TENORMIN Tablets (2017)
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Περιεχόμενα
Name of the medicinal product
Tenormin 100 mg Tablets.
Qualitative and quantitative composition
Atenolol 100 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White, round, biconvex, film-coated tablets of diameter 10 mm, which are intagliated with 100 on one face and bisected on the reverse face. The bisection is only to facilitate breaking ...
Therapeutic indications
Tenormin is indicated in the treatment of: Management of hypertension. Management of angina pectoris. Management of cardiac arrhythmias. Management of myocardial infarction. Early intervention in the acute ...
Posology and method of administration
Posology The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage. The following are guidelines: Adults Hypertension One tablet daily. Most ...
Contraindications
Tenormin, as with other beta-blockers, should not be used in patients with any of the following: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1. Cardiogenic ...
Special warnings and precautions for use
Tenormin as with other beta-blockers: Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta-blocker dosage. Patients should ...
Interaction with other medicinal products and other forms of interaction
Combined use of beta-blockers and calcium channel blockers with negative inotropic effects, e.g. verapamil and diltiazem, can lead to an exaggeration of these effects particularly in patients with impaired ...
Fertility, pregnancy and lactation
Caution should be exercised when Tenormin is administered during pregnancy or to a woman who is breast-feeding. Pregnancy Tenormin crosses the placental barrier and appears in the cord blood. No studies ...
Effects on ability to drive and use machines
Tenormin has no or negligible influence on the ability to drive and use machines. However, it should be taken into account that occasionally dizziness or fatigue may occur.
Undesirable effects
Tenormin is well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of atenolol. The following undesired events, listed by body system, ...
Overdose
The symptoms of overdosage may include bradycardia, hypotension, acute cardiac insufficiency and bronchospasm. General treatment should include: close supervision; treatment in an intensive care ward; ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-blocking agents, plain, selective ATC code: CO7A B03 Mechanism of action Atenolol is a beta-blocker which is beta1-selective, (i.e. acts preferentially on beta1-adrenergic ...
Pharmacokinetic properties
Absorption Absorption of atenolol following oral dosing is consistent but incomplete (approximately 40–50%) with peak plasma concentrations occurring 2–4 hours after dosing. The atenolol blood levels are ...
Preclinical safety data
Atenolol is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Prescribing Information.
List of excipients
Gelatin Glycerol Heavy Magnesium Carbonate Magnesium Stearate Maize Starch Hypromellose Sodium Laurilsulfate Titanium Dioxide (E171)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 60 months.
Special precautions for storage
Do not store above 25°C. Store in the original package. Keep the container in the outer carton.
Nature and contents of container
Aluminium PVC blister strips of 14 tablets in cartons: 28 Tablets. Aluminium PVC blister strips of 7 tablets: 504 Tablets (for Hospital Use) (pack is subdivided into 6 cartons each containing 12 blister ...
Special precautions for disposal and other handling
No special requirements for storage.
Marketing authorization holder
AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK
Marketing authorization number(s)
PL 17901/0054
Date of first authorization / renewal of the authorization
Date of first authorisation: 1<sup>st</sup> June 2000 Date of latest renewal: 5<sup>th</sup> November 2003
Date of revision of the text
16<sup>th</sup> June 2017
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