国: イスラエル
言語: 英語
ソース: Ministry of Health
ARMODAFINIL
ABIC MARKETING LTD, ISRAEL
N06BA07
TABLETS
ARMODAFINIL 250 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
MODAFINIL
Nuvigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD).
2016-04-14
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only NUVIGIL 50 MG TABLETS COMPOSITION Each tablet contains: armodafinil 50 mg NUVIGIL 150 MG TABLETS COMPOSITION Each tablet contains: armodafinil 150 mg NUVIGIL 250 MG TABLETS COMPOSITION Each tablet contains: armodafinil 250 mg For information about inactive and allergenic ingredients, see section 2 under the heading “Important information about some of the ingredients of the medicine” and section 6 “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. THIS MEDICINE IS NOT INTENDED FOR USE IN CHILDREN OR ADOLESCENTS UNDER 18 YEARS OF AGE. THE MEDICINE MAY REDUCE THE EFFECTIVENESS OF HORMONAL BIRTH CONTROL METHODS. You must use additional effective birth control methods. SEE UNDER THE HEADING “DRUG INTERACTIONS” IN SECTION 2 OF THIS LEAFLET. 1. WHAT IS THE MEDICINE INTENDED FOR? Nuvigil is intended to improve wakefulness in adults with excessive sleepiness associated with one of the following diagnosed sleep disorders: • Narcolepsy – uncontrollable daytime sleeping bouts. • Sleep disorder due to obstructive sleep apnea )OSA(, in combination with other treatments. Nuvigil does not take the place of a CPAP machine or other treatments prescribed by the doctor. It is important to continue these treatments as prescribed by the doctor. • Sleep disorder due to working in shifts )shift work disorder – SWD(. Nuvigil will not cure these sleep disorders. Nuvigil may relieve the sleepiness caused by these conditions, but it may not prevent it entirely. Nuvigil is not intended to take the place of sufficient s 完全なドキュメントを読む
1 Nuvigil HS 09/2019 Certification SUMMARY OF PRODUCT CHARACTERISTICS NUVIGIL 50 MG, 150 MG AND 250 MG TABLETS Each tablet contains: Armodafinil 50 mg, 150 mg or 250 mg For the list of excipients, see section 16 "Pharmaceutical particulars". 1. INDICATIONS AND USAGE NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). LIMITATIONS OF USE In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness. 2. DOSAGE AND ADMINISTRATION 2.1 DOSAGE IN OBSTRUCTIVE SLEEP APNEA (OSA) AND NARCOLEPSY The recommended dosage of NUVIGIL for patients with OSA or narcolepsy is 150 mg to 250 mg taken orally once a day as a single dose in the morning. In patients with OSA, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that these doses confer additional benefit beyond that of the 150 mg/day dose _[see Clinical Pharmacology (12.3) and Clinical Studies (14.1, _ _14.2)]_. 2.2 DOSAGE IN SHIFT WORK DISORDER (SWD) The recommended dosage of NUVIGIL for patients with SWD is 150 mg taken orally once a day as a single dose approximately 1 hour prior to the start of their work shift. 2.3 DOSAGE MODIFICATION IN PATIENTS WITH SEVERE HEPATIC IMPAIRMENT In patients with severe hepatic impairment, the dosage of NUVIGIL should be reduced _[see _ _Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]_. 2.4 USE IN GERIATRIC PATIENTS Consideration should be given to the use of lower doses and close monitoring in geriatric patients _[see Use in Specific Populations (8.5)]_. _ _ 3. DOSAGE FORMS AND STRENGTHS 50 mg – round, white to off-white tablet with on one side and "205" on the othe 完全なドキュメントを読む