국가: 네덜란드
언어: 네덜란드어
출처: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
CODEINEDIWATERSTOFFOSFAAT 0,5-WATER 20 mg/stuk SAMENSTELLING overeenkomend met ; CODEINE 14,7 mg/stuk
CODEINEDIWATERSTOFFOSFAAT 0,5-WATER 20 mg/stuk SAMENSTELLING overeenkomend met ; CODEINE 14,7 mg/stuk
Tablet
AARDAPPELZETMEEL ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), AARDAPPELZETMEEL ; CELLULOSE, MICROKRISTALLIJN (E 460) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B)
Oraal gebruik
1900-01-01
1A Pharma GmbH Page 1/10 Codeïnefosfaat 1A Pharma 10, 15, 20, 30 mg, tabletten RVG 127427-30 1313-v2 1.3.1.3 bijsluiter Februari 2024 BIJSLUITER: INFORMATIE VOOR DE PATIËNT CODEÏNEFOSFAAT SANDOZ 10 MG, TABLETTEN CODEÏNEFOSFAAT SANDOZ 15 MG, TABLETTEN CODEÏNEFOSFAAT SANDOZ 20 MG, TABLETTEN CODEÏNEFOSFAAT SANDOZ 30 MG, TABLETTEN codeïnefosfaathemihydraat _ _ 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 (or for your child) 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 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. 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 codeine. It belongs to the group of weak pain medications, so called opioid analgesics, and can be used alone or in combination with other pain medication such as paracetamol. Codeine is also used to treat coughing (by suppressing the cough) and diarrhoea (by its action on the gut). [Nationally completed name] is used for: • short-term relief of moderate pain that cannot be relieved by other pain medication like (only) paracetamol or ibuprofen in adults and children older than 12 years of age, • treatment of symptoms of a dry cough in adults and children older than 12 years of age, • treatment of symptoms of diarrhoea in adults if treatment with loperamide (a diarrhoea 전체 문서 읽기
1A Pharma GmbH Page 1/15 Codeïnefosfaat 1A Pharma 10, 15, 20, 30 mg, tabletten RVG 127427-30 1311-V2 1.3.1.1 SmPC Februari 2024 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Codeïnefosfaat 1A Pharma 10 mg, tabletten Codeïnefosfaat 1A Pharma 15 mg, tabletten Codeïnefosfaat 1A Pharma 20 mg, tabletten Codeïnefosfaat 1A Pharma 30 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION {[Nationally completed name] 10 mg tablets} Each tablet contains 10 mg codeine phosphate hemihydrate equivalent to 7.37 mg of codeine. {[Nationally completed name] 15 mg tablets} Each tablet contains 15 mg codeine phosphate hemihydrate equivalent to 11.05 mg of codeine. _ _ {[Nationally completed name] 20 mg tablets} Each tablet contains 20 mg codeine phosphate hemihydrate equivalent to 14.73 mg of codeine. {[Nationally completed name] 30 mg tablets} Each tablet contains 30 mg codeine phosphate hemihydrate equivalent to 22.10 mg of codeine. Excipient(s) with known effect {[Nationally completed name] 10 mg tablets} Each tablet contains 29.45 mg lactose (as monohydrate). {[Nationally completed name] 15 mg tablets} Each tablet contains 44.18 mg lactose (as monohydrate). {[Nationally completed name] 20 mg tablets} Each tablet contains 58.90 mg lactose (as monohydrate). {[Nationally completed name] 30 mg tablets} Each tablet contains 88.35 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 1A Pharma GmbH Page 2/15 Codeïnefosfaat 1A Pharma 10, 15, 20, 30 mg, tabletten RVG 127427-30 1311-V2 1.3.1.1 SmPC Februari 2024 Tablet {[Nationally completed name] 10 mg tablets} White or almost white, biconvex tablet of round shape (diameter 6 mm), debossed ‘COD’ over ‘10’ on one side. {[Nationally completed name] 15 mg tablets} White or almost white, biconvex tablet of round shape (diameter 7 mm), debossed ‘COD’ over ‘15’ on one side. _ _ {[Nationally completed name] 20 mg tablets} White or almost white, biconvex tablet of round shape (diameter 8 mm), debosse 전체 문서 읽기