Source: Health Products Regulatory Authority (ZA) Revision Year: 2019 Publisher: Sanofi-aventis south africa (pty) ltd, 2 Bond Street, Midrand, 1685, South Africa
Caution should be exercised in the following patients:
In patients with pulmonary disease and limited pulmonary reserve.
Particular caution should be exercised with the elderly and debilitated who are at particular risk of over-sedation, respiratory depression and ataxia. (The initial oral dosage should be reduced in these patients).
Care should be taken to avoid aggravation of respiratory insufficiency and the dosage should be reduced (see DOSAGE AND DIRECTIONS FOR USE).
Caution should be exercised in the following patients:
DORMONOCT is not recommended for the primary treatment of psychotic illness.
DORMONOCT should not be used alone to treat depression, or anxiety with depression, as suicide may be precipitated in such patients. DORMONOCT should be used with extreme caution in patients with a history of alcohol or drug abuse.
There is a potential for abuse and the development of physical and psychological 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: de-realisation, depersonalisation, hyperacusis, numbness and tingling of extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
A transient syndrome, which may occur in withdrawal of treatment, whereby the symptoms that led to treatment with DORMONOCT recur in an enhanced form. It may be accompanied by other reactions including mood changes, anxiety and restlessness. Since the risk of withdrawal or rebound phenomena, is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.
The duration of treatment should be as short as possible (see DOSAGE AND DIRECTIONS FOR USE), but should not exceed four weeks for insomnia, including the tapering-off process. Extension beyond these periods should not take place without re-evaluation of the patient. 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 is aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the product is being discontinued.
There are indications that, in the case of benzodiazepines with a short duration of action like DORMONOCT, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
Some loss of efficacy to the hypnotic effects of benzodiazepines, such as DORMONOCT, may develop after repeated use for a few weeks.
Benzodiazepines, such as DORMONOCT, may induce anterograde amnesia. The condition occurs most often several hours after ingesting the medicine and therefore, to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7 – 8 hours (see SIDE EFFECTS).
Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, use of DORMONOCT should be discontinued. They are more likely to occur in children and the elderly.
Since DORMONOCT tablets contain lactose, patients with rare hereditary problems of galactose intolerance e.g. galactosaemia, Lapp-lactase deficiency or glucose-galactose malabsorption, should not take DORMONOCT.
Concomitant intake with alcohol: the sedative effect may be enhanced when DORMONOCT is used in combination with alcohol. This affects the ability to drive or use machines (see WARNINGS AND SPECIAL PRECAUTIONS).
Combination with central nervous system depressants: enhancement of the central depressive effect of DORMONOCT may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant medicines, narcotic analgesics, anti-epileptic medicines, anaesthetics and sedative antihistamines (see WARNINGS AND SPECIAL PRECAUTIONS).
In the case of narcotic analgesics, enhancement of the euphoria may also occur, leading to an increase in psychic dependence.
Additive synergy has been observed with neuromuscular depressants (curare-like medicines and muscle relaxants).
The risk of a withdrawal syndrome occurring is increased when DORMONOCT is combined with other benzodiazepines prescribed as anxiolytics or hypnotics.
Safety in pregnancy has not been established.
During labour it crosses the placenta and may cause the “floppy-infant” syndrome characterised by central respiratory depression, hypothermia and poor sucking.
It should not be administered to mothers breastfeeding their babies. Infants born to mothers who took benzodiazepines chronically during the later stages of pregnancy may develop physical dependence and may be at risk for developing withdrawal symptoms in the postnatal period.
Patients should be advised, particularly at the initiation of therapy, not to drive a motor vehicle or perform potentially hazardous tasks where impaired decision making could lead to accidents.
The following CIOMS frequency rating is used, when applicable: Very common: (≥1/10); common: (≥1/100, <1/10 ; uncommon: (≥1/1000, <1/100); rare: (≥1/10 000, <1/1000); very rare: (<1/10000), including isolated reports.
Very common: drowsiness, over-sedation. Drowsiness is most common in elderly and debilitated patients, and those receiving high doses.
Uncommon: depression of mood and affect, disorientation or confusion, lethargy, ataxia
Frequency unknown: anterograde amnesia may occur using therapeutic dosages, with the risk increasing at higher dosages.
Uncommon: changes in libido
Frequency unknown: paradoxical reactions such as acute hyper-excitability with rage. If these occur, DORMONOCT should be discontinued.
Pre-existing depression may be unmasked by benzodiazepine use.
There is a potential for abuse. Withdrawal symptoms (including convulsions) have occurred following abrupt cessation, especially in patients who have received large doses for prolonged periods.
Uncommon: constipation, nausea, diarrhoea
Frequency unknown: hypersensitivity reactions such as rash and pruritus
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