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

Logo NORIPAM 10 mg TABLETS
NORIPAM 15 mg TABLETS
NORIPAM 30 mg TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

NORIPAM 10 mg TABLETS
NORIPAM 15 mg TABLETS
NORIPAM 30 mg TABLETS

COMPOSITION:
Per tablet:
Oxazepam 10 mg, 15 mg and 30 mg

PHARMACOLOGICAL CLASSIFICATION:
A2.6 Tranquillizers

PHARMACOLOGICAL ACTION:
Oxazepam is a bensodiazepine derivative with sedative, hypnotic, aniolytic, anticonvulsant and muscle relaxant properties. The half life ranges from six to twenty hours.

INDICATIONS:
NORIPAM is indicated for:
-        the management of anxiety in neurotic patients, tension and fear;
-        alcoholics with acute tremor, inebriation, or anxiety associated with alcohol withdrawal.
NORIPAM is not indicated in patients with a primary depressive disorder or with psychosis.

CONTRA-INDICATIONS:
Sensitivity to Oxazepam or other bensodiazepine derivatives.
Oxazepam should not be given to patients suffering from mental depresssion or suicidal tendencies and in psychotic patients, unless there is a marked component of anxiety in their illness.

WARNINGS:
There is a potential for abuse especially with prolonged use and high doses.
Withdrawal symptoms may occur after long periods of normal therapeutic doses.
Patients should be advised particularly at the initiation of therapy not to drive a motor vehicle, climb dangerous heights or operate dangerous machinery.
In these situations, impaired decision-making could lead to accidents.
Oxazepam should be given with care in elderly or debilitated patients who may be prone to adverse effects.
Caution is required in patients with impaired liver, kidney or respiratory function, and in patients receiving other central nervous system depressant medicines.

DOSAGE AND DIRECTIONS FOR USE:
For the treatment of anxiety:
15 mg to 30 mg three or four times per day.
Suggested initial dose for elderly or debilitated patients:
10 mg three times per day

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
- tolerance and physical dependence.
- drowsiness and oversedation - drowsiness occurs more frequently in aged and debilitated patients and in patients taking high doses.
- less common are depression of mood and effect, disorientation or confusion, lethargy and ataxia, tremor, blurred vision.
- paradoxical reactions such as acute hyperexcitable states with rage may show. If this occurs, the medicine should be discontinued.
- skin rashes, headaches, nausea, vertigo, light-headedness, impairment of sexual function, and urinary retention or incontinence, gastro-intestinal disturbances, changes in salivation, jaundice and blood disorders have been reported.
- menstrual irregularities have been noted and women may fail to ovulate while taking Oxazepam.
Special precautions:
Hypotension has occurred. Oxazepam should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac complications.
Caution should be observed when giving Oxazepam to patients:
- with impaired hepatic or renal function. In elderly or debilitated patients large doses may produce syncope, oversedation, respiratory depression and ataxia. The initial dosage should be reduced in these patients. With prolonged treatment, periodic blood counts and liver function tests are advisable
- with pulmonary disease and limited pulmonary function reserves
- suffering from anxiety accompanied by an underlying depressive disorder
- receiving barbiturates, phenothiazines, mono-amine oxidase inhibitors, tricyclic antidepressants and to patients taking alcohol.
Because of the risk of additive central nervous system depression Oxazepam should be used judiciously during pregnancy and preferably avoided. Given during labour, it crosses the placenta and may cause the floppy-infant syndrome characterized by central respiratory depression, hypothermia and poor sucking. It should not be administered to lactating mothers.
Care may be needed in epileptic patients, in whom the initiation or abrupt withdrawal of Oxazepam therapy can provoke seizures. Oxazepam should be used with caution in patients with glaucoma.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Sedation, ataxia, dysarthria, hypotension, confusion, respiratory and cardiovascular depression and occasionally sleep and coma.
Treatment is symptomatic and supportive.

IDENTIFICATION:
10 mg: a white, flat, scored tablet with bevelled edges.
15 mg: a yellow, flat, scored tablet with bevelled edges.
30 mg: a pink, flat, scored tablet with bevelled edges.

PRESENTATION:
Tablets 10 mg:        30’s, 100’s and 250's in securitainers
Tablets 15 mg:        30’s, 100’s and 250's in securitainers
Tablets 30 mg:        30’s, 100’s and 250's in securitainers

STORAGE INSTRUCTIONS:
Store below 25°C in well-closed containers and protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER
Noripam 10 mg:        Y/2.6/68
Noripam 15 mg:        Y/2.6/69
Noripam 30 mg:        Y/2.6/70

NAME AND BUSINESS ADDRESS OF APPLICANT:
Brainware Compu (Pty) Ltd
476 Kings Highway
Lynnwood
Pretoria

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

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