Source: European Medicines Agency (EU)
In patients who are being treated simultaneously with anticoagulants (coumarin derivatives), it is advisable to measure the International Normalisation Ratio (INR) regularly. In patients with mild or moderate disorders of the hepatic function this function must be measured regularly (see section 4.3).
Concomitant treatment with anticoagulants (coumarin derivatives, heparin) is not recommended and should generally be avoided (see section 4.5). If concurrent use cannot be avoided, frequent monitoring of the INR is indicated and patients should be cautioned to watch for signs of bleeding, especially in the gastrointestinal tract.
Close medical monitoring is also necessary for patients with asthma bronchiale, allergic rhinitis (ASA may cause severe urticaria, angioedema, or bronchospasm).
Patients with a history of peptic ulcer disease should avoid using ASA (which can cause gastric mucosal irritation and bleeding) (see section 4.3).
The concomitant administration of this active substance with uricosuric agents like benzbromarone, probenecid, sulphinpyrazone is not recommended (see section 4.5).
Acetyl salicylic acid must be used with care in cases of very severe menstrual bleeding. It is preferable to stop use of acetyl salicylic acid before a surgical procedure (including tooth extraction) because of the risk of a prolonged bleeding time or an aggravation of the bleeding. The length of the interruption of the treatment should be determined on a case-by-case basis, but will usually be one week.
This product should be administered with caution in patients with renal impairment (see section 4.3). Patients with hypertension should be monitored carefully.
In patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency, some cases of haemolytic anaemia have been reported with high doses of acetylsalicylic acid, i.e. higher than daily recommended doses.
There is possible association between acetyl salicylic acid 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 acetyl salicylic acid should not be given to children and adolescents aged under 16 years unless specifically indicated (see section 4.2).
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This medicinal product contains 24,6 mg sodium per effervescent tablet, equivalent to 1,2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
The use of several platelet aggregation inhibitors, i.e. acetylsalicylic acid, NSAIDs, ticlopidine, clopidogrel, tirofiban, eptifibatide, increases the risk of bleeding, likewise their combination with heparin and its derivatives (hirudine, fondaparinux), oral anticoagulants and thrombolytics. Clinical and biological parameters of haemostasis should be regularly monitored.
Methotrexate (used at doses >15mg/week): the combined drugs, methotrexate and ASA, increase haematological toxicity of methotrexate due to the decreased renal clearance of methotrexate by ASA. Therefore, the concomitant use of methotrexate with Ascal Brisper Cardio-Neuro is contra-indicated (see section 4.3).
Uricosurics agents (benzbromarone, probenecid, and sulphinpyrazone): reduced effect of uric acid excretion by competition of renal tubular uric acid elimination. Therefore, the concomitant use of Ascal Brisper Cardio-Neuro with uricosurics agents is not-recommended (see section 4.4).
Diuretics: risk of acute renal failure due to the decreased glomerular filtration via decreased renal prostaglandin synthesis. Hydrating the patient and monitoring renal function at the start of the treatment.
Systemic glucocorticoids (except hydrocortisone used as a replacement therapy in Addison’s disease): the concomitant use of ASA with glucocorticoids can lead to a decrease in blood salicylate level during corticosteroid treatment and a risk of salicylate overdose after this treatment is stopped via increased elimination of salicylate by corticosteroids. This combination requires precaution. Furthermore, risk of blood loss in the gastrointestinal tract is enhanced. Therefore, doses of ASA should be adjusted during the combination and after glucocorticoid treatment is stopped.
Methotrexate used at doses lower than 15mg/week: the combined drugs, methotrexate and ASA, increased haematological toxicity of methotrexate due to the decreased renal clearance of methotrexate by acetylsalicylic acid. Weekly blood count checks should be done during the first weeks of the combination. Enhanced monitoring in the presence of even mildly impaired renal function, as well, as in elderly.
