Package Insert: Information for the User

Roasax 5 mg/100 mg Hard Capsules

rosuvastatina/acid acetilsalicilic

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Roasax contains two active principles rosuvastatina and acetylsalicylic acid.

• Rosuvastatina belongs to a group of medications called statins, which are medications that regulate lipids (fats) used to reduce lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes on their own have failed. Cholesterol is a fatty substance (lipids) that can cause the narrowing of blood vessels in the heart and cause heart disease. If you are at risk of suffering another heart attack, rosuvastatina can also be used to reduce this risk, even if your cholesterol levels are normal. You must maintain a diet to reduce cholesterol during treatment.
• Acetylsalicylic acid, at low doses, belongs to the group of medications called antiplatelet agents. Platelets are tiny cells in the blood that cause the blood to clot and are involved in thrombosis. When a blood clot forms in an artery, it stops blood flow and cuts off oxygen supply. 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 previously had a heart attack or if you suffer from unstable chest pain (angina pectoris).Roasaxis indicated in patients who are already taking rosuvastatina and acetylsalicylic acid at these doses. Instead of taking rosuvastatina and acetylsalicylic acid in separate tablets, you will receive a capsule ofRoasaxthat contains both ingredients with the same dose as before.

Do not take Roasax

• If you are allergic to rosuvastatin, acetylsalicylic acid or any other salicylate or nonsteroidal anti-inflammatory drugs (NSAIDs) or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding or if you become pregnant while taking Roasax, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with Roasax using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unjustified muscle pain and cramps.
• If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir medications (used to treat a viral liver infection called hepatitis C).
• If you are taking a medication called ciclosporin (used, for example, after an organ transplant).
• If you have had an asthma attack or inflammation of some parts of the body, such as the face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs.
• If you currently have or have had a stomach or intestinal ulcer or any other type of bleeding, such as a cerebral hemorrhage.
• If you have bleeding disorders.
• If you have gout.
• If you have uncompensated heart failure.
• If you are taking a medication called metotrexato (for example, for cancer or rheumatoid arthritis) in doses higher than 15 mg per week.
• If you have ever developed a severe skin rash or skin peeling, blisters, and/or mouth sores after taking Roasax or other related medications.
• This medication contains soy lecithin. It should not be used in case of an allergy to peanuts or soy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Roasax:

• If you have kidney problems.
• If you have liver problems.
• If you have repeated or unjustified muscle pain and cramps, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medications. Inform your doctor immediately if you have unjustified muscle pain or cramps, especially if you have general discomfort or fever. Also inform your doctor or pharmacist if you have constant muscle weakness.
• If you regularly consume large amounts of alcohol.
• If your thyroid gland does not function correctly.
• If you are taking other medications called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medications previously.
• If you are taking medications to treat HIV (HIV virus) infections, such as ritonavir with lopinavir and/or atazanavir. See "Other medications and Roasax".
• If you are taking or have taken within the last 7 days a medication called ácido fusídico (an antibiotic), orally or by injection. Taking Roasax with ácido fusídico may cause severe muscle problems (rabdomiólisis), please see "Other medications and Roasax".
• The risk of muscle-related adverse effects may be higher when daptomycin is taken during treatment with Roasax. Your doctor may decide not to administer daptomycin or to stop taking Roasax for a while.
• If you have severe respiratory failure.
• If you are over 70 years old.
• If you are of Asian origin (for example, Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should establish the appropriate starting dose of Roasax for you.
• If you have or have had stomach or intestinal problems (ulcers or gastrointestinal bleeding).
• If you are taking anti-inflammatory nonsteroidal medications, such as ibuprofen and naproxen (pain, fever, or inflammation medications).
• If you have high blood pressure.
• If you are asthmatic, have hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may cause an asthma attack.
• In case of hypersensitivity (allergy) to other pain and anti-inflammatory medications, other rheumatism medications, or other factors that cause allergy.
• If you have other allergies (for example, skin reactions, itching).
• If you are taking other medications called anticoagulants (for example, derivatives of coumarin, heparin, except for low-dose heparin).
• With renal insufficiency or reduced cardiac and vascular blood flow (for example, renal vascular disease, cardiac muscle weakness, reduced blood volume, major surgery, poisoning, or increased bleeding): acetylsalicylic acid may further increase the risk of renal dysfunction and acute renal failure.
• If you have heavy menstrual periods.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes eye muscle weakness), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

You should see your doctor immediately if your symptoms worsen or if you experience severe or unexpected side effects, for example, unusual bleeding symptoms, severe skin reactions, or any other sign of severe allergy (see section "Possible side effects").

