The efficacy of modafinil in patients with obstructive sleep apnoea (OSA) exhibiting excessive day time sleepiness despite treatment with continuous positive airways pressure (CPAP) has been studied in short term randomised controlled clinical trials. If you have ever had an allergic reaction to a medicine. 0000001429 00000 n If symptoms occur, discontinuation of modafinil may be required.An ECG is recommended in all patients before Modafinil treatment is initiated. Rare cases of serious or life-threatening rash, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience.Because safety and effectiveness in controlled studies in children have not been established and because of the risk of serious cutaneous hypersensitivity and psychiatric adverse reactions, the use of modafinil is not recommended in the paediatric population (below 18 years).Multi-organ hypersensitivity reactions, including at least one fatality in post-marketing experience, have occurred in close temporal association to the initiation of modafinil.Although there have been a limited number of reports, multi-organ hypersensitivity reactions may result in hospitalization or be life-threatening. By continuing to browse the site you are agreeing to our policy on the use of cookies. 0000007443 00000 n The most common reactions occurred in 5 percent or more of the participants. 0000005466 00000 n If psychotic or manic symptoms occur, discontinuation of modafinil may be required.Care should be taken in using modafinil in patients with co-morbid bipolar disorder because of concern for possible precipitation of a mixed/manic episode in such patients. 0000003338 00000 n This site uses cookies. Modafinil also doesn’t have a crash or withdrawal, the way many smart drugs do. There are no factors that are known to predict the risk of occurrence or the severity of multi-organ hypersensitivity reactions associated with modafinil. At exposures similar to human levels at the recommended human dose, modafinil slightly increased the time to mate in female rats.Patients with abnormal levels of sleepiness who take modafinil should be advised that their level of wakefulness may not return to normal. One of the three studies suggested an increase in the incidence rate of stroke in modafinil treated patients compared to patients not treated with modafinil, however, results across the three studies were not consistent. Although statistically significant improvements in sleepiness were noted, the magnitude of effect and response rate to modafinil was small when assessed by objective measurements and limited to a small sub-population of the treated patients. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.If you experience any other symptoms which you think may be due to the tablets, speak with your doctor or pharmacist for further advice.Never take more than the prescribed dose. Page 1 of 4 > Filter Search Results. %PDF-1.3 %���� 0000007780 00000 n Undesirable effects such as blurred vision or dizziness might also affect ability to drive (see section 4.8).The following adverse reactions have been reported in clinical trials and/or post-marketing experience. Never give it to other people even if their condition appears to be the same as yours.If you buy any medicines, check with a pharmacist that they are suitable to take with your other medicines.Do not keep out-of-date or unwanted medicines. Signs and symptoms of this disorder were diverse; however, patients typically, although not exclusively, presented with fever and rash associated with other organ system involvement. In view of the potential for lower clearance and increased systemic exposure, it is recommended that patients over 65 years of age commence therapy at 100 mg daily.Modafinil should not be used in children aged less than 18 years old because of safety and efficacy concerns (see section 4.4).Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.Modafinil should be used only in patients who have had a complete evaluation of their excessive sleepiness, and in whom a diagnosis of narcolepsy, has been made in accordance with ICSD diagnostic criteria. Lipostat (pravastatin) 10mg, 20mg and 40mg tablets are being discontinued by Bristol-Myers Squibb from early November 2015. Patient monitoring and clinical assessment of the need for treatment should be performed on a periodic basis.The recommended starting daily dose is 200 mg. The onset or worsening of aggressive or hostile behaviour can be caused by treatment with modafinil. Consult your doctor before breastfeeding. Ask your doctor about which contraceptive methods are suitable for you while you are taking modafinil - hormonal contraceptives are not suitable.Coronavirus: how quickly do COVID-19 symptoms develop and how long do they last?Coronavirus: what are asymptomatic and mild COVID-19?Coronavirus: what are moderate, severe and critical COVID-19?What are the differences between colds, flu and COVID-19?Are any coronavirus home remedies safe or effective?COVID-19: how to tell hay fever and coronavirus apartIs losing your sense of taste and smell a symptom of coronavirus?Although there is no cure for narcolepsy, modafinil can help to control your symptoms.