Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
ALPRAZOLAM
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
N05BA12
TABLETS
ALPRAZOLAM 0.5 MG
PER OS
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
ALPRAZOLAM
ALPRAZOLAM
Treatment of anxiety accompanied by depression. Treatment of panic states with or without accompanying phobia.
2014-04-30
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS )PREPARATIONS(-1986 This medicine can be sold with a physician’s prescription only XANAGIS 0.25 MG TABLETS XANAGIS 0.5 MG TABLETS XANAGIS 1 MG TABLETS Each tablet contains: Alprazolam 0.25 mg Alprazolam 0.5 mg Alprazolam 1 mg Inactive ingredients and allergens: See in section 6 " ADDITIONAL INFORMATION” and in section 2 " IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THIS MEDICINE " . READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It might harm them, even if you think that their medical condition is similar. WHAT IS THE MOST IMPORTANT INFORMATION I NEED TO KNOW ABOUT THE MEDICINE? TAKING THIS MEDICINE WITH MEDICINES FROM THE OPIOID FAMILY, OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS )INCLUDING DRUGS( OR ALCOHOL MAY CAUSE A SENSE OF DEEP DROWSINESS, BREATHING DIFFICULTY )RESPIRATORY DEPRESSION(, COMA AND DEATH. Introduction to the benzodiazepines patient leaflet This medicine belongs to the benzodiazepines group, which has special characteristics necessitating great caution with its use. • Close medical monitoring is very important when taking this medicine. • When you take this medicine, be sure to refer to the doctor after 2-4 weeks, as the treatment is meant for short periods only. • Prolonged use of the medicine may cause the medicine’s effect to decrease. • Prolonged use may cause severe dependence, which will make it difficult for the patient to stop taking the medicine. • Uncontrolled discontinuation of treatment may be accompanied by withdrawal symptoms, such as: tension, nervousness, confusion, tremor, insomnia, abdominal pain, vomiting, nausea, sweating, spasms, muscle cramps and pain. • Sometimes, prolonged use of the medicine may cause changes in behavior patterns and obsessi Perskaitykite visą dokumentą
NAME OF THE MEDICINAL PRODUCT Xanagis 0.25 mg Xanagis 0.5 mg Xanagis 1 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Xanagis 0.25 mg contains 0.25 mg of alprazolam. Each tablet of Xanagis 0.5 mg contains 0.5 mg of alprazolam. Each tablet of Xanagis 1 mg contains 1 mg of alprazolam PHARMACEUTICAL FORM Tablets INDICATIONS AND USAGE • Treatment of anxiety accompanied by depression . • Treatment of panic states with or without accompanying phobia . WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. • Reserve concomitant prescribing of these drugs for 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 (see WARNINGS AND PRECAUTIONS). • The use of benzodiazepines, including XANAGIS , exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing XANAGIS and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS AND PRECAUTIONS). • The continued use of benzodiazepines, including XANAGIS , may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of XANAGIS after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAGIS or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS). DESCRIPTIO Perskaitykite visą dokumentą