· Prevention of secondary cardiovascular and cerebrovascular complications in patients with atheromatous disease, ischemic stroke (eg, myocardial infarction, stable and unstable stroke, ischemic stroke or ischemic stroke)

· Prevention of thromboembolic events, after surgery or vascular intervention such as: transluminal coronary angioplasty, coronary artery bypass grafting, carotid endarterectomy, shunt, arteriovenous. >
· Reduction of graft occlusion after bypass surgery, aortocoronary

This medication is not recommended in emergency situations. It is reserved for after-care treatment and management of emergency situations.

Reserved for adults: Oral use

The tablets should be swallowed whole with sufficient beverage (1/2 glass of water).

Due to the enteric coating, the tablets must not be crushed, broken or chewed.

The coating prevents the local irritant effects on the stomach mucosa.

In chronic treatment

The recommended dosage is 100 mg to 300 mg per day to be swallowed with a glass of water, preferably before meals.
Subject: aged

In general, acetylsalicylic acid should be used with caution in elderly people who are more prone to adverse effects. The usual adult dose is recommended in the absence of severe renal or hepatic impairment (see section 4.3). Treatment should be reviewed regularly.

Population, pediatric

Acetylsalicylic acid should not be administered to children and adolescents under 16 years of age except on medical advice and when the benefit outweighs the risk (see Warnings and Precautions for Use).

White film-coated tablet with a diameter of 7 mm.

ANTI-THROMBOTICS / INHIBITORS OF PLATELET AGREGATION, HEPARIN EXCLUDED

(B01AC06: blood, organs, hematopoietics)

Aspirin is an inhibitor of platelet activation: by blocking platelet cyclooxygenase by acetylation, it inhibits the synthesis of thromboxane A2, a physiological activating substance, released by platelets, and which would play a role in Complications of lesions, atheromatous.

Repeated doses of 20-325-330 mg result in inhibition of enzyme activity of 30-95%. Beyond 325-330 mg, the inhibitory activity increases only very little, and the effect on platelet aggregation is almost identical.

The inhibitory effect is not exhausted, during prolonged treatment and the enzyme activity is progressively resumed as the platelets are renewed 24 to 48 hours after the end of treatment. Br>

At the recommended dosage, aspirin reduces the synthesis of prostacyclin, but the clinical significance of this action is obscure and less important in practice than in theory, it seems. >

Aspirin increases bleeding time by about 50 to 100% on average, but individual variations can be observed.

Experimental evidence suggests that ibuprofen may inhibit the platelet anti-aggregation effect of a low dose of aspirin when taken concomitantly. A study with a single dose of 400 mg of ibuprofen taken 8 hours before or within 30 minutes after taking 81 mg of immediate-release aspirin showed a decrease in the effect of ibuprofen, Aspirin on the formation of thromboxane or platelet aggregation. However, the limitations of these ex vivo data and the uncertainties with regard to their extrapolation in clinical practice do not make it possible to give a formal conclusion as to the regular use of ibuprofen, The occurrence of a clinically relevant effect appears to be unlikely (see Interactions with other medicinal products and other forms of interactions.)
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Six primary prevention studies (aspirin versus placebo) were performed in people at risk, with cardiovascular conditions generally low to moderate. The meta-analysis of these 6 studies showed a significant decrease in cardiovascular events (on the order of 3 per 1,000) at the price of a tendency to increase accidents, severe haemorrhagic (estimated at 2 For 1000). However, the populations of the studies included in the meta-analysis are too heterogeneous to determine in which patients the aspirin has a favorable risk-benefit ratio in primary prevention. The benefit, if any, of aspirin treatment in primary prevention in high-risk individuals should therefore be weighed against the increased risk of hemorrhage, particularly in the elderly, where this hemorrhagic risk is increased.

A 2-year, double-blind, double-blind, CLIPS study compared the efficacy of aspirin (at a dose of 100 mg) with high doses of antioxidant ( 300 mg of vitamin E, 250 mg of Vitamin C and 10 mg of beta-carotene) to placebo in patients with Stage III or IV Lower Arterial Disease (AOMI) (or peripheral arterial disease) . The primary endpoint was the incidence of fatal and nonfatal vascular events, as well as ischemia of the lower limbs. 366 patients (185 patients in the aspirin group and 181 in the placebo group) were included. The results show that aspirin significantly reduces the risk of vascular accidents by 64% (p '= 0.016 or HR' = 0.35 (95% CI, 0.15-0.82)).

