Roasax 10 mg/100 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Roasax 10 mg/100 mg hard capsules

rosuvastatin/acetylsalicylic acid

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Roasax is and what it is used for

Roasax contains two active substances: rosuvastatin and acetylsalicylic acid.

• Rosuvastatin belongs to a group of medicines called statins, which are lipid-regulating (fatty) medicines used to reduce lipids known as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes alone have failed. Cholesterol is a fatty substance (lipid) that can cause narrowing of the blood vessels in the heart and lead to heart disease. If you are at risk of having another heart attack, rosuvastatin may also be used to reduce this risk, even if your cholesterol levels are normal. You should maintain a cholesterol-lowering diet during treatment.
• Acetylsalicylic acid, at low doses, belongs to a group of medicines called antiplatelet agents. Platelets are tiny cells in the blood that cause blood to clot and are involved in thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off 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 previously had a heart attack or suffer from episodes of chest pain (unstable angina). Roasax is indicated for patients who are already taking rosuvastatin and acetylsalicylic acid at these doses. Instead of taking rosuvastatin and acetylsalicylic acid in separate tablets, you will receive one Roasax capsule containing both ingredients at the same dose as before.

2. What you need to know before taking 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 to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant or breastfeeding, or if you become pregnant while taking Roasax, stop taking it immediately and inform your doctor. Women must avoid becoming pregnant during treatment with Roasax by using an appropriate contraceptive method.
• If you have liver disease.
• If you have severe kidney problems.
• If you experience repeated or unexplained muscle pain and cramps.

If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used for the viral liver infection called hepatitis C).

• If you are taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If you have previously had an asthma attack or swelling of certain parts of the body, e.g., face, lips, throat, or tongue (angioedema) after taking salicylates or NSAIDs.
• If you currently have or have previously had a stomach or small intestine ulcer or any other type of bleeding, such as a cerebral hemorrhage.
• If you have blood clotting disorders.
• If you suffer from gout.
• If you have uncompensated heart failure.
• If you are taking a medicine called methotrexate (for example, 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 sores after taking Roasax or other related medicines.
• This medicine contains soy lecithin. It should not be used if you are allergic to peanuts or soy.

Warnings and precautions

Talk to 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 and cramps, a personal or family history of muscle disorders, or a previous history of muscle problems during treatment with other cholesterol-lowering medicines. Inform your doctor immediately if you experience unexplained muscle pain or cramps, especially if accompanied by malaise or fever. Also inform your doctor or pharmacist if you experience 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 cholesterol-lowering medicines.
• If you are taking medicines to treat HIV infection (AIDS virus), such as ritonavir with lopinavir and/or atazanavir. See “Other medicines and Roasax”.
• If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine for bacterial infection), taken orally or by injection. Taking Roasax with fusidic acid may cause serious muscle problems (rhabdomyolysis); please see “Other medicines and Roasax”.
• The risk of adverse effects affecting muscles may be higher when daptomycin is taken during treatment with Roasax. Your doctor may decide not to administer daptomycin or to temporarily discontinue Roasax.
• If you have severe respiratory insufficiency.
• 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 appropriate starting dose of Roasax 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 are asthmatic, have hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may trigger an asthma attack.
• In case of hypersensitivity (allergy) to other painkillers and anti-inflammatory medicines, other medicines for rheumatism, or other allergy-causing agents.
• 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).
• In cases of 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 characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

Metamizole or certain NSAIDs, such as ibuprofen or naproxen (substances used to reduce pain and fever), may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot) when taken concomitantly. 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 the liver. This is detected by a simple blood test showing increased levels of liver enzymes. For this reason, your doctor will usually perform blood tests (liver function tests) before and during treatment with Roasax.

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

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 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 disease affecting the brain and liver and can be potentially fatal. For this reason, Roasax 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 accelerated breakdown or collapse of red blood cells or a certain type of anemia. This risk may be increased by factors such as high doses, fever, or acute infections.

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

If you are cut or injured, bleeding may last slightly longer than normal. This is related to the effect of acetylsalicylic acid. Minor cuts and injuries (e.g., while shaving) are usually not significant. If you experience unusual bleeding (in an unusual location 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 with rosuvastatin treatment. Stop using Roasax 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 prolonged periods or at high doses without consulting a doctor.

