INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BROMAZE 3 TABLETS
BROMAZE 6 TABLETS
SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

BROMAZE 3 TABLETS
BROMAZE 6 TABLETS

COMPOSITION:
BROMAZE 3 –3 mg Bromazepam per tablet.
BROMAZE 6 –6 mg Bromazepam per tablet.

PHARMACOLOGICAL CLASSIFICATION:
A 2.6 Tranquilizers.

PHARMACOLOGICAL ACTION:
BROMAZE is a benzodiazepine derivative with anxiolytic, sedative, muscle-relaxing and anticonvulsant properties. In low doses it diminishes anxiety and tension. In higher dosages the sedative and muscle-relaxant properties appear.
BROMAZE has, at therapeutic doses, primarily a selective inhibitory action on the limbic system. The cortical centres respond only to relatively high doses. The muscle-relaxing effect is produced by the inhibition of spinal reflexes as well as by influencing central substrates related to the limbic, thalamic and hypothalamic systems.

INDICATIONS:
Treatment of anxiety disorders.
BROMAZEis only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.

CONTRA-INDICATIONS:
Hypersensitivity to bromazepam or benzodiazepines. Psychotic patients, and in those suffering from mental depression or suicidal tendencies unless there is a marked component of anxiety in their illness. Pregnancy and lactation. Labour.
Safety and efficacy of BROMAZE has not been established in children. Paradoxical reactions such as excitement and irritability may occur in children. Smaller children are more prone to these reactions.
Given during labour, BROMAZE crosses the placenta and may cause the "flopp-infant"' syndrome characterised by central respiratory depression, hypothermia and poor sucking.
Myasthenia gravis.

WARNINGS:
Patients receiving BROMAZE should be advised not to operate motor vehicles or dangerous machinery, or climes dangerous heights until it is established that they do not become drowsy or dizzy while receiving BROMAZE. In these situations impaired decision making could lead to accidents.
Patients should avoid alcohol while taking BROMAZE since the individual response cannot be foreseen.
There is a potential for abuse and dependence. Withdrawal symptoms may occur after long periods of ordinary therapeutic doses.

DOSAGE AND DIRECTIONS FOR USE:
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
Average dose for outpatient therapy: 1,5 - 3 mg three times daily.
Severe cases especially in hospital: 6 - 12 mg two or three times daily.
These amounts are average recommendations, and dosage should be individually determined. Treatment of outpatients in general begins with the lowest dosage, gradually increasing if necessary to optimum level.
Elderly patients: Reduce dosage by half.
According to progress in therapy, dosage can usually be gradually reduced and then stopped. Treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. The overall duration of treatment generally should not be more than 8 -12 weeks, including a 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.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
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, changes in salivation, jaundice, and occasional blood disorders have been reported. BROMAZEpam can cause amnesia and may produce paradoxical excitation.
If BROMAZE is combined with other centrally acting medicines such as neuroleptics, tranquilizers, antidepressants, hypnotics, analygesics and anaesthetics, pronounced sedation may result.
Monitoring of the blood count and of liver function is recommended during long-term therapy. Particular caution should be exercised with the elderly and debilitated – who are at particular risk of ovesedation, respiratory depression and ataxia. (The initial oral dosage should be reduced in these patients.)
Special precautions should be taken in the following instances: Patients with pulmonary disease and limited pulmonary reserve; patients with impaired renal or hepatic function; patients suffering from anxiety accompanied by an underlying endogenous depressive disorder.
Treatment with BROMAZE should be withdrawn if paradoxical reactions such as acute anxiety, hallucinations, insomnia or excitation occur.
BROMAZE is not recommended for the primary treatment of psychotic illness. BROMAZE should not be used alone to treat depression or anxiety with depression (suicide may be precipitated in such patients). BROMAZE should be used with extreme caution in patients with a history of alcohol or drug abuse.
Dependence
There is a potential for abuse and the development of physical and psychic dependence, especially with prolonged use and high doses. The risk of dependence is also greater in patients with a history of alcohol or drug abuse. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.
In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations and epileptic seizures.
Rebound Effects
A transient syndrome whereby the symptoms which led to the treatment with BROMAZE recur in an enhanced form may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.
Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
Duration of Treatment
The duration of treatment should be as short as possible (see Dosage), but should not exceed 4 weeks for insomnia and eight to twelve weeks in case of anxiety; including tapering off process. Extension beyond these periods should not take place without re-evaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover it is important that the patient should be aware of the possibility of rebound phenomena thereby minimising anxiety over such symptoms, should they occur while the product is being discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage can produce central nervous system depression, respiratory depression, hypotension and coma. Excitation and hyperactivity may appear during recovery phase.
Treatment should consist of general supportive and symptomatic measures.

IDENTIFICATION:
BROMAZE 3:         Green, round, scored tablets.
BROMAZE 6:         Green, oval, scored tablets.

PRESENTATION:
BROMAZE 3:         100.
BROMAZE 6:         100.

STORAGE INSTRUCTIONS:
Store below 25°C and protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
BROMAZE 3:         28/2.6/0215
BROMAZE 6:         28/2.6/0216

NAME AND ADDRESS OF THE APPLICANT:
HEXAL PHARMA (SA) (PTY) LTD
Unit A
10 Fangio Road
Mahogany Ridge
Westmead
3610

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30 March 1994.

Updated on this site: February 2000

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