Zahron Asa

Leaflet accompanying the packaging: Patient information

Zahron ASA, 5 mg + 100 mg, hard capsules

Zahron ASA, 10 mg + 100 mg, hard capsules

Zahron ASA, 20 mg + 100 mg, hard capsules

Rosuvastatine + Acetylsalicylic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Zahron ASA and what is it used for
• 2. Important information before taking Zahron ASA
• 3. How to take Zahron ASA
• 4. Possible side effects
• 5. How to store Zahron ASA
• 6. Contents of the packaging and other information

1. What is Zahron ASA and what is it used for

Zahron ASA contains two active substances - rosuvastatine and acetylsalicylic acid.

• Rosuvastatine belongs to a group of substances called statins, which are lipid-regulating medicines used to lower the level of lipids (fats) such as cholesterol and triglycerides in the blood when a low-fat diet and lifestyle changes are not enough. Cholesterol is a fatty substance that can cause narrowing of the blood vessels in the heart, leading to coronary artery disease. If the patient is at risk of another heart attack, rosuvastatine can also be used to reduce this risk, even if the cholesterol level is normal. A standard cholesterol-lowering diet should be followed during treatment.
• Acetylsalicylic acid in low doses belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells that cause blood to clot and participate in thrombosis. When a blood clot forms in an artery, it blocks the flow of blood and cuts 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 risk of another heart attack if the patient has had a heart attack or if the patient has angina (unstable angina). Zahron ASA is indicated for patients who are already taking rosuvastatine and acetylsalicylic acid in these doses. Instead of taking rosuvastatine and acetylsalicylic acid as separate tablets, the patient will receive one Zahron ASA capsule containing both ingredients at the same strength as previously used.

2. Important information before taking Zahron ASA

When not to take Zahron ASA:

• If the patient is allergic to rosuvastatine, acetylsalicylic acid, any other salicylan or non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6).
• In case of known hypersensitivity to peanuts or soy (see below).
• If the patient is pregnant or breastfeeding, or if they become pregnant while taking Zahron ASA, they should stop taking it immediately and inform their doctor. Women should avoid becoming pregnant while taking Zahron ASA by using appropriate contraception.
• If the patient has liver disease.
• If the patient has severe kidney disease.
• If the patient has recurring or unexplained muscle pain.
• If the patient is taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat hepatitis C virus infection).
• If the patient is taking a medicine called cyclosporine (used, for example, after organ transplantation).
• If the patient has had an asthma attack or swelling of certain parts of the body (e.g., face, lips, throat, or tongue) (angioedema) after taking salicylan or NSAIDs.
• If the patient has had stomach or duodenal ulcers or any other bleeding, such as a stroke.
• If the patient has had bleeding disorders.
• If the patient has gout.
• If the patient has uncontrolled heart failure.
• If the patient is taking a medicine called methotrexate (e.g., for cancer or rheumatoid arthritis) in doses higher than 15 mg per week.
• If the patient has ever had a severe skin rash or peeling, blisters, and (or) ulcers in the mouth after taking Zahron ASA or other similar medicines.

Warnings and precautions

Before starting to take Zahron ASA, the patient should discuss it with their doctor or pharmacist

• If the patient has kidney problems.
• If the patient has liver problems.
• If the patient has had recurring or unexplained muscle pain, muscle problems, or a family history of muscle problems, or muscle problems while taking other cholesterol-lowering medicines in the past. The patient should immediately inform their doctor if they experience unexplained muscle pain, especially if they feel unwell or have a fever. The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness.
• If the patient regularly consumes large amounts of alcohol.
• If the patient's thyroid gland does not work properly.
• If the patient is taking other medicines, called fibrates, to lower cholesterol. The patient should carefully read the leaflet, even if they have taken other cholesterol-lowering medicines before.
• If the patient is taking medicines for HIV infection, e.g., ritonavir with lopinavir and (or) atazanavir; see "Zahron ASA and other medicines".
• If the patient is taking or has taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) orally or by injection; taking Zahron ASA with fusidic acid may lead to severe muscle problems (rhabdomyolysis); see "Zahron ASA and other medicines".
• It is possible that the risk of muscle side effects may be higher when daptomycin is taken with Zahron ASA. The doctor will decide whether to stop daptomycin or temporarily discontinue Zahron ASA.

