Země: Nizozemsko
Jazyk: nizozemština
Zdroj: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ALPRAZOLAM 1 mg/stuk
Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)
N05BA12
ALPRAZOLAM 1 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; DOCUSAAT NATRIUM ; INDIGOKARMIJN (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMBENZOAAT (E 211) ; SILICIUMDIOXIDE (E 551) ; ZETMEEL, GEPREGELATINEERD, CELLULOSE, MICROKRISTALLIJN (E 460) ; DOCUSAAT NATRIUM ; INDIGOKARMIJN (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMBENZOAAT (E 211) ; SILICIUMDIOXIDE (E 551) ; ZETMEEL, GEPREGELATINEERD,
Oraal gebruik
Alprazolam
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); DOCUSAAT NATRIUM; INDIGOKARMIJN (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); NATRIUMBENZOAAT (E 211); SILICIUMDIOXIDE (E 551); ZETMEEL, GEPREGELATINEERD;
1900-01-01
Hexal AG Page 1/9 Alprazolam Hexal 0,5-1,0 mg, tabletten RVG 100526-100531 1313 V11 1.3.1.3 Package Leaflet December 2023 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ALPRAZOLAM HEXAL 0,5 MG, TABLETTEN ALPRAZOLAM HEXAL 1,0 MG, TABLETTEN alprazolam READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illnes are the same as yours. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Content of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [Nationally completed name] is a tranquilliser containing the active substance alprazolam. Alprazolam belongs to one of a group of medicines called benzodiazepines. Benzodiazepines affect chemical activity in the brain to promote sleep and to reduce anxiety and worry. [Nationally completed name] is used to TREAT ANXIETY that is severe, disabling or causing the sufferer great distress. [Nationally completed name] tablets should only be used for short-term treatment of anxiety. The overall duration of treatment should not be more than 12 weeks including a period where the dose is gradually reduced (this is called dose ‘tapering’). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU • are allergic to alprazolam or any of the other ingredients of this medicine (listed in section 6), ), or previ Přečtěte si celý dokument
Hexal AG Page 1/13 Alprazolam Hexal 0,5-1,0 mg, tabletten RVG 100526-100531 1311 V10 1.3.1.1 Summary of Product Characteristics December 2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Alprazolam Hexal 0,5 mg, tabletten Alprazolam Hexal 1,0 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.25 mg of alprazolam. Excipients with known effect Each tablet contains 92.5 mg of lactose (as monohydrate) and 0.12 mg of sodium benzoate. Each tablet contains 0.5 mg of alprazolam. Excipients with known effect Each tablet contains 92.2 mg of lactose (as monohydrate) and 0.12 mg of sodium benzoate. Each tablet contains 1 mg of alprazolam. Excipients with known effect Each tablet contains 91.7 mg of lactose (as monohydrate) and 0.12 mg of sodium benzoate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. _0.25 mg tablet: _ White, oblong tablet with a score line and debossed "APZM 0.25". The tablet can be divided into equal doses. _0.5 mg tablet: _ Pink, oblong tablet with a score line and debossed "APZM 0.5". The tablet can be divided into equal doses. _1 mg tablet: _ Light blue _,_ oblong tablet with a score line and debossed “APZM 1”. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hexal AG Page 2/13 Alprazolam Hexal 0,5-1,0 mg, tabletten RVG 100526-100531 1311 V10 1.3.1.1 Summary of Product Characteristics December 2023 Symptomatic treatment of anxiety. Alprazolam should only be used if the disorder is severe or is causing invalidity, or if the patient is experiencing inordinate suffering as a result of the disorder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The treatment period should be as short as possible. The total length of treatment should not exceed 8-12 weeks, including the period of gradual dose reduction. Prolonged treatment may be necessary in certain circumstances, but this should not be done until the patient’s condition has been reassessed since the risk of abuse and depen Přečtěte si celý dokument