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LEXOTAN Tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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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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