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GERAX

Information leaflet

                                                    Irish Medicines Board




                                  Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 Gerax Tablet 250 micrograms.

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains 250 micrograms alprazolam (as active). Also contains 92.77 mg lactose (as excipient).

 For a full list of excipients, see section 6.1.

 3 PHARMACEUTICAL FORM

 Tablet
 White, oval tablets scored and marked ‘AL 0.25’ on one side and “G” on the other.

 The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic Indications

 Anxiety
 Benzodiazepines are only indicated when the disorder is severe, disabling or subjecting the individual to extreme
 distress.

 4.2 Posology and method of administration

 Treatment should be as short as possible. The overall duration of treatment generally should not be more than 8-12
 weeks, including a tapering off process. The patient should be reassessed regularly and the need for continued
 treatment should be evaluated, especially in case the patient is symptom free.

 Anxiety:
 250 microgram (0.25 mg) to 500 microgram (0.5 mg) three times daily increasing, if required, to a total of 3 mg daily.

 Treatment should be started with the lower recommended dose. The maximum dose should not be exceeded.

 Initial doses may be given at bedtime to minimise daytime lethargy. If side effects occur with the starting dose, the dose
 should be lowered.

 In certain cases extension beyond the maximum treatment period may be necessary, if so, it should not take place
 without re-evaluation of the patient’s status.




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Date Printed 30/03/2011                               CRN 2091729                                         page number: 1
                                                     Irish Medicines Board




 4.3 Contraindications

 Gerax is contra-indicated in patients with known hypersensitivity to benzodiazepines and any component of the product
 formulation.
 Myasthenia gravis
 Severe respiratory insufficiency
 Sleep apnoea syndrome
 Severe hepatic insufficiency

 4.4 Special warnings and precautions for use

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

 Dependence
 Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products. The risk
 of dependence increases with dose and duration of treatment, it 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: derealisation, depresonalisation, 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, mild dysphoria, anxiety or sleep disturbances, abdominal and muscle cramps,
 vomiting, sweating, tremor 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.

 Duration of treatment
 The duration of treatment should be as short as possible (see section 4.3, Posology and method of administration) but
 should not exceed eight to twelve weeks including tapering off process. Extension beyond these periods should not take
 place without re-evaluation 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.

 During discontinuation of Gerax treatment, the dosage should be reduced slowly in keeping with good medical
 practice. It is suggested that the daily dosage of alprazolam be decreased by no more than 0.5 mg every three days.
 Some patients may require an even slower dosage reduction.




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Date Printed 30/03/2011                               CRN 2091729                                         page number: 2
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