Metamizol (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells stick together and form a blood clot), when taken concomitantly. Therefore, this combination should be used with caution in patients taking aspirin in low doses for cardioprotection.

In a reduced number of people, statins may affect the liver. This is detected by a simple test that detects increased levels of liver enzymes in the blood. For this reason, your doctor will usually perform blood tests (liver function test) before and after treatment with Roasax.

While taking this medication, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You may be at risk of developing diabetes if you have high blood sugar and lipid levels, are overweight, and have high blood pressure.

You should be careful not to become dehydrated (you may feel thirsty with a dry mouth), as the use of acetylsalicylic acid at the same time may cause deterioration of renal function.

Inform your doctor if you are planning to undergo surgery (even a small one, such as tooth extraction), as acetylsalicylic acid thins the blood, increasing the risk of bleeding.

Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a rare disease that affects the brain and liver and can be potentially fatal. For this reason, Roasax should not be administered to children and adolescents under 18 years old.

In patients with severe glucose-6-phosphate dehydrogenase deficiency: acetylsalicylic acid may cause rapid collapse or red blood cell collapse or a certain type of anemia. This risk may be caused by factors such as high doses, fever, or acute infections that may increase.

Acetylsalicylic acid reduces uric acid excretion in low doses. This may trigger a gout attack in patients at risk.

If you cut or injure yourself, bleeding may be slightly longer than usual. This is related to the effect of acetylsalicylic acid. Small cuts and injuries (for example, when shaving) are usually not significant. If you have unusual bleeding (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 associated with rosuvastatin treatment. Stop using Roasax and seek medical attention immediately if you notice any of the symptoms described in section 4.

Medications containing acetylsalicylic acid should not be taken for prolonged periods or in high doses without consulting a doctor.

Children and adolescents

Roasax should not be used in children and adolescents.

Other medications and Roasax

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Roasax may affect or be affected by other medications such as:

• fibrates (such as gemfibrozil, fenofibrate) or any other medication used to lower cholesterol (such as ezetimiba).
• medications for indigestion (used to neutralize stomach acid).
• oral contraceptives (the pill).
• hormone replacement therapy.
• fostamatinib (used to treat low platelet counts)
• febuxostat (used to treat and prevent high levels of uric acid in the blood)
• teriflunomida (used in the treatment of multiple sclerosis).
• regorafenib (used to treat cancer).
• darolutamida (used to treat cancer).
• capmatinib (used to treat cancer).
• any other medication used to treat viral infections, including HIV or hepatitis C, alone or in combination (please see “Warnings and Precautions”): ritonavir, lopinavir, atazanavir,sofosbuvir, voxilaprevir,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).
• itraconazol (antifungals).
• erythromycin, clarithromycin (antibiotics).
• anticoagulants/prevention of blood clots (for example, warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidina): 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, you should pay attention to signs of external or internal bleeding (for example, hematomas).
• organ rejection after transplantation (ciclosporina, tacrolimus).
• high blood pressure (for example, diuretics and ACE inhibitors).
• heart rhythm control (digoxina).
• manic-depressive disease (litio).
• Analgesics and anti-inflammatory medications (nonsteroidal anti-inflammatory drugs / anti-inflammatory medications) and rheumatism medications that contain salicylic acid: increased risk of bleeding and ulcers in the gastrointestinal tract.
• gout (for example, probenecid, benzbromarona).
• glaucoma (acetazolamida).
• cancer or rheumatoid arthritis (metotrexato; in doses less than 15 mg per week).
• medications to reduce blood sugar (antidiabetic medications)such as insulin, tolbutamide,glibenclamide (the so-called sulfonylureas) in combination with acetylsalicylic acid in higher doses, blood sugar levels may drop.
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine).
• use as hormone replacement therapy when the adrenal glands or the pituitary gland have been destroyed or removed (except for products applied to the skin or corticosteroid replacement therapy for Addison's disease), or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids). Concomitant use increases the risk of gastrointestinal side effects.
• seizures of the brain [epilepsy] (valproic acid).
• medications that cause increased urine excretion (diuretics: the so-called aldosterone antagonists such as spironolactone and canrenone, diuretics of the loop, for example, furosemide).
• alcohol: increased risk of gastrointestinal ulcers and bleeding.

If you need to take ácido fusídico orally to treat a bacterial infection, you should temporarily stop using Roasax. Your doctor will indicate when it is safe to resume taking this medication. Taking Roasax with ácido fusídico rarely may cause muscle weakness, sensitivity, or pain (rabdomiólisis). See more information about rabdomiólisis in section 4.

