TERAPIA

ASPENTER 100MG X 28 TABLETS

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Composition

The active substance is acetylsalicylic acid. One gastro-resistant tablet contains 100 mg acetylsalicylic acid. The other components are: core - microcrystalline cellulose (type PH 112), pregelatinized starch, stearic acid, anhydrous colloidal silicon dioxide; film - talc, methacrylic acid-ethyl acrylate copolymer (as 30% dispersion), triethyl citrate, simethicone emulsion (as 30% aqueous dispersion), red iron oxide (E172).

Therapeutic indications

Aspenter 100 mg inhibits the adhesion and aggregation of blood platelets (thrombocytes) and thus prevents the formation of developing blood clots (thrombi) (inhibition of platelet aggregation).

Aspenter 100 mg is used:

• To reduce the risk of mortality in patients suspected of acute myocardial infarction
• To reduce the risk of morbidity and mortality in patients with a history of myocardial infarction
• For secondary prophylaxis of stroke
• To reduce the risk of transient ischemic attacks (TIAs) and stroke in patients with TIAs
• To reduce the risk in patients with stable and unstable angina pectoris
• For prophylaxis of thromboembolism after vascular surgery or surgical interventions, for example, PTCA (percutaneous transluminal coronary angioplasty), CABG (coronary artery bypass grafting), carotid endarterectomy, arteriovenous shunts
• For prophylaxis of deep vein thrombosis and pulmonary embolism after long-term immobilization, for example, after major surgery
• To reduce the primary risk of myocardial infarction in individuals with cardiovascular risk factors, for example, diabetes mellitus, hyperlipidemia, hypertension, obesity, smoking, advanced age
• For prophylactic inhibition of platelet aggregation in coronary aneurysm.

Contraindications/Warnings

Do not use Aspenter 100 mg

• If you are allergic to acetylsalicylic acid, other salicylates or any of the other ingredients of this medicine
• If you have a history of reacting to certain pain, fever or inflammation medications (salicylates or other non-steroidal anti-inflammatory drugs), with asthma attacks or other hypersensitivity (allergy);
• If you have a gastric or duodenal ulcer;
• If you have an abnormally increased tendency to bleed (hemorrhagic diathesis);
• If you have liver disease or kidney failure;
• If you have severe heart failure for which you are not receiving adequate treatment;
• If you are taking 15 mg methotrexate or more per week concurrently;
• If you are in the last trimester of pregnancy

Dosage and administration

Always use exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Unstable angina pectoris, prophylaxis of myocardial infarction recurrence, after vascular surgery, prophylaxis of transient ischemic attacks (TIAs) and cerebral infarction:

The recommended daily dose is 100-300 mg acetylsalicylic acid per day (1-3 gastro-resistant tablets of Aspenter 100 mg per day).

Acute myocardial infarction:

The recommended daily dose is 1-3 gastro-resistant tablets of Aspenter 100 mg (equivalent to 100-300 mg acetylsalicylic acid per day).

Prophylaxis of venous thrombosis and pulmonary embolism:

The recommended daily dose is one Aspenter 100 mg tablet (equivalent to 100 mg acetylsalicylic acid).

Prophylaxis of coronary vessel thrombosis in patients with multiple risk factors:

The recommended daily dose is 1-2 Aspenter 100 mg tablets (equivalent to 100-200 mg acetylsalicylic acid) or 3 Aspenter 100 mg tablets (equivalent to 300 mg acetylsalicylic acid) at 2-day intervals.

Tablets should be taken after meals and swallowed whole with a sufficient amount of liquid (e.g., a glass of water).

For the treatment of acute myocardial infarction, the first gastro-resistant tablet should be crushed or chewed.

Special warnings

Please note that acetylsalicylic acid should not be taken with alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you discover that you have become pregnant during treatment with Aspenter 100 mg, you must contact your doctor immediately. In the first and second trimesters of pregnancy, Aspenter 100 mg can only be taken if your doctor has recommended it. In the last trimester of pregnancy, acetylsalicylic acid, the active ingredient of Aspenter 100 mg, should not be taken in doses greater than 150 mg per day, due to an increased risk of complications for the mother and child before and during birth. In the last trimester of pregnancy, doses of up to 150 mg acetylsalicylic acid per day can only be taken if prescribed by your doctor.

Breastfeeding

Small amounts of acetylsalicylic acid and its active metabolites pass into breast milk. No negative effects on the child have been reported to date, therefore it is not necessary to interrupt breastfeeding, but the daily dose should not exceed 150 mg. If you take higher doses (more than 150 mg per day), the patient should stop breastfeeding.

Driving and using machines

Aspenter 100 mg does not affect your ability to drive or operate machinery.

Packaging

Box with 4 oPA-Al-PVC/Al blisters, each containing 7 gastro-resistant tablets.

Page updated on: 09.06.2021