Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
ZOLPIDEM TARTRATE
SANOFI ISRAEL LTD
N05CF02
FILM COATED TABLETS
ZOLPIDEM TARTRATE 10 MG
PER OS
Required
SANOFI WINTHROP INDUSTRIE, FRANCE
ZOLPIDEM
ZOLPIDEM
Indications are limited to treatment of severe sleep disorders in the following cases: - Occasional insomnia - Transient insomnia.
2017-06-30
1 *816921* 816921 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only STILNOX 10 MG TABLETS ACTIVE INGREDIENT AND ITS QUANTITY: Each tablet contains: Zolpidem Tartrate 10 mg INACTIVE AND ALLERGENIC INGREDIENTS IN THE PREPARATION – SEE SECTION 2 “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THE MEDICINE” AND SECTION 6 “FURTHER INFORMATION”. READ THIS 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 to treat you. 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 children and adolescents under the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR? For the treatment of insomnia. THERAPEUTIC GROUP: Hypnotic and sedative substances. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: ∙ You have ever experienced complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not being fully awake) after taking Stilnox (see “Special warnings regarding use of the medicine”). ∙ You are sensitive (allergic) to the active ingredient (zolpidem) or to any of the additional ingredients contained in the medicine (see section 6). ∙ You have suffered in the past from an allergic reaction to zolpidem-containing medicines. Symptoms of severe allergic reaction to zolpidem may include: swelling of your face, lips and throat that may cause difficulty in breathing or swallowing. ∙ You are suffering from severe liver failure. ∙ You drank alcohol in the evening or before bedtime. ∙ You will not be able to get a full night's sleep after taking the medicine (7-8 hours) before you need to be active again. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: ∙ DO NOT TAKE MORE STILNOX THAN PRE Lesen Sie das vollständige Dokument
1 _STIL-SPC-10MG-21.0 _ _ _ STILNOX 10MG TABLETS PRESCRIBING INFORMATION WARNING: COMPLEX SLEEP BEHAVIORS COMPLEX SLEEP BEHAVIORS INCLUDING SLEEP-WALKING, SLEEP-DRIVING, AND ENGAGING IN OTHER ACTIVITIES WHILE NOT FULLY AWAKE MAY OCCUR FOLLOWING USE OF STILNOX. SOME OF THESE EVENTS MAY RESULT IN SERIOUS INJURIES, INCLUDING DEATH. DISCONTINUE STILNOX IMMEDIATELY IF A PATIENT EXPERIENCES A COMPLEX SLEEP BEHAVIOR _[SEE CONTRAINDICATIONS (4) AND WARNINGS _ _AND PRECAUTIONS (8.1)]._ 1 NAME OF THE MEDICINAL PRODUCT STILNOX 10MG TABLETS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains zolpidem tartrate 10 mg Excipients with known effect: Each Stilnox tablet contains 90.4 mg lactose monohydrate 3 PHARMACEUTICAL FORM Stilnox tablets are white to off-white film coated oblong tablets 4 THERAPUTIC INDICATIONS AND USAGE Indications are limited to treatment of severe sleep disorders in the following cases: - Occasional insomnia - Transient insomnia. The short-term treatment of insomnia in situations where the insomnia is debilitating or is causing severe distress to the patient. As with all hypnotics long term use is not recommended and a course of treatment should not exceed 4 weeks. Hypnotics should generally be limited to 7 to10 days of use, and reevaluation of the patient is recommended if they are to be taken for more than 2 to 3 weeks. 5 DOSAGE AND ADMINISTRATION 5.1 DOSAGE IN ADULTS Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is 2 not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (8.2)]. The total dose of Stilnox should not exceed 10 mg once daily immediately before bedtime. St Lesen Sie das vollständige Dokument