Source: Health Products Regulatory Authority (IE) Revision Year: 2020 Publisher: Pinewood Laboratories Ltd, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
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 (two or more distinct episodes of proven ulceration or bleeding).
Severe heart failure.
Coagulation deficiency disorders.
Hypersensitivity to aspirin or to other non-steriodal anti-inflammatory drugs.
The use of Caprin with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (See section 4.2).
Gastrointestinal bleeding, ulceration and perforation: GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (See section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (See below and 4.5).
Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents (See section 4.5).
When GI bleeding or ulceration occurs in patients receiving Caprin, the treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as their condition may be exacerbated (See section 4.8 – undesirable effects).
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDSs (see 4.8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Caprin should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Undesirable effects may be minimised by using the shortest duration necessary to control symptoms (see section 4.2).
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
Clinical trial and epidemiology data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for aspirin.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with aspirin after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).
There is a possible association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver and can be fatal. For this reason aspirin should not be given to children and adolescents aged under 16 years unless specifically indicated.
Aspirin should be used with caution in patients with impaired renal function or hepatic function (avoid if severe), or in patients who are dehydrated.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (See section 4.4).
Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (See section 4.4).
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (See section 4.4).
CAPRIN 75 mg may enhance the effects of phenytoin and sodium valproate.
The activity of methotrexate may he markedly enhanced and its toxicity increased.
CAPRIN 75mg may inhibit action of uricosurics.
The toxicity of sulphonamides may also be increased.
CAPRIN 75mg may reduce the efficacy of antihypertensive drugs.
Aspirin is pharmaceutically incompatible with iron salts and alkalis.
Patients using enteric-coated aspirin should be advised against ingesting antacids simultaneously, to avoid premature drug release.
Care should be taken in patients treated with any of the following drugs as interactions have been reported:
Diuretics: reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.
Lithium: decreased elimination of lithium.
Methotrexate: decreased elimination of methotrexate.
Ciclosporin: increased risk of nephrotoxicity with NSAIDs.
Other NSAIDs: avoid concomitant use of two or more NSAIDs.
Aminoglycosides: reduction in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentrations.
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 cardioprotection.
Probenecid: reduction in metabolism and elimination of NSAID and metabolites.
Oral hypoglycaemic agents: inhibition of metabolism of sulphonylurea drugs, prolonged jhalf-life and increased risk of hypoglycaemia.
Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
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 feeding should be avoided because of possible risk of Reye’s syndrome.
Regular use of high doses could impair platelet function and produce hypoprothrombinaemia in the infant if neonatal Vitamin K stores are low.
Aspirin does not usually affect the ability to drive or operate machinery.
Gastrointestinal: 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 section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (See section 4.4 – Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed.
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Aspirin may precipitate bronchospasm, and induce attacks of asthma in susceptible subjects.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
Not applicable.
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