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. Therefore, the frequencies are referenced as indeterminate.

Blood and lymphatic system disorders

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

· Gastrointestinal and intracranial hemorrhages may also occur. In some cases, the vital prognosis may be threatened. An 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, angioedema.

Metabolism and nutrition disorders

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

Central nervous system disorders

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

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

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

· Intracranial hemorrhage which 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 which 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 tract 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 may be the cause of bleeding. This digestive bleeding can cause acute or chronic anemia.

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

· The digestive toxicity of AAS is dose-dependent and exists from the 75 mg dose. 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; the bleeding may 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 a history of serious gastrointestinal conditions.

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

Hepatobiliary disorders

· Elevations of liver enzymes, liver damage mainly hepatocellular.

· Chronic hepatitis.

Skin and subcutaneous tissue disorders

· Urticaria, skin reactions.

· Fixed drug eruption.

Renal and urinary disorders

· Renal insufficiency.

Reproductive system and breast disorders

· Hematospermia.

General disorders and administration site conditions

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

· Edema has been reported for high doses (anti-inflammatory doses) of acetylsalicylic acid.

a The formation of diaphragm-like intestinal stenoses has been reported following chronic use.

Reporting of suspected adverse reactions

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