Medicinal Products

ASPIRINE PROTECT 100 mg

Generic drug of the therapeutic class: Haemostasis and blood
active ingredients: Acetylsalicylic acid
laboratory: Bayer Healthcare

Gastroresistant tablet
Box of 30
All forms

Indication

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

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

· Reduced graft occlusion after coronary artery bypass grafting.

This medicine is not recommended in emergency situations. It is reserved for maintenance treatment after taking care of emergency situations.

Dosage ASPIRINE PROTECT 100 mg Gastroresistant tablet Box of 30

Reserved for adults. Oral way.

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

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

The coating prevents local irritant effects on the stomach lining.

In chronic treatment:

The recommended dosage is 100 mg to 300 mg daily to be swallowed with a glass of water, preferably before meals.

Elderly:

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

Pediatric population:

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

Against indications

This medication should never be prescribed in the following situations:

Hypersensitivity to acetylsalicylic acid or to any of the excipients (see section Composition ), or other nonsteroidal anti-inflammatory drugs (cross reaction),

· A history of asthma induced by the administration of salicylates or substances of similar activity, including nonsteroidal anti-inflammatory drugs,

· Progressive peptic ulcer,

· Constitutional or acquired haemorrhagic disease, including gastrointestinal haemorrhage, history of haemorrhagic stroke and thrombocytopenia,

· After 24 weeks of amenorrhea, ie 5 months for doses greater than or equal to 100 mg per day of acetylsalicylic acid (see section on Pregnancy and lactation ),

· Haemorrhagic risk,

· Severe renal insufficiency,

· Severe liver failure,

· Severe uncontrolled heart failure.

Adverse effects Aspirine Protect

The frequency of adverse events can not be estimated. As a result, the frequencies are referenced as indeterminate.

Immune system disorders

Hypersensitivity reactions, anaphylactic reactions, asthma, bronchospasm, angioedema, rhinitis, rash, urticaria, and sometimes cardiorespiratory distress or anaphylactic shock.

Blood and lymphatic system disorders

Hematologic effects: Haemorrhagic syndromes (hematoma, urogenital hemorrhage, epistaxis, gingivorragia, purpura ...) with increased bleeding time. This action persists 4 to 8 days after stopping aspirin. It can create a haemorrhagic risk in case of surgery. Gastrointestinal and intracranial hemorrhages may also occur (particularly in patients with uncontrolled hypertension).

In some cases, the vital prognosis can be engaged.

Serious haemolytic events have been observed after high doses of ASA in subjects with G6PD deficiency.

Metabolism and nutrition disorders

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 central nervous system: headache, dizziness, sensation of low hearing, tinnitus, which are usually the first signs of overdose (see section Overdose ).

Intracranial hemorrhage.

Gastrointestinal disorders

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

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

Hepatobiliary disorders

Hepatic enzyme elevations, liver damage mainly hepatocellular (liver failure).

Skin and subcutaneous tissue disorders

Urticaria, skin reactions, which may be severe (exudative erythema multiforme).

Renal and urinary disorders

Acute renal failure, particularly in patients with pre-existing renal insufficiency, cardiac decompensation, or concomitant diuretic therapy.

General disorders and administration site conditions

Reye's syndrome (see Warnings and Precautions section ).

Declaration of adverse effects

The reporting of adverse reactions suspected to be due to a drug after its approval is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals are asked to report any adverse reactions suspected to be due to a drug at the regional pharmacovigilance center on which they depend and whose contact details are available on the ANSM website.

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