Children and adolescents

Roasax must not be used in children and adolescents.

Other medicines and Roasax

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 (e.g., ezetimibe).
• Treatments for indigestion (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 uric acid levels).
• Teriflunomide (used in the treatment of multiple sclerosis).
• Leflunomide (used to treat rheumatoid arthritis).
• Regorafenib (used for cancer treatment).
• 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 (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).
• Momelotinib (used to treat myelofibrosis in adults with anemia).
• Itraconazole (antifungals).
• Erythromycin, clarithromycin (antibiotics).
• Anticoagulants/blood clot prevention (e.g., warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding if taken before clot dissolution or blood-thinning treatment. Therefore, if undergoing such treatment, pay attention to signs of external or internal bleeding (e.g., bruising).
• Organ transplant rejection (cyclosporine, tacrolimus).
• High blood pressure (e.g., diuretics and ACE inhibitors).
• Heart rhythm control (digoxin).
• Bipolar disorder (lithium).
• Painkillers and anti-inflammatory medicines (non-steroidal analgesics/anti-inflammatories) and anti-rheumatic medicines containing salicylic acid: increased risk of gastrointestinal bleeding and ulcers.
• Gout (e.g., probenecid, benzbromarone).
• Glaucoma (acetazolamide).
• Cancer or rheumatoid arthritis (methotrexate; at doses below 15 mg per week).
• Medicines to lower blood sugar (antidiabetic medicines) such as insulin, tolbutamide, glibenclamide (sulfonylureas); when combined with higher-dose acetylsalicylic acid, blood sugar levels may drop.
• Depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine).
• Hormone replacement therapy when adrenal or pituitary glands have been destroyed or removed (except for skin-applied products or cortisone replacement therapy for Addison's disease), or to treat inflammation, including rheumatic diseases and intestinal inflammation (corticosteroids). Concomitant use increases the risk of gastrointestinal adverse effects.
• Brain seizures [epilepsy] (valproic acid).
• Medicines that increase urinary excretion (diuretics: 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 using Roasax. Your doctor will advise you when it is safe to resume taking this medicine. Rarely, taking Roasax with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

Taking Roasax with food and drinks

Drinking alcohol may possibly 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 must avoid becoming pregnant during treatment with this medicine by using an appropriate contraceptive method.

Driving and using machines

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

Roasax contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Roasax contains soybean oil

This medicine contains soybean oil. It should not be used if you are allergic to peanuts or soy.

3. How to take Roasax

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults

Your doctor will determine the most appropriate dose for you, depending on your condition, your current treatment, and your individual risk.

This medicine is not suitable for initiating treatment. Treatment initiation should only be done by administering the active substances separately. After appropriate doses have been established, switching to Roasax at the suitable concentration becomes possible.

The recommended dose is one capsule daily.

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

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

Elderly patients

No dose adjustment is necessary for elderly patients.

Children and adolescents

Roasax must not be used in children and adolescents.

Patients with renal impairment

Dose adjustment is not required if you have mild or moderate renal impairment.

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

Patients with hepatic impairment

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

If you take more Roasax than you should

Contact your doctor or nearest hospital for advice. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Roasax

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

If you stop taking Roasax

Your doctor will advise you on how long you should take the medicine. Your cholesterol levels may rise again if you stop taking Roasax. Your condition may recur if you stop using the medicine before instructed to do so.

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

4. Possible adverse effects

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

Stop taking Roasax and see your doctor immediately if you experience any of the following very rare and serious adverse effects after taking this medicine:

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat causing severe difficulty breathing and/or swallowing.
• Severe skin reactions, such as severe rash, hives, redness of the skin all over the body, intense itching, blisters, skin peeling, and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), or other allergic reactions.
• If you have black stools or vomit blood (signs of significant stomach bleeding).
• Red, non-elevated, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, ulcers in 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 Roasax and speak to your doctor immediately

• If you have unexplained muscle pain or cramps lasting longer than expected. As with other statins, a very small number of people have experienced unpleasant muscle effects, and rarely these have led to potentially life-threatening muscle damage known as rhabdomyolysis.
• If you experience muscle rupture.
• If you develop lupus or a lupus-like illness (including skin rash, joint disorders, and effects on blood cells).