Heparin used at curative dosage or in elderly patients: when ASA is coadministered with heparin at curative dosage or in elderly patients, there is an increased risk of bleeding. Close monitoring of the INR, aPTT and/or bleeding time should be performed in the case of concomitant administration of both drugs, Ascal Brisper Cardio-Neuro 100 mg and heparin.
Other anticoagulants (coumarin derivatives, heparin at preventive dosage), other platelet anti-aggregants and other thrombolytics: increased risk of bleeding.
NSAIDs: increased risk of bleeding and of damage on gastro-intestinal mucosa and enhancement of prolonging bleeding time
Selective Serotonin Re-uptake Inhibitors (SSRIs): the combination may result in an increased risk of upper gastrointestinal bleeding due to a possible synergistic effect.
Ibuprofen: 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).
Antacids: antacids can increase the renal excretion of ASA by alkalinising the urine.
Alcohol: addition of their own damage on gastro-intestinal mucosa and enhancement of prolonging bleeding time.
Spironolacton, furosemide: the effect of spironolactone and furosemide can be weakened by carbasalate calcium.
Clinical studies indicate that doses up to 100 mg acetylsalicylic acid/day for restricted obstetrical use, which require specialised monitoring, appear safe.
There is insufficient clinical experience regarding the use of doses above 100 mg acetylsalicylic acid/day up to 500 mg acetylsalicylic acid/day. Therefore, the following recommendations for doses of 500 mg acetylsalicylic acid/day and above apply also for this dose range:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, acetyl salicylic acid should not be given unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
Consequently, 128 mg carbasalate calcium/day which is equivalent to 100 mg acetylsalicylic acid/day and higher (more than 1 tablet Ascal Brisper Cardio-Neuro/day) is contraindicated during the third trimester of pregnancy.
Acetyl salicylic acid is excreted into the maternal milk in small amounts. Since after incidental use no adverse effects were observed in the infant, 100 mg acetyl salicylic acid can be taken once during breastfeeding as indicated in the posology (not more than 1 tablet per day). With chronic use or intake of high doses, breast feeding should be stopped.
No studies on the effects on the ability to drive and use machines have been performed. On the basis of the pharmacodynamic profile and/or adverse reactions profile it is unlikely that carbasalate calcium affects the ability to drive and use machines.
The undesirable effects are often dose-dependent and are due to the pharmacological effect of acetyl salicylic acid (see section 5.1). Most undesirable effects are usually associated with the gastrointestinal tract.
The frequencies of the adverse reactions below are defined as follows: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000).
Common: prolongation of the bleeding time. This effect can persist for several days after stopping the treatment and can give rise to haemorrhagic risks in the event of surgery or can lead to heavier menstruation.
Uncommon: intracranial bleeding, blood in urine
Rare: haemorrhagic syndrome (nosebleeds, bleeding gums, bloody vomiting and blood loss via the faeces, etc.)
Uncommon: urticaria, skin rash, angio-oedema, rhinitis, bronchial spasms
Very rare: anaphylactic shock, aggravation of the allergic symptoms of food allergy
Very rare: hypoglycaemia.
Very rare: low-dose ASA can reduce the excretion of uric acid (which can lead to acute gout in pre-disposed patients).
Rare: dizziness, headache, tinnitus. These are usually the first indications of overdose (see also section 4.9).
Very common: gastric complaints such as hyperacidity and nausea
Common: vomiting, gastritis, mild to moderate blood loss in the gastrointestinal tract, diarrhoea. With long-term or repeated use this blood loss can lead to anaemia.
Uncommon: gastric bleeding, gastric ulcers
Very rare: gastrointestinal perforation
Very rare including isolated reports: liver impairment
Very rare: severe skin reactions (e.g. erythema exsudativum multiforme)
Very rare: acute renal insufficiency, especially in patients with existing renal insufficiency, heart decompensation, nephrotic syndrome or concomitant treatment with diuretics.
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 the national reporting system listed in Appendix V*.
Not applicable.
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