and

• If the patient has severe respiratory failure.
• If the patient is over 70 years old.
• If the patient is of Asian origin (i.e., Japan, China, Philippines, Vietnam, Korea, and India). The doctor must choose an appropriate initial dose of Zahron ASA that is suitable for the patient.
• If the patient currently has or has had stomach or duodenal problems (ulcers or gastrointestinal bleeding).
• If the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen (painkillers, antipyretics, or anti-inflammatory drugs).
• If the patient has high blood pressure.
• If the patient has asthma, hay fever, nasal polyps, or other chronic respiratory diseases; acetylsalicylic acid may cause an asthma attack.
• In case of hypersensitivity (allergy) to other painkillers and anti-inflammatory drugs, other anti-rheumatic drugs, or other allergens.
• If the patient has other allergies (e.g., skin reactions, itching).
• If the patient is taking other anticoagulant medicines (e.g., coumarin derivatives, heparin - except for low-dose heparin).
• In case of impaired kidney function or reduced blood flow to the heart and blood vessels (e.g., kidney vessel disease, heart muscle weakness, reduced blood volume, severe surgery, blood poisoning, or increased bleeding): acetylsalicylic acid may further increase the risk of kidney function disorders and acute kidney failure.
• If the patient has heavy menstrual bleeding.
• If the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

The patient should immediately consult their doctor if their symptoms worsen or if they experience severe or unexpected side effects, e.g., unusual bleeding symptoms, severe skin reactions, or any other symptoms of severe allergy (see "Possible side effects").

Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting of blood cells and formation of a clot) if these medicines are taken together. Therefore, caution should be exercised when taking metamizole in patients receiving low-dose acetylsalicylic acid for heart protection.

In a small number of people, statins may affect the liver. This is identified by a simple test that detects elevated liver enzyme activity in the blood. For this reason, the doctor will usually recommend that this blood test (liver function test) be performed before and during treatment with Zahron ASA.

During treatment with this medicine, the doctor will closely monitor the patient's condition if they have diabetes or are at risk of developing diabetes. The risk of developing diabetes is likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure.

Care should be taken not to cause dehydration (the patient may feel thirsty with dry mouth), as concurrent use of acetylsalicylic acid may worsen kidney function.

The patient should inform their doctor if they plan to undergo surgery (even minor, e.g., tooth extraction), as acetylsalicylic acid thins the blood and may increase the risk of bleeding.

Acetylsalicylic acid may 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 fatal. Therefore, Zahron ASA should not be given 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 breakdown of red blood cells or a certain form of anemia. This risk may be caused by factors such as high doses, fever, or acute infections.

Low doses of acetylsalicylic acid reduce the excretion of uric acid. This may cause a gout attack in patients at risk.

In case of injury or trauma, bleeding may take a little longer than usual. This is related to the effect of acetylsalicylic acid. Minor injuries and traumas (e.g., during shaving) are usually not significant. If the patient experiences unusual bleeding (in an unusual location or duration), they should contact their doctor.

Regarding the use of rosuvastatine, severe skin reactions have been reported, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS). If any of the symptoms described in section 4 occur, the patient should stop taking Zahron ASA and contact their doctor immediately.

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

Children and adolescents

Zahron ASA should not be used in children and adolescents.

Zahron ASA and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.

