Zahron asa

Package leaflet: Information for the patient

Zahron ASA, 5 mg + 100 mg, hard capsules
Zahron ASA, 10 mg + 100 mg, hard capsules
Zahron ASA, 20 mg + 100 mg, hard capsules
Rosuvastatin + Acetylsalicylic acid
Please read this entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Zahron ASA is and what it is 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 pack and other information

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

Zahron ASA contains two active substances – rosuvastatin and acetylsalicylic acid.

• Rosuvastatin belongs to a group of substances called statins, which are lipid-regulating medicines used to lower blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone have proven insufficient. Cholesterol is a fatty substance (lipid) that can narrow blood vessels in the heart, leading to coronary artery disease. If you are at risk of a subsequent heart attack, rosuvastatin may also be used to reduce this risk, even if cholesterol levels are within the normal range. A standard cholesterol-lowering diet should be maintained during treatment.
• Acetylsalicylic acid, in low doses, belongs to a group of medicines called antiplatelet agents. Platelets are small blood cells involved in blood clotting and thrombosis. When a blood clot forms in an artery, it blocks blood flow and cuts off oxygen supply. If this occurs in the heart, it may cause a heart attack or angina pectoris. These two active substances, taken together, reduce the risk of a subsequent heart attack in patients who have already suffered a heart attack or who experience chest pain attacks (unstable angina pectoris). Zahron ASA is indicated for patients already taking rosuvastatin and acetylsalicylic acid at these doses. Instead of taking rosuvastatin and acetylsalicylic acid as separate tablets, the patient receives one capsule of Zahron ASA containing both components at the same strength as previously used.

2. Important information before using Zahron ASA

When not to use Zahron ASA:

• If the patient is allergic to rosuvastatin, acetylsalicylic acid, any other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6).
• If the patient has a known hypersensitivity to peanuts or soy (see below).
• If the patient is pregnant or breastfeeding, or becomes pregnant while taking Zahron ASA, she should immediately stop taking it and inform her 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 recurrent or unexplained muscle pain.
• If the patient is taking the combination sofosbuvir/velpatasvir/voxilaprevir (used to treat viral hepatitis C).
• If the patient is taking a medicine called cyclosporine (e.g. after organ transplantation).
• If the patient has experienced asthma attacks or swelling of certain body parts such as face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs.
• If the patient currently has or has previously had stomach or small intestine ulcers or any other bleeding, such as stroke.
• If the patient has ever had blood clotting disorders.
• If the patient has gout.
• If the patient has decompensated heart failure.
• If the patient is taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) in doses exceeding 15 mg per week.
• If the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral ulcers after taking Zahron ASA or similar medicines.

Warnings and precautions
Before starting Zahron ASA, discuss this with your doctor or pharmacist:

• If the patient has impaired kidney function.

• If the patient has liver problems.

• If the patient has previously experienced recurrent or unexplained muscle pain, muscle problems in the patient or family members, or muscle problems while previously taking other cholesterol-lowering medicines. The patient should immediately inform the doctor if unexplained muscle pain occurs, especially if accompanied by feeling unwell or fever. The patient should also inform the doctor or pharmacist if persistent muscle weakness occurs.

• If the patient regularly consumes large amounts of alcohol.

• If the patient has thyroid dysfunction.

• If the patient is taking other medicines called fibrates to lower cholesterol. Carefully read the package leaflet, even if the patient has previously taken other cholesterol-lowering medicines.

• If the patient is taking HIV antiviral medicines such as ritonavir with lopinavir and/or atazanawir; see section "Zahron ASA with other medicines".

• If the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used for bacterial infections); concomitant use of Zahron ASA with fusidic acid may lead to severe muscle problems (rhabdomyolysis); see section "Zahron ASA with other medicines".

• The risk of muscle-related adverse effects may be increased when daptomycin is taken during treatment with Zahron ASA. The doctor will decide whether to discontinue daptomycin or temporarily suspend Zahron ASA.

