CORLENTOR Film-coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Corlentor 5 mg film-coated tablets. Corlentor 7.5 mg film-coated tablets.
Qualitative and quantitative composition
Corlentor 5 mg film-coated tablets:* One film-coated tablet contains 5 mg ivabradine (equivalent to 5.390 mg ivabradine as hydrochloride). Excipient with known effect: 63.91 mg lactose monohydrate. Corlentor ...
Pharmaceutical form
Film-coated tablet. Corlentor 5 mg film-coated tablets: Salmon-coloured, oblong, film-coated tablet scored on both sides, engraved with 5 on one face and S on the other face. The tablet can be divided ...
Therapeutic indications
Symptomatic treatment of chronic stable angina pectoris Ivabradine is indicated for the symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm ...
Posology and method of administration
Posology For the different doses, film-coated tablets containing 5 mg and 7.5 mg ivabradine are available. Symptomatic treatment of chronic stable angina pectoris It is recommended that the decision to ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Resting heart rate below 70 beats per minute prior to treatment. Cardiogenic shock. Acute myocardial infarction. ...
Special warnings and precautions for use
Special warnings Lack of benefit on clinical outcomes in patients with symptomatic chronic stable angina pectoris Ivabradine is indicated only for symptomatic treatment of chronic stable angina pectoris ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Concomitant use not recommended QT prolonging medicinal products: Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, ...
Fertility, pregnancy and lactation
Women of childbearing potential Women of child-bearing potential should use appropriate contraceptive measures during treatment (see section 4.3). Pregnancy There are no or limited amount of data from ...
Effects on ability to drive and use machines
A specific study to assess the possible influence of ivabradine on driving performance has been performed in healthy volunteers where no alteration of the driving performance was evidenced. However, in ...
Undesirable effects
Summary of the safety profile Ivabradine has been studied in clinical trials involving nearly 45,000 participants. The most common adverse reactions with ivabradine, luminous phenomena (phosphenes) and ...
Overdose
Symptoms Overdose may lead to severe and prolonged bradycardia (see section 4.8). Management Severe bradycardia should be treated symptomatically in a specialised environment. In the event of bradycardia ...
Pharmacodynamic properties
Pharmacotherapeutic group: Cardiac therapy, other cardiac preparations ATC code: C01EB17 Mechanism of action Ivabradine is a pure heart rate lowering agent, acting by selective and specific inhibition ...
Pharmacokinetic properties
Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (>10 mg/ml). Ivabradine is the S-enantiomer with no bioconversion demonstrated in vivo. The N-desmethylated ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential. Reproductive toxicity studies showed ...
List of excipients
Core: Lactose monohydrate Magnesium stearate (E470B) Maize starch Maltodextrin Silica, colloidal anhydrous (E551) Film-coating: Hypromellose (E 464) Titanium dioxide (E171) Macrogol 6000 Glycerol (E422) ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Aluminium/PVC blister packed in cardboard boxes. Pack sizes: Calendar packs containing 14, 28, 56, 84, 98, 100 or 112 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Les Laboratoires Servier, 50, rue Carnot, 92284 Suresnes cedex, France
Marketing authorization number(s)
Corlentor 5 mg film-coated tablets: EU/1/05/317/001-007 Corlentor 7.5 mg film-coated tablets: EU/1/05/317/008-014
Date of first authorization / renewal of the authorization
Date of first authorisation: 25/10/2005 Date of latest renewal: 31/08/2010
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