CAPRIN Gastro-resistant tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Caprin 75 mg Gastro-resistant Tablets.
2. Qualitative and quantitative composition
Each tablet contains 75 mg of Aspirin (acetylsalicylic acid). <u>Excipients:</u> Each tablet contains 62mg of Anhydrous Lactose. For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant tablets. Pink enteric coated, round, biconvex tablets printed with 75 in black ink.
4.1. Therapeutic indications
CAPRIN 75mg may be used to reduce the risk of myocardial infarction in patients with unstable angina or ischaemic stroke and in patients with a previous history of myocardial infarction. The enteric coating ...
4.2. Posology and method of administration
Adults (including the elderly) One tablet daily. In cases where a rapid onset of action is required e.g. immediately following acute myocardial infarction, then three tablets should be given for the first ...
4.3. Contraindications
CAPRIN 75mg tablets are contraindicated in the following: History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active, or history of recurrent peptic ulcer/haemorrhage ...
4.4. Special warnings and precautions for use
The use of Caprin with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided. <u>Elderly:</u> The elderly have an increased frequency of adverse reactions to NSAIDs especially ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>Corticosteroids:</u> increased risk of gastrointestinal ulceration or bleeding (See section 4.4). <u>Anti-coagulants:</u> NSAIDs may enhance the effects of anti-coagulants, such as warfarin (See section ...
4.6. Fertility, pregnancy and lactation
Aspirin should not be used routinely during pregnancy. Aspirin may prolong labour and contribute to maternal and neonatal bleeding, and is best avoided at term. It is excreted in breast milk and breast ...
4.7. Effects on ability to drive and use machines
Aspirin does not usually affect the ability to drive or operate machinery.
4.8. Undesirable effects
<u>Gastrointestinal:</u> The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (See ...
4.9. Overdose
Dizziness, tinnitus, deafness, vasodilation and sweating, nausea and vomiting, headache and mental confusion. If more severe hyperventilation, fever, restlessness, ketosis, respiratory alkalosis and metabolic ...
5.1. Pharmacodynamic properties
Aspirin is an analgesic and antipyretic with anti-inflammatory properties. Aspirin inhibits prostaglandin synthetase. Aspirin inhibits platelet aggregation. Experimental data suggest that ibuprofen may ...
5.2. Pharmacokinetic properties
A<ju>bsorption:</u> Aspirin is rapidly absorbed after oral administration, with some hydrolysis to salicylate before absorption. Absorption is delayed by the presence of food and is impaired in patients ...
5.3. Preclinical safety data
Not applicable.
6.1. List of excipients
Anhydrous lactose Collodial anhydrous silica Pregelatinised starch Zinc stearate Titanium dioxide (E171) Polyvinyl acetate phthalate Acetylated vegetable oil monoglyceride Hydroxypropyl cellulose Red iron ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Store below 25°C. Keep the container tightly closed to protect from moisture.
6.5. Nature and contents of container
White polypropylene container (securitainer) and lid, containing 20 or 100 tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
8. Marketing authorization number(s)
PA0281/130/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 23 June 2000 Date of last renewal: 23 June 2010
10. Date of revision of the text
January 2020
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