Rompirin E, 100 mg, 30 gastro-resistant tablets, Antibiotice SA

Indications:
Rompirin E inhibits the adhesion and aggregation of blood platelets (thrombocytes) and thus prevents the formation of developing blood clots (thrombi) (inhibition of platelet aggregation).

Rompirin E is used:
- to reduce the risk of mortality in patients with suspected acute myocardial infarction,
- to reduce the risk of morbidity and mortality in patients with a history of myocardial infarction,
- for secondary prevention of stroke,
- to reduce the risk of transient ischemic attacks (TIA) and stroke in patients with TIA,
- to reduce the risk in patients with stable and unstable angina pectoris,
- for the prophylaxis of thromboembolism after vascular surgery or surgical interventions, e.g. PTCA (Percutaneous Transluminal Coronary Angioplasty), CABG (Coronary Bypass), carotid endarterectomy, arteriovenous shunts,
- to reduce the primary risk of myocardial infarction in people with cardiovascular risk factors, e.g. diabetes mellitus, dyslipidemia, hypertension, obesity, smoking, advanced age.
- for the prophylactic inhibition of platelet aggregation in coronary aneurysm.

Rompirin E tablets contain low doses of acetylsalicylic acid and are not suitable for use in reducing inflammation, fever or pain. These effects occur with the use of higher doses of acetylsalicylic acid.

Composition:
One tablet contains acetylsalicylic acid 100 mg and excipients: microcrystalline cellulose, pregelatinized starch, stearic acid, acryl Eze 93018359.

Method of administration:
The recommended daily dose is 1-2 gastro-resistant tablets of Rompirin E (equivalent to 100-200 mg acetylsalicylic acid) or the equivalent of 300 mg acetylsalicylic acid at intervals of 2 days. The tablets should be taken after meals and swallowed whole with a sufficient amount of liquid (e.g. a glass of water).

Precautions and contraindications:
Do not use Rompirin E
- if you are allergic (hypersensitive) to acetylsalicylic acid, other salicylates or any of the other ingredients of Rompirin E;
- if you have had bronchial asthma related to the use of salicylates or related substances, especially non-steroidal anti-inflammatory drugs;
- if you have a tendency to bleed, low platelet count in the blood, hemophilia;
- if you have an ongoing gastric or duodenal ulcer;
- if you have severe liver or kidney failure;
- if you have severe heart failure;
- if you use Rompirin E concomitantly with methotrexate in doses ≥15 mg/week.
- if you are in the last trimester of pregnancy (see section Pregnancy and breast-feeding)
- if you have hypersensitivity to analgesics/anti-inflammatory/anti-rheumatic drugs and in the presence of other allergies;
- if you have other allergies (e.g. skin reactions, itching, hives);
- if you have bronchial asthma, hay fever, swelling of the nasal mucosa (nasal polyps) or chronic respiratory tract diseases;
- if you are receiving concomitant treatment with anticoagulant drugs (e.g. coumarin derivatives, heparin - except for treatment with low-dose heparin);
- if you have a history of gastrointestinal ulcers, including chronic or recurrent ulcers or a history of gastrointestinal bleeding;
- if you have severe liver failure;
- if you have renal failure or cardiovascular circulatory failure (e.g. renal vascular disease, congestive heart failure, hypovolemia, major surgery, sepsis or major bleeding events), as acetylsalicylic acid may further increase the risk of renal failure and acute renal failure;
- if you need to have surgery (including minor surgery such as tooth extractions): an increased tendency to bleed may occur. Please inform your dentist if you have taken Rompirin E;
- if you suffer from congenital glucose-6-phosphate dehydrogenase (G6PD) deficiency, acetylsalicylic acid may induce haemolysis or haemolytic anaemia. Factors that may increase the risk of haemolysis are, for example, high doses, fever or acute infections.
At low doses, acetylsalicylic acid reduces the excretion of uric acid. This can cause gout attacks in predisposed patients.
If you cut or injure yourself, it may take longer than usual for the bleeding to stop. This is due to the way Rompirin E works. Minor cuts and wounds (for example, when shaving) are generally not serious. If you have unusual bleeding (in an unusual place or for an unusual length of time), see your doctor.

Children and adolescents:
Rompirin E should not be taken by children or adolescents unless a doctor has prescribed this medicine for them and other therapeutic measures have failed.
Prolonged vomiting related to such illnesses could be a sign of Reye's syndrome, a very rare, life-threatening illness that requires immediate medical attention.

Rompirin E with other medicines:
The effect of some medicines or groups of substances administered concurrently may affect the effect of treatment with Rompirin E.
- Anticoagulants (e.g. coumarin, heparin) and thrombolytic drugs: acetylsalicylic acid may increase the risk of bleeding if taken before anticoagulant treatment. You should therefore be alert to signs of internal or external bleeding (e.g. bruising) if they occur during such treatment;
- Other platelet aggregation inhibitors (medicines that inhibit aggregation together with platelets) e.g. ticlopidine, clopidogrel: increased risk of bleeding;
- Medicines containing cortisone or cortisone-like substances (except products that are applied topically or cortisone for replacement therapy for Addison's disease): increased risk of gastrointestinal side effects.
- Alcohol: increased risk of gastrointestinal ulcers and bleeding.
- Other analgesics and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs), as well as other antirheumatic drugs in general: increased risk of gastrointestinal ulcers and bleeding.
- Antidiabetic: blood sugar levels may be reduced.
- Digoxin (a medicine that strengthens the contraction of the heart muscle).
- Methotrexate (a medicine used to treat cancer and some rheumatic diseases).
- Valproic acid (a medicine for the treatment of brain seizures [epilepsy]).
- Selective serotonin reuptake inhibitors (medicines for the treatment of depression): increased risk of gastrointestinal bleeding.
- Certain medicines increase urine excretion (diuretics so-called aldosterone antagonists, e.g. spironolactone and canrenoate, and loop diuretics, e.g. furosemide).
- Certain antihypertensive drugs (especially ACE inhibitors).
- Gout remedies that increase uric acid excretion (e.g. probenecid, benzbromarone).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Rompirin E with food and alcohol
Do not use Rompirin E with alcohol, as it may increase the risk of gastrointestinal bleeding.

Pregnancy and breastfeeding:
Task
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
During the first and second trimester of pregnancy, Rompirin E can only be taken if your doctor has recommended it. During the last trimester of pregnancy, acetylsalicylic acid, the active ingredient of
Rompirin E should not be taken in doses higher than 150 mg per day due to an increased risk of complications for the mother and baby before and during birth (see also “Do not use
Rompirin E”). In the last trimester of pregnancy, doses of up to 150 mg of acetylsalicylic acid per day can only be taken if prescribed by your doctor.

breast-feeding
Small amounts of acetylsalicylic acid and its active metabolites pass into breast milk. No negative effects on the child have been reported so far, it is therefore not necessary to interrupt breastfeeding, but the daily dose should not exceed 150 mg. In case of taking higher doses (more than 150 mg per day), the patient should discontinue breastfeeding.

Driving and using machines:
Rompirin E does not affect the ability to drive and use machines.

Presentation:
30 gastro-resistant tablets

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.