Zahron ASA may affect other medicines or other medicines may affect it:

• Fibrates (such as gemfibrozil, fenofibrate) or other medicines used to lower cholesterol levels (such as ezetimibe),
• Antacids (used to neutralize stomach acid),
• Oral contraceptives (the pill),
• Hormone replacement therapy,
• Fostamatinib (used to treat low platelet count),
• Febuxostat (used to treat and prevent high uric acid levels in the blood),
• Teriflunomide (used to treat multiple sclerosis),
• Regorafenib (used to treat cancer),
• Darolutamide (used to treat cancer),
• Kampatynib (used to treat cancer),
• Any of the following medicines used to treat viral infections, including HIV or hepatitis C virus infection, taken alone or in combination with other medicines (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 (an antibiotic, see "Warnings and precautions"),
• Tafamidis (used to treat transthyretin amyloidosis),
• Itaconazole (antifungal medicines),
• Erythromycin, clarithromycin (antibiotics),
• Medicines that thin the blood and prevent blood clots (e.g., warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding if taken before medicines that dissolve blood clots or thin the blood. Therefore, if such treatment is to be used, attention should be paid to signs of external or internal bleeding (e.g., bruising),
• Organ rejection after transplantation (cyclosporine, tacrolimus),
• High blood pressure (e.g., diuretics and ACE inhibitors),
• Heart rate regulation (digoxin),
• Bipolar disorder (lithium),
• Painkillers and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs/anti-inflammatory drugs) and anti-rheumatic drugs containing salicylic acid: increased risk of bleeding and gastrointestinal ulcers.
• Gout (e.g., probenecid, benzbromarone),
• Glaucoma (acetazolamide),
• Cancer or rheumatoid arthritis (methotrexate; in doses lower than 15 mg per week),
• Medicines that lower blood sugar levels (antidiabetic medicines) such as insulin, tolbutamide, glibenclamide (sulfonylurea derivatives) in combination with acetylsalicylic acid in higher doses - may lead to decreased blood sugar levels.
• Depression (selective serotonin reuptake inhibitors (SSRIs), such as sertraline or paroxetine).
• Medicines used as hormone replacement therapy in case of adrenal or pituitary gland damage or removal (except for products used on the skin or corticosteroid replacement therapy for Addison's disease) or for the treatment of inflammatory conditions, including rheumatic diseases and inflammatory bowel disease (corticosteroids). Concurrent use increases the risk of gastrointestinal side effects.
• Seizures (valproic acid).
• Medicines that increase urine production (diuretics: e.g., aldosterone antagonists, such as spironolactone and canrenone, loop diuretics, e.g., furosemide).
• Alcohol: increases the risk of stomach ulcers and bleeding.

If the patient needs to take fusidic acid orally to treat a bacterial infection, they will need to temporarily stop taking Zahron ASA. The doctor will inform the patient when it is safe to restart the medicine. Taking Zahron ASA with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis is provided in section 4.

Taking Zahron ASA with food and drink

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

Pregnancy and breastfeeding

Zahron ASA should not be taken if the patient is pregnant or breastfeeding. If the patient becomes pregnant while taking Zahron ASA, they should stop taking it immediately and inform their doctor. Women should avoid becoming pregnant while taking Zahron ASA by using appropriate contraception.

Driving and using machines

Most people can drive and use machines while taking Zahron ASA - it will not affect their ability to drive vehicles. However, some people may experience dizziness while taking Zahron ASA. If the capsules cause nausea, dizziness, or fatigue, or headache, the patient should not drive or operate machinery and should contact their doctor immediately.

Zahron ASA contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Zahron ASA contains soybean oil

Do not take if the patient is hypersensitive to peanuts or soy.

3. How to take Zahron ASA

This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

Adults

The doctor will determine the appropriate dose for the patient based on their health, current treatment, and individual risk.

This medicine is not suitable for starting treatment. Treatment should be started with separate administration of the active substances; after determining the appropriate doses, it is possible to switch to Zahron ASA with the appropriate dose.

