BUSPIRONE Tablet (2016)
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Περιεχόμενα
Name of the medicinal product
BUSPIRONE 5mg TABLETS.
Qualitative and quantitative composition
Each dosage form contains 5mg buspirone hydrochloride. Excipients with known effect: each tablet contains 60.80mg Lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet. White, uncoated, flat bevelled edge with A5 on one side and plain on the other.
Therapeutic indications
Buspirone is indicated for the treatment of short-term management of anxiety disorders and the relief of symptoms of anxiety with or without accompanying symptoms of depression.
Posology and method of administration
Posology The dosage should be individualised for each patient. Adults (including the elderly): the usual starting dosage is 5mg given two to three times per day. The dosage may be increased every 2-3 days. ...
Contraindications
Buspirone is contraindicated in the following groups of patients. Patients with known hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with epilepsy. ...
Special warnings and precautions for use
The administration of buspirone to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone has been ...
Interaction with other medicinal products and other forms of interaction
The concomitant use of buspirone with other CNS-active drugs should be approached with caution. Effect of other drugs on buspirone Association not recommended MAO inhibitors Co-administration of MAO inhibitors ...
Pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of buspirone in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see ...
Effects on ability to drive and use machines
Buspirone has moderate influence on the ability to drive and use machines. Attention is drawn to the risks associated with drowsiness or dizziness induced by this drug (see section 4.8). This medicine ...
Undesirable effects
Side effects of buspirone, if they occur, are generally observed at the beginning of drug therapy and usually subside with use of the medication and/or decreased dosage. Clinical experience When patients ...
Overdose
Features In normal volunteers, the maximum tolerated dose of buspirone was 375 mg/day. As the maximum dose levels were approached, the most commonly observed symptoms include nausea, vomiting, headache, ...
Pharmacodynamic properties
ATC code: NO5BE01 Buspirone is an azaspirodecanedione. The exact mechanism of Buspirone anxioselective action is not fully known. It does not act on benzodiazepine receptor sites and lacks sedative, anticonvulsant ...
Pharmacokinetic properties
Absorption Buspirone hydrochloride is rapidly absorbed from the gastrointestinal tract reaching peak plasma concentrations within 40 to 90 minutes after administration by mouth. Systemic bioavailability ...
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Lactose monohydrate Magnesium stearate Purified talc Polyvidone K-25 Potato starch
Incompatibilities
Not applicable.
Shelf life
Three years.
Special precautions for storage
Do not store above 25°C. Store in the original container.
Nature and contents of container
250µm white opaque PVC/20µm aluminium foil blister packs. Blister pack sizes: 20, 21, 28, 30, 56, 60, 84, 90, 100, 112, 126
Special precautions for disposal and other handling
There are no special instructions for use/handling.
Marketing authorization holder
Actavis UK Limited (Trading styles: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS
Marketing authorization number(s)
PL 0142/0455
Date of first authorization / renewal of the authorization
24 July 2002 / 23 January 2009
Date of revision of the text
14/07/2016
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