Temazepam Restomed 30mg 1 Strips

Description

RESTOMED

(temazepam)

Composition:

Temazepam Capsules 15 mg: Each capsule contains: 15 n-ig temazepam

Temazepam Capsules 30mg:

Each capsule contains: 30 mg temazepam

Pharmaceutical Form

Capsules for oral administration.

Therapeutic indication For the short-term treatment of insomnia in cases where it is severe, disabling or subjecting the individual to extreme distress.

• Temazepam is also indicated for pre-operative medication prior to minor surgery or other similar procedures.

Dosage and Administration

The recommended’ usual adults dose is one to two 15 mg capsules Or one 30 mg capsule before retiring. As with a 4 medications, dosage should be individualized for maximum beneficial effects. In elderly and/or debilitated it is recommended that therapy, be initiate d with 15 mg until individual response is determined.

Contraindications

Temazepam is contra-indicated in the treatment of patients suffering from severe respiratory ‘ or hepatic insufficiency, neurasthenia gravies or sleep appease syndrome. It is also contra-

• fnrftcated for use in those who have previously experienced hypersensitivity to This or other benzodiazepines.

Special Warnings and Precautions for Use:

The cause for insomnia should be determined prior to the use’of temazepam, and it . .should not be used for first line treatment of psychotic illness. Temazepam should also not be used on its own to treat depression or anxiety accompanying depression. The duration of treatment should be as short as possible (less than 4 weeks) including . the tapering off process. More long-term treatment is not advised without re-assessment of the condition.

Treatment should be discontinued gradually to minimize the risk of withdrawal or rebound phenomenon where the symptoms requiring the treatment re cure in an enhanced form.

Temazepam should also-be used cautiously in patients with a history of alcohol or drug abuse, or severe hepatic or renal’in sufficiency.

When used to treat insomnia patients should ensure that they will be able to have 7-8 hours of uninterrupted sleep in order to reduce the risk of retrograde amnesia occurring. If insufficient sleep dose occur, this could lead to impaired aiertness. Sedation, amnesia,’ impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines,

• When temazepam .is- used for pre-medication, patients should be accompanied home afterwards.

There is a risk of drug dependency developing with the use of temazepam. This risk increases in severity with increasing dose and duration of treatment. There is also a greater risk in patients with a history of alcohol or drug abuse, or personality disorder. If dependence does develop, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. Tho use of benzodiazepines in patients also suffering from depression may unveil suicidal tendencies. Amnesia may occur and in case of loss and bereavement, psychological adjustment may be inhibited by benzodiazspines.

Interaction With Other Medicinal Products and Other Forms of Interaction

The concomitant use of temazepam and alcohol may enhance the sedative effect and is therefore not recommended.

Concurrent use of anti psychotics, antidepressants, narcotic analgesics, hypnotics, anxiolytics/sedatives. Sedative antihistamines, anesthetics and anti epileptic drugs may further-enhance the central depressive effect.

Enhanced euphoria may also occur with combined use of temazepam and narcotic analgesics, therefore possibly increasing the risk of dependence.

Pregnancy and Lactation

If the product’ is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant

If, for compelling medical reasons, the product is administered during the late phase of pregnancy, or during labor at high doses, effects on the net-mate, such as hypothermia, hypotonia and moderate respiratory depression, can be expected, due to the pharmacological action of the compound.

Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

Since benzodiazepines are found in the breast milk benzodiazepines should not be given to breast feeding mothers.

Effects on Ability to Drive and Use Machines

The side-effects of temazepam. such as sedation and impaired muscle function, may adversely affect the ability to-drive or use machines. Insufficient sleep may also increase the likelihood of impaired alertness. ‘

Undesirable Effects

At the start of treatment patients may suffer from drowsiness, reduced alertness, dizziness, confusion, fatigue, muscle weakness, numbed emotions, headache, ataxia or double vision. These will normally disappear with continued treatment.

More rarely, vivid dreams/nightmares, restless sleep, palpitations, change in libido, skin reactions, sedation, impaired muscular function, dry mouth and gastro-intestinal disturbances may occur.

Pre-existing depression may be unmasked during treatment with temazepam.

Blood dyspepsia, urinary retention, increased liver enzymes. Jaundice and visual disturbances have also been reported to occur occasionally. If any of these effects do occur, treatment should be discontinued.

Other effects, including delusions, psychoses, hallucinations, irritability and restlessness, aggressiveness and rages or other inappropriate behavior have ‘also been reported to occur, predominantly in elderly patients. If any of these effects occur, treatment should be discontinued.

Overdose Symptoms:

Benzodiazepines commonly cause drowsiness, ataxia. dysarthria and nystagmus. Coma, hypotension and respiratory depression occasionally occur but are seldom serious if these drugs are taken alone. Coma usually fasts only a few hours but in elderly people it may be more protracted and cyclical. Benzodiazepines respiratory depressant effects are more serious in-patients with severe chronic respiratory disease.

Benzodiazepines potentiate the effects of other central nervous system depressants, including alcohol.

Management:                                 •

Consider activated charcoal in adults or children who have taken more than 1 mg 7 kg within 1 hour, provided .they are not too drowsy. Gastric lavage is unnecessary if these drugs have been taken alone. Patients who are asymptomatic at four hours are unlikely to develop symptoms. Institute supportive measures as indicated by the patient’s clinical state.

If CNS depression  is severe consider the use of ftumazenil (Anexate), a benzodiazepine antagonist. This should,rarely be required. It has a short half-life (about an hour) and should NOT TO BE USED IN MIXED OVERDOSE OR AS A “Diagnostic” TEST. It is contral indicated in the presence of drugs that reduce seizure threshold (e.g. tri cyclic antidepressants).

Pharmacol Dynamic Properties:

Temazepam Is known to have hypnotic/sedative and analytic properties. It therefore results in anxiousness, muscle relaxation and central nervous system sedation. It has been suggested that a close molecular association between the sites and action for gamma-arnlno-butyric acid (GABA) and bonzodiazepines and potentiate of GABA may be responsible for these effects.

_ Other neuro transmitters may also be affected.

Pharmacol Kinetic Properties:

Temazepam is readily and almost completely absorbed from the gastro-intestinal tract and has been reported to be relatively extensively bound to plasma proteins (75-95%).

Peak plasma concentrations are reached approximately one hour after dosing. The majority of a dose of lemazepam is metabolized to inactive gluco-uranides, which  are then excreted in the urine.

Special Precautions for Storage:

Protect from heat, light and moisture.

All medicines should be kept out of reach of children.

Nature and Contents of Container:

Restored. 15 mg Capsules = Pack of 10’s.            .                ;       ‘

Restored 30 mg Capsules = Pack of 10’s.