Description
Posology / application frequency and duration:
The recommended daily dose is 200-400 mg. According to the patient’s response, it should be started with 200 mg and may be given in the morning and noon according to the clinic once or twice daily.
Method of Application:
Oral application. The tablets must be swallowed as a whole.
Additional information on special populations: Kidney / Liver failure:
In patients with severe hepatic or renal insufficiency, the dose should be reduced (100 or 200 mg daily).
Pediatric population:
Children are not recommended for use because they have not yet proven efficacy and safety (see section 4.4).
Geriatric population:
Limited data on the use of modafinil in the elderly are available. Due to decreased hepatic and renal function in the elderly, it is recommended to start treatment with 100 mg / day in patients over 65 years of age. The maximum dose of 400 mg should only be used when there is no renal or hepatic impairment.
Other:
4.3. contraindications
4.4. Special use warnings and precautions
Although no effect has been observed which may cause deterioration in the modafinilin functions, Any medication that affects the central nervous system may cause judgment, thinking, or changes in motor skills. The patient should be advised to be careful during the MODIWAKE treatment until they are sure that their ability to drive or use the machine is not affected. Patients with left ventricular hypertrophy and modafinil use in patients with ischemic ECG changes associated with CNS stimulants, chest pain, arrhythmias, or other significant clinical manifestations of mitral valve prolapse have not been recommended. Modafinil has not been evaluated in patients with recent myocardial infarction or angina who are not stable. In these people, treatment should be followed carefully. Modafinil has not been systemically evaluated in patients with hypertension. These patients should also be monitored periodically.
During the use of 600 mg MODİWAKE in healthy volunteers, reference delusions, paranoid delusions and sensory hallucinations and sleep deprivation developed. There is no evidence of psychosis 36 hours after the cessation of the drug. Patients with a history of psychosis should be cautious when using MODİWAKE.