The recommended dose is one capsule per day.

The medicine should be taken with food. The medicine should be taken every day at the same time.

The capsules should be swallowed with a large amount of liquid; they should not be crushed or chewed.

If the patient is hospitalized or treated for another disease, they should inform the medical staff that they are taking Zahron ASA.

Use in elderly patients

No dose adjustment is necessary in elderly patients.

Use in children and adolescents

Zahron ASA should not be used in children and adolescents.

Patients with kidney problems

Dose adjustment is not necessary in patients with mild or moderate kidney problems.

Taking Zahron ASA is contraindicated in patients with severe kidney problems.

Patients with liver problems

Taking Zahron ASA is contraindicated in patients with severe liver problems.

Taking a higher dose of Zahron ASA than recommended

The patient should consult their doctor or the nearest hospital for advice.

Missing a dose of Zahron ASA

The patient should not worry. If they miss a capsule, they should skip that dose.

The next dose should be taken at the right time. The patient should not take a double dose to make up for the missed dose.

Stopping Zahron ASA

The doctor will inform the patient how long to take the medicine. After stopping Zahron ASA, cholesterol levels may rise again. If the patient stops taking the medicine without consulting their doctor, the disease may recur.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Zahron ASA can cause side effects, although not everybody gets them.

The patient should stop taking Zahron ASA and seek medical help immediately if they experience any of the following very rare, serious side 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 significant breathing or swallowing difficulties
• Severe skin reactions, including intense rash, urticaria, redness of the skin all over the body, severe itching, blistering, peeling, and skin swelling, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions
• If black stools or vomiting blood occur (signs of severe stomach bleeding).
• Red, flat, plate-like, or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of this type of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or hypersensitivity syndrome).

The patient should also stop taking Zahron ASA and contact their doctor immediately:

• In case of unusual muscle painthat lasts longer than expected. Like other statins, rosuvastatine has caused unpleasant muscle effects in a very small number of patients, which have rarely led to potentially life-threatening muscle damage, known as rhabdomyolysis.
• In case of muscle rupture.
• In case of systemic lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

The following side effects have been reported. If any of them cause the patient trouble or last longer than a week, they should contact their doctor.

ROSUVASTATINE

Common(occurring in no more than 1 in 10 people):

• Headache.
• Abdominal pain.
• Constipation.
• Nausea.
• Muscle pain.
• Feeling weak.
• Dizziness.
• Diabetes. It is more likely to occur if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. During treatment with this medicine, the doctor will monitor the patient's condition.

Uncommon(occurring in no more than 1 in 100 people):

• Rash, itching, urticaria, or other skin reactions.
• Increased protein in the urine - usually resolves on its own without the need to stop taking the capsules (only 5-20 mg doses).

Rare(occurring in no more than 1 in 1000 people):

• Severe allergic reaction - symptoms include swelling of the face, lips, tongue, and (or) throat, difficulty swallowing and breathing, severe itching of the skin (with raised lumps). In case of suspected allergic reaction, the patient should stop taking Zahron ASA and seek medical help immediately.
• Muscle damage in adults - as a precaution, the patient should stop taking Zahron ASA and contact their doctor immediately in case of unusual muscle pain, lasting longer than expected.
• Severe abdominal pain (pancreatitis).
• Elevated liver enzyme levels in the blood.
• Decreased platelet count, which increases the risk of bleeding or bruising (thrombocytopenia).
• Systemic lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Very rare(occurring in no more than 1 in 10,000 people):

• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflammation of the liver).
• Blood in the urine.
• Nerve damage in the limbs (e.g., numbness).
• Joint pain.
• Memory loss.
• Gynecomastia (breast enlargement in men).

