COMPOSITION: Each tablet contains 2 mg flunitrazepam.
PHARMACOLOGICAL CLASSIFICATION: A 2.2 Sedatives and hypnotics
PHARMACOLOGICAL ACTION: Flunitrazepam is a benzodiazepine which has anxiolytic, sedative, muscle relaxant and anticonvulsant properties.
INDICATIONS: Flunitrazepam is indicated for the short-term treatment of insomnia.
CONTRA-INDICATIONS: Insom is contra-indicated in children, pregnancy and lactation.
Patients with a known sensitivity to Flunitrazepam or other benzodiazepines.
Pre-existing central nervous system depression or coma.
Psychotic patients, and those suffering from mental depression or suicidal tendencies, unless there is a marked component of anxiety in their illness.
Patients with acute closed-angle glaucoma and myasthenia.
Severe chronic hypercapnia.
WARNINGS: KEEP OUT OF REACH OF CHILDREN.
There is potential for abuse. Prolonged use may lead to the development of dependence of the barbiturate-alcohol type. The withdrawal of Flunitrazepam should be gradual after long-term use. Even after short-term use, a tapering-off regime is recommended.
Insom may enhance the effects of other central nervous system depressants.
Insom causes drowsiness and sedation. Patients should be warned not to drive motor vehicles, operate machinery or climb dangerous heights, until the individual effect on the patient is known.
Patients should be advised that their tolerance for alcohol will be reduced and alcohol should be avoided.
DOSAGE AND DIRECTIONS FOR USE: Treatment of insomnia:
Half to one tablet (1 - 2 mg) at night immediately before going to bed.
A quarter to half a tablet (0,5 - 1 mg) at night immediately before going to bed.
The return of normal sleep habits eventually allows treatment to be discontinued; this is best done by gradually decreasing the dosage.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The side-effects most commonly encountered are drowsiness and oversedation. Drowsiness is more common in elderly and debilitated patients and in patients receiving high doses. Less frequently occurring side-effects are depression of mood, disorientation or confusion, lethargy and ataxia.
Paradoxical reactions such as acute hyperexcitable states with rage, may occur. If these occur, the medicine should be discontinued.
Other side-effects observed include dizziness, vertigo, light-headedness, headache, confusion, mental depression, slurred speech or dysarthria, changes in libido, ataxia, tremor, blurred vision, urinary retention or incontinence, gastro-intestinal disturbances, charges in salivation, jaundice and blood disorders. Flunitrazepam can cause amnesia and may produce paradoxical excitation, respiratory depression and hypotension may occur with high dosage.
Flunitrazepam may affect the central control of endocrine function by an action on the hypothalamus or anterior pituitary. Endocrine symptoms occurring in long-term users include menstrual irregularities, premenstrual tension, breast engorgement, gynaecomastia and galactorrhoea.
On being awakened from deep sleep, a patient may not recall some events which occur during the awakening period.
Insom potentiates medicine used in anaesthetics such as centrally acting analgesics, sedatives and neuroleptics.
Special precautions: Particular caution should be exercised in:
the elderly and debilitated - who are at a particular risk of oversedation, respiratory depression and ataxia (the initial dosage should be reduced in these patients);
patents with pulmonary disease and limited pulmonary reserve;
patients suffering from impairment of renal, hepatic or respiratory function;
patients suffering from anxiety accompanied by an underlying depressive disorder;
myasthenia gravis patients on account of the pre-existing muscle weakness;
caesarian section: Insom should not be used for premedication due to placental transfer thereof. Care may be needed in epileptic patients, in whom the initiation or abrupt withdrawal of Insom therapy has provoked seizures.
Given during labour it crosses the placenta and may cause the 'floppy-infant' syndrome characterised by central respiratory depression, hypothermia and poor sucking.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Manifestations of overdosage include somnolence, confusion, coma, respiratory and cardiovascular depression and hypotension.
The stomach should be emptied by aspiration and lavage following recent ingestion of an overdose. Treatment is symptomatic and supportive with particular attention being paid to the maintenance of cardiovascular, respiratory and renal function, and to the maintenance of the electrolyte balance.
IDENTIFICATION: A white, round, biconvex tablet, quadrisected on one side and imprinted F2on the other.
PRESENTATION: Blister pack with 30 and 100 tablets.
STORAGE INSTRUCTIONS: Store below 25°C. KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: Z/2.2/325
NAME AND ADDRESS OF APPLICANT: Lennon Limited, 7 Fairclough Road, PORT ELIZABETH 6001
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 29/12/1993