ASADROX 5 mg/100 mg Hard Capsule

Содержание инструкции

1. ASADROX 5 mg/100 mg hard capsules, 10 mg/100 mg hard capsules, 20 mg/100 mg hard capsules
   1. What is ASADROX and what is it used for
   2. What you need to know before taking ASADROX
   3. How to take ASADROX
   4. How to store ASADROX
   5. Package contents and other information

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

Rosuvastatin/Acetylsalicylic acid

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is ASADROX and what is it 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 the 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 can also be used to reduce that risk, even if your cholesterol levels are normal. During treatment you should continue to follow a standard diet to lower cholesterol.
• Low-dose acetylsalicylic acid belongs to a group of medicines called antiplatelet agents. Platelets are tiny blood cells that cause blood to clot and are involved in thrombosis. When a clot forms in an artery, it blocks blood flow and interrupts the supply of oxygen. When this happens 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 had one previously or if you suffer from attacks of chest pain (unstable angina pectoris). ASADROX is indicated in patients who are already taking rosuvastatin and acetylsalicylic acid at these dosages. Instead of taking rosuvastatin and acetylsalicylic acid separately, you will receive an ASADROX capsule 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, to any other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other components of this

medicinal product (listed in section 6);

• if you are allergic to peanuts or soy (see below);
• if you are pregnant or breastfeeding. If you become pregnant while taking ASADROX, stop taking it immediately and contact your doctor. Women must avoid pregnancy during treatment with ASADROX using appropriate contraceptive measures;
• if you have a 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 sofosbuvir/velpatasvir/voxilaprevir medicines (used for a viral liver infection called hepatitis C);
• if you are taking a medicine called cyclosporine (used, for example, after organ transplantation);
• if you have had an asthma attack, or swelling of some parts of the body, such as the face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs;
• if you currently suffer from or have suffered in the past from stomach or small intestine ulcers or any other type of bleeding, such as a stroke;
• if you have ever had a problem with your blood not clotting properly;
• if you suffer from gout;
• if you suffer from decompensated heart failure;
• if you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses greater than 15 mg per week;
• if you have ever developed a severe skin rash or peeling of the skin, blisters and/or ulcers in the mouth after taking rosuvastatin or other 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 problems, or if you have had a previous history of muscle problems while taking other medicines that lower cholesterol. Tell your doctor immediately if you have unexplained muscle aches or pains, especially if you do not feel well or have a fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness;
• if you regularly consume significant amounts of alcohol;
• if your thyroid is not functioning properly;
• if you are taking other medicines called fibrates to lower cholesterol. Read carefully

cholesterol;

• if you are taking medicines used to fight HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, see section “Other medicines and ASADROX”;
• if you are taking or have taken in the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and ASADROX can lead to serious muscle problems (rhabdomyolysis). See section “Other medicines and ASADROX”;
• It is possible that the risk of undesirable effects on the muscles may be greater when daptomycin is taken during treatment with ASADROX. Your doctor may decide not to prescribe daptomycin or to stop the use of ASADROX for a certain period of time;
• if you have severe respiratory failure;
• if you are over 70 years of age;
• if you are of Asian origin (i.e. Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor must choose the correct starting dose of ASADROX suitable for you;
• if you have or have had problems with your stomach or small intestine (ulcers or gastrointestinal bleeding);
• if you are taking non-steroidal anti-inflammatory drugs (NSAIDs) at the same time, such as ibuprofen and naproxen (medicines for pain, fever or inflammation);
• if you suffer from high blood pressure;
• if you are asthmatic, suffer from hay fever, have nasal polyps or other chronic respiratory diseases; acetylsalicylic acid can cause an asthma attack;
• in case of hypersensitivity (allergy) to other pain or anti-inflammatory medicines, or other medicines for rheumatism or other factors that can cause allergies;
• if you have other allergies (e.g. with skin reactions, itching);
• if you are taking other medicines called anticoagulants (e.g. coumarin derivatives, heparin - except for treatment with low-dose heparin);
• with impaired kidney function or reduced blood flow to the heart or blood vessels (e.g. kidney vascular disease, weak heart muscle, reduced blood volume, major surgery, blood poisoning or increased bleeding): acetylsalicylic acid can further increase the risk of kidney dysfunction and acute renal failure;
• if you have heavy menstrual periods;
• 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 that causes weakness of the eye muscles), as statins can sometimes worsen myasthenia or cause it to occur (see section 4).

