Flormidal® 15mg midazolam 30 film tablets in Box – By Galenika

Therapeutic indications
Short-term insomnia therapy.
Benzodiazepines are indicated only in severe sleep disorders that inhibit patient functioning and lead to extreme agitation.
Patient preparation (premedication) for surgical or diagnostic procedures.
Dosage and method of administration
Benzodiazepines should only be administered after careful consideration of the indications and as briefly as possible to avoid the risk of addiction. Generally, treatment lasts from a few days to a maximum of two weeks. Treatment should not be interrupted abruptly and the exclusion of the drug should be adjusted individually for each patient. If prolonged treatment is required (longer than two weeks), the patient should be monitored.
In cases where treatment should be extended beyond two weeks, a prior reassessment of the patient’s condition is required. Due to the rapid onset of action, midazolam tablets are taken immediately before going to bed with fluid. Midazolam tablets can be taken at any time of the day, providing the patient with at least 7-8 hours of undisturbed sleep.
The standard dose of midazolam is 7.5 mg to 15 mg.
Treatment should be started with the lowest recommended dose. The maximum recommended dose should not be exceeded because of an increased risk of CNS side effects, including clinically significant depression of the cardiovascular and respiratory systems.
Premedication
In premedication, the drug is administered 30-60 minutes before the planned intervention.
Specific dosage
Elderly and / or exhausted patients
For elderly and / or exhausted patients, the recommended dose is 7.5 mg. In elderly patients, midazolam has a more pronounced sedative effect, which is why these individuals may be at increased risk of cardiovascular and respiratory depression. In these patients, the drug should be used with extreme caution and consideration of a lower dose may be considered if necessary.
Patients with impaired liver function
In patients with impaired hepatic function, the recommended dose is 7.5 mg and the drug should be administered very carefully. If necessary, a lower dose may be considered.
Patients with impaired renal function
Patients with severe renal impairment may experience accumulation of the major metabolite midazolam, 1′-hydroxymidazolam glucuronide, leading to more pronounced and longer sedation, which can cause clinically significant depression of the respiratory and cardiovascular systems. Therefore, midazolam should be used with caution in these patients. The recommended dose is 7.5 mg and a lower dose may be considered if necessary.