VERAPAMIL Film-coated tablets (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
VERAPAMIL TABLETS BP 40mg.
Qualitative and quantitative composition
Each tablet contains 40mg Verapamil Hydrochloride PhEur. Excipient with known effect: Sunset yellow aluminium lake (E110). For the full list of excipients, see section 6.1.
Pharmaceutical form
Yellow film-coated tablets. Yellow, circular, biconvex film-coated tablets, impressed C on one face and the identifying letters VR on the reverse. Tablet diameter: 6.18-6.82mm.
Therapeutic indications
The management of mild to moderate hypertension and renal hypertension, used alone or in combination with other antihypertensive therapy (see section 4.3 for warning regarding concomitant administration ...
Posology and method of administration
Posology Adults Hypertension: initially 120mg twice daily increasing to 160mg twice daily where necessary. In some cases doses of up to 480mg daily, in divided doses, have been used. A further reduction ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hypotension (of less than 90mmHg systolic) Second or third degree atrioventricular block; sick sinus syndrome ...
Special warnings and precautions for use
Verapamil may affect left ventricular contractility as a result of its mode of action. The effect is small and not normally important, however, cardiac failure may be aggravated or precipitated if it exists. ...
Interaction with other medicinal products and other forms of interaction
In vitro metabolic studies indicate that verapamil hydrochloride is metabolized by cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil has been shown to be an inhibitor of CYP3A4 enzymes ...
Pregnancy and lactation
Animal studies have shown no teratogenic effect. Verapamil should not be administered during pregnancy unless, in the clinicians judgement, it is essential for the welfare of the patient. The possibility ...
Effects on ability to drive and use machines
Depending on individual susceptibility, the patients ability to drive or operate machines may be impaired due to feelings of drowsiness. This is particularly true in the initial stages of treatment, or ...
Undesirable effects
Immune system disorders: allergic reactions (e.g. erythema, pruritus, urticaria) are very rarely seen. Nervous system disorders: headaches occur rarely, dizziness, paraesthesia, tremor, extrapyramidal ...
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
Pharmacotherapeutic group: Selective calcium channel blockers with direct cardiac effects, phenylalkylamine derivatives ATC code: C08DA01 Verapamil hydrochloride is a calcium channel blocker and is classified ...
Pharmacokinetic properties
Absorption Verapamil is approximately 90% absorbed from the gastrointestinal tract. Distribution Verapamil acts within 1-2 hours after oral administration with a peak plasma concentration after 1-2 hours. ...
Preclinical safety data
Not applicable.
List of excipients
Also contains: Croscarmellose sodium Magnesium stearate Maize starch Propylene glycol Sunset yellow aluminium lake (E110) Quinoline yellow aluminium lake (E104) Titanium dioxide (E171) Microcrystalline ...
Incompatibilities
None known.
Shelf life
Shelf life: Three years from the date of manufacture.
Special precautions for storage
Store below 25°C in a dry place.
Nature and contents of container
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and snap-on polyethylene lids; in case any supply difficulties should arise the alternative ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS
Marketing authorization number(s)
PL 0142/0281
Date of first authorization / renewal of the authorization
Date of first authorisation: 18<sup>th</sup> September 1989 Date of latest renewal: 7<sup>th</sup> July 1997
Date of revision of the text
11<sup>th</sup> September 2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