Taking Roasax with food and drinks

Drinking alcohol may increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding

Do not take Roasax if you are pregnant or breastfeeding. If you become pregnant while taking Roasax, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medication using an appropriate contraceptive method.

Driving and operating machinery

Most patients can drive vehicles and use machinery during treatment with Roasax as it will not affect their ability. However, some people may feel dizzy during treatment with this medication. If you feel sick, dizzy, or tired, or have a headache, do not drive or use machinery and consult your doctor immediately.

Roasax contains lactose

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

Roasax contains soy oil

This medication contains soy oil. It should not be used in case of an allergy to peanuts or soy.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

Your doctor will establish the most suitable dose for you, depending on your condition, current treatment, and personal risk.

This medication is not suitable for starting treatment. Treatment initiation should only be done by administering the active principles separately and after adjusting the appropriate doses, it will be possible to switch toRoasaxat the appropriate concentration.

The recommended dose is one capsule per day.

This medication should be taken with food. You should take your medication at the same time every day. Capsules should be swallowed with plenty of liquid and should not be crushed or chewed.

If you are admitted to a hospital or receive treatment for another condition, inform the medical staff that you are takingRoasax.

Older patients

No dose adjustment is necessary for older patients.

Children and adolescents

Roasaxshould not be used in children and adolescents.

Patients with renal insufficiency

No dose adjustment is necessary if you have mild or moderate renal insufficiency.

The use of Roasax in patients with severe renal insufficiency is contraindicated.

Patients with hepatic insufficiency

The use of Roasax in patients with severe hepatic insufficiency is contraindicated.

If you take more Roasax than you should

Contact your doctor or nearest hospital for advice. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Roasax

Do not worry. If you forget to take a capsule, omit that dose completely. Take the next scheduled dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Roasax

Your doctor will advise you for how long you should take your medication. Your cholesterol levels may increase again if you stop taking Roasax. Your condition may recur if you stop using your medication before it is indicated.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Stop taking Roasax and see your doctorimmediatelyif you experience any of the following rare and serious side effects after taking this medicine.

• Abrupt onset of wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes severe difficulty breathing and/or swallowing.
• Severe skin reactions, such as intense skin rash, urticaria, skin redness all over the body, intense itching, blisters, peeling, and skin swelling, Stevens-Johnson syndrome, or other allergic reactions.
• If you experience black stools or vomiting with blood (signs of severe stomach bleeding).
• Reddish patches on the trunk, often with blisters, peeling skin, mouth, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Also, stop takingRoasaxand talk to your doctor immediately

• If you have unexplained muscle pain or crampsthat last longer than expected. Like other statins, a very small number of people have experienced unpleasant muscle side effects and, rarely, potentially fatal muscle damage known as rhabdomyolysis.
• If you experience muscle rupture..
• If you have lupus or a similar disease(including skin rash, joint disorders, and effects on blood cells).

The followingside effects have been reported. If any of these cause you problems or ifthey last more than a week, you shouldcontact your doctor.

ROSUVASTATINA

Common(can affect up to 1 in 10 people):

• Headache.
• Stomach pain.
• Constipation.
• Nausea.
• Muscle pain.
• Feeling weak.
• Dizziness.
• Diabetes. This is more likely if you 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(can affect up to 1 in 100 people):

• Hives, itching, urticaria, or other skin reactions.
• An increase in the amount of protein in the urine: this usually returns to normal on its own without the need to interrupt treatment with Roasax capsules (only doses of 5 to 20 mg).

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

• Severe allergic reaction – symptoms include swelling of the face, lips, tongue, and/or throat, difficulty swallowing and breathing, intense skin itching (with rashes).If you think you are having an allergic reaction, stop taking Roasaxand seek medical attention immediately.
• Adult muscle injury – as a precaution, stop takingRoasax and consult your doctor immediately if you have unexplained muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in the blood.
• Reduced platelet count, increasing the risk of bleeding or bruising (thrombocytopenia).
• Lupus or similar disease (including skin rash, joint disorders, and effects on blood cells).

Very rare(can 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 (with numbness or tingling).
• Joint pain.
• Memory loss.
• Gynecomastia (enlargement of breast tissue in men).

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

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Edema (swelling).
• Sleep disturbances, including insomnia and nightmares.
• Sexual difficulties.
• Depression.
• Respiratory problems, including persistent cough and/or shortness of breath or fever.
• Tendon damage.
• Nerve disorder that can cause weakness, numbness, or tingling.
• Constant muscle weakness.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).

