国: イスラエル
言語: 英語
ソース: Ministry of Health
ALPRAZOLAM
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N05BA12
TABLETS SUSTAINED RELEASE
ALPRAZOLAM 0.5 MG
PER OS
Required
PFIZER ITALIA S.R.L, ITALY
ALPRAZOLAM
For the treatment of anxiety and anxiety associated with depression.Treatment of panic disorder with or without phobic avoidance
2017-05-24
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only XANAX ® XR 0.5 MG XANAX ® XR 1 MG XANAX ® XR 2 MG SUSTAINED-RELEASE TABLETS ACTIVE INGREDIENT AND ITS QUANTITY: Each sustained-release tablet contains: ALPRAZOLAM 0.5 MG, 1 MG, 2 MG For a list of inactive ingredients and allergens, see section 2 under ‘Important information about some of this medicine’s ingredients’ and section 6 ‘Further information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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. XANAX ® XR IS A PSYCHOTROPIC MEDICATION CONTAINING ALPRAZOLAM, THAT CAN BE ABUSED OR LEAD TO DEPENDENCE. INFORM YOUR DOCTOR IF YOU CURRENTLY ABUSE OR HAVE PREVIOUSLY ABUSED OR DEVELOPED A DEPENDENCE ON ALCOHOL, PRESCRIPTION MEDICINES OR DRUGS. GIVING AWAY OR SELLING THE MEDICINE MAY HARM OTHERS AND IS AGAINST THE LAW. KEEP THE MEDICINE IN A SAFE PLACE AND AWAY FROM CHILDREN. WHAT IS IMPORTANT TO KNOW ABOUT XANAX ® XR? THIS MEDICINE BELONGS TO THE BENZODIAZEPINE GROUP, which has special characteristics that require extra caution when using it. TAKING THIS MEDICINE WITH MEDICINES OF THE OPIOID GROUP, ALCOHOL, OR OTHER CENTRAL NERVOUS SYSTEM DEPRESSANTS (INCLUDING STREET DRUGS) CAN CAUSE SEVERE DROWSINESS, BREATHING PROBLEMS (RESPIRATORY DEPRESSION), COMA AND DEATH. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate dangerous machines until you know how this medicine affects you. RISK OF ABUSE, MISUSE AND ADDICTION. There is a risk of abuse, misuse and addiction with use of benzodiazepines, including Xanax ® X 完全なドキュメントを読む
Xanax XR LPD CC 300323 FULL PRESCRIBING INFORMATION 1. DOSAGE FORMS AND STRENGTHS XANAX ® XR 0.5 mg XANAX ® XR 1 mg XANAX ® XR 2 mg QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient is Alprazolam. For the full list of excipients, see section 11, DESCRIPTION. Excipient with known effect Each tablet XANAX ® XR 0.5 mg, 1 mg & 2 mg contains 221.7 mg lactose 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 _[_SEE _WARNINGS, DRUG _ _INTERACTIONS]_. 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 (5.1), DRUG INTERACTIONS (7.1)]_. • . THE USE OF BENZODIAZEPINES, INCLUDING XANAX XR, 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 XANAX XR AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION _[SEE WARNINGS AND PRECAUTIONS (5.2)]._ • THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING XANAX XR, 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 XANAX XR 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 XANAX XR OR REDUCE THE DOSAGE _[SEE DOSAGE AND _ _ADMINISTRATION (3.2), WARNINGS AND PRECAUTIONS (5.3)]._ X 完全なドキュメントを読む