You should seek immediate medical advice if your symptoms worsen or if serious
or unexpected side effects occur, e.g. unusual signs of bleeding, severe skin reactions or
any other sign of a serious allergy (see section “Possible side effects”).
Metamizole (a substance to reduce pain and fever) can reduce the effect of acetylsalicylic acid on
platelet aggregation (blood cells that adhere to each other and
form a blood clot), if taken at the same time. Therefore, this combination
should be used with caution in patients taking aspirin at low doses for the
In a small number of people, statins can alter liver function. This is
detected with a simple test that allows monitoring of increased levels of liver enzymes
in the blood. 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 check if you have diabetes or are at
risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugars and fats
in your blood, are overweight and have high blood pressure.
You should be careful not to become dehydrated (you may feel thirsty with a dry mouth) because
the simultaneous use of acetylsalicylic acid can worsen kidney function.
Tell your doctor if you are planning to undergo surgery (even minor, such as
a tooth extraction) as acetylsalicylic acid thins the blood and there may be an increase in
the risk of bleeding.
Acetylsalicylic acid can cause Reye's syndrome when given to children. The
Reye's syndrome is a very rare disease that affects the brain and liver and can be life-threatening.
For this reason, ASADROX should not be given to children and adolescents with
less than 18 years of age.
In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid can cause
destruction or accelerated destruction of red blood cells or a certain type of anemia. This risk
may be caused by factors such as high dosage; fever or acute infections may increase.
Acetylsalicylic acid at low doses reduces the excretion of uric acid. This can trigger
an attack of gout in patients at risk.
If you cut or produce a lesion, bleeding may take a little longer to stop.
This depends on the effect of acetylsalicylic acid. Small cuts or lesions (e.g. during shaving)
usually do not matter. If unusual bleeding occurs (in an unusual place or of
unusual duration), contact your doctor.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with treatment with rosuvastatin.
Stop using 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 of time or at
high doses without consulting a doctor.

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

Other medicines and ASADROX
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
ASADROX can influence or be influenced by other medicines such as:

• fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe);
• remedies for indigestion (used to neutralize stomach acid);
• an oral contraceptive (the pill);
• hormone replacement therapy;
• fostamatinib (used for the treatment of low platelet count);
• febuxostat (used for the treatment and prevention of high levels of uric acid in the blood);
• teriflunomide (used for the treatment of multiple sclerosis);
• regorafenib (used for the treatment of tumors);
• darolutamide (used for the treatment of tumors);
• capmatinib (used for the treatment of tumors);
• one of the following medicines used for the treatment of 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 anemia 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 thinning/prevention of blood clots (e.g. warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid can increase the risk of bleeding if taken before removal of a clot or blood thinning treatment; therefore, if you are to undergo such treatment, you should be careful of signs of external or internal bleeding (e.g. bruising);
• organ rejection after transplantation (cyclosporine, tacrolimus);
• high blood pressure (e.g. diuretics and ACE inhibitors);
• regulation of heart rate (digoxin);
• treatment of manic-depressive illness (lithium);
• anti-inflammatory and pain medicines (non-steroidal analgesics/anti-inflammatory drugs) and rheumatic medicines containing salicylic acid: increased risk of bleeding and ulcers in the gastrointestinal tract);
• gout (probenecid, benzbromarone);
• glaucoma (acetazolamide);
• cancer or rheumatoid arthritis (methotrexate at doses less than 15 mg/week);
• medicines to lower blood sugar (antidiabetics) such as e.g. insulin, tolbutamide, glibenclamide (so-called sulfonylureas) in combination with acetylsalicylic acid in higher doses - the blood sugar level may decrease;
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline and

paroxetine);

• use of hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed or removed (except for medicines applied to the skin or cortisone replacement therapy for Addison's disease), or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids). Concurrent use increases the risk of gastrointestinal side effects;
• seizures (valproic acid);
• medicines that cause increased urinary excretion (diuretics: so-called aldosterone antagonists, such as spironolactone and canrenonate, 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 tell you when it is safe to start
taking ASADROX again. Taking ASADROX with fusidic acid can rarely cause
weakness, soreness or muscle pain (rhabdomyolysis). For more information on
rhabdomyolysis see section 4.

