LEXOTAN Tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Lexotan 1.5 mg Tablets. Lexotan 3 mg Tablets.
Qualitative and quantitative composition
Lexotan 1.5 mg Tablets Each tablet contains 1.5 mg bromazepam. Excipients: Also contains 96.1 mg lactose monohydrate. Lexotan 3 mg Tablets Each tablet contains 3 mg bromazepam. Excipients: Also contains ...
Pharmaceutical form
Lexotan 1.5 mg Tablets Tablet. Off-white to slightly yellow, cylindrical, biplane tablets scored on one side and marked Roche 1.5 on reverse. Lexotan 3 mg Tablets Tablet. Pale red, slightly speckled, cylindrical, ...
Therapeutic indications
Anxiety Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme distress.
Posology and method of administration
Anxiety Treatment should be as short as possible. The overall duration of treatment generally should not be more than 8–12 weeks, including a tapering off process. These amounts are general recommendations, ...
Contraindications
Bromazepam is contraindicated in patients with: Known hypersensitivity to benzodiazepines or to any of the excipients listed in section 6.1. Severe respiratory insufficiency. Severe hepatic impairment ...
Special warnings and precautions for use
Amnesia Benzodiazepines may induce anterograde amnesia. The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic Interaction Benzodiazepines may produce enhanced side effects such as sedation and cardio-respiratory depression when co-administered with alcohol or other CNS depressants. Concomitant ...
Pregnancy and lactation
Pregnancy Although no specific clinical data are available for bromazepam, a large amount of data based on cohort studies indicate that first trimester exposure to benzodiazepine is not associated with ...
Effects on ability to drive and use machines
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines. If insufficient sleep duration occurs, the likelihood of impaired ...
Undesirable effects
Lexotan is well tolerated in therapeutic doses. The following undesirable effects have been reported during treatment with bromazepam with the following frequencies: Very common: ≥1/10; Common ≥1/100 to ...
Overdose
Symptoms Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose of bromazepam is seldom life-threatening if the drug is taken alone, but may lead to slurred speech areflexia, ...
Pharmacodynamic properties
Pharmacotheapeutic group: Anxiolytic ATC code: N05BA08 Bromazepam is a pyridylbenzodiazepine compound with anxiolytic properties.
Pharmacokinetic properties
Absorption Bromazepam is rapidly absorbed from the gastro-intestinal tract and reaches peak plasma concentrations within 2 hours of oral administration. The absolute bioavailability of bromazepam from ...
Preclinical safety data
Carcinogenicity Carcinogenicity studies conducted in rats did not reveal any evidence of a carcinogenic potential for bromazepam. Genotoxicity Bromazepam was not genotoxic in in-vitro and in-vivo tests. ...
List of excipients
<u>Lexotan 1.5 mg Tablets:</u> Microcrystalline cellulose Lactose monohydrate Magnesium stearate Talc <u>Lexotan 3 mg Tablets:</u> Microcrystalline cellulose Lactose monohydrate Magnesium stearate Talc ...
Incompatibilities
Not applicable.
Shelf life
PVDC blister packs: 5 year shelf life. HDPE bottles: 5 year shelf life. PVC blister packs: 5 year shelf life.
Special precautions for storage
Do not store above 25°C. Store in the original package in order to protect from light and moisture.
Nature and contents of container
PVDC blister packs of 4, 10, 20, 60 or 100 tablets. HDPE bottles of 100 tablets. PVC blister packs of 30 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
The release of pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided.
Marketing authorization holder
Roche Products (Ireland) Limited, 3004 Lake Drive, City West, Naas Road, Dublin 24, Ireland
Marketing authorization number(s)
Lexotan 1.5 mg Tablets: PA 2307/003/001 Lexotan 3 mg Tablets: PA 2307/003/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 31 October 1980 Date of last renewal: 31 October 2010
Date of revision of the text
4 December 2018
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