk level.
This medicine is not suitable for initial treatment. Therapy must initially be started with separate administration of the two active substances; only after the appropriate doses have been established can you switch to the appropriate dose of ASADROX.
The recommended dose is one capsule daily.
This medicine should be taken with food. Take the medicine at the same time each day. The capsules must be swallowed whole with plenty of liquid and must not be broken or chewed.
If you are admitted to hospital or receive treatment for another condition, inform medical staff that you are taking ASADROX.
Use in elderly patients
Dose adjustment is not necessary in elderly patients.
Use in children and adolescents
ASADROX must not be used in children and adolescents.
Patients with renal impairment
Dose adjustment is not required in patients with mild to moderate renal impairment.
The use of ASADROX is contraindicated in patients with severe renal impairment.
Patients with hepatic impairment
The use of ASADROX is contraindicated in patients with severe hepatic impairment.
If you take more ASADROX than you should
Contact your doctor or the nearest hospital for advice immediately.
If you forget to take ASADROX
Do not worry. If you forget to take a capsule, skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for a missed capsule.
If you stop taking ASADROX
Your doctor will advise you on how long you should continue taking the medicine. Your cholesterol levels may rise again if you stop taking ASADROX. Your condition may recur if you discontinue treatment with this medicine before being instructed to do so.

  1. Possible side effects Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking ASADROX and consult your doctor immediately if you experience any of the following very rare but serious side effects after taking this medicine:

  • Sudden shortness of breath, chest pain, difficulty breathing;
  • Swelling of the eyelids, face or lips;
  • Swelling of the tongue and throat causing severe difficulty breathing and/or swallowing;
  • Severe skin reactions including severe rash, hives, widespread redness of the skin, intense itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions;
  • Black stools or vomiting blood (signs of severe stomach bleeding);
  • Flat, non-elevated red spots, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe 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).

Additionally, stop taking ASADROX and contact your doctor immediately

  • if you have any unusual muscle pain or tenderness that lasts longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, which rarely progressed to a potentially life-threatening muscle damage known as rhabdomyolysis.

  • if muscle breakdown occurs;

  • if you develop lupus-like syndrome (including skin rash, joint problems and blood cell abnormalities).

The following side effects have been reported. If any of these cause you problems or persist for more than one week, you must contact your doctor.

ROSUVASTATIN
Common (may affect up to 1 in 10 people):

  • Headache
  • Stomach pain
  • Constipation
  • Feeling unwell
  • Muscle pain
  • Feeling weak
  • Dizziness
  • Diabetes. This is more likely if you already have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Uncommon (may affect up to 1 in 100 people):

  • Rash, itching, hives or other skin reactions
  • Increased amount of protein in the urine – values usually return to normal spontaneously without needing to stop taking ASADROX (only at doses of 5–20 mg).

Rare (may affect up to 1 in 1,000 people):

  • Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, intense itching of the skin (with raised lumps). If you suspect an allergic reaction, stop taking ASADROX and seek immediate medical help.
  • Muscle damage in adults – as a precaution, stop taking ASADROX and contact your doctor immediately if you experience unusual muscle pain or tenderness lasting longer than expected
  • Severe stomach pain (inflammation of the pancreas)
  • Increased liver enzymes in the blood
  • Reduced platelets in the blood, increasing the risk of bleeding or bruising (thrombocytopenia)
  • Lupus-like syndrome (includes skin reaction, joint problems and effects on blood cells).

Very rare (may affect up to 1 in 10,000 people):

  • Jaundice (yellowing of the skin and eyes)
  • Hepatitis (inflamed liver)
  • Blood traces in the urine
  • Nerve damage in arms and legs (e.g. numbness)
  • Joint pain
  • Memory loss
  • Gynaecomastia (breast enlargement in men)

Not known (frequency cannot be estimated from available data)

  • Diarrhoea (loose stools)
  • Cough
  • Shortness of breath
  • Oedema (swelling)
  • Sleep disorders, including insomnia and nightmares
  • Sexual problems
  • Depression
  • Respiratory problems, including persistent cough and/or breathlessness or fever
  • Tendon injury
  • A nerve disorder that may cause weakness, tingling or numbness
  • Persistent muscle weakness
  • Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing)
  • Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or breathlessness.
ACETYLSALICYLIC ACID
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people):

  • Bleeding from the stomach or intestine. After long-term use of acetylsalicylic acid, anaemia (iron deficiency anaemia) may occur due to occult blood loss from the stomach or intestine
  • Gastric or intestinal ulcers, which very rarely may lead to perforation
  • Intracranial bleeding, blood in the urine
  • Gastrointestinal inflammation
  • Skin reactions.