The antithrombotic meta-analysis of the 2002 Trialists' Collaboration evaluated the effect of antiplatelet therapy compared to the absence of such treatment in 195 randomized trials involving 135,640 patients Vascular risk. The results show a significant decrease (p

Unless absolutely necessary, ASA should not be prescribed during the first 2 trimesters of pregnancy (first 24 weeks, amenorrhea). If ASA is administered to a woman wishing to be pregnant or pregnant less than 6 months (during the first 24 weeks of amenorrhoea), the dose should be as low as possible and the duration of treatment Short, possible.

After 24 weeks of amenorrhea (5 months) all inhibitors of prostaglandin synthesis may expose the fetus to
Cardiopulmonary toxicity (with closure, premature ductus arteriosus and pulmonary arterial hypertension)

· Renal dysfunction that may progress to renal failure associated with an oligohydroamnios

At the end of pregnancy, the mother and the newborn can present

· An increase in bleeding time due to an antiaggregant action which may occur even after very low doses of drug

· Inhibition of uterine contractions resulting in delayed delivery or prolonged childbirth

As a result, ASA at doses of 100 mg daily or more is contraindicated, beyond 24 weeks of amenorrhea (5 months) (see Contraindications). >

Breastfeeding

Acetylsalicylic acid passing through breast milk is not recommended during breast-feeding.

The frequency of undesirable effects can not be estimated. Because of this, the frequencies are referenced as: undetermined.

Immune system disorders

Reactions: hypersensitivity, anaphylactic reactions, asthma, bronchospasm, angioedema, rhinitis, skin rash, urticaria, and sometimes cardio-respiratory distress or even anaphylactic shock.
Hematologic and lymphatic system disorders

Hematological effects: Hemorrhagic syndromes (hematoma, haemorrhage, urogenital, 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 surgery. Gastrointestinal and intracranial haemorrhages may also occur (particularly in patients with uncontrolled hypertension).
Severe hemolytic accidents have been observed following administration, high doses of ASA in subjects with a deficit, G6PD

Disorders, metabolism and nutrition

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

Central nervous system disorders

Effects on the nervous system Central: headache, dizziness, sensation of hearing loss, ringing in the ear, usually the first signs of overdose (see section 4.3).

Hemorrhage, intracranial.

Gastrointestinal disorders

Digestive symptoms such as abdominal pain, dyspepsia, hyperacidity have been reported. Such lesions as gastritis, gastric or duodenal ulcer, or even digestive perforation are described, which may be at the origin of bleeding. This bleeding, digestive may cause acute or chronic anemia.

The digestive toxicity of ASA is dose-dependent and exists as soon as 75 mg dose. Prolonged intake of aspirin may induce gastritis, gastroduodenal erosions or extension of pre-existing ulcer 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

Hepatobiliary disorders

Elevations of enzymes, hepatic, liver damage mainly, hepatocellular (hepatic impairment)

Skin and subcutaneous tissue disorders

Urticaria, reactions, cutaneous, severe (exudative erythema multiforme).

Renal and urinary tract disorders

Acute renal failure, especially in patients with pre-existing renal insufficiency, cardiac decompensation, or treatment, concomitant diuretic

Disorders, general and administration site abnormalities

Reye Syndrome (see Warnings and Precautions),

Declaration of undesirable effects

The declaration of undesirable effects suspected of being due to a drug after authorization is important., It allows continuous monitoring of the ratio, benefit / risk of the drug. Health professionals are required to report any suspected adverse reactions to a medicinal product at the regional pharmacovigilance center on which they are dependent and whose contact details are available on the website of the ANSM. Code>
Prevention of secondary cardiovascular and cerebrovascular complications in patients with atheromatous disease, ischemic stroke (eg myocardial infarction, stable and unstable angina, stroke, constituted or transient, ischemic origin). Prevention of thromboembolic events after surgery or vascular intervention such as angioplasty, transluminal coronary angioplasty, coronary artery bypass grafting, carotid endarterectomy, shunt, arteriovenous occlusion Reduction of graft occlusion after bypass, aortocoronary Is not recommended in emergency situations. It is reserved for after-care treatment and management of emergency situations.