Composition, Properties, Indications, Reactions, Contraindication, Dosage, Side effects, Precautions, Dependence, Withdrawal, Pack, Storage, and Maker of Talen Tablet Medicine for Sedation.
Talen contains per tablet 1.5 or 3 mg 7-bromo-1, 3-dihydro-5-2-(pyridyl)-2H-1, 4-benzodiazepin-2-one (bromazepam).
Talen® is a powerful psychotropic agent. In low dosage, it selectively reduces tension and anxiety. In high dosage, sedative and muscle-relaxing properties appear.
Emotional disturbances, Acute tension and anxiety states, Difficulties in interpersonal contact, Agitation, insomnia, Anxious/agitated depressive reactions, Functional disturbances in the cardiovascular and respiratory systems (pseudoangina pectoris, precordial anxiety, tachycardia, emotiogenic hypertension, dyspnea, hyperventilation); in the gastrointestinal system (irritable bowel syndrome, epigastric pain, spasm, bloating, diarrhoea, etc.); In the genitourinary system (frequency irritable bladder, dysmenorrhea), Psychosomatic disorders, Psychogenic headache, Psychogenic dermatosis, Asthma, Gastric and duodenal ulcer, ulcerative colitis.
Emotional reactions to chronic organic disease
Adjutant to psychotherapy in psychoneurosis.
Average dose for outpatient therapy: 1.5-3mg three times daily.
Severe cases, especially in hospital: 6-12 mg two or three times daily. These amounts are average recommendations, and dosage should be individually determined. Treatment of outpatients in general begin with the lowest dose, gradually increasing if necessary to the optimum level.
After about three to six weeks, according to progress in therapy, dosage can usually be gradually reduced and then stopped.
Talen® is well tolerated. Side effects such as fatigue, drowsiness and rarely muscle weakness can occur with high doses. No evidence of toxic effects on the blood, or on the liver or kidney function has been revealed by clinical experience.
Elderly and debilitated patients require cautious dosage because of individual variations in sensitivity to psychotropic medication.
If Talen® is combined with other centrally acting drugs such as neuroleptics, tranquilizers, antidepressants, hypnotics, analgesics and anesthetics, it should be borne in mind that pronounced sedation may result. This intensification can sometimes be exploited therapeutically.
With Talen® as with other psychoactive substances, patients should avoid taking alcohol while under the influence of the treatment, since the individual response cannot be foreseen. Like all medicaments of this type, Talen® may modify the patient’s reactions (driving ability, behavior in traffic, etc.) to a varying extent depending on dosage, administration and individual susceptibility.
Dependence may occur during benzodiazepine therapy. The risk is more pronounced in patients on long term use, on high dosage and particularly so in predisposed patients with a history of alcoholism, drug abuse, marked personality or other severe psychiatric disorders. In order to minimize the risk of dependence, benzodiazepines should only be prescribed after careful consideration of the indication and should be taken for the shortest possible duration. The necessity of continuing treatment should be closely monitored. Prolonged duration of treatment is justified only after careful assessment of the benefit and the risk.
The onset of withdrawal symptoms is variable, ranging from a few hours to a week or more. In less severe cases, the symptomatology of withdrawal may remain restricted to tremor, restlessness, insomnia, anxiety, headache and inability to concentrate. However, withdrawal symptoms such as sweating, muscular and abdominal spasms, perceptional changes and in rare cases, delirium and convulsions may occur.
At the occurrence of withdrawal symptoms, close medical control and support of the patient is necessary. Abrupt discontinuation should generally be avoided and a gradual tapering schedule followed.
Tablets 1.5mg 30, 500
Tablets 3mg 30, 500
Keep out of reach of children.
Made in Nigeria by
Swiss Pharma Nigeria Ltd.,
5, Dopemu Road, Agege – Lagos.
Version 1 valid as of 08/11 Rev: 0