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

Logo AREM®-5 TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

AREM®-5 TABLETS

COMPOSITION:
Each tablet contains 5 mg of
Nitrazepam

PHARMACOLOGICAL CLASSIFICATION:
A 2.2 Sedatives, hypnotics.

PHARMACOLOGICAL ACTION:
The major molecular targets of the benzodiazepines are inhibitory neurotransmitter receptors directly activated by the amino-acid, gamma-aminobutyric acid (GABA). The half-life is 26 hours +/-3 and are increased in the elderly and obese patients.

INDICATIONS:
Relief of insomnia.
Nitrazepam is only indicated when the disorder is severe, disabling or subjecting the individual to extreme stress.

CONTRA-INDICATIONS:
- Psychotic patients.
- Chronic obstructive lung disease states.
- Patients with a known hypersensitivity towards nitrazepam or other benzodiazepines.
- Pregnancy (given during labour it crosses the placenta and may cause the floppy-infant syndrome characterised by central respiratory depression, hypothermia and poor sucking).
- Lactating mothers.
- Patients suffering from depression and suicidal tendencies.
- Acute porphyria
Nitrazepam should not be used in patients with pre-existing central nervous system depression or coma, acute pulmonary insufficiency, or sleep apnoea.

WARNING:
This medicine particularly at the initiation of therapy may lead to drowsiness or impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should not drive, climb dangerous heights or operate dangerous machinery where loss of attention might be hazardous.
KEEP OUT OF REACH OF CHILDREN

DOSAGE AND DIRECTIONS FOR USE:
Treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded.
The usual dose is one tablet (5 mg) at night, although two tablets (10 mg) may be required.
Elderly or debilitated patients should not be given more than half of the normal adult dose.
Treatment should be as short as possible. Generally the duration of treatment varies from a few days to two weeks, with a maximum, including tapering off process of four weeks. 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:
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. Depression of mood, disorientation or confusion, lethargy, blurred vision, urinary retention, or incontinence, jaundice, changes in salivation, blood disorders, dizziness, vertigo, light-headedness and ataxia may occur. Nightmares, hallucinations, insomnia and agitation, convulsions, cutaneous reactions such as rash and pruritus, headache, gastro-intestinal disturbances, slurred speech, changes in libido and tremor have been reported. Hypothermia, and tingling and numbness of the hands may occur.
Hypersensitivity reactions has been reported less frequently. Respiratory depression and hypotension occasionally occur with high doses. This product may cause amnesia.
Paradoxical reactions such as acute hyperexcitable states with rage may occur. If these occur, the medicine should be discontinued.
The benzodiazepines have a moderate potential for abuse. Withdrawal symptoms (including convulsions) have occurred following abrupt cessation especially in patients receiving large doses for prolonged periods.
Special Precautions:
Particular caution should be exercised in:
- The elderly and debilitated - who are at a particular risk of oversedation, respiratory depression especially sleep disturbances may occur and ataxia ( See Dosage and Directions for use).
- patients with chronic pulmonary disease and limited pulmonary reserve, and in patients with elevated carbon dioxide levels due to chronic obstructive lung disease.
- patients suffering from impairment of renal or hepatic function or from hypoalbuminaemia;
- patients suffering from anxiety accompanied by an underlying depressive disorder;
- patients receiving barbiturates or other central nervous system depressants since there is an additive risk of central nervous depression when these medicines are taken together;
- patients should be cautioned regarding the addictive effect of alcohol;
- patients with myasthenia gravis on account of pre-existing muscle weakness;
- patients with organic brain changes particularly arteriosclerosis.
- patients with acute closed-angle glaucoma.
- patients with gout.
Monitoring of cardiorespiratory function is recommended when benzodiazepines are used for conscious sedation.
Nitrazepam is not recommended for the primary treatment of psychotic illness or chronic psychosis or obsessional states. Nitrazepam should not be used alone to treat depression or anxiety with depression (suicide may be precipitated in such patients). Nitrazepam 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 extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound effects
A transient syndrome whereby the symptoms that led to treatment with nitrazepam 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, including a 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.
INTERACTIONS WITH OTHER MEDICINES:
The effects of nitrazepam (enhanced sedation or respiratory and cardiovascular depression) may be enhanced by alcohol, antidepressants, medicines to treat colds, medicines for seizure, antihistamines, muscle relaxants, antipsychotics, general anaesthetics, other hypnotics or sedatives, opioid analgesics, or other medicines that have central depressant properties or that interfere with their metabolism..
Cimetidine has also been reported to inhibit the metabolism of nitrazepam.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Following recent ingestion of an overdose of nitrazepam, the stomach may be emptied by lavage. Treatment is symptomatic and supportive although the specific benzodiazepine antagonist, flumazenil, may be indicated in emergencies. Flumazenil may also be useful in the diagnosis of Benzodiazepine overdosage.

IDENTIFICATION:
Flat, white bisected tablets with bevelled edges, engraved with "Arem" on the one side and mortar and pestle on the other side.

PRESENTATION:
White securitainers containing 30 or 250 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C
Store in airtight containers, protected from light and moisture.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
K/2.2/210

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
PORT ELIZABETH 6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
28/3/1978

                D014
                        A & S PRINTERS

Updated on this site: May 2000
Current: September 2004
Source: Community Pharmacy

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