CORDARONE X 100 Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Cordarone X 100.
Qualitative and quantitative composition
Cordarone X 100 contain 100 mg of amiodarone hydrochloride. For excipients, see 6.1.
Pharmaceutical form
Tablet. Round, white tablet with a breakline on one side, imprinted with 100 on the other.
Therapeutic indications
Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Cordarone X is indicated only for the treatment of severe rhythm disorders not responding to other ...
Posology and method of administration
Adults It is particularly important that the minimum effective dose be used. In all cases the patients management must be judged on the individual response and well being. The following dosage regimen ...
Contraindications
Sinus bradycardia and sino-atrial heart block. In patients with severe conduction disturbances (high grade AV block, bifascicular or trifascicular block) or sinus node disease, Cordarone X should be used ...
Special warnings and precautions for use
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Amiodarone can cause serious adverse reactions ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Drugs inducing Torsade de Pointes or prolonging QT Drugs inducing Torsade de Pointes Combined therapy with the following drugs which prolong the QT interval is contra-indicated ...
Pregnancy and lactation
Pregnancy There are insufficient data on the use of amiodarone during pregnancy in humans to judge any possible toxicity. However, in view of its effect on the foetal thyroid gland, amiodarone is contraindicated ...
Effects on ability to drive and use machines
The ability to drive or to operate machinery may be impaired in patients with clinical symptoms of amiodarone-induced eye disorders.
Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: very common (≥10%), common (≥1% and <10%); uncommon (≥0.1% and ...
Overdose
Little information is available regarding acute overdosage with oral amiodarone. Few cases of sinus bradycardia, heart block, attacks of ventricular tachycardia, torsades de pointes, circulatory failure ...
Pharmacodynamic properties
Amiodarone hydrochloride is an antiarrhythmic. No controlled paediatric studies have been undertaken. In published studies the safety of amiodarone was evaluated in 1118 paediatric patients with various ...
Pharmacokinetic properties
Amiodarone is strongly protein bound and the plasma half-life is usually of the order of 50 days. However there may be considerable inter-patient variation; in individual patients a half-life of less than ...
Preclinical safety data
In a 2-year carcinogenicity study in rats, amiodarone caused an increase in thyroid follicular tumours (adenomas and/or carcinomas) in both sexes at clinical relevant exposures. Since mutagenicity findings ...
List of excipients
Lactose monohydrate Maize starch Povidone Colloidal anhydrous silica Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C, protect from light.
Nature and contents of container
Cordarone X 100 tablets are supplied in blister packs of 28 and 30 tablets packed in cardboard cartons. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Marketing authorization number(s)
PL 17780/0586
Date of first authorization / renewal of the authorization
28/04/2012
Date of revision of the text
31<sup>st</sup> July 2018
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