Special Warning : אזהרת שימוש

   4.4. Special warnings and precautions for use

•   Duration of Treatment - The duration of treatment should be as short as possible depending on the indication, but should not exceed 4 weeks including tapering off process. Treatment should not continue beyond 4 weeks without re-evaluation of the patient's condition. Where long-term therapy is essential, it is recommended that the patient's requirements be reviewed on a regular basis.

•   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 minimizing anxiety over such symptoms should they occur while Assival is being discontinued.

•   Dependence and Withdrawal - Withdrawal symptoms occur with benzodiazepines following normal therapeutic doses given for short periods of time.

Use of Assival may lead to the development of physical and psychic dependence. The dependence potential on benzodiazepines is low, particularly when restricted to short term use, when high doses are used this increases especially when given over long periods. Patients with marked personality disorders. a history of alcoholism or drug abuse are most susceptible. Monitoring of patients at regular intervals is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms (see Section 4.8 Undesirable Effects). These may consist of headache, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures may occur.

Rebound insomnia and anxiety may occur. This is a transient syndrome where the symptoms that led to the use of Assival recur in an enhanced form. This may occur on withdrawal of treatment and may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.

Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.

As sudden discontinuation of benzodiazepines may result in convulsions, particular care should be taken in patients with epilepsy, other patients who have had a history of seizures or in alcohol dependants.

•   Tolerance - Limits of tolerance in patients with organic cerebral changes (particularly arteriosclerosis) or cardio respiratory insufficiency may be very wide; care must be taken in adapting the dosage with such patients.
Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.
•   Alcohol should be avoided during treatment with Assival (additive CNS depression).
•   Risk from concomitant use of opioids:
Concomitant use of Assival and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as Assival with opioids should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Assival concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible (see also information for patients in section 4.2).
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of these symptoms (see section 4.5).
•   Amnesia - Benzodiazepines may induce anterograde amnesia. Amnestic effects may be associated with inappropriate behaviour. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages The condition occurs most often several hours after ingesting the product and therefore to reduce the risk patients should ensure that they will be able to have uninterrupted sleep of 7-8 hours. Anterograde amnesia may occur using therapeutic doses, the risk increases with higher doses.
• In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.
• Assival should be used with caution in patients with a history of alcohol or drug abuse as these are patients predisposed to habituation and dependence.
• Hypo-albuminaemia may predispose patient to higher incidence of sedative side effects.
• Extreme caution should be used in prescribing Assival to patients with personality disorders.
• Benzodiazepines should not be used in patients with severe hepatic insufficiency as they may precipitate encephalopathy.
Patients with chronic pulmonary insufficiency and patients with chronic hepatic disease may require a reduced dosage.
In renal failure, the half-life of Assival is unchanged and therefore no dosage adjustments are required in these patients.

• Cerebral sensitivity is increased in severe renal failure; therefore, lower doses should be used (see section 4.2).
•   Hypnotics should be avoided in the elderly who are at risk of becoming ataxic and confused and so liable to fall and injure themselves. If, based on clinical need, a decision to treat is nevertheless taken, treatment should be initiated a lower dose (see section 4.2).

Paediatric population
Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum. Safety and effectiveness of Assival in pediatric patients below the age of 6 months have not been established.
Caution should be exercised when using diazepam peri-operatively in children, as effects and timing of response may be unreliable and paradoxical effects may occur.
•   Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behavior and other adverse behavioral effects are known to occur when using benzodiazepines. Should this occur, the use of the drug should be discontinued. They are more likely to occur in children and the elderly.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Assival 5mg tablets contain FD&C Yellow No.6 (E110), which may cause allergic reactions.

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