Country: Холандија
Језик: Холандски
Извор: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
TRAZODONHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; TRAZODON 91,1 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N06AX05
TRAZODONHYDROCHLORIDE 100 mg/stuk SAMENSTELLING overeenkomend met ; TRAZODON 91,1 mg/stuk
Tablet
CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201), CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201),
Oraal gebruik
Trazodone
Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 2-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201);
1900-01-01
Sandoz B.V. Page 1/14 Trazodon HCl Sandoz 100 mg, tabletten RVG 111061 1311-v3 1.3.1.3 Bijsluiter March 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRAZODON HCL SANDOZ 100 MG, TABLETTEN trazodone hydrochloride 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 or illness 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 the 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. Contents of the pack and other information 1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR [nationally completed name] is one of a group of medicines called anti – depressants. It is used to treat depressive disorders (major depressive episodes). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME] DO NOT TAKE [NATIONALLY COMPLETED NAME] - if you are allergic to trazodone hydrochloride or any of the other ingredients of this medicine (listed in section 6). Sandoz B.V. Page 2/14 Trazodon HCl Sandoz 100 mg, tabletten RVG 111061 1311-v3 1.3.1.3 Bijsluiter March 2020 - Alcohol intoxication and intoxication with hypnotics (if you are drunk, or under the influence of hypnotic drugs) - if you have recently had a heart attack WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using [nationally completed name]. Carefull use and regular medical checks are advisable if any of the following applies to you: - you have epilepsy. Abrupt increase or decrease of dosage sho Прочитајте комплетан документ
Sandoz B.V. Page 1/19 Trazodon HCl Sandoz 100 mg, tabletten RVG 111061 1311-v4 1.3.1.1 Samenvatting van de Productkenmerken March 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Trazodon HCl Sandoz 100 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of trazodone hydrochloride. Excipient with known effect Each tablet contains 160.75 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Oblong off-white tablets, with three scorelines. The tablet is about 18.5 mm long and about 6.7 mm wide. The tablet can be divided into equal doses if broken in the middle, into a threequarter and a quarter tablet, if broken at an end scoreline, or into equal quarters if broken at all three scorelines. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS [Nationally completed name] is indicated for major depressive episode. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Sandoz B.V. Page 2/19 Trazodon HCl Sandoz 100 mg, tabletten RVG 111061 1311-v4 1.3.1.1 Samenvatting van de Productkenmerken March 2020 _Adults: _ The optimum dosage should be individually determined for each patient. The initial dose is 150 mg a day, administered in divided doses after food, or as a single dose upon retiring. The dose will be increased every 3 to 4 days by 50 mg a day (preferably upon retiring) until an optimal therapeutic effect is achieved. This may be increased up to a dose of 400 mg a day, administered in divided doses after food, or as a single dose upon retiring. In administering divided doses the major part of the divided dose should be taken upon retiring. In hospitalised patients, the maximum daily dose may be incrementally increased to a maximum of 600 mg per day, administered as divided doses. After reaching an effective dosage, clinical response is usually evident within two to four weeks. In the case of non – responders the dosage may be increased to the maximimum recommended. If, following this, there is no Прочитајте комплетан документ