ASADROX with food and drink
Drinking alcohol may possibly 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 while taking ASADROX, stop taking it immediately and
inform your doctor.
Women must avoid becoming pregnant during treatment with ASADROX
by using adequate contraception.

Driving and operating machinery
Most people can drive vehicles and use machines during treatment with
ASADROX as it does not affect their abilities.
However, some people may experience dizziness during treatment with ASADROX.
If the capsules cause you to feel unwell, dizzy or tired, or give you a headache, do not drive
vehicles or use machines and contact your doctor immediately.

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

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

3. How to take ASADROX

Take this medicine always exactly as your doctor or pharmacist has told you.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist

Adults
The doctor will decide the appropriate dosage for you, according to your conditions, the ongoing treatment and your
personal risk level.
This medicine is not suitable for initial treatment. The start of treatment should only occur
with the administration of the two active substances separately and after defining the appropriate doses
it is possible to switch to the adequate dosage of ASADROX.
The recommended dose is one capsule per day.
This medicine must be taken with food. You must take the medicine every day at the
same time. The capsules must be swallowed with plenty of liquid and must not be broken or
chewed.
If you go to hospital or receive care for another condition, inform the medical staff that you are
taking ASADROX.

Use in elderly patients
It is not necessary to modify the dose in elderly patients.

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

Patients with renal impairment
It is not necessary to modify the dose if you suffer from 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.

If you forget to take ASADROX
Do not worry. If you forget to take a capsule, completely skip that dose. Take the next dose
at the right time. Do not take a double dose to make up for the forgotten capsule.

If you stop taking ASADROX
The doctor will advise you how long you should take the medicine. Your cholesterol levels
may increase again if you stop taking ASADROX. Your condition may
reappear if you stop treatment with the medicine before you are told to do so.

• 4. Possible side effectsLike all medicines, this medicine can cause side effects, although not everyone gets them.

Stop taking ASADROX and consult your doctor immediatelyif you experience any of the
following very rare and serious side effects after taking this medicine.

• Sudden shortness of breath, chest pain, wheezing or difficulty breathing;
• Swelling of the eyelids, face or lips;
• Swelling of the tongue and throat causing great difficulty in breathing and/or swallowing;
• Severe skin reactions including severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome) or other allergic reactions;
• If black stools or vomiting with blood appear (sign of severe bleeding in the stomach);
• Reddish, non-raised, target-shaped or circular patches on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome);
• Widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop taking ASADROX and contact your doctor immediately

• if you have any unusual muscle soreness or painthat lasts longer than you would expect. As with other statins, a very small number of people have experienced unpleasant muscle effects that rarely progressed to a

life-threatening muscle damage known as rhabdomyolysis.

• If a muscle breaks down;
• If you have a lupus-like syndrome(including skin rash, joint disorders and effects on blood cells). The following side effectshave been reported. If any of these cause you problems or if they persist for more than a week, you should 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 blood sugar and fat levels, 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
• An increase in the amount of protein in the urine - values usually return to normal spontaneously without having to stop taking ASADROX (only 5-20 mg dosages).

Rare(may affect up to 1 in 1000 people):

• Severe allergic reaction - signs include swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with raised bumps). If you think you are having an allergic reaction, stop takingASADROXand seek immediate medical help.
• Muscle damage in adults - as a precaution, stop taking ASADROXand see your doctor immediately if you have unusual muscle soreness or painthat lasts longer than expected
• Severe stomach pain (inflammation of the pancreas)
• Increased liver enzymes in the blood
• Reduced platelets in the blood, which increases the risk of bleeding or bruising (thrombocytopenia)
• Lupus-like syndrome (includes skin reaction, joint disorders 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)
• Traces of blood in the urine
• Nerve damage in the legs and arms (such as numbness)
• Joint pain
• Memory loss
• Gynecomastia (breast enlargement in men)

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

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

Contact your doctor if you experience weakness in your arms or legs that worsens after periods of
activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
ACETYLSALICYLIC ACID

Common(may affect up to 1 in 10 people)

• Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain and diarrhea
• Minor blood loss from the gastrointestinal tract (micro-bleeding)
• Bleeding, e.g. nosebleeds, bleeding gums, skin bleeding or bleeding from the urinary tract and reproductive organs with possible increased bleeding time. This effect can persist for 4 to 8 days after taking it.

