NEBILET Tablet (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
NEBILET 5 mg tablets.
Qualitative and quantitative composition
Each Nebilet tablet contains 5 mg of nebivolol (as nebivolol hydrochloride): 2.5 mg of SRRR-nebivolol (or d-nebivolol) and 2.5 mg of RSSS-nebivolol (or l-nebivolol). Excipient with known effect: each tablet ...
Pharmaceutical form
Tablet. White, round, cross-scored tablet. The tablet can be divided in equal quarters.
Therapeutic indications
Hypertension Treatment of essential hypertension. Chronic heart failure (CHF) Treatment of stable mild and moderate chronic heart failure in addition to standard therapies in elderly patients ≥70 years. ...
Posology and method of administration
Posology Hypertension Adults The dose is one tablet (5 mg) daily, preferably at the same time of the day. The blood pressure lowering effect becomes evident after 1-2 weeks of treatment. Occasionally, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Liver insufficiency or liver function impairment. Acute heart failure, cardiogenic shock or episodes of heart ...
Special warnings and precautions for use
See also 4.8 Undesirable effects. The following warnings and precautions apply to beta-adrenergic antagonists in general. Anaesthesia Continuation of beta-blockade reduces the risk of arrhythmias during ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions The following interactions apply to beta-adrenergic antagonists in general. Combinations not recommended <u>Class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, ...
Pregnancy and lactation
Pregnancy Nebivolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. Pharmacodynamic studies have shown that Nebilet 5 mg does not affect psychomotor function. When driving vehicles ...
Undesirable effects
Adverse events are listed separately for hypertension and CHF because of differences in the background diseases. Hypertension The adverse reactions reported, which are in most of the cases of mild to moderate ...
Overdose
No data are available on overdosage with Nebilet. Symptoms Symptoms of overdosage with beta-blockers are: bradycardia, hypotension, bronchospasm and acute cardiac insufficiency. Treatment In case of overdosage ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agent, selective ATC code: C07AB12 Nebivolol is a racemate of two enantiomers, SRRR-nebivolol (or d-nebivolol) and RSSS-nebivolol (or l-nebivolol). It combines ...
Pharmacokinetic properties
Both nebivolol enantiomers are rapidly absorbed after oral administration. The absorption of nebivolol is not affected by food; nebivolol can be given with or without meals. Nebivolol is extensively metabolised, ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of genotoxicity and carcinogenic potential.
List of excipients
Polysorbate 80 (E433) Hypromellose (E464) Lactose monohydrate Maize starch Croscarmellose sodium (E468) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551) Magnesium stearate (E572)
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage precautions.
Nature and contents of container
Tablets are provided in blister packs (PVC/aluminium blister). Pack sizes of 7, 14, 28, 30, 50, 56, 90, 100, 500 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg
Marketing authorization number(s)
PL 16239/0013
Date of first authorization / renewal of the authorization
Date of first authorisation: 4<sup>th</sup> January 1999 Date of latest renewal: 18 October 2010
Date of revision of the text
01/08/2018
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