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
Rosuvastatin + Acetylsalicylic acid
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for the patient.
- You should keep this leaflet, so that you can read it again if you need to.
- If you have any further questions, you should 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 symptoms are the same as yours.
- If you experience any side effects, including those not listed in this leaflet, you should tell your 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 - rosuvastatin and acetylsalicylic acid.
- Rosuvastatin 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 on their own have not been enough. Cholesterol is a fatty substance that can cause narrowing of the blood vessels in the heart, leading to coronary artery disease. If you are at risk of having another heart attack, rosuvastatin can also be used to reduce this risk, even if your cholesterol level is normal. You should keep to a standard cholesterol-lowering diet while taking this medicine.
- 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 can block the flow of blood and cut off the supply of oxygen. If this happens in the heart, it can cause a heart attack or angina. These two active substances taken together reduce the risk of having another heart attack if you have had a heart attack or if you have had episodes of chest pain (unstable angina). Zahron ASA is indicated for patients who are already taking rosuvastatin and acetylsalicylic acid in these doses. Instead of taking rosuvastatin and acetylsalicylic acid as separate tablets, the patient receives one capsule of Zahron ASA containing both ingredients at the same strength as previously used.
2. Important information before taking Zahron ASA
When not to take Zahron ASA:
- If you are 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 you have been diagnosed with hypersensitivity to peanuts or soya (see below).
- If you are pregnant or breastfeeding, or if you become pregnant while taking Zahron ASA, you should stop taking it immediately and inform your doctor. Women should avoid becoming pregnant while taking Zahron ASA by using appropriate contraception.
- If you have liver disease.
- If you have severe kidney disease.
- If you have had repeated or unexplained muscle pain, muscle problems in you or your family, or muscle problems while taking other cholesterol-lowering medicines.
- If you are taking a combination of sofosbuvir/velpatasvir/voxilaprevir (used to treat a viral infection of the liver called hepatitis C).
- If you are taking a medicine called ciclosporin (used, for example, after organ transplantation).
- If you have had an asthma attack or swelling of some parts of the body (e.g. face, lips, throat or tongue) after taking salicylates or NSAIDs.
- If you have had stomach or duodenal ulcers or any other bleeding, such as a stroke.
- If you have had bleeding disorders.
- If you have gout.
- If you have uncontrolled heart failure.
- If you are taking a medicine called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses greater than 15 mg per week.
- If you have had a severe skin rash or peeling and blistering of the skin and mucous membranes after taking Zahron ASA or other similar medicines.
Warnings and precautions
You should discuss the use of Zahron ASA with your doctor or pharmacist before starting treatment
- If you have kidney problems.
- If you have liver problems.
- If you have had repeated or unexplained muscle pain, muscle problems in you or your family, or muscle problems while taking other cholesterol-lowering medicines. You should tell your doctor immediately if you experience unexplained muscle pain, especially if you feel unwell or have a fever. You should also tell your doctor if you experience 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 your cholesterol level. You should carefully read the leaflet, even if you have taken other cholesterol-lowering medicines before.
- If you are taking medicines for HIV infection, e.g. ritonavir with lopinavir and/or atazanavir, see "Zahron ASA with other medicines".
- If you are taking or have taken in 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 serious muscle problems (rhabdomyolysis); see "Zahron ASA with other medicines".
- It is possible that the risk of side effects affecting the muscles may be higher when daptomycin is taken during treatment with Zahron ASA. Your doctor will decide whether to stop daptomycin or temporarily discontinue Zahron ASA.
and
- If you have severe respiratory failure.
- If you are over 70 years old.
- If you are of Asian origin (i.e. Japan, China, Philippines, Vietnam, Korea and India). Your doctor will choose an appropriate starting dose of Zahron ASA for you.
- If you currently have or have had stomach or duodenal ulcers or bleeding (gastrointestinal bleeding).
- If you are taking non-steroidal anti-inflammatory drugs (NSAIDs) at the same time, such as ibuprofen and naproxen (painkillers, antipyretics or anti-inflammatory drugs).
- 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 painkillers and anti-inflammatory drugs, other anti-rheumatic drugs or other allergens.
- If you have other allergies (e.g. skin reactions, itching).
- If you are 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, major surgery, blood poisoning or increased bleeding): acetylsalicylic acid may further increase the risk of kidney function disorders and acute kidney failure.