• If the patient has severe respiratory insufficiency.

• 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 starting dose of Zahron ASA suitable for the patient.

• If the patient currently has or has previously had stomach or small intestine problems (ulcers or gastrointestinal bleeding).

• If the patient is concurrently taking non-steroidal anti-inflammatory drugs such as ibuprofen and naproxen (analgesic, antipyretic or anti-inflammatory medicines).

• If the patient has hypertension.

• If the patient has asthma, hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid may trigger asthma attacks.

• In case of hypersensitivity (allergy) to other analgesic and anti-inflammatory medicines, other anti-rheumatic medicines or other allergens.

• If the patient has other allergies (e.g. with skin reactions, itching).

• If the patient is taking other anticoagulant medicines (e.g. coumarin derivatives, heparin – except low-dose heparin).

• In case of impaired kidney function or reduced blood flow to the heart and blood vessels (e.g. renal vascular disease, cardiac muscle weakness, reduced blood volume, sepsis or increased bleeding): acetylsalicylic acid may further increase the risk of kidney dysfunction and acute kidney failure.

• If the patient experiences heavy menstrual bleeding.

• If the patient has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), since statins may sometimes worsen symptoms or lead to myasthenia (see section 4).

Seek immediate medical advice if symptoms worsen or if serious or unexpected adverse effects occur, such as unusual bleeding symptoms, severe skin reactions or any other symptoms of severe allergy (see section "Possible side effects").
Metamizole or certain non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen (analgesic and antipyretic agents), may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and clot formation) when used concomitantly. Therefore, caution should be exercised when using them together in patients receiving low-dose acetylsalicylic acid for cardioprotection.
In a small number of people, statins may affect the liver. This is detected by a simple blood test showing elevated liver enzyme activity. For this reason, the doctor will usually recommend this blood test (liver function test) before starting and during treatment with Zahron ASA.
While taking this medicine, the doctor will closely monitor the patient if the patient has diabetes or is at risk of developing diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight and has high blood pressure.
Care should be taken to avoid dehydration (the patient may feel thirsty with dry mouth), as concomitant use of acetylsalicylic acid may lead to worsening kidney function.
Inform the doctor if the patient is planning a surgical procedure (even minor, 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 given to children. Reye's syndrome is a very rare condition affecting the brain and liver and may lead to death. For this reason, 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 or excessive breakdown of red blood cells or a certain form of anaemia. This risk may be increased by factors such as high doses, fever or acute infections.
Low doses of acetylsalicylic acid may reduce uric acid excretion. This may trigger gout attacks in patients at risk.
In case of cuts or injury, bleeding may last slightly longer than usual. This is related to the effect of acetylsalicylic acid. Minor cuts and injuries (e.g. during shaving) usually are not significant. If the patient experiences unusual bleeding (in an unusual location or of unusual duration), contact the doctor.
Severe skin reactions, including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with rosuvastatin use. If any of the symptoms described in section 4 occur, stop taking Zahron ASA and contact a doctor immediately.
Acetylsalicylic acid-containing medicines should not be used long-term or in high doses without consulting a doctor.

Children and adolescents
Zahron ASA should not be used in children and adolescents.

Zahron ASA with other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Zahron ASA may interact with the following medicines or may be affected by them:

• Fibrates (such as gemfibrozil, fenofibrate) or other medicines used to lower cholesterol (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 blood uric acid levels),

• Teriflunomide (used to treat multiple sclerosis),

• Leflunomide (used to treat rheumatoid arthritis),

• Regorafenib (used to treat cancer),

• Darolutamide (used to treat cancer),

• Camptothecin (used to treat cancer),

• Any of the following antiviral medicines used to treat viral infections, including HIV or hepatitis C virus, administered 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 anaemia in patients with chronic kidney disease),