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

• Bleeding from the stomach or intestines. After long-term use of acetylsalicylic acid, anemia (iron deficiency anemia) may occur due to occult blood loss from the stomach or intestines
• Gastric or intestinal ulcers, which very rarely can 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 of the skin, respiratory tract, gastrointestinal tract and cardiovascular system, especially in asthmatics. The following manifestations may occur: lowering of blood pressure, attacks of shortness of breath, inflammation of the nasal mucosa, nasal congestion, anaphylactic shock, swelling of the face, tongue and larynx (Quincke's edema)
• Severe bleeding, such as brain bleeding, especially in patients with uncontrolled hypertension and/or concomitant treatment with anticoagulants (blood-thinning medications), which in individual cases can be life-threatening
• Confusion
• Headache, dizziness
• Impaired hearing or ringing in the ears (tinnitus), especially in children and the elderly, which may be signs of an overdose (see also “If you take more ASADROX than you should”).

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

• Increases in liver function values
• Kidney dysfunction and acute renal failure
• Decreased blood sugar (hypoglycemia)
• Acetylsalicylic acid at low doses reduces the excretion of uric acid. This can trigger a gout attack in patients at risk
• Skin rash with fever with involvement of the mucous membranes (exudative multiforme erythema).

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

• Accelerated degradation or decay of red blood cells in the blood and a specific form of anemia (low number of red blood cells) in patients with severe glucose-6-phosphate dehydrogenase deficiency
• In case of previous damage to the intestinal mucosa, membranes can form in the intestinal cavity with possible subsequent narrowing.

If any of the side effects worsen, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can 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 that is stated on the packaging after Exp. The
expiry date refers to the last day of that month.
Store at a temperature below 30°C. Store in the original packaging to protect the
medicine from moisture.
Do not dispose of any medicine in 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 salt) 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 ingredients are:

Film-coated tablet with rosuvastatin:
Tablet core
Lactose monohydrate
Microcrystalline cellulose
Magnesium oxide, heavy
Croscarmellose sodium (type A)
Anhydrous colloidal silica
Magnesium stearate
Film coating system
Polyvinyl alcohol
Titanium dioxide (E171)
Talc
Yellow iron oxide (E172)
Lecithin (soybean)
Red iron oxide (E 172)
Xanthan gum
Black iron oxide (E 172)

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

Capsule shell
Gelatin
Titanium dioxide (E171)
Indigo carmine (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: size 2 opaque white body and opaque dark green cap hard gelatin capsule.
Each capsule contains a white to almost white, biconvex, oval, uncoated acetylsalicylic acid tablet and a
brown, biconvex, round, film-coated rosuvastatin 5 mg tablet.
ASADROX 10 mg/100 mg: size 1 hard gelatin capsule with opaque white body printed with black “ASA 100 mg”
and opaque light green cap printed with black “RSV 10 mg”. Each capsule contains a white to almost white,
biconvex, oval, uncoated acetylsalicylic acid tablet and a brown, biconvex, round, film-coated rosuvastatin 10 mg tablet.
ASADROX 20 mg/100 mg: size 0 hard gelatin capsule with opaque white body printed with black “ASA 100 mg”
and opaque green cap printed with black “RSV 20 mg”. Each capsule contains a white to almost white,
biconvex, oval, uncoated acetylsalicylic acid tablet and two brown, biconvex, round, film-coated rosuvastatin 10 mg tablets.
ASADROX is available in blisters containing 10, 28, 30, 56, 60, 90, 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Adamed S.r.l., Via G. Mazzini 20, 20123 Milan, Italy

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
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