Država: Izrael
Jezik: angleščina
Source: Ministry of Health
FLUNITRAZEPAM
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
N05CD03
TABLETS
FLUNITRAZEPAM 2 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
FLUNITRAZEPAM
FLUNITRAZEPAM
Insomnia of various etiology.
2013-06-30
THIS LEAFLET FORMAT HAS BEEN DETERMINED BY THE MINISTRY OF HEALTH AND THE CONTENT THEREOF HAS BEEN CHECKED AND APPROVED PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only HYPNODORM ® TABLETS COMPOSITION Each tablet contains: Flunitrazepam 2 mg. For a list of the inactive ingredients, see section 6 in this leaflet. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS 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. INTRODUCTION This medicine belongs to the benzodiazepine group, which has special characteristics that demand great caution when used. Medicines from this group impair the quality of sleep, suppress deep refreshing sleep and therefore cause ineffective and superficial sleep. • Close medical monitoring is very important when taking this medicine. Therefore, when you are taking this medicine, be sure to refer to a doctor after 7-10 days of treatment, as the treatment is intended for a short period of time only. • Prolonged use of this medicine may lead to a diminution in the efficacy of the medication. Such use may also cause severe dependence, in which the patient will find it difficult to discontinue the intake of this medicine. Sometimes, prolonged use of this medicine may cause changes in behavior patterns as well as bring on troublesome thoughts. • Uncontrolled discontinuation of treatment may be accompanied by withdrawal symptoms such as: tension, nervousness, confusion, trembling, recurrence of insomnia, abdominal pain, nausea, vomiting, sweating, seizures. • Elderly: Be careful to lean on something when standing up from a lying or sitting position, as this medicine impairs alertness and sometimes body movement Preberite celoten dokument
HYPNODORM 1 6 2013, RH " ע עבקנ הז ןולע טמרופ " רשואו קדבנ ונכותו תואירבה דרשמ י ." רשואמ ןולע : יאמ 2013 “This leaflet format has been determined by the Ministry of Health and the content thereof has been checked and approved.” Date of approval: May 2013 HYPNODORM TABLETS COMPOSITION Each tablet contains: _ Active Ingredient _ Flunitrazepam 2 mg _ Other Ingredients _ Microcrystalline cellulose, lactose, talc, magnesium stearate _ _ _Lactrose content: 63.8 mg per tablet. _ ACTION Hypnodorm contains flunitrazepam, a benzodiazepine hypnotic. Hypnodorm induces sleep within 15-20 minutes, which lasts for 6-8 hours. Hypnodorm enjoys a wide therapeutic margin, is well tolerated and during prolonged use, tolerance has practically not been observed. INDICATIONS Insomnia of various etiology. CONTRAINDICATIONS Known hypersensitivity to benzodiazepines or to any other ingredient of the preparation. First trimester of pregnancy and in breastfeeding. Acute pulmonary insufficiency; respiratory depression, chronic psychoses, phobic or obsessional states. Acute narrow-angle glaucoma because of atropine-like side effects. Benzodiazepines may be used in patients with open-angle glaucoma who are receiving appropriate therapy). Myasthenia gravis. Severe hepatic insufficiency Sleep apnea syndrome. Use in children. WARNINGS (See also Precautions) _Effect on Ability to Drive and/or Operate Machinery _ Complex behaviours such as “sleep -driving” (i.e.driving while not fully awake after taking a sedative-hypnotic, with amnesia for the event) have been reported with sedative hypnotics. These events can occur in sedative-hypnotic naive as well as in sedative-hypnotic experienced persons. These events can occur at normal therapeutic doses, and the risk appears to be increased when sedative-hypnotics are combined with alcohol or other CNS depressants or used at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of s Preberite celoten dokument