METOPROLOL TARTRATE Tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Metoprolol Tartrate 100 mg tablets.
Qualitative and quantitative composition
Each tablet contains Metoprolol tartrate 100 mg. For a full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White to off-white, approximately 10 mm round, biconvex tablet marked 125 A on one side and a scoreline on the other side. The tablet can be divided into equal halves.
Therapeutic indications
In the management of: Hypertension. Angina pectoris. Cardiac arrhythmias(in particular supraventricular tachycardias). As an adjunctive treatment of thyrotoxicosis. Early intervention of metoprolol tartrate ...
Posology and method of administration
Posology The following dosage regimes are intended only as a guideline and should always be adjusted to the individual requirements of the patient but should not exceed 400 mg/day. Adults Hypertension ...
Contraindications
Known hypersensitivity to metoprolol, related derivatives, any other β-blockers or to any of the excipients listed in section 6.1. Second-or third-degree atrioventricular block. Uncontrolled heart failure. ...
Special warnings and precautions for use
Abrupt cessation of therapy with a beta-blocker should be avoided especially in patients with ischaemic heart disease. When possible, metoprolol should be withdrawn gradually over a period of 10 days, ...
Interaction with other medicinal products and other forms of interaction
Anaesthetic drugs may attenuate reflex tachycardia and increase the risk of hypotension. Metoprolol therapy should be reported to the anaesthetist before the administration of a general anaesthetic. If ...
Pregnancy and lactation
Pregnancy It is recommended that metoprolol should not be administered during pregnancy or lactation unless it is considered that the benefit outweighs the possible risk to the foetus/infant. Should therapy ...
Effects on ability to drive and use machines
As with all beta-blockers, metoprolol can affect patients ability to drive and operate machinery. It should be taken into account that occasionally dizziness and fatigue may occur. Patient should be warned ...
Undesirable effects
Frequency estimates: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available ...
Overdose
Poisoning due to an overdose of metoprolol may lead to severe hypotension, sinus bradycardia, atrioventricular block, heart failure, cardiogenic shock, cardiac arrest, bronchospasm, impairment of consciousness, ...
Pharmacodynamic properties
Pharmacotherapeutic category: Beta blocking agents, selective ATC code: C07AB02 Mechanism of action Metoprolol tartrate is a cardioselective beta-adrenergic blocking agent. It has a relatively greater ...
Pharmacokinetic properties
Absorption Metoprolol is readily and completely absorbed from the gastrointestinal tract. Metoprolol is absorbed fully after oral administration. Within the therapeutic dosage range, the plasma concentrations ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Cellulose, microcrystalline (E460) Gelatin (E441) Sodium starch glycolate Silica, colloidal hydrated (E551) Stearic acid
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Tablets are packed in PVC/PVdC Aluminium blisters containing 10, 20, 28, 30, 50, 56, 60, 84 and 90 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA14HF, United Kingdom
Marketing authorization number(s)
PL 20075/0305
Date of first authorization / renewal of the authorization
23/09/2011
Date of revision of the text
08/03/2019
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