See your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

ACID ACETILSALICILICO

Common(can affect up to 1 in 10 people):

• Gastrointestinal disorders such as heartburn, nausea, vomiting, abdominal pain, and diarrhea.
• Minor bleeding from the gastrointestinal tract (micro-bleeding)
• Bleeding such as nosebleeds, bleeding gums, skin bleeding, or bleeding from the urinary tract and genital organs, with a possible extension of the bleeding time. This effect can last from 4 to 8 days after ingestion.

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

• Bleeding from the stomach or intestines. After long-term use of aspirin, anemia (anemia due to iron deficiency) may occur due to occult bleeding from the stomach or intestines.
• Subdural hematoma, blood in the urine.
• Stomach or intestinal ulcers, which very rarely may cause perforation.
• Gastrointestinal inflammation.
• Skin reactions.

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

• Severe skin hypersensitivity reactions, respiratory tract, gastrointestinal tract, and cardiovascular system, especially in asthmatics. The following characteristics of the disease may be present: hypotension, dyspnea, nasal mucosa inflammation, nasal congestion, anaphylactic shock, facial swelling, tongue, and laryngeal edema (Quincke's edema).
• Severe bleeding, such as cerebral hemorrhage, especially in patients with uncontrolled high blood pressure and/or concomitant anticoagulant treatment (anticoagulant medications), which may be potentially fatal in individual cases.
• Confusion.
• Headache, dizziness.
• Disability or tinnitus in the ears, especially in children and the elderly, which may be signs of an overdose (see also the section "If you take moreRoasaxthan you should").

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

• Increases in liver function tests.
• Renal dysfunction and acute renal failure.
• Low blood sugar (hypoglycemia).
• Aspirin reduces the excretion of uric acid at low doses. This may trigger a gout attack in patients at risk.
• Febrile eruptions with mucous membrane involvement (erythema multiforme).

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

-Accelerated degradation or decomposition of red blood cells and a specific form of anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.

- In the case of previous mucosal damage, membranes may form in the intestinal cavity with possible subsequent narrowing.

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C. Store in the original packaging protected from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Roasax

The active principles are rosuvastatina (as rosuvastatina calcium) and acetic acid salicylic.

Roasax 5 mg/100 mg: each hard capsule contains 5 mg of rosuvastatina (as rosuvastatina calcium) and 100 mg of acetic acid salicylic.

The other components are:

Coated tablet with rosuvastatina:

Core

Lactose monohydrate

Microcrystalline cellulose

Heavy magnesium oxide

Crospovidone (type A)

Anhydrous colloidal silica

Magnesium stearate

Covering

Polivinyl alcohol

Titanium dioxide (E171)

Talc

Yellow iron oxide (E172)

Soy lecithin

Red iron oxide (E172)

Xanthan gum

Black iron oxide (E172)

Tablet with acetic acid salicylic:

Microcrystalline cellulose

Maize starch

Anhydrous colloidal silica

Stearic acid

Capsule coating:

Gelatin

Titanium dioxide (E171)

Indigotin (E132)

Yellow iron oxide (E172)

Black ink:

Shellac

Propylene glycol

Strong ammonia solution

Black iron oxide (E172)

Potassium hydroxide

Appearance of the product and contents of the package

Roasax 5 mg/100 mg: hard gelatin capsules of size 2 and opaque white body and opaque dark green cap. Each capsule contains a white or almost white, biconvex, oval-shaped, uncoated tablet of acetic acid salicylic and a brown, biconvex, round, coated tablet with 5 mg of rosuvastatina.

Roasax is presented in blisters containing 10, 28, 30, 56, 60, 90 and 100 hard capsules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31

2nd floor

28023 - Madrid

Manufacturer responsible

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

or

IASIS PHARMACEUTICALS HELLAS S.A.

137 Filis Ave., Kamatero

13451 Athens

Greece

or

BELUPO D.D.

Ulica Danica 5

48000 Koprivnica

Republic of Croatia

or

Genericon Pharma Gesellschaft m.b.H.

Hafnerstrasse 211, 8054 Graz

Austria

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Poland: Rosuvastatin+Acetylsalicylic acid Adamed

Austria: RosuASS 5 mg/100 mg Hartkapseln

Bulgaria: ????????????/???????????????? ???????? Adamed

Spain: Roasax 5 mg/100 mg hard capsules

Germany: RosuASS APONTIS, 5 mg/100 mg Hartkapseln

Cyprus: ROSU-ASA

Greece: ROSU-ASA

Croatia: ROSIX DUO 5 mg/100 mg tvrde kapsule

Slovenia: BELOROSTIN 5 mg/100 mg trde kapsule

Portugal: ESTASP

Italy: ASADROX

Last review date of this leaflet: April 2025

The detailed and updated information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es