Tranqipam 0,5 mg/1 mg/2,5 mg Tablet

TRANQIPAM is indicated for:

• Anxiety disturbances or anxiety states:
• general anxiety disturbances
• panic disturbances
• phobic anxiety disturbances
• Anxiety associated with and caused by organic disease.
• Adjustment disturbances with anxiety or stress reactions.

Anxiety or tension associated with everyday life does not require treatment with an anxiolytic. It is recommended that the need for continued therapy with TRANQIPAM be determined periodically. Dosage for children under 12 years has not been established. Dosage should be individualised for optimal beneficial effect. The average dosage for the treatment of anxiety is 2 mg to 3 mg daily administered in two to four portions: however, this may range between 1 mg and 6 mg daily. For elderly or debilitated patients, an initial dosage of 1 mg or 2 mg per day in two to four portions is recommended to be adjusted as needed and tolerated.

Known hypersensitivity to benzodiazepines, and in patients with pre-existing CNS depression or coma. The administration of TRANQIPAM is contraindicated in patients with porphyria.

Patients should be advised that their tolerance for alcohol and other central nervous system depressants will be diminished. TRANQIPAM treatment should be avoided in general in psychotic patients and in those suffering from mental depression or suicidal tendencies unless there is a marked component of anxiety in their illness. Care may be needed in epileptic patients, in whom the initiation or abrupt withdrawal of benzodiazepine therapy has provoked seizures. Particular caution should be exercised with the elderly and debilitated who are at particular risk of over-sedation, respiratory depression, unsteadiness and ataxia. The initial dosage should be reduced in those patients. Caution should be exercised in patients with pulmonary disease and limited pulmonary reserve, as well as in patients with acute narrow-angle glaucoma. Caution is required in patients with impaired liver, kidney or respiratory function and in patients receiving other central nervous system depressant medicines in whom CNS depression may be potentiated. The pharmacokinetics of TRANQIPAM may change in impaired renal function. There is potential for abuse and addiction-prone individuals, such as drug addicts and alcoholics, should be under careful surveillance when receiving TRANQIPAM. The use of TRANQIPAM may lead to dependence. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuance of TRANQIPAM. These symptoms can range from mild dysphoria and insomnia to a major syndrome which may include convulsions, tremor, abdominal and muscle cramps, vomiting and sweating. These symptoms, especially the more serious ones, are more common in those patients who have received excessive doses over an extended period of time. However, withdrawal symptoms have also been reported following abrupt discontinuance of TRANQIPAM taken continuously at therapeutic levels. Accordingly, TRANQIPAM should be terminated gradually to help avoid occurrence of withdrawal symptoms.

TRANQIPAM produces additive central nervous system depressant effects when co-administered with other central nervous system depressants e.g. barbiturates or alcohol.

TRANQIPAM should be used judiciously during pregnancy and preferably avoided. In humans, blood levels obtained from umbilical cord indicate placental transfer of TRANQIPAM and its glucuronide. Neonates appear to conjugate TRANQIPAM slowly, the glucuronide being detectable in the urine for more than seven days. Glucuronidation of TRANQIPAM may competitively inhibit the conjugation of bilirubin, leading to hyperbilirubinaemia in the newborn. Given during labour, TRANQIPAM crosses the placenta and may cause the floppy infant syndrome, characterised by central respiratory depression, hypothermia and poor sucking. It should not be administered to nursing mothers since there is evidence that TRANQIPAM is excreted in human breast milk.

Patients receiving TRANQIPAM should be warned not to operate dangerous machinery or motor vehicles, or climb dangerous heights until it is established that they do not become drowsy or dizzy or experience psychomotor impairment from TRANQIPAM therapy.

The most frequent adverse reactions reported are drowsiness and over-sedation followed by dizziness, weakness, unsteadiness, confusion and lethargy. Vertigo, light-headedness, mental depression, slurred speech or dysarthria, changes in libido, ataxia, tremor, urinary retention or incontinence, changes in salivation and jaundice may also occur. Respiratory depression and hypotension may occur with high doses. Other adverse reactions reported include nausea, change in appetite, headache, sleep disturbance, agitation, dermatological symptoms and eye-function disturbance. Transient amnesia or memory impairment has been reported. Some patients on benzodiazepines have developed blood dyscrasias and some have had elevations in liver enzymes. Periodic blood counts and liver-function tests are recommended for patients on long-term therapy. Paradoxical reactions such as acute hyperexcitable states with rage may occur.

Symptoms: Overdosage of TRANQIPAM is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma, respiratory and cardiovascular depression. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, hypotension, hypnosis, coma and death.

Treatment: Treatment is symptomatic and supportive.