HYPNODORM Film coated tablet Ref.[9829] Active ingredients: Flunitrazepam

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2019  Publisher: Alphapharm Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.mylan.com.au

Therapeutic indications

Severe cases of insomnia.

Posology and method of administration

In most patients, Hypnodorm need only be administered for a few nights. Treatment should be discontinued gradually by decreasing the dosage.

Dosage should be selected carefully, due consideration being given to the patient’s age and general condition, as well as the type of sleep disturbance.

The drug should be taken immediately before going to bed. In general, the following dosages are recommended.

Adults

1 to 2 mg on going to bed.

Elderly patients

0.5 to 1 mg.

In impaired renal or hepatic function

Elimination of metabolites will be impaired. For these patients, commence treatment with small doses which are increased slowly until the desired response is attained.

Overdose

Symptoms

Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression, ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, coma, and very rarely death.

Treatment

In the management of overdosage with any medication, it should be borne in mind that multiple agents may have been taken.

Following overdosage with flunitrazepam tablets, activated charcoal should be given to reduce absorption. General symptomatic and supportive measures are recommended. Hypotension and respiratory depression should be managed according to general principles.

Haemoperfusion and haemodialysis are not useful in benzodiazepine intoxication. The benzodiazepine antagonist flumazenil may be used in hospitalised patients for the reversal of acute benzodiazepine effects. Please consult the flumazenil product information prior to usage.

If excitation occurs in patients following overdosage, barbiturates should not be used.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Shelf life

Shelf life: In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Special precautions for storage

Store below 30°C.

Nature and contents of container

Available in HDPE bottles of 30 tablets.

Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

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