Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
DIAZEPAM
TEVA ISRAEL LTD
N05BA01
TABLETS
DIAZEPAM 5 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
DIAZEPAM
Tension, anxiety, agitation due to acute alcohol withdrawal, adjunct for the relief of skeletal muscle spasm, convulsive disorders.
2021-01-31
Assival 2,5,10mg Tablets PIL, NA-SD, 05-2023 Notification PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor's prescription only ASSIVAL 2 MG TABLETS ASSIVAL 5 MG TABLETS ASSIVAL 10 MG TABLETS ACTIVE INGREDIENT ACTIVE INGREDIENT ACTIVE INGREDIENT Each tablet contains: Diazepam 2 mg Each tablet contains: Diazepam 5 mg Each tablet contains: Diazepam 10 mg Inactive ingredients and allergens: see section 2 under ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. INTRODUCTION This medicine belongs to the group of benzodiazepines, which has special properties that require extreme caution when used. • Close medical follow-up is very important when taking this medicine. • When you take this medicine, be sure to contact your doctor after 2-4 weeks, as the treatment is only intended for short periods of time. • Prolonged use of this medicine may cause it to be less effective. • This use may lead to a serious side effect of dependence, where it will be difficult for the patient to stop taking the medicine. • Uncontrolled discontinuation of treatment is accompanied by withdrawal symptoms such as tension, nervousness, confusion, tremors, insomnia, abdominal pain, nausea, vomiting, sweating, spasms. • At times, prolonged use of this medicine may cause changes in behavioural patterns and intrusive thoughts. • Particularly in the elderly, be careful when walking, as the medicine inhibits alertness and at times coordination of body movements, and therefore there is a concern of slips and falls. TAKING THIS MEDICINE AL Olvassa el a teljes dokumentumot
Assival notification NA-SD 05.2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Assival 2mg tablets Assival 5mg tablets Assival 10mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Assival 2mg: Each tablet contains 2mg Diazepam. Assival 5mg: Each tablet contains 5mg Diazepam. Assival 10mg: Each tablet contains 10mg Diazepam. Excipients with known effect Each Assival 2mg tablet contains 74.0mg lactose Each Assival 5mg tablet contains 72.0mg lactose, 0.03mg FD&C Yellow No.6 (E110) Each Assival 10mg tablet contains 48.8mg lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Uncoated tablets. Assival 2mg: white, round flat tablet with beveled edges, scored in half on one side, engraved "TEVA" on the other. Assival 5mg: yellow, round flat tablet with beveled edges, scored in half on one side, engraved "TEVA" on the other. Assival 10mg: light blue, round flat tablet with beveled edges, scored in half on one side, engraved "TEVA" on the other. All tablets can be divided into 2 equal doses. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS • CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH [SEE SECTION 4.4]. • RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. • LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tension, anxiety, agitation due to acute alcohol withdrawal, adjunct for the relief of skeletal muscle spasm, convulsive disorders. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology INFORMATION FOR PATIENTS Treatment is usually intended for short periods only. Patients should be instructed to consult their physician after 2-4 weeks of the treatment. Since benzodiazepines may produce psychologic and physical dependence, patients should be advised to consult their physician before in Olvassa el a teljes dokumentumot