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Concomitant use of alcohol/CNS depressants

The concomitant use of diazepam with alcohol and/or CNS depressants should be avoided. Diazepam Actavis 2mg

Such concomitant use has the potential to increase the clinical effects of diazepam possibly including severe sedation,

clinically relevant respiratory and/or cardio-vascular depression (see section 4.5).

Medical history of alcohol or drug abuse

Diazepam should be used with extreme caution in patients with a history of alcohol or drug abuse.

Tolerance

Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks.

Dependence

Treatment with diazepam can result in mental or physical dependency. The risk increases with dose and duration of treatment;

it is also greater in patients with a history of alcohol or drug abuse or in patients with marked personality disorders.

Regular monitoring in such patients is essential, routine repeat prescriptions should be avoided and treatment should be withdrawn gradually.

Withdrawal

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: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities,

hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.

Rebound insomnia and anxiety: a transient syndrome whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form,

may occur on withdrawal of treatment. It may be accompanied by other reactions including mood changes,

anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment,

it is recommended that the dosage is decreased gradually.

Sudden discontinuation of treatment with diazepam in patients with epilepsy or other patients

who have had a history of seizures can result in convulsions or epileptic status.

Convulsions can also be seen following sudden discontinuation in individuals with alcohol or drug abuse.

Discontinuation should be gradual in order to minimise the risk of withdrawal symptoms.

Duration of treatment

The duration of treatment should be as short as possible (see section 4.2) depending on the indication.

The patient must be evaluated after a period of no more than 4weeks and then regularly thereafter in order to

assess the need for continued treatment, especially if the patient is free of symptoms.

In general, treatment must not last any longer than 8‑12weeks, including the tapering off process.

Extension beyond these periods should not take place without re-evalutaion of the situation.

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 minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.

There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.

When benzodiazepines with a long duration of action are being used it is important to warn against changing to a

benzodiazepine with a short duration of action, as withdrawal symptoms may develop.

Amnesia

Anterograde amnesia may occur even if benzodiazepines are used within the normal dose range,

though this is seen in particular at high dose levels. 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 an

uninterrupted sleep of 7–8 hours (see also section 4.8). Amnestic effects may be associated with inappropriate behaviour.

Psychiatric and ‘paradoxical’ reactions

Paradoxical reactions (such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares,

hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects)

have been reported from the use of benzodiazepines. Such reactions are possibly seen more often in the

treatment of children and elderly patients and should result in the discontinuation of treatment.

Specific patient groups

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 diazepam in paediatric patients below the age of 6months have not been established.

Elderly and debilitated patients should be given a reduced dose (see section 4.2).

Due to the myorelaxant effect there is a risk of falls and consequently hip fractures in the elderly.

A lower dose is also recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.

Benzodiazepines are not indicated to treat patients with severe hepatic insufficiency as they may precipitate encephalopathy.

In patients with chronic hepatic disease dosage may need to be reduced.

The usual precautions in treating patients with impaired renal function should be observed.

In renal failure, the half-life of diazepam is not clinically significantly changed, and dose adjustment is usually not necessary.

Benzodiazepines are not recommended for the primary treatment of psychotic illness.

Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).

Potentially suicidal individuals should not have access to large amounts of diazepam due to the risk of overdosing.

Diazepam Actavis contains lactose. Patients with rare hereditary problems of galactose intolerance,

the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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