देश: नीदरलैंड
भाषा: डच
स्रोत: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ACETYLCYSTEÏNE
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
R05CB01
Acetyl cysteine
Poeder voor oraal gebruik
ASPARTAAM (E 951) ; BRAMENSMAAKSTOF ; CARMELLOSE NATRIUM (E 466) ; CITROENZUUR 0-WATER (E 330) ; GLUCONOLACTON (E 575) ; MAGNESIUMCARBONAAT (E 504 (I)) ; MAGNESIUMCITRAAT 0-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MALTODEXTRINE ; MANNITOL (D-) (E 421) ; NATRIUMDIWATERSTOFCITRAAT (E 331) ; POLYSORBAAT 65 (E 436) ; SILICIUMDIOXIDE (E 551) ; SORBITOL (D-)(E 420) ; TRIPALMITINE ; VANILLINE ; XYLITOL (E 967),
Oraal gebruik
Acetylcysteine
Hulpstoffen: ASPARTAAM (E 951); BRAMENSMAAKSTOF; CARMELLOSE NATRIUM (E 466); CITROENZUUR 0-WATER (E 330); GLUCONOLACTON (E 575); MAGNESIUMCARBONAAT (E 504 (I)); MAGNESIUMCITRAAT 0-WATER; MAGNESIUMSTEARAAT (E 470b); MALTODEXTRINE; MANNITOL (D-) (E 421); NATRIUMDIWATERSTOFCITRAAT (E 331); POLYSORBAAT 65 (E 436); SILICIUMDIOXIDE (E 551); SORBITOL (D-)(E 420); TRIPALMITINE; VANILLINE; XYLITOL (E 967);
2017-12-04
Sandoz B.V. Page 1/8 Acetylcysteïne Sandoz ® 600 mg, poeder voor oraal gebruik in sachet RVG 119475 1313-V5 1.3.1.3 Bijsluiter September 2020 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ACETYLCYSTEÏNE SANDOZ 600 MG, POEDER VOOR ORAAL GEBRUIK IN SACHET acetylcysteine _ _ _ _ READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • [NATIONALLY COMPLETED NAME] SHOULD NOT BE TAKEN FOR MORE THAN 14 DAYS WITHOUT ANY MEDICAL ADVISE. • You must talk to a doctor if you do not feel better or if you feel worse after 4-5 days. FOR RX PRODUCTS 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 illness are the same as yours. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS 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] contains the active substance acetylcysteine and liquefies viscous mucus in the airways. [Nationally completed name] is used पूरा दस्तावेज़ पढ़ें
Sandoz B.V. Acetylcysteine Sandoz 600 mg, poeder voor oraal gebruik in sachet Page 1/10 RVG 119475 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken Augustus 2020 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Acetylcysteïne Sandoz 600 mg, poeder voor oraal gebruik in sachet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 600 mg of acetylcysteine. Excipients with known effect Each sachet contains 0.5mg of aspartame and up to 527 mg of sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral powder. White to slightly yellowish powder, easily disaggregating agglomerates if any with an odour like blackberry, possibly slightly sulfuric. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Secretolytic therapy in acute and chronic bronchopulmonary diseases where a reduction in the viscosity of the bronchial mucus is required in order to facilitate expectoration in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The following dosage is recommended for [Nationally completed name]: For adults only 1 sachet once daily (equivalent to 600 mg acetylcysteine per day) [Nationally completed name] is not suitable for use in adolescents and children. But other appropriate pharmaceutical forms are available. Method of administration Sandoz B.V. Acetylcysteine Sandoz 600 mg, poeder voor oraal gebruik in sachet Page 2/10 RVG 119475 1311-V4 1.3.1.1 Samenvatting van de Productkenmerken Augustus 2020 The oral powder of one sachet should be placed directly on the tongue. The oral powder stimulates the salivation so the oral powder can be swallowed easily. The oral powder should not be chewed before swallowing. Can be taken without water. Elderly and weakened patients Patients with a reduced cough reflex (elderly and weakened patients) should take the oral powder preferably in the morning. Duration of use [Nationally completed name] should not be taken for more than -14 days without medical advice. The patient should consult a doctor in case that the sympt पूरा दस्तावेज़ पढ़ें