ROASAX 20 MG/100 MG HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Roasax 20 mg/100 mg hard capsules

rosuvastatin/acetylsalicylic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Roasax and what is it used for

Roasax contains two active substances, rosuvastatin and acetylsalicylic acid.

• Rosuvastatin belongs to a group of medicines called statins, which are used to lower lipid levels (fats) in the blood when a low-fat diet and lifestyle changes on their own have not worked. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels in the heart, leading to heart disease. If you are at risk of having another heart attack, rosuvastatin can also be used to reduce this risk, even if your cholesterol levels are normal. You should keep to a cholesterol-lowering diet while taking Roasax.
• Acetylsalicylic acid, at low doses, belongs to a group of medicines called antiplatelet agents. Platelets are tiny cells in the blood that help the blood to clot and are involved in the formation of blood clots. When a blood clot forms in an artery, it can stop the flow of blood and cut off 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 previously had a heart attack or if you suffer from unstable angina (chest pain). Roasax is indicated in patients who are already taking rosuvastatin and acetylsalicylic acid at these doses. Instead of taking rosuvastatin and acetylsalicylic acid as separate tablets, you will receive one Roasax capsule that contains both ingredients at the same dose as before.

2. What you need to know before you take Roasax

Do not take Roasax

• If you are allergic to rosuvastatin, acetylsalicylic acid, or any other salicylate or non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breast-feeding, 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 by using appropriate contraceptive measures.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle pain or weakness.
• If you are taking a combination of medicines called sofosbuvir/velpatasvir/voxilaprevir (used for hepatitis C virus infection).
• If you are taking a medicine called ciclosporin (used, for example, after an organ transplant).
• If you have had an asthma attack or inflammation of some parts of the body, e.g. face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs.
• If you currently have or have had stomach or duodenal ulcers or any other type of bleeding, such as a stroke.
• If you have bleeding disorders.
• If you have gout.
• If you have uncontrolled heart failure.
• If you are taking a medicine called methotrexate (for example, for cancer or rheumatoid arthritis) at doses higher than 15 mg per week.
• If you have ever developed a severe skin rash or peeling and/or sores in the mouth after taking Roasax or other related medicines.
• This medicine contains soya lecithin. Do not use if you are allergic to peanuts or soya.

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 unexplained muscle pain or weakness, a personal or family history of muscle problems, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Tell your doctor immediately if you have unexplained muscle pain or weakness, especially if you feel unwell or have a fever. Also, tell your doctor or pharmacist if you have persistent muscle weakness.
• If you regularly drink large amounts of alcohol.
• If your thyroid gland does not work properly.
• If you are taking other medicines called fibrates to lower cholesterol. Read this leaflet carefully, even if you have taken cholesterol-lowering medicines before.
• If you are taking medicines to treat HIV infection, such as ritonavir with lopinavir and/or atazanavir. See "Other medicines and Roasax".
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic), by mouth or by injection. Taking Roasax with fusidic acid can cause serious muscle problems (rhabdomyolysis), please see "Other medicines and Roasax".
• The risk of side effects that affect the muscles may be greater when daptomycin is taken during treatment with Roasax. Your doctor may decide not to give you 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 (e.g. Japanese, Chinese, Filipino, Vietnamese, Korean, or Indian). Your doctor should determine the starting dose of Roasax that is right for you.
• If you have or have had stomach or duodenal problems (ulcers or gastrointestinal bleeding).
• If you have high blood pressure.
• If you have asthma, 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 medicines, other medicines for rheumatism, or other factors that cause allergy.
• If there are other allergies (e.g. skin reactions, itching).
• If you are taking other medicines called anticoagulants (e.g. coumarin derivatives, heparin, with the exception of treatment with low-dose heparin).
• With renal insufficiency or reduced cardiac and vascular blood flow (e.g. kidney vascular disease, cardiac muscle weakness, reduced blood volume, major surgery, blood 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 general muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia to appear (see section 4).

You should go to your doctor immediately if your symptoms worsen or if you experience serious or unexpected side effects, e.g. unusual bleeding symptoms, severe skin reactions, or any other sign of severe allergy (see "Possible side effects").

Metamizole (a substance used 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 together. Therefore, this combination should be used with caution in patients taking aspirin in low doses for cardioprotection.

In a small 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 normally do blood tests (liver function test) before and after treatment with Roasax.

While you are taking this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of glucose and lipids 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), as taking acetylsalicylic acid at the same time may cause kidney function to deteriorate.

Tell your doctor if you are planning to have an operation (even a small one, such as a tooth extraction), as acetylsalicylic acid thins the blood, which may increase the risk of bleeding.