• Daptomycin (an antibiotic; see section "Warnings and precautions"),

• Tafamidis (used to treat transthyretin amyloidosis),

• Momelotinib (used to treat myelofibrosis in adults with anaemia),

• Itraconazole (antifungal medicines),

• Erythromycin, clarithromycin (antibiotics),

• Medicines reducing blood clotting and preventing thrombosis (e.g. warfarin, heparin, coumarin, ticagrelor, clopidogrel, ticlopidine): acetylsalicylic acid may increase the risk of bleeding when taken with medicines that dissolve blood clots or thin the blood. Therefore, if such treatment is planned, watch for signs of external or internal bleeding (e.g. bruising),

• Organ transplant rejection (cyclosporine, tacrolimus),

• Hypertension (e.g. diuretics and ACE inhibitors),

• Heart rate regulation (digoxin),

• Bipolar disorder (lithium),

• Analgesic and anti-inflammatory medicines (non-steroidal analgesic/anti-inflammatory drugs) 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; doses lower than 15 mg per week),

• Medicines lowering blood sugar (antidiabetic medicines) such as insulin, tolbutamide, glibenclamide (sulfonylureas) in combination with higher doses of acetylsalicylic acid – may lead to reduced 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 topical products or cortisone replacement therapy for Addison's disease) or for treating inflammatory conditions, including rheumatic diseases and inflammatory bowel disease (corticosteroids). Concomitant use increases the risk of gastrointestinal adverse effects.

• Seizures (valproic acid).

• Medicines causing increased urine excretion (diuretics: aldosterone antagonists such as spironolactone and canrenone, loop diuretics such as furosemide).

• Alcohol: increases the risk of gastrointestinal ulcers and bleeding.

If the patient needs to take oral fusidic acid for bacterial infection treatment, temporary discontinuation of Zahron ASA is required. The doctor will inform the patient when it is safe to resume taking this 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
Alcohol consumption may potentially increase the risk of gastrointestinal bleeding and prolong bleeding time.

Pregnancy and breastfeeding
Do not take Zahron ASA if the patient is pregnant or breastfeeding. If pregnancy occurs while taking Zahron ASA, immediately stop taking it and inform the doctor. Women should avoid becoming pregnant while taking Zahron ASA by using appropriate contraception.

Driving and using machines
Most people can drive and operate machinery while taking Zahron ASA – it will not affect their ability to drive motor vehicles. However, some people may experience dizziness while taking Zahron ASA. If the capsules cause nausea, dizziness, fatigue or headache, do not drive or operate machinery and contact a doctor immediately.

Zahron ASA contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Zahron ASA contains soybean oil
Do not use if the patient has a known hypersensitivity to peanuts or soy.

3. How to take Zahron ASA

This medicine should always be taken exactly as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Adults
The doctor will determine the appropriate dose strength for the patient, depending on their health condition, current treatment, and individual risk.
This medicine is not suitable for initiating treatment. Treatment should be started by administering the active substances separately; once the appropriate doses have been established, a switch to Zahron ASA of the appropriate dose strength may be made.
The recommended dose is one capsule per day.
This medicine should be taken with food. The medicine should be taken every day at the same time.
The capsules should be swallowed whole with plenty of fluid; they must not be crushed or chewed.
If the patient is admitted to hospital or is treated for another illness, it is important to inform medical staff that they are taking Zahron ASA.
Use in elderly patients
There is no need to modify the dose in elderly patients.
Use in children and adolescents
Zahron ASA should not be used in children and adolescents.
Patients with renal impairment
Dose adjustment is not required in patients with mild or moderate renal impairment.
Zahron ASA is contraindicated in patients with severe renal impairment.
Patients with hepatic impairment
Zahron ASA is contraindicated in patients with severe hepatic impairment.
Overdose of Zahron ASA
In case of overdose, seek advice from a doctor or go to the nearest hospital immediately.
Missed dose of Zahron ASA
Do not worry. If a capsule is missed, completely skip that dose.
Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Zahron ASA
The doctor will inform the patient how long the medicine should be taken. After stopping Zahron ASA, cholesterol levels may rise again. If the patient stops taking the medicine before receiving appropriate advice, the condition may recur.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Treatment with Zahron ASA must be discontinued and immediate medical help sought
if any of the following very rare, serious adverse effects occur 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 difficulty in breathing and/or swallowing
• Severe skin reactions, including intense rash, urticaria, generalized redness of the skin, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), or other allergic reactions
• Black stools or vomiting blood (signs of severe gastrointestinal bleeding)
• Flat, red, circular or target-like spots on the trunk, often with blisters in the center, skin peeling, oral, throat, nasal, genital, or ocular ulcers. Such potentially life-threatening skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome)
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

