Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Acetylsalicylic acid
Blackhall Pharmaceutical
B01AC; B01AC06
Acetylsalicylic acid
75 milligram(s)
Gastro-resistant tablet
Product subject to prescription which may be renewed (B)
Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid
Authorised
2013-02-08
Health Products Regulatory Authority 19 November 2019 CRN009GJC Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nu-seals 75 mg Gastro-resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Aspirin (Acetylsalicylic acid) 75mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablets _Product imported from UK:_ Smooth, white tablets printed with ‘75’ in red. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aspirin has an antithrombotic action, mediated through inhibition of platelet activation, which has been shown to be useful in secondary prophylaxis following myocardial infarction, and in patients with unstable angina or ischaemic stroke. Nu-Seals 75 is indicated wherever prolonged dosage of aspirin is required. The special coating resists dissolution in gastric juice, but will dissolve readily in the relatively less acid environment of the duodenum. Owing to the delay that the coating imposes on the release of the active ingredient, Nu-Seals 75 is unsuitable for the short-term relief of pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nu-Seals 75 is for oral administration to adults only. Antithrombotic action: The usual dose is 75mg, daily. When rapid absorption is required (e.g., following acute myocardial infarction), two tablets (150mg) should be taken together and chewed. The elderly: As for adults. In general, aspirin should be used with particular caution in elderly patients who are more prone to adverse events. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Treatment should be reviewed at regular intervals. Children: do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk (see section 4.4). 4.3 CONTRAINDICATIONS Hypersensitivity to aspirin (e.g.- bronchospasm, rhinitis, urticaria) or to non-steroidal anti-inflammatory drugs. Hypoprothromb Read the complete document