ASPIRIN Gastro-resistant tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Aspirin 75mg Gastro-Resistant Tablets.
Qualitative and quantitative composition
Each tablet contains aspirin 75 mg. Also includes 17mg/tablet lactose. For the full list of excipients, see 6.1.
Pharmaceutical form
Gastro-resistant tablet. White, film coated, round tablet.
Therapeutic indications
For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery.
Posology and method of administration
Posology For the management of cardiovascular or cerebrovascular disease Patients should seek the advice of a doctor before commencing therapy for the first time. The usual dosage, for long-term use, is ...
Contraindications
Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, ...
Special warnings and precautions for use
Aspirin 75 mg tablets is not suitable for use as an anti-inflammatory/ analgesic/ antipyretic. Caution should be exercised in patients with allergic disease, impairment of hepatic or renal function (avoid ...
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
Aspirin does not usually affect the ability to drive or operate machinery.
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
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than ...
Pharmacodynamic properties
Pharmacotherapeutic group: Platelet Aggregation Inhibitor excl. Heparin ATC code: B01AC06 The antiplatelet effect of aspirin is largely unrelated to its systemic bioavailability and its duration of effect ...
Pharmacokinetic properties
Aspirin is rapidly absorbed after oral administration of conventional release preparations, with some hydrolysis to salicylate before absorption. Absorption is delayed by the presence of food and is impaired ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.
List of excipients
Microcrystalline cellulose Lactose monohydrate Corn starch Colloidal anhydrous silica Stearic acid Enteric coating constituents: Methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30% Talc Triethyl ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Blister made of PVDC opaque (child resistant aluminium blister foil). 28, 56, 84 or 100 tablets per pack. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Dexcel-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK
Marketing authorization number(s)
PL 14017/0022
Date of first authorization / renewal of the authorization
16/05/2005
Date of revision of the text
18/07/2018
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