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

• Diarrhea (loose stools).
• Cough.
• Shortness of breath.
• Swelling (edema).
• Sleep disorders, including insomnia and nightmares.
• Sexual problems.
• Depression.
• Breathing problems, including persistent cough and (or) shortness of breath or fever.
• Tendon damage.
• Nerve disorder that can cause weakness, numbness, or tingling.
• Persistent muscle weakness.
• Myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing).
• Ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including any not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to:

Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181 C

02-222 Warszawa

Tel.: + 48 22 49 21 301

Fax: + 48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Zahron ASA

The medicine should be stored out of 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 stated.

Store in a temperature below 30°C. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Zahron ASA contains

The active substances of the medicine are rosuvastatine (in the form of rosuvastatine calcium) and acetylsalicylic acid.

Zahron ASA 5 mg + 100 mg: each hard capsule contains 5 mg of rosuvastatine (in the form of rosuvastatine calcium) and 100 mg of acetylsalicylic acid.

Zahron ASA 10 mg + 100 mg: each hard capsule contains 10 mg of rosuvastatine (in the form of rosuvastatine calcium) and 100 mg of acetylsalicylic acid.

Zahron ASA 20 mg + 100 mg: each hard capsule contains 20 mg of rosuvastatine (in the form of rosuvastatine calcium) and 100 mg of acetylsalicylic acid.

Other ingredients are:

Rosuvastatine film-coated tablet:

Core

Lactose monohydrate

Microcrystalline cellulose

Heavy magnesium oxide

Crospovidone (type A)

Silica, colloidal anhydrous

Magnesium stearate

Coating

Partially hydrolyzed polyvinyl alcohol

Titanium dioxide (E 171)

Talc

Yellow iron oxide (E 172)

Soybean lecithin

Red iron oxide (E 172)

Xanthan gum

Black iron oxide (E 172)

Acetylsalicylic acid tablet:

Microcrystalline cellulose

Corn starch

Silica, colloidal anhydrous

Stearic acid

Capsule shell:

Gelatin

Titanium dioxide (E 171)

Indigo carmine (E 132)

Yellow iron oxide (E 172)

Black ink:

Shellac

Propylene glycol

Ammonium hydroxide, solution

Black iron oxide (E 172)

Potassium hydroxide

What Zahron ASA looks like and contents of the pack

Zahron ASA 5 mg + 100 mg: hard gelatin capsules, size 2, with a white opaque body and dark green opaque cap. Each capsule contains one white or almost white, biconvex, oval, uncoated acetylsalicylic acid tablet and one coated, brown, biconvex, round rosuvastatine 5 mg tablet.

Zahron ASA 10 mg + 100 mg: hard gelatin capsules, size 1, with a white opaque body with black printing "ASA 100" and light green opaque cap with black printing "RSV 10". Each capsule contains one white or almost white, biconvex, oval, uncoated acetylsalicylic acid tablet and one coated, brown, biconvex, round rosuvastatine 10 mg tablet.

Zahron ASA 20 mg + 100 mg: hard gelatin capsules, size 0, with a white opaque body with black printing "ASA 100" and green opaque cap with black printing "RSV 20". Each capsule contains one white or almost white, biconvex, oval, uncoated acetylsalicylic acid tablet and two coated, brown, biconvex, round rosuvastatine 10 mg tablets.

Zahron ASA is available in blisters containing 10, 28, 30, 56, 60, 90, 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Tel.: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.

ul. Marszałka Józefa Piłsudskiego 5

95-200 Pabianice

Iasis Pharmaceuticals Hellas Abee

137 Filis Ave

Kamatero Attiki, 134 51

Greece

Belupo Inc.

Ulica Danica 5

48000 Koprivnica

Croatia

Genericon Pharma Gesellschaft m.b.H.,

8054 Graz,

Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:

Zahron ASA

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, 5 mg/100 mg Hartkapseln

RosuASS® APONTIS, 10 mg/100 mg Hartkapseln

RosuASS® APONTIS, 20 mg/100 mg Hartkapseln

Italy:

ASADROX

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

Date of last revision of the leaflet: 04.2025