You should also stop taking Zahron ASA and immediately contact your doctor:

• if you experience unusual muscle pain that persists longer than expected. As with other statins, a small number of patients have experienced muscle-related adverse effects, which in rare cases have led to potentially life-threatening muscle damage known as rhabdomyolysis.
• if there is a muscle tear.
• if symptoms of a lupus-like syndrome occur (including rash, joint disorders, and effects on blood cells).

The following adverse effects have been reported. If any of these cause discomfort to the patient or persist for longer than one week, contact your doctor.
ROSUVASTATIN
Common (occurring in up to 1 in 10 people):

• Headache
• Abdominal pain
• Constipation
• Nausea
• Muscle pain
• Feeling of weakness
• Dizziness
• Diabetes. The risk of developing diabetes is higher if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

Uncommon (occurring in up to 1 in 100 people):

• Rash, itching, urticaria, or other skin reactions
• Increased protein in urine – usually resolves spontaneously without the need to discontinue Zahron ASA capsules (only for doses 5–20 mg)

Rare (occurring in 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, severe skin itching (with raised bumps). If an allergic reaction is suspected, stop taking Zahron ASA immediately and seek urgent medical help.
• Muscle damage in adults – as a precaution, stop taking Zahron ASA and contact your doctor immediately if you experience unusual muscle pain that persists longer than expected.
• Severe abdominal pain (pancreatitis)
• Elevated liver enzyme levels in blood
• Decreased platelet count, increasing the risk of bleeding or bruising (thrombocytopenia)
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells)

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

• Jaundice (yellowing of the skin and eyes)
• Hepatitis (inflammatory liver condition)
• Blood in urine
• Nerve damage in upper and lower limbs (e.g., numbness)
• Joint pain
• Memory loss
• Gynaecomastia (enlargement of breast tissue in men)

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

• Diarrhoea (loose stools)
• Cough
• Shortness of breath
• Oedema (swelling)
• Sleep disturbances, including insomnia and nightmares
• Sexual problems
• Depression
• Breathing problems, including persistent cough and/or shortness of breath or fever
• Tendon damage
• Nerve disorder that may cause weakness, tingling, or numbness
• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, in some cases affecting muscles involved in breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles). Consult your doctor if you experience weakness in hands or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

ACETYLSALICYLIC ACID
Common (occurring in up to 1 in 10 people):

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

Uncommon (occurring in up to 1 in 100 people):

• Stomach or intestinal bleeding. Prolonged use of acetylsalicylic acid may lead to anaemia (iron deficiency anaemia) due to occult blood loss from the stomach or intestines
• Intracranial bleeding, blood in urine
• Stomach or intestinal ulcers, which very rarely may lead to perforation
• Inflammation of the gastrointestinal tract
• Skin reactions

Rare (occurring in up to 1 in 1,000 people):

• Hypersensitivity reactions affecting the skin, respiratory tract, gastrointestinal tract, and cardiovascular system, especially in patients with asthma. Symptoms may include: drop in blood pressure, breathing attacks, inflammation of the nasal mucosa, nasal obstruction, anaphylactic shock, swelling of the face, tongue, and larynx (Quincke's oedema)
• Severe bleeding, such as brain haemorrhage, especially in patients with uncontrolled hypertension and/or those concurrently taking anticoagulant medicines, which in individual cases may be life-threatening
• Confusion (state of disorientation)
• Dizziness, headache
• Hearing impairment or ringing in the ears (tinnitus), particularly in children and elderly patients, which may indicate overdose (see also section “Overdose of Zahron ASA”)