- If you have heavy menstrual bleeding.
- If you have or have 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 the symptoms of the disease or lead to the development of myasthenia (see section 4).
You should immediately consult a doctor if your symptoms worsen or if you 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 (clumping of blood cells and formation of a clot) if these medicines are taken at the same time. 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 blood test that detects elevated liver enzyme activity. For this reason, your doctor will usually recommend that you have this blood test (liver function test) before and during treatment with Zahron ASA.
During treatment with this medicine, your doctor will closely monitor your condition if you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is likely if you have high blood sugar and fat levels, are overweight and have high blood pressure.
You should be careful not to become dehydrated (you may feel thirsty with dry mouth) as taking acetylsalicylic acid at the same time may worsen kidney function.
You should inform your doctor if you are planning to have 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 due to the effect of acetylsalicylic acid. Minor injuries and trauma (e.g. during shaving) are usually not significant. If you experience unusual bleeding (in an unusual location or lasting longer than usual), you should contact your doctor.
With the use of rosuvastatin, serious skin reactions have been reported, including Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS). If you experience any of the symptoms described in section 4, you should stop taking Zahron ASA and contact your 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 with other medicines
You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you 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 levels of uric acid 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, 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,
- roksadustat (used to treat anemia in patients with chronic kidney disease),
- daptomycin (an antibiotic, see "Warnings and precautions"),
- tafamidis (used to treat a disease called transthyretin amyloidosis),
- itraconazole (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 (ciclosporin, 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 stomach ulcers.
- gout (e.g. probenecid, benzbromarone),
- glaucoma (acetazolamide),
- cancer or rheumatoid arthritis (methotrexate; at doses less than 15 mg per week),
- medicines that lower blood sugar levels (anti-diabetic 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 cortisol replacement therapy for Addison's disease) or for the treatment of inflammatory conditions, including rheumatic diseases and inflammatory bowel disease (corticosteroids). Concomitant 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 you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking Zahron ASA. Your doctor will tell you when you can safely restart taking this medicine. Taking Zahron ASA with fusidic acid may rarely lead to weakness, tenderness or pain in the muscles (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
You should not take Zahron ASA if you are pregnant or breastfeeding. If you become pregnant while taking Zahron ASA, you should stop taking it immediately and inform your 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, you should not drive or operate machinery and should contact your doctor immediately.
Zahron ASA contains lactose
If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
Zahron ASA contains soya oil
Do not take if you are hypersensitive to peanuts or soya.
3. How to take Zahron ASA
You should always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, you should ask your doctor or pharmacist.
Adults
Your doctor will determine the appropriate dose for you, depending on your 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.
This 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 you are hospitalized or treated for another disease, you should inform the medical staff that you are taking Zahron ASA.
Taking Zahron ASA in elderly patients
No dose adjustment is necessary in elderly patients
Taking Zahron ASA in children and adolescents
Zahron ASA should not be used in children and adolescents.
Patients with kidney problems
No dose adjustment is 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
You should consult a doctor or the nearest hospital for advice.
Missing a dose of Zahron ASA
You should not worry. If you miss a capsule, you should skip that dose completely.
The next dose should be taken at the right time. You should not take a double dose to make up for a missed dose.
Stopping treatment with Zahron ASA
Your doctor will tell you how long to take the medicine. If you stop taking Zahron ASA, your cholesterol level may rise again. If you stop taking the medicine without getting proper advice from your doctor, your condition may worsen.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should stop taking Zahron ASA and seek medical help immediately if you 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 and/or swallowing difficulties
- Severe skin reactions, including intense rash, hives, redness of the skin all over the body, severe itching, blistering and peeling of the skin, mucous membrane inflammation (Stevens-Johnson syndrome) or other allergic reactions
- If you experience black stools or vomit blood (signs of severe stomach bleeding).
- Red, flat, round or oval patches 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 serious skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
- Widespread rash, high fever and enlarged lymph nodes (DRESS syndrome or hypersensitivity syndrome).
You should also stop taking Zahron ASA and contact your doctor immediately:
- if you experience unusual muscle painthat lasts longer than expected. Like other statins, rosuvastatin has caused unpleasant muscle effects in a very small number of patients, which in rare cases have led to potentially life-threatening muscle damage, known as rhabdomyolysis.
