Nu-seals 75 mg Gastro-resistant Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Acetylsalicylic acid

Tilgjengelig fra:

Blackhall Pharmaceutical

ATC-kode:

B01AC; B01AC06

INN (International Name):

Acetylsalicylic acid

Dosering :

75 milligram(s)

Legemiddelform:

Gastro-resistant tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid

Autorisasjon status:

Authorised

Autorisasjon dato:

2013-02-08

Preparatomtale

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