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

• Increased liver function test results
• Kidney function disorders and acute kidney failure
• Decreased blood sugar levels (hypoglycaemia)
• Low doses of acetylsalicylic acid reduce uric acid excretion. This may trigger an attack of gout in patients at risk
• Fever-associated rash with mucosal involvement (multiform exudative erythema)

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

• In patients with severe glucose-6-phosphate dehydrogenase deficiency, accelerated or excessive breakdown of red blood cells and a certain form of anaemia have been observed
• In cases of prior intestinal mucosal damage, intestinal membranes may form in the intestinal lumen, potentially leading to subsequent narrowing

If any of these adverse effects are severe or if the patient experiences any adverse symptoms not listed in this leaflet, inform the doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including those not mentioned in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Zahron ASA

Keep this medicine 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 stated month.
Store below 30°C. Keep in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to safely dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the Packaging and Other Information

What Zahron ASA Contains
The active substances in Zahron ASA are rosuvastatin (as rosuvastatin calcium) and acetylsalicylic acid.
Zahron ASA, 5 mg + 100 mg: each hard capsule contains 5 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
Zahron ASA, 10 mg + 100 mg: each hard capsule contains 10 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylosalicylic acid.
Zahron ASA, 20 mg + 100 mg: each hard capsule contains 20 mg of rosuvastatin (as rosuvastatin calcium) and 100 mg of acetylosalicylic acid.

The other ingredients are:
Tablet with rosuvastatin:
Tablet core
Lactose monohydrate
Microcrystalline cellulose
Magnesium oxide, heavy
Crospovidone (type A)
Anhydrous colloidal silicon dioxide
Magnesium stearate
Tablet coating
Polyvinyl alcohol, partially hydrolyzed
Titanium dioxide (E 171)
Talc
Iron oxide yellow (E 172)
Lecithin (soy)
Iron oxide red (E 172)
Xanthan gum
Iron oxide black (E 172)

Tablet with acetylsalicylic acid:
Microcrystalline cellulose
Corn starch
Anhydrous colloidal silicon dioxide
Stearic acid

Capsule shell:
Gelatin
Titanium dioxide (E 171)
Indigotine (E 132)
Iron oxide yellow (E 172)

Black ink:
Shellac
Propylene glycol
Ammonium hydroxide, solution
Iron oxide black (E 172)
Potassium hydroxide

What Zahron ASA Looks Like and Contents of the Packaging
Zahron ASA 5 mg + 100 mg: hard gelatin capsules of size 2, with an opaque white body and a dark green opaque cap. Each capsule contains one white or almost white, oval, biconvex, uncoated tablet of acetylsalicylic acid and one coated, brown, biconvex, round tablet of 5 mg rosuvastatin.
Zahron ASA 10 mg + 100 mg: hard gelatin capsules of size 1, with an opaque white body printed in black with "ASA 100" and a light green opaque cap printed in black with "RSV 10". Each capsule contains one white or almost white, oval, biconvex, uncoated tablet of acetylsalicylic acid and one coated, brown, biconvex, round tablet of 10 mg rosuvastatin.
Zahron ASA 20 mg + 100 mg: hard gelatin capsules of size 0, with an opaque white body printed in black with "ASA 100" and a green opaque cap printed in black with "RSV 20". Each capsule contains one white or almost white, oval, biconvex, uncoated tablet of acetylsalicylic acid and two coated, brown, biconvex, round tablets of 10 mg rosuvastatin.

Zahron ASA is available in blister packs containing 10, 28, 30, 56, 60, 90, or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in 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 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