Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Acetylsalicylic acid
Alliance Pharma (Ireland) Limited
B01AC; B01AC06
Acetylsalicylic acid
75 milligram(s)
Gastro-resistant tablet
Platelet aggregation inhibitors excl. heparin; acetylsalicylic acid
Marketed
2002-04-23
Nu-Seals 75 PIL ROI 019 PATIENT INFORMATION LEAFLET NU-SEALS ® 75MG GASTRO-RESISTANT TABLETS aspirin (acetylsalicylic acid) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. WHAT NU-SEALS 75MG IS AND WHAT IT IS TAKEN FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NU-SEALS 75MG 3. HOW TO TAKE NU-SEALS 75MG 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE NU-SEALS 75MG 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT NU-SEALS 75MG IS AND WHAT IT IS TAKEN FOR Nu-Seals 75mg contains aspirin. Aspirin is used: • to prevent recurrence of heart attacks or strokes by thinning the blood. If someone who has previously had a heart attack or stroke takes Nu-Seals 75mg regularly, it reduces the risk of a blood clot occurring in the heart or brain. This can prevent further heart attacks or strokes. IF YOU TAKE ASPIRIN IN HIGH DOSES OR OVER A LONG PERIOD OF TIME, IT CAN IRRITATE YOUR STOMACH LINING. TO PREVENT STOMACH IRRITATION, THESE TABLETS HAVE A SPECIAL COATING (CALLED ENTERIC) SO THAT THE ASPIRIN IS NOT RELEASED UNTIL IT HAS PASSED THROUGH THE STOMACH. Aspirin is released slowly from these tablets, so Nu-Seals 75mg is not suitable for the short-term relief of pain, such as headaches or toothache. Nu-Seals 75 PIL ROI 019 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NU-SEALS 75MG DO NOT TAKE NU-SEALS 75MG: • if you are allergic to aspirin or any of the other ingredients in this medicine (listed in section 6) • if you have had a cerebral haemorrhage (a type of stroke caused by bleeding in your brain) • if y Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 21 July 2022 CRN00CYNF Page 1 of 11 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. Excipients withknowneffect Benzyl Alcohol 0.128mg per tablet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant tablet 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 Posology _Adults_ 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. _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. _Paediatric population_ _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)._ Methodofadministration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to aspirin (e.g.- bronchospasm, rhinitis, urticaria), t Lesen Sie das vollständige Dokument