KARDEGIC

Prevention of cardiovascular and cerebrovascular complications related to atherosclerosis in high vascular risk patients with confirmed ischemic arterial disease (see section 5.1).

Reduction of graft occlusion after aortocoronary bypass.

Prevention of cerebrovascular accidents in patients with atrial fibrillation for whom vitamin K antagonist treatment is contraindicated or not indicated, after assessment of benefit and risk (cf. section 5.1).

No effect on the ability to drive vehicles and use machines has been observed.

The frequency of adverse effects cannot be estimated. As a result, frequencies are referenced as undetermined.

Hematological and lymphatic system disorders

Hematological effects:

· Hemorrhagic syndromes (hematoma, urogenital hemorrhage, epistaxis, gingivorrhagia, purpura...) with increased bleeding time. This action persists 4 to 8 days after stopping aspirin. It can create a hemorrhagic risk in case of surgical intervention.

· Gastrointestinal and intracranial hemorrhages may also occur. In certain cases, life may be at risk. Intracranial hemorrhage can be fatal, particularly in elderly subjects.

· Thrombocytopenia, pancytopenia, bicytopenia, aplastic anemia, bone marrow failure, agranulocytosis, neutropenia, leukopenia.

· Hemolytic anemia in patients with G6PD deficiency (see section 4.4).

Immune system disorders

· Hypersensitivity reactions, anaphylactic reactions, asthma, bronchospasm, Quincke's edema.

Metabolism and nutrition disorders

· Low-dose AAS can reduce the excretion of uric acid, which may lead to a gout attack in predisposed patients.

Nervous system disorders

· Tinnitus which may appear during long-term treatments with high doses and which is usually a sign of overdose (see section 4.9).

· Sensation of decreased hearing acuity which generally constitutes the first sign of an overdose, see section 4.9,

· Headache, dizzy sensation which may appear during long-term treatments with high doses. In case of dizziness, treatment must be stopped immediately.

· Intracranial hemorrhage can be fatal, particularly in elderly subjects.

Cardiac disorders

· Kounis syndrome in the context of a hypersensitivity reaction to acetylsalicylic acid.

Vascular disorders

· Vasculitis including Henoch-Schönlein purpura.

· Hemorrhages can be fatal.

Respiratory, thoracic and mediastinal disorders

· Non-cardiogenic pulmonary edema possible in case of long-term use which may also appear in the context of a hypersensitivity reaction related to acetylsalicylic acid.

· Bronchospasm and asthma.

Gastrointestinal disorders

· Upper gastrointestinal disorders: digestive symptoms such as abdominal pain, dyspepsia, hyperacidity have been reported. Lesions such as esophagitis, esophageal ulceration, erosive gastritis, erosive duodenitis, gastric or duodenal ulcer or even digestive perforation are described, which can be the cause of bleeding. This digestive bleeding can cause acute or chronic anemia.

· Lower gastrointestinal disorders such as small intestine ulcers (jejunum, ileum) and large intestine (colon, rectum), colitis and intestinal perforation have also been described; as well as the formation of diaphragm-like intestinal stenoses at an undetermined frequency.

· The digestive toxicity of AAS is dose-dependent and exists from the dose 75 mg. Prolonged intake of aspirin can induce gastritis, gastroduodenal erosions or the extension of pre-existing ulcerative lesions. The hemorrhage that may appear is aggravated by the anti-thrombotic action of aspirin; bleeding can be asymptomatic (hematemesis and melena are rare); more frequently chronic anemia is observed.

These reactions can occur in patients with or without warning signs or serious gastrointestinal history.

· Acute pancreatitis in the context of a hypersensitivity reaction to acetylsalicylic acid.

Hepatobiliary disorders

· Elevations of liver enzymes, primarily hepatocellular liver involvement.

· Chronic hepatitis.

Skin and subcutaneous tissue disorders

· Urticaria, skin reactions.

· Fixed pigment erythema.

Renal and urinary disorders

· Renal failure.

Reproductive system and breast disorders

· Hematospermia.

General disorders and administration site abnormalities

· Reye syndrome (particularly in children and adolescents with signs of viral infections (particularly chickenpox and flu-like episodes) - see section 4.4).

· Edemas have been reported for high doses (anti-inflammatory doses) of acetylsalicylic acid.

a The formation of diaphragmatic intestinal stenoses has been reported following chronic use.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr/