DALMANE Capsule (2020)
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Περιεχόμενα
Name of the medicinal product
Dalmane 15 mg Capsules.
Qualitative and quantitative composition
Capsules with opaque grey cap and opaque yellow body with ICN 15 printed in red on both cap and body, containing 16.4 mg flurazepam monohydrochloride (equivalent to 15 mg flurazepam). Each capsule contains ...
Pharmaceutical form
Dalmane capsules 15 mg.
Therapeutic indications
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 ...
Posology and method of administration
Posology Adults The dosage of Dalmane should be determined on an individual basis taking into account the severity of the insomnia and the patients response to treatment. Dosage is important in determining ...
Contraindications
Dalmane is contraindicated in: Patients with known hypersensitivity to flurazepam, other benzodiazepines or to any of the excipients listed in section 6.1. myasthenia gravis; severe pulmonary insufficiency; ...
Special warnings and precautions for use
Dalmane should not be used alone to treat depression or anxiety associated with depression, since suicide may be precipitated in such patients. Benzodiazepines should be used in extreme caution in patients ...
Interaction with other medicinal products and other forms of interaction
The benzodiazepines, including flurazepam, produce additive CNS depressant effects when co-administered with other CNS drugs such as barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, ...
Pregnancy and lactation
Pregnancy There is no evidence as to drug safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Do not use during pregnancy, especially during the first and last ...
Effects on ability to drive and use machines
Patients should be advised that, like all medicaments of this type, Dalmane might modify patients' performance at skilled tasks (driving, operating machinery, etc) to a varying degree depending upon dosage, ...
Undesirable effects
Common adverse effects include somnolence during the day, emotional poverty, reduced alertness, confusional state, fatigue, headache, dizziness, muscle weakness, ataxia and diplopia. These phenomena are ...
Overdose
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). Symptoms Depending on ...
Pharmacodynamic properties
Pharmacotherapeutic group: Hypnotics and Sedatives, Benzodiazepine derivatives ATC code: N05CD01 Flurazepam is a psychotropic substance from the class of 1,4-benzodiazepines. Onset of sedative effects ...
Pharmacokinetic properties
The pharmacokinetic properties of Dalmane make it particularly indicated for patients whose total duration of sleep is less than adequate. The dosage of the drug is important in balancing the duration ...
Preclinical safety data
Mutagenic and tumourigenic potential There is insufficient data available to evaluate the genotoxic potential of flurazepam. The limited studies performed to date showed no evidence of genotoxicity.
List of excipients
15 mg capsules contain the following excipients: Lactose Talc purified Magnesium stearate Black iron oxide E172 Titanium dioxide E171 Yellow iron oxide E172
Incompatibilities
Not applicable.
Shelf life
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.
Special precautions for storage
Dalmane capsules should be stored in a dry place with a recommended maximum storage temperature of 25°C.
Nature and contents of container
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.
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0125
Date of first authorization / renewal of the authorization
03/05/1999
Date of revision of the text
August 2020
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