SECURON SR Modified-release tablet (2024)
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Περιεχόμενα
Name of the medicinal product
Securon SR.
Qualitative and quantitative composition
Verapamil hydrochloride Ph Eur 240 mg.
Pharmaceutical form
Modified Release Tablets. The tablets are oblong, pale, green, scored and embossed with two Knoll logos (triangles) on one side.
Therapeutic indications
Securon SR 240 mg tablets are indicated for the treatment of mild to moderate hypertension. The treatment and prophylaxis of angina pectoris. Secondary prevention of re-infarction after an acute myocardial ...
Posology and method of administration
For oral use only. Securon SR tablets should be taken without sucking or chewing, with sufficient liquid, preferably with or shortly after meals. Securon SR tablets are scored and may be halved without ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Cardiogenic shock; acute myocardial infarction complicated by bradycardia, marked hypotension or left ventricular failure; second or ...
Special warnings and precautions for use
Since verapamil is extensively metabolised in the liver, careful dose titration is required in patients with liver disease. Although the pharmacokinetics of verapamil in patients with renal impairment ...
Interaction with other medicinal products and other forms of interaction
In rare instances, including when patients with severe cardiomyopathy, congestive heart failure or recent myocardial infarction were given intravenous beta-adrenergic blocking agents or disopyramide concomitantly ...
Pregnancy and lactation
There are no adequate and well-controlled study data in pregnant women. Although animal studies have not shown any teratogenic effects (see section 5.3), verapamil should not be given during the first ...
Effects on ability to drive and use machines
Depending on individual susceptibility, the patients ability to drive a vehicle, operate machinery or work under hazardous conditions may be impaired. This is particularly true in the initial stages of ...
Undesirable effects
Reactions from Postmarketing Surveillance or Phase IV Clinical Trials The following adverse events reported with verapamil are listed below by system organ class: Immune system disorders: allergic reactions ...
Overdose
The course of symptoms in verapamil intoxication depends on the amount taken, the point in time at which detoxification measures are taken and myocardial contractility (age-related). The main symptoms ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Selective calcium channel blockers with direct cardiac effects, phenylalkylamine derivatives <b>ATC-Code:</b> C08DA01 Verapamil, a phenylalkylamine calcium antagonist, ...
Pharmacokinetic properties
Verapamil hydrochloride is a racemic mixture consisting of equal portions of the R-enantiomer and the S-enantiomer. Verapamil is extensively metabolized. Norverapamil is one of 12 metabolites identified ...
Preclinical safety data
Reproduction studies have been performed in rabbits and rats at oral verapamil doses up to 0.6 (180 mg/m²/day) and 1.2 times (360 mg/m²/day) respectively the equivalent maximum recommended human oral daily ...
List of excipients
Microcrystalline cellulose Sodium alginate Povidone K30 Magnesium stearate Purified water Hypromellose 2910 Macrogol 400 Macrogol 6000 Talc Titanium dioxide (E171) L-green lake [quinoline yellow (E104) ...
Incompatibilities
None stated.
Shelf life
36 months.
Special precautions for storage
Do not store above 25°C and store in the original package.
Nature and contents of container
Calendar pack consisting of a PVC/PVDC blister in a cardboard outer container. Pack size: 28 tablets.
Special precautions for disposal and other handling
The tablets should not be chewed or sucked. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mylan Products Ltd., 20 Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0027
Date of first authorization / renewal of the authorization
14<sup>th</sup> March 2002
Date of revision of the text
20/03/2024
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