ASCAL Effervescent tablet
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Περιεχόμενα
1. Name of the medicinal product
Ascal Brisper Cardio-Neuro 100 mg, effervescent tablets.
2. Qualitative and quantitative composition
One effervescent tablet contains 100 mg carbasalate calcium, corresponding to 78 mg acetyl salicylic acid. <u>Excipient with known effect:</u> Lactose Monohydrate 150.0 mg Sodium 24,6 mg For the full list ...
3. Pharmaceutical form
Effervescent tablet. White- to cream-coloured, round, flat tablet with bevelled edge.
4.1. Therapeutic indications
Ascal Brisper Cardio-Neuro is indicated for secondary prevention after a first myocardial or cerebrovascular event linked to atherosclerosis: Myocardial infarction Unstable and stable angina pectoris ...
4.2. Posology and method of administration
<u>Secondary prevention of myocardial infarction:</u> In acute cases a loading dose of an initial 2 effervescent tablets (200 mg carbasalate calcium, corresponding to 156 mg acetylsalicylic acid) per day ...
4.3. Contraindications
Peptic ulcer and/or gastrointestinal haemorrhages. Gastric patients, and patients who have experienced gastric pain when previously using the medicine. A history of haemorrhagic cerebrovascular accident. ...
4.4. Special warnings and precautions for use
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 ...
4.5. Interaction with other medicinal products and other forms of interaction
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 ...
4.6. Pregnancy and lactation
Pregnancy Low doses, up to 128 mg carbasalate calcium/day which is equivalent to 100 mg acetylsalicylic acid/day (1 tablet Ascal Brisper Cardio-Neuro/day) Clinical studies indicate that doses up to 100 ...
4.7. Effects on ability to drive and use machines
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 ...
4.8. Undesirable effects
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 ...
4.9. Overdose
The following are associated with moderate intoxication: dizziness, headache, tinnitus, confusion and gastrointestinal symptoms (nausea, vomiting and gastric pain). With severe intoxication, serious disturbances ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Antithrombotic agents, Platelet aggregration inhibitors excl. Heparin <b>ATC code:</b> B01AC08 Ascal Brisper Cardio-Neuro 100 mg contains carbasalate calcium, a complex ...
5.2. Pharmacokinetic properties
Absorption After oral administration, acetyl salicylic acid is rapidly absorbed in the proximal part of the small bowel. The maximum plasma concentration is reached after 0.5-2 hours. However, a considerable ...
5.3. Preclinical safety data
<b>Mutagenic and carcinogenic potential.</b> The acetylsalicylic acid has been assessed in many in vitro and in vivo pre-clinical studies. Taken together the results didnt reveal any mutagenic effect. ...
6.1. List of excipients
Lactose monohydrate Adipic acid (E355) Sodium hydrogen carbonate (E500a) Magnesium stearate (E470b) Crospovidone (E1202) Povidone K90 (E1201)
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Shelf life of the medicinal product as packaged for sale (30 effervescent tablets): 3 years, Shelf life after first opening the container: 1 month. Shelf life of the medicinal product as packaged for sale ...
6.4. Special precautions for storage
Do not refrigerate or freeze. Store in the original packaging, in order to protect from moisture. Keep the container tightly closed. Do not store above 30°C.
6.5. Nature and contents of container
30, 90 or 100 effervescent tablets in a polypropylene tablet container with polyethylene cap (containing a desiccant cartridge), packed in a cardboard outer box. Not all pack sizes may be marketed
6.6. Special precautions for disposal and other handling
No special requirements
9. Date of first authorization / renewal of the authorization
Renewal 09.02.2009
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