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

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

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

If you cut or injure yourself, bleeding may take a little longer than usual to stop. This is related to the effect of acetylsalicylic acid. Small cuts and injuries (e.g. when shaving) are generally not important. 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 in association with rosuvastatin treatment. Stop using Roasax and seek medical attention immediately if you notice any of the symptoms described in section 4.

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

Children and adolescents

Roasax should not be used in children and adolescents.

Other medicines and Roasax

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Roasax may affect or be affected by other medicines, such as:

• fibrates (e.g. gemfibrozil, fenofibrate) or any other medicine used to lower cholesterol (such as ezetimibe).
• indigestion treatments (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 levels of uric acid in the blood).
• teriflunomide (used in the treatment of multiple sclerosis).
• regorafenib (used to treat cancer).
• darolutamide (used to treat cancer).
• capmatinib (used to treat cancer).
• any other medicine used to treat viral infections, including HIV or hepatitis C infection, alone or in combination (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).
• itraconazole (antifungals).
• erythromycin, clarithromycin (antibiotics).
• anticoagulants/prevention of blood clots (e.g. warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding if taken before blood clotting is eliminated or blood thinning treatment is diluted. Therefore, if you are going to undergo such treatment, you should be aware of the signs of external or internal bleeding (e.g. bruising).
• organ rejection after transplantation (ciclosporin, tacrolimus).
• high blood pressure (e.g. diuretics and ACE inhibitors).
• heart rate control (digoxin).
• manic-depressive illness (lithium).
• Pain relievers and anti-inflammatory medicines (non-steroidal anti-inflammatory drugs / anti-inflammatory medicines) and anti-rheumatic medicines that contain salicylic acid: increased risk of bleeding and ulcers in the gastrointestinal tract.
• gout (e.g. probenecid, benzbromarone).
• glaucoma (acetazolamide).
• cancer or rheumatoid arthritis (methotrexate; at doses below 15 mg per week).
• medicines to lower blood sugar levels (antidiabetic medicines) such as insulin, tolbutamide, glibenclamida (the so-called sulfonylureas) in combination with acetylsalicylic acid at higher doses, the level of sugar in the blood may drop.
• depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine).
• used as hormone replacement therapy when the adrenal or pituitary glands have been destroyed or removed (with the exception of 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.
• brain seizures [epilepsy] (valproic acid).
• medicines that cause increased urine excretion (diuretics: the so-called aldosterone antagonists such as spironolactone and canrenone, 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 will need to temporarily stop taking Roasax. Your doctor will tell you when it is safe to start taking this medicine again. Taking Roasax with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

Taking Roasax with food and drink

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

Pregnancy and breast-feeding

Do not take Roasax if you are pregnant or breast-feeding. If you become pregnant while taking Roasax, stop taking it immediately and inform your doctor. Women should avoid becoming pregnant during treatment with this medicine by using appropriate contraceptive measures.

Driving and using machines

Most patients can drive and use machines while taking Roasax as it will not affect their ability. However, some people may feel dizzy during treatment with this medicine. If you feel unwell, dizzy, or tired, or get a headache, do not drive or use machinery and consult your doctor immediately.

Roasax contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Roasax contains soya oil

This medicine contains soya oil. Do not use if you are allergic to peanuts or soya.

3. How to take Roasax

Follow exactly the administration instructions of this medication 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 illness, current treatment, and personal risk.

This medication is not suitable for starting treatment. The initiation of treatment should only be done by administering the active principles separately, and after adjusting the appropriate doses, it will be possible to switch to Roasax at 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. The capsules should be swallowed with plenty of liquid and should not be crushed or chewed.

If you are hospitalized or receive treatment for another condition, inform the medical staff that you are taking Roasax.

Elderly patients

No dose modification is necessary for elderly patients.

Children and adolescents

Roasax should not be used in children and adolescents.

Patients with renal insufficiency

Dose change is not 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 the 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 planned time. Do not take a double dose to make up for missed doses.

If you interrupt treatment with Roasax

Your doctor will advise you how long you should take your medication. Your cholesterol levels may increase again if you stop taking Roasax. Your illness may reappear if you stop using your medication before being indicated.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not all people suffer from them.

Stop taking Roasax and visit your doctor immediatelyif you experience any of the following very rare and serious side effects after taking this medication.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes great difficulty breathing and/or swallowing.
• Severe skin reactions, such as intense skin rash, hives, redness of the skin all over the body, intense itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome) or other allergic reactions.
• If you experience black stools or vomiting with blood (signs of heavy stomach bleeding).
• Reddish spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Generalized rash, high body temperature, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Also, stop takingRoasaxand talk to your doctor immediately

• If you have unjustified muscle pain or crampsthat last longer than expected. Like other statins, a very small number of people have experienced unpleasant muscle effects and have rarely become potentially life-threatening 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 following side effectshave been reported. If any of these cause you problems or last more than a week, you should contact your doctor.