- if you experience muscle rupture.
- If you experience a condition similar to lupus (including rash, joint disorders and effects on blood cells).
Side effects have been reported. If any of them cause you trouble or last longer than a week, you should contact your doctor.
ROSUVASTATIN
Common(occurring in less than 1 in 10 people):
- Headache.
- Abdominal pain.
- Constipation.
- Nausea.
- Muscle pain.
- Feeling weak.
- Dizziness.
- Diabetes. It is more likely to occur if you have high blood sugar and fat levels, are overweight and have high blood pressure. Your doctor will monitor your condition while you are taking this medicine.
Uncommon(occurring in less than 1 in 100 people):
- Rash, itching, hives or other skin reactions.
- Increased amount of protein in the urine - usually goes away on its own without the need to stop taking the capsules of Zahron ASA (only doses 5-20 mg).
Rare(occurring in less 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). If you suspect an allergic reaction, you should stop takingZahron ASA and seek medical help immediately.
- Muscle damage in adults - as a precaution, you should stop takingZahron ASA and contact your doctor immediatelyif you experience 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).
- A condition similar to lupus (including rash, joint disorders and effects on blood cells).
Very rare(occurring in less 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.
- Gynaecomastia (breast enlargement in men).
Frequency not known(cannot be estimated from the available data):
- Diarrhoea (loose stools).
- Cough.
- Shortness of breath.
- Swelling (oedema).
- Sleep disorders, including insomnia and nightmares.
- Sexual problems.
- Depression.
- Breathing problems, including persistent cough and/or shortness of breath or fever.
- Tendon damage.
- A 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). You should talk to your doctor if you experience muscle weakness in your arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.
If you experience any of these side effects or any other side effects not listed in this leaflet, you should tell your doctor or pharmacist.
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist or nurse. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.
5. How to store Zahron ASA
The medicine should be stored out of the sight and reach of children.
You should not take this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Store in a temperature not exceeding 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
6. Contents of the packaging and other information
What Zahron ASA contains
The active substances of Zahron ASA are rosuvastatin (in the form of rosuvastatin calcium) and acetylsalicylic acid.
Zahron ASA 5 mg + 100 mg: each hard capsule contains 5 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
Zahron ASA 10 mg + 100 mg: each hard capsule contains 10 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
Zahron ASA 20 mg + 100 mg: each hard capsule contains 20 mg of rosuvastatin (in the form of rosuvastatin calcium) and 100 mg of acetylsalicylic acid.
The other ingredients are:
Coated tablet with rosuvastatin:
Core of the tablet
Lactose monohydrate
Microcrystalline cellulose
Heavy magnesium oxide
Crospovidone (type A)
Silica, colloidal, anhydrous
Magnesium stearate
Coating of the tablet
Partially hydrolyzed polyvinyl alcohol
Titanium dioxide (E 171)
Talc
Yellow iron oxide (E 172)
Soya lecithin
Red iron oxide (E 172)
Black iron oxide (E 172)
Tablet with acetylsalicylic acid:
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 a dark green opaque cap. Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one coated, brown, biconvex, round tablet of rosuvastatin 5 mg
Zahron ASA 10 mg + 100 mg: hard gelatin capsules, size 1, with a white opaque body with black print "ASA 100" and a light green opaque cap with black print "RSV 10". Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and one coated, brown, biconvex, round tablet of rosuvastatin 10 mg
Zahron ASA 20 mg + 100 mg: hard gelatin capsules, size 0, with a white opaque body with black print "ASA 100" and a green opaque cap with black print "RSV 20". Each capsule contains one white or almost white, biconvex, oval, uncoated tablet of acetylsalicylic acid and two coated, brown, biconvex, round tablets of rosuvastatin 10 mg
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 hard capsules
ROSIX DUO 10 mg/100 mg hard capsules
ROSIX DUO 20 mg/100 mg hard capsules
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 hard capsules
BELOROSTIN 10 mg/100 mg hard capsules
BELOROSTIN 20 mg/100 mg hard capsules
Spain:
Roasax 5 mg/ 100 mg hard capsules
Roasax 10 mg/ 100 mg hard capsules
Roasax 20 mg/ 100 mg hard capsules
Greece:
ROSU-ASA
Cyprus:
ROSU-ASA
Date of last revision of the leaflet: 04.2025