The following side effects have been reported. If any of these cause you problems or if they last longer than one week, you should contact your doctor.

ROSUVASTATIN

Common (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 sugar and fats in your 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: this usually returns to normal on its own without the need to stop treatment with Roasax capsules (only at 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 skin itching (with rashes). If you think you are having an allergic reaction, stop taking Roasax and seek immediate medical attention.
• Muscle injury in adults – as a precaution, stop taking Roasax and consult your doctor immediately if you have unexplained muscle pain or cramps lasting longer than expected.
• Severe stomach pain (possible sign of inflammation of the pancreas).
• Increase in liver enzymes (transaminases) in blood.
• Reduction in blood platelets, increasing the risk of bleeding or bruising (thrombocytopenia).
• Lupus or lupus-like illness (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 arms and legs (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 disorders that may cause weakness, tingling, or numbness.
• Persistent muscle weakness.
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

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

ACETYLSALICYLIC ACID

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

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

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 hidden blood loss from the stomach or intestines.
• Intracranial bleeding, blood in the urine.
• Stomach or intestinal ulcers, which very rarely may lead to perforation.
• Gastrointestinal inflammation.
• Skin reactions.

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

• Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal area, and cardiovascular system, especially in asthmatics. The following symptoms may occur: drop in 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 bleeding in the brain, especially in patients with uncontrolled high blood pressure and/or concomitant treatment with anticoagulants (blood-thinning medicines), which may be potentially fatal in individual cases.
• Confusion.
• Headache, dizziness.
• Hearing impairment or ringing in the ears (tinnitus), especially in children and elderly people, which may be signs of overdose (see also 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.
• Decrease in blood sugar (hypoglycemia).
• Acetylsalicylic acid reduces the excretion of uric acid at low doses. This may trigger an attack of gout in at-risk patients.
• Feverish rashes with involvement of mucous membranes (multiforme erythema).

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

• Accelerated breakdown or destruction of red blood cells and a specific form of anemia in patients with severe glucose-6-phosphate dehydrogenase deficiency.
• In case of pre-existing intestinal mucosal damage, membranes may form in the intestinal cavity with possible subsequent narrowing.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of Roasax

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 the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Roasax

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

Roasax 10 mg/100 mg: each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.

The other components are:

Tablet coated with rosuvastatin film:

Core

Monohydrate lactose

Microcrystalline cellulose

Heavy magnesium oxide

Crospovidone (type A)

Anhydrous colloidal silica

Magnesium stearate

Coating

Polyvinyl alcohol

Titanium dioxide (E171)

Talc

Yellow iron oxide (E172)

Lecithin (soy)

Red iron oxide (E172)

Xanthan gum

Black iron oxide (E172)

Acetylsalicylic acid tablet:

Microcrystalline cellulose

Corn starch

Anhydrous colloidal silica

Stearic acid

Capsule shell:

Gelatin

Titanium dioxide (E171)

Indigotine (E132)

Yellow iron oxide (E172)

Black printing ink:

Shellac

Propylene glycol

Strong ammonia solution

Black iron oxide (E172)

Potassium hydroxide

Nature of the product and pack contents

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

Roasax is available in blister packs containing 10, 28, 30, 56, 60, 90 and 100 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.
Calle de las Rosas de Aravaca, 31
2nd floor
28023 - Madrid, Spain

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, Republic of Croatia

or

Genericon Pharma Gesellschaft m.b.H.
Hafnerstrasse 211, 8054 Graz, Austria

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:

Poland: Rosuvastatin+Acetylsalicylic acid Adamed
Austria: RosuASS 10 mg/100 mg Hartkapseln
Bulgaria: ????????????/???????????????? ???????? Adamed
Spain: Roasax 10 mg/100 mg hard capsules
Germany: RosuASS APONTIS, 10 mg/100 mg Hartkapseln
Cyprus: ROSU-ASA
Greece: ROSU-ASA
Croatia: ROSIX DUO 10 mg/100 mg tvrde kapsule
Slovenia: BELOROSTIN mg/100 mg trde kapsule
Portugal: ESTASP
Italy: ASADROX

Date of the most recent review of this leaflet: December 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es