ROSUVASTATIN

Frequent(may 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 levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

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: this usually reverses on its own without the need to interrupt treatment with Roasax capsules (only doses of 5 to 20 mg).

Rare(may 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 itching of the skin (with hives). If you think you are having an allergic reaction, stop taking Roasaxand seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Roasax and consult your doctor immediately if you have unjustified muscle pain or crampsthat last longer than expected.
• Severe stomach pain (possible sign of pancreatitis).
• Increased liver enzymes (transaminases) in blood.
• Reduced platelet count, which increases the risk of bleeding or bruising (thrombocytopenia).
• Lupus or similar disease (including skin rash, 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 (with numbness or tingling).
• Joint pain.
• Memory loss.
• Gynecomastia (enlargement of the breasts in men).

Frequency not known(frequency cannot be estimated from 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 injuries.
• Nerve disorder that can cause weakness, numbness, or tingling.
• Constant muscle weakness.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia of the eyes (a disease that causes weakness of the eye muscles).

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

ACETYLSALICYLIC ACID

Frequent(may affect up to 1 in 10 people):

• Gastrointestinal disorders such as stomach acid, 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 possible prolongation of bleeding time. This effect can last from 4 to 8 days after ingestion.

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

• Stomach or intestinal bleeding. After long-term use of acetylsalicylic acid, anemia (iron deficiency anemia) may occur due to hidden blood loss from the stomach or intestines.
• Intracranial bleeding, blood in the urine.
• Stomach or intestinal ulcers, which can very rarely cause perforation.
• Gastrointestinal inflammation.
• Skin reactions.

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

• Hypersensitivity reactions of the skin, respiratory tract, gastrointestinal area, and cardiovascular system, especially in asthmatics. The following characteristics of the disease may be presented: drop in blood pressure, dyspnea attacks, nasal mucosa inflammation, 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 high blood pressure and/or concomitant treatment with anticoagulants (anticoagulant medications), which can be potentially fatal in individual cases.
• Confusion.
• Headache, dizziness.
• Hearing loss or ringing in the ears (tinnitus), especially in children and the elderly, may be signs of an overdose (see also the section "If you take more Roasax than you should").

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

• Increases in liver function tests.
• Kidney dysfunction and acute kidney failure.
• Low blood sugar (hypoglycemia).
• Acetylsalicylic acid reduces the excretion of uric acid at low doses. This can trigger a gout attack in patients at risk.
• Febrile eruptions with mucous membrane involvement (multiform exudative erythema).

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

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

If you consider that any of the side effects you suffer from is serious or if you notice any side effect not mentioned in this prospectus, 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Roasax

Keep this medication out of 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Roasax

The active ingredients are rosuvastatin (as rosuvastatin calcium) and acetylsalicylic acid.

Roasax 20 mg/100 mg: each hard capsule contains 20 mg rosuvastatin (as rosuvastatin calcium) and 100 mg acetylsalicylic acid.

The other components are:

Coated tablet with rosuvastatin:

Core

Lactose monohydrate

Microcrystalline cellulose

Heavy magnesium oxide

Crospovidone (type A)

Anhydrous colloidal silica

Magnesium stearate

Coating

Polyvinyl alcohol

Titanium dioxide (E171)

Talc

Yellow iron oxide (E172)

Soy lecithin

Red iron oxide (E172)

Xanthan gum

Black iron oxide (E172)

Acetylsalicylic acid tablet:

Microcrystalline cellulose

Cornstarch

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

Appearance of the product and package contents

Roasax 20 mg/100 mg: hard gelatin capsules, size 0, with a white opaque body and black printing "ASA 100" and a green opaque cap with black printing "RSV 20". Each capsule contains a white or almost white, biconvex, oval-shaped acetylsalicylic acid tablet and two brown, biconvex, and round tablets with 10 mg of rosuvastatin.

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

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31

2ª planta

28023 - Madrid

Manufacturer

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

Croatia

or

Genericon Pharma Gesellschaft m.b.H.

Hafnerstrasse 211, 8054 Graz

Austria

This medication is authorized in the Member States of the European Economic Area with the following names:

Poland: Rosuvastatin+Acetylsalicylic acid Adamed

Austria: RosuASS 20 mg/100 mg Hartkapseln

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

Spain: Roasax 20 mg/ 100 mg hard capsules

Germany: RosuASS APONTIS, 20 mg/100 mg Hartkapseln

Cyprus: ROSU-ASA

Greece: ROSU-ASA

Croatia: ROSIX DUO 20 mg/100 mg hard capsules

Slovenia: BELOROSTIN 20 mg/100 mg hard capsules

Portugal: ESTASP

Italy: ASADROX

Date of the last revision of this prospectus: April 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es