PINDOLOL Tablet (2014)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Pindolol Tablets 5mg.
Qualitative and quantitative composition
Each tablet contains pindolol 5 mg. For the full list of excipients see section 6.1.
Pharmaceutical form
Tablet. White, flat bevelled edged tablet, marked PL breakline 5 on one side of the tablet and G on the reverse.
Therapeutic indications
Essential hypertension: For reduction of blood pressure in essential hypertension. Onset of action of Pindolol is usually rapid, most patients showing a response within the first one to two weeks of treatment. ...
Posology and method of administration
Posology Adults Hypertension Initially one 5 mg tablet two or three times a day. According to the response of the patient the dose may be increased at weekly intervals to a maximum of 45 mg given in divided ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, untreated cardiac failure, atrioventricular block, cardiogenic shock, pronounced bradycardia, second and third ...
Special warnings and precautions for use
Patients with a poor cardiac reserve should be stabilised with digitalis before treatment with pindolol to prevent impairment of myocardial contractility. As for other beta blockers, and especially in ...
Interaction with other medicinal products and other forms of interaction
During treatment with pindolol patients should not undergo anaesthesia with agents causing myocardial depression (e.g. halothane, cyclopropane, trichlorethylene, ether, chloroform). Pindolol should be ...
Pregnancy and lactation
Pregnancy Pindolol is contraindicated in pregnancy. Breast-feeding Pindolol passes in small quantities into breast milk Breast-feeding is therefore not recommended following administration.
Effects on ability to drive and use machines
Because dizziness or fatigue may occur during the initial phase of treatment with beta-adrenoceptor blocking drugs, patients driving vehicles or operating machinery should exercise caution until their ...
Undesirable effects
The following undesirable effects have been observed with the following frequencies: not known (frequency cannot be estimated from the available data). Metabolism and nutrition disorders Not known: Beta-blockers ...
Overdose
Management Treat by elimination of any unabsorbed drug and general supportive measures. Marked bradycardia as a result of overdosage or idiosyncrasy should be treated with atropine sulphate 1 to 2 mg intravenously. ...
Pharmacodynamic properties
Pharmacotherapeutic group: beta-adrenergic blocking agents; beta blockers ATC code: C07AA03 Mechanism of action Pindolol is a potent beta-adrenoceptor antagonist (beta-blocker) with uses similar to those ...
Pharmacokinetic properties
Absorption The rapid, nearly complete absorption (>95%) and the negligible hepatic first-pass effect (13%) of pindolol result in a high bioavailability (87%). Maximum plasma concentration is reached within ...
Preclinical safety data
There are no additional preclinical data of relevance to the prescriber.
List of excipients
Cellulose, microcrystalline Starch, pregelatinised Magnesium stearate Colloidal silicon dioxide
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store below 25°C. Store in the original package in order to protect from light.
Nature and contents of container
Polypropylene containers with polyethylene caps (with optional use of polyethylene ullage filler) and PVC/aluminium foil blister packs containing 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56, 60, 84, 90, 100, ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Generics [UK] Limited, T/A Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Marketing authorization number(s)
PL 04569/0118
Date of first authorization / renewal of the authorization
Date of first authorisation: 7<sup>th</sup> October 1986 Date of latest renewal: 23<sup>rd</sup> February 2004
Date of revision of the text
04/09/2014
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