Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
Benzodiazepines are recommended for the treatment of anxiety only if it is severe, disabling or causes significant distress.
Given by mouth, Remedium is indicated for the symptomatic relief of anxiety, agitation and psychological stress due to psychoneurosis and transient situational disturbances.
In patients undergoing alcohol withdrawal, it may be useful for the symptomatic relief of acute agitation, tremor and hallucinations.
It is a useful adjunct for the relief of musculoskeletal pain due to spasm or local disorders (inflammation of the muscles or joints, trauma, etc.). It can also be used to o suppress spasticity caused by affections of the spinal and supraspinal interneurons, such as cerebral palsy and paraplegia, as well as athetosis and generalized stiffness.
Taken orally, Remedium can be used as an adjunct for the treatment of seizure disorders; however, it has not been shown to be useful as monotherapy. In such cases, the physician must review the usefulness of the medication for each individual patient at regular intervals.
The dose of Remedium tablets should be tailored to the needs of each patient, using the lowest effective dose possible, especially in children and adolescents, frail and elderly subjects, or patients with liver disease or low serum albumin.
The tablets should be taken when the patient needs them the most, usually in the afternoon or evening.
The patient should be monitored at regular intervals at the beginning of treatment in order to reduce the dose or frequency of administration if necessary and thus prevent the risk of overdose due to accumulation.
The adult dose is:
Relief of symptoms of anxiety: 2 to 10 mg, 2 to 4 times daily, depending on the severity of the symptoms.
Symptomatic relief in acute alcohol withdrawal: 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed.
Adjunctively for relief of skeletal muscle spasm: 2 to 10 mg, 3 or 4 times daily.
Adjunctively in convulsive disorders: 2 to 10 mg, 2 to 4 times daily.
2 to 2.5 mg, 1 or 2 times daily initially, increasing the dose gradually as needed and tolerated; as a general rule 0.1 to 0.3 mg/kg/day. Benzodiazepines should only be used in children after careful review of the indication. Due to variations in response to treatment with CNS-active drugs in children, treatment should be started at the lowest dose and increased as needed. Do not use in children under 6 months of age.
The pharmacological effects of benzodiazepines appear to be greater in elderly patients than in the rest of the adult population, even at similar plasma concentrations, possibly due to age-related changes in drug-receptor interactions, post-receptor mechanisms, and organ function (see section 5.2).
In elderly patients or in the presence of debilitating diseases, it is recommended to use the lowest possible dose, 2 to 2.5 mg once or twice daily, and to increase it gradually as needed and tolerated.
2 to 2.5 mg once or twice daily, to be increased gradually as needed and tolerated. These patients should be closely monitored at the start of treatment to minimise the dose and/or frequency of administration and thus prevent the risk of overdose due to accumulation (see section 5.2).
These patients should not be treated with Remedium tablets (see section 4.3).
The duration of treatment should be as short as possible (see section 4.4). The patient should be reassessed at regular intervals, including the need to continue treatment, especially in patients who are free of symptoms.
After six weeks of treatment, no greater improvements can be expected, so that more continuous approaches should be considered only as maintenance therapy. During long-term maintenance therapy, regular medication-free intervals should be allowed to determine the need for continued treatment. The decision can only be made by the treating physician, based on the patient’s progress. However, treatment should not be abruptly discontinued; instead, the dose should be tapered off gradually. The effectiveness of long-term treatments (e.g. more than 6 months) has not been evaluated in systematic clinical studies.
Remedium is for oral administration.
Remedium tablets should be swallowed whole with a little water or a non-alcoholic drink, and should be taken when the patient needs them the most, usually in the afternoon or evening.
Benzodiazepines frequently cause drowsiness, ataxia, dysarthria and nystagmus. Remedium overdose is rarely life-threatening if the drug is taken alone, but it can cause areflexia, apnea, hypotension, cardiorespiratory depression and coma. If coma occurs, it usually lasts only a few hours, but may be prolonged and cyclical, especially in elderly patients. Respiratory depressant effects are more severe in patients with respiratory disease.
Benzodiazepines potentiate the effects of other CNS depressants, including alcohol.
The vital signs of the patient should be monitored and appropriate supportive measures instituted. In particular, some patients may require symptomatic treatment to alleviate the cardiorespiratory or central nervous system effects of overdose.
To prevent further absorption of the drug, an appropriate method such as activated charcoal treatment should be used within the first 1-2 hours. If activated charcoal is given to a drowsy patient, it is essential to keep the airways open. As an exceptional measure, gastric lavage may be considered in cases of overdose due to concomitant intake of multiple drugs.
If CNS depression is severe, the use of flumazenil, a benzodiazepine antagonist should be considered. It should only be administered under close monitoring. Flumazenil has a short half-life (about one hour); therefore, patients who receive it should be monitored after the effects wear off. Flumazenil should be used with extreme caution in combination with medicines that lower the seizure threshold (e.g. tricyclic antidepressants).
5 years.
Store below 25°C. Protect from light and moisture.
Cardboard box containing Aluminium-PVC blisters of 10 tablets.
Pack sizes of 40, 100 and 1000 tablets.
Polypropylene container with a polyethylene security closure.
Pack size of 1000 tablets.
Not all pack sizes may be marketed.
None.
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