NU-SEALS Tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Nu-Seals 75, Aspirin 75mg Gastro-resistant Tablets, PostMI 75EC, Nu-Seals Cardio 75.
2. Qualitative and quantitative composition
Acetylsalicylic Acid 75mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, gastro-resistant tablets, coded 75 or GP.
4.1. Therapeutic indications
For the secondary prevention of thrombotic cerebrovascular or cardiovascular disease and following by-pass surgery in adults (see below). Aspirin has an antithrombotic action, mediated through inhibition ...
4.2. Posology and method of administration
Posology Nu-Seals 75 is for oral administration to adults only. Patients should seek the advice of a doctor before commencing therapy for the first time. The usual dosage, for long-term use, is 75-150mg ...
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypoprothrombinaemia, haemophilia, haemorrhagic disease or a history of bleeding disorders, cerebral haemorrhage, ...
4.4. Special warnings and precautions for use
There is a possible association between aspirin and Reyes syndrome when given to children. Reyes syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason, aspirin ...
4.5. Interaction with other medicinal products and other forms of interaction
Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation, when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for ...
4.6. Fertility, pregnancy and lactation
Fertility Findings from a variety of animal models with a number of NSAIDs including aspirin indicate that these active substances block blastocyst implantation which may have an impact on female fertility ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
The most commonly observed adverse events are gastrointestinal in nature. Undesirable effects are listed by MedDRA System Organ Classes. Assessment of undesirable effects is based on the following frequency ...
4.9. 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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Salicylic Acid & Derivatives <b>ATC code:</b> B01AC06 Aspirin has analgesic, antipyretic and anti-inflammatory actions. It also has antithrombotic action which is mediated ...
5.2. Pharmacokinetic properties
In a bioequivalence study comparing the pharmacokinetics of the 300mg product with 4 75mg presentation in human volunteers, measures such as terminal phase half-life, area-under-the curve and peak plasma ...
5.3. Preclinical safety data
There are no pre-clinical data of relevance to the prescriber in addition to that summarised in other sections of the Summary of Product Characteristics.
6.1. List of excipients
Maize starch Hypromellose Talc Methacrylic acid – ethyl acrylate (1:1) copolymer dispersion 30 per cent Polyethylene glycol 3350 Propylene glycol Benzyl alcohol Emulsion silicone Printing Ink containing ...
6.2. Incompatibilities
None known.
6.3. Shelf life
UPVC/Al blisters – 3 years. HDPE bottles 2 years.
6.4. Special precautions for storage
Do not store above 25°C. Keep containers tightly closed.
6.5. Nature and contents of container
Blisters comprising of UPVC on one side and aluminium foil on the other containing 14, 28, 56 or 84 tablets. HDPE bottles with screw caps containing 500 tablets.
6.6. Special precautions for disposal and other handling
None.
7. Marketing authorization holder
Alliance Pharmaceuticals Limited, Avonbridge House, Bath Road, Chippenham, Wiltshire, SN15 2BB
8. Marketing authorization number(s)
PL 16853/0062
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 21 April 1994 Date of last renewal of authorisation: 12 May 2006
10. Date of revision of the text
February 2020
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