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ASPIRIN Tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Aspirin 75mg Tablets.

Qualitative and quantitative composition

Each tablet contains 75 mg acetylsalicylic acid. For the full list of excipients, see section 6.1.

Pharmaceutical form

Tablet. Oval, white, biconvex tablets, 9.0 5.0 mm.

Therapeutic indications

Secondary prevention of myocardial infarction. Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris. History of unstable angina pectoris, except during the acute phase. ...

Posology and method of administration

Adults Secondary prevention of myocardial infarction: The recommended dose is 75-160 mg once daily. Prevention of cardiovascular morbidity in patients suffering from stable angina pectoris: The recommended ...

Contraindications

Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint) or to any of the excipients listed in section 6.1; ...

Special warnings and precautions for use

Aspirin Tablets is not suitable for use as an anti-inflammatory/analgesic/antipyretic. Recommended for use in adults and adolescents from 16 years of age. This medicinal product is not recommended for ...

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations Methotrexate (used at doses >15 mg/week) The combined drugs, methotrexate and acetylsalicylic acid, enhance haematological toxicity of methotrexate due to the decreased renal ...

Pregnancy and lactation

Pregnancy Low doses (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe. Doses of 100- 500 mg/day: ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed with Acetylsalicylsyra Actavis. Based on the pharmacodynamic properties and the side effects of acetylsalicylic acid, ...

Undesirable effects

Side effects are grouped on the basis of System Organ Class. Within each system organ class the frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), ...

Overdose

Although considerable inter-individual variations are involved, it can be considered that the toxic dose is about 200 mg/kg in adults and 100 mg/kg in children. The lethal dose of acetylsalicylic acid ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antithrombotic agents: platelet aggregation inhibitors excl. heparin ATC code: B01AC06 Acetylsalicylic acid inhibits the platelet activation: blocking the platelet cyclooxygenase ...

Pharmacokinetic properties

Absorption After oral administration, acetylsalicylic acid is rapidly absorbed from the gastrointestinal tract. However, a significant portion of the dosage is already hydrolysed to salicylic acid in the ...

Preclinical safety data

The nonclinical safety profile of acetylsalicylic acid is well documented. In experimental animal studies, salicylates have shown no other organ injury than renal damage. In rat studies, fetotoxicity and ...

List of excipients

Microcrystalline cellulose Maize starch Silica, colloidal anhydrous Stearic acid

Incompatibilities

Not applicable.

Shelf life

Shelf life: 2 years.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Blister (PVC/PVdC/Aluminium). Child resistant blister packs (PVC/PVdC/Al/PET/paper). Child resistant blister packs (PVC/PE/PVdC/Al/glassine paper). HDPE tablet container with a PP cap. HDPE tablet container ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Marketing authorization number(s)

PL 30306/0776

Date of first authorization / renewal of the authorization

07/10/2016

Date of revision of the text

06/11/2018

Πηγαίο έγγραφο

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