HYPNODORM Film coated tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Flunitrazepam.
Qualitative and quantitative composition
Each Hypnodorm tablet contains 1 mg flunitrazepam. Molecular formula: C<sub>16</sub>H<sub>12</sub>FN<sub>3</sub>O<sub>3</sub> Molecular weight: 313.3 Flunitrazepam is a pale yellow crystalline solid, sparingly ...
Pharmaceutical form
Flunitrazepam 1 mg tablets: green, oval, normal convex, scored, film coated tablet debossed FM |1 on one side and α on the other.
Therapeutic indications
Severe cases of insomnia.
Posology and method of administration
In most patients, Hypnodorm need only be administered for a few nights. Treatment should be discontinued gradually by decreasing the dosage. Dosage should be selected carefully, due consideration being ...
Contraindications
Hypnodorm is contraindicated in: Patients with known hypersensitivity to flunitrazepam or to any other components of Hypnodorm. Patients with known hypersensitivity to benzodiazepines. Patients with chronic ...
Special warnings and precautions for use
Severe allergic reactions Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics. Some patients ...
Interaction with other medicinal products and other forms of interaction
CNS Depressant Drugs The benzodiazepines, including flunitrazepam, produce additive CNS depressant effects when co-administered with other medications which themselves produce CNS depression, e.g. barbiturates, ...
Fertility, pregnancy and lactation
Effects on Fertility Studies have not been performed to assess the potential of flunitrazepam to impair fertility. Use in Pregnancy (Category C) Benzodiazepines cross the placenta and may cause hypotonia, ...
Effects on ability to drive and use machines
Complex behaviours such as sleep-driving (i.e. driving while not fully awake after taking a sedativehypnotic, with amnesia for the event) have been reported with sedative hypnotics. These events can occur ...
Undesirable effects
Note: Percentages indicate the incidence of adverse reactions in clinical trials. About 13% of patients experience adverse effects, usually due to the persistence or accentuation of the pharmacological ...
Overdose
Symptoms Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression, ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion ...
Pharmacodynamic properties
Mechanism of Action Flunitrazepam is a member of the benzodiazepine group of drugs and is closely related to nitrazepam, flurazepam and clonazepam. It has marked sedative and hypnotic properties with a ...
Pharmacokinetic properties
Absorption Following oral administration, flunitrazepam is almost completely absorbed. Peak blood levels of flunitrazepam occur usually 45 minutes after ingestion. 10% to 15% is metabolised by a liver ...
Preclinical safety data
Genotoxicity Studies have not been performed to assess the mutagenic potential of flunitrazepam. Carcinogenicity Studies have not been performed to assess the carcinogenic potential of flunitrazepam. ...
List of excipients
The tablets also contain the following excipients: Lactose monohydrate Maize starch Pregelatinised maize starch Magnesium stearate Indigo carmine CI73015 Opadry Green OY-LS-21051
Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
Shelf life
Shelf life: In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Special precautions for storage
Store below 30°C.
Nature and contents of container
Available in HDPE bottles of 30 tablets.
Special precautions for disposal and other handling
In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.
Marketing authorization holder
Alphapharm Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au
Date of first authorization / renewal of the authorization
04/10/2001
Date of revision of the text
18/12/2019
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