Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Short-term treatment of insomnia when it is severe, disabling or subjecting the individual to extreme distress. Dalmane is helpful in overcoming difficulties in getting to sleep and also in the problem of frequent nocturnal awakenings. Its properties make it particularly indicated where the total duration of sleep is less than adequate.
An underlying cause for insomnia should be sought before deciding upon the use of benzodiazepines for symptomatic relief.
Benzodiazepines are not recommended for the primary treatment of psychotic illness.
The dosage of Dalmane should be determined on an individual basis taking into account the severity of the insomnia and the patient’s response to treatment. Dosage is important in determining the duration of effect and the occurrence of residual effects.
The usual dose is 15 or 30mg. 15 mg is optimal for most patients and this will ensure a full night’s sleep with minimal residual effects on wakening. Patients with severe insomnia may require 30 mg (but no more than 60 mg), but residual effects on awakening, associated with an anxiolytic effect, are more frequent at this dose.
The elderly will be particularly susceptible to the adverse effects of Dalmane. The initial dose should not exceed 15 mg. If organic brain changes are present, the dosage of Dalmane should not exceed 15 mg.
The initial dose is 15 mg and in general should not be exceeded.
In patients with chronic pulmonary insufficiency the dosage may need to be reduced.
Dalmane is contra-indicated for use in children.
Treatment should, if possible, be on an intermittent basis.
Treatment should be as short as possible and should be started with the lowest recommended dose. The maximum dose should not be exceeded. Generally the duration of treatment varies from a few days to two weeks with a maximum of four weeks, including the tapering off process.
In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status. Long-term chronic use is not recommended.
Flurazepam is a long-acting benzodiazepine so the patient must be regularly checked to reduce the dosage or frequency of administration if necessary to prevent overdose due to accumulation.
Patients who have taken benzodiazepines for a prolonged time may require a longer period during which doses are reduced. Specialist help may be appropriate. Little is known regarding the efficacy or safety of benzodiazepines in long-term use.
Dalmane capsules are for oral administration.
The product should be taken just before going to bed.
To be swallowed with water without chewing.
When taken alone in overdosage Dalmane presents few problems in management and should not present a threat to life unless combined with other CNS depressants (including alcohol).
Depending on the dose ingested, intoxication with benzodiazepines is usually manifested by various degrees of central nervous system depression ranging from somnolence, mental confusion, dysarthria and lethargy, impaired vision and dystonia to ataxia, unconsciousness, central respiratory and/or circulatory depression and rarely coma and very rarely death.
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents might have been taken.
Following overdose with oral benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption.
General supportive and symptomatic measures are recommended.
Special attention should be paid to respiratory and cardiovascular functions in intensive care.
The value of dialysis has not been determined and is expected to be low for Dalmane.
Flumazenil is a specific IV antidote for use in emergency situations. Patients requiring such intervention should be monitored closely in hospital (see separate prescribing information).
The physician should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.
If excitation occurs, barbiturates should not be used.
Amber glass bottles and plastic adept containers: 5 years.
PVDC blister packs: 3 years.
Polythene bags in tins and small HDPE bottles: 2 years.
White securitainers: 1 year.
Dalmane capsules should be stored in a dry place with a recommended maximum storage temperature of 25°C.
PVDC blister packs, amber glass bottles, polythene bags in tins, plastic adept containers, white securitainers and small HDPE bottles, containing 30 capsules.
Not all pack sizes may be marketed.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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