Rare (may affect up to 1 in 1,000 people):

  • Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal system and cardiovascular system, especially in asthmatics. The following may occur: drop in blood pressure, breathing difficulties, nasal mucosa inflammation, 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 concomitant treatment with anticoagulants (blood thinners), which in individual cases may be life-threatening
  • Confusion
  • Headache, dizziness
  • Hearing impairment or ringing in the ears (tinnitus), especially in children and elderly patients, which may be signs of overdose (see also “If you take more ASADROX than you should”).

Very rare (may affect up to 1 in 10,000 people):

  • Increased liver function test values
  • Renal dysfunction and acute renal failure
  • Decreased blood sugar (hypoglycaemia)
  • Low-dose acetylsalicylic acid reduces uric acid excretion. In at-risk patients, this may trigger an attack of gout
  • Skin rash with fever and mucosal involvement (exudative multiform erythema).

Not known (frequency cannot be estimated from available data):

  • Accelerated breakdown or destruction of red blood cells in the blood and a specific form of anaemia (low red blood cell count) in patients with severe glucose-6-phosphate dehydrogenase deficiency
  • In patients with previous intestinal mucosal damage, membranes may form in the intestinal lumen, possibly leading to subsequent narrowing.

If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store ASADROX

Keep this medicine 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 that month.
Store below 30°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ASADROX contains
The active substances are rosuvastatin (as rosuvastatin calcium) and acetylsalicylic acid.
ASADROX 5 mg/100 mg: each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
ASADROX 10 mg/100 mg: each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
ASADROX 20 mg/100 mg: each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

The other components are:
Tablet coated with film containing rosuvastatin:
Tablet core
Monohydrate lactose
Microcrystalline cellulose
Magnesium oxide, heavy
Crospovidone (type A)
Anhydrous colloidal silica
Magnesium stearate

Film coating system
Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Yellow iron oxide (E172)
Lecithin (soy)
Red iron oxide (E172)
Xanthan gum
Black iron oxide (E172)

Tablet with acetylsalicylic acid
Microcrystalline cellulose
Maize starch
Anhydrous colloidal silica
Stearic acid

Capsule shell
Gelatin
Titanium dioxide (E171)
Indigotine (E132)
Yellow iron oxide (E172)

Black ink:
Shellac
Propylene glycol
Strong ammonia solution
Black iron oxide (E172)
Potassium hydroxide

Description of the appearance of ASADROX and contents of the pack
ASADROX 5 mg/100 mg: hard gelatin capsule of size 2 with an opaque white body and dark green opaque cap. Each capsule contains one tablet of acetylsalicylic acid, white to almost white, biconvex, oval, uncoated, and one film-coated tablet, brown, biconvex, round, containing 5 mg of rosuvastatin.
ASADROX 10 mg/100 mg: hard gelatin capsule of size 1 with an opaque white body printed in black with “ASA 100 mg” and a light green opaque cap printed in black with “RSV 10 mg”. Each capsule contains one tablet of acetylsalicylic acid, white to almost white, biconvex, oval, uncoated, and one film-coated tablet, brown, biconvex, round, containing 10 mg of rosuvastatin.
ASADROX 20 mg/100 mg: hard gelatin capsule of size 0 with an opaque white body printed in black with “ASA 100 mg” and an opaque green cap printed in black with “RSV 20 mg”. Each capsule contains one tablet of acetylsalicylic acid, white to almost white, biconvex, oval, uncoated, and two film-coated tablets, brown, biconvex, round, each containing 10 mg of rosuvastatin (total 20 mg).

ASADROX is available in blister packs containing 10, 28, 30, 56, 60, 90, 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed S.r.l., Via G. Mazzini 20, 20123 Milano, Italy

Manufacturers
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland
IASIS PHARMACEUTICALS HELLAS ABEE
Filis Ave 137
134 51 Kamatero Attiki
Greece
BELUPO Inc.
Ulica Danica 5
48000 Koprivnica
Republic of Croatia

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria: RosuASS 5 mg/100 mg Hartkapseln
RosuASS 10 mg/100 mg Hartkapseln
RosuASS 20 mg/100 mg Hartkapseln
Bulgaria: Розувастатин/Ацетилсалицилова киселина Adamed
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: RosuASS APONTIS
Italy: ASADROX
Poland: Zahron ASA
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: Roasax 5 mg/100 mg cápsulas duras
Roasax 10 mg/100 mg cápsulas duras
Roasax 20 mg/100 mg cápsulas duras
Greece: ROSU-ASA
Cyprus: ROSU-ASA