Negara: Afrika Selatan
Bahasa: Inggris
Sumber: South African Health Products Regulatory Authority (SAHPRA)
GLAXOSMITHKLINE SOUTH AFRICA (PTY) LIMITED
Tablet
Each tablet contains RANITIDINE HYDROCHLORIDE 168 mg equivalent to 150 mg RANITIDINE
1982-07-09
G LAXO S MITH K LINE S OUTH A FRICA (P TY ) L IMITED Submission Date 14/05/2018 Type A ZANTAC O RAL R ANGE Implementation 15/05/2018 Category 10(b) T ABLETS /S YRUP 150 mg OR 300 mg Reference GDSv45 - v0005 CONFIDENTIAL 1.3.2 PATIENT INFORMATION LEAFLET (CLEAN) Page 1 of 11 GDS-045 ZANTAC ORAL RANGE 1 PATIENT INFORMATION LEAFLET 2 3 4 SCHEDULING STATUS: 5 S3 6 7 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM: 8 ZANTAC TABLETS 9 ZANTAC 300 MG Tablets 10 ZANTAC EFFERVESCENT 150 Tablets 11 ZANTAC EFFERVESCENT 300 Tablets 12 ZANTAC SYRUP 13 Ranitidine 150 mg or 300 mg 14 15 Read all of this leaflet carefully before you start taking ZANTAC. 16 Keep this leaflet. You may need to read it again. 17 If you have further questions, please ask your doctor or your pharmacist. 18 ZANTAC has been prescribed for you personally and you should not share your 19 medicine with other people. It may harm them, even if their symptoms are the same 20 as yours. 21 22 WHAT ZANTAC CONTAINS: 23 ZANTAC TABLETS: Each tablet contains the active substance, ranitidine 150 mg (as the 24 hydrochloride). 25 ZANTAC 300 MG: Each tablet contains the active substance, ranitidine 300 mg (as the 26 hydrochloride). 27 G LAXO S MITH K LINE S OUTH A FRICA (P TY ) L IMITED Submission Date 14/05/2018 Type A ZANTAC O RAL R ANGE Implementation 15/05/2018 Category 10(b) T ABLETS /S YRUP 150 mg OR 300 mg Reference GDSv45 - v0005 CONFIDENTIAL 1.3.2 PATIENT INFORMATION LEAFLET (CLEAN) Page 2 of 11 GDS-045 The other ingredients include: 28 _Tablet core:_ Croscarmellose sodium (300 mg tablet only), magnesium stearate and 29 microcrystalline cellulose. 30 _Film coat:_ Hydroxypropyl cellulose, hydroxypropyl methylcellulose 2910 and titanium 31 dioxide (E171). 32 Sugar-free. 33 34 ZANTAC EFFERVESCENT 150: Each effervescent tablet contains the active substance, 35 ranitidine 150 mg (as the hydrochloride). 36 Contains sugar (sorbitol): 1,14 mg/tablet. 37 These tablets contain aspartame as a sweetening agent and 38 sodium benzoate. 39 ZANTAC 150 mg efferves Baca dokumen lengkapnya
G LAXO S MITH K LINE S OUTH A FRICA (P TY ) L IMITED Submission Date 14/05/2018 Type A ZANTAC O RAL R ANGE Implementation 15/05/2018 Category 10(b) T ABLETS /S YRUP 150 mg OR 300 mg Reference GDSv45 - v0005 CONFIDENTIAL 1.3 SOUTH AFRICAN LABELLING AND PACKAGING 1.3.1 SOUTH AFRICAN PACKAGE INSERT 1.3.1.1 PACKAGE INSERT (CLEAN) Page 1 of 14 GDS-045 ZANTAC 1 TABLETS/DISPERSIBLE TABLETS/SYRUP 2 3 SCHEDULING STATUS: 4 S3 5 6 PROPRIETARY NAME AND DOSAGE FORM: 7 ZANTAC TABLETS 8 ZANTAC 300 MG Tablets 9 ZANTAC EFFERVESCENT 150 Tablets 10 ZANTAC EFFERVESCENT 300 Tablets 11 ZANTAC SYRUP 12 13 COMPOSITION: 14 ZANTAC TABLETS: Each tablet contains ranitidine 150 mg (as the hydrochloride). 15 ZANTAC 300 MG TABLETS: Each tablet contains ranitidine 300 mg (as the 16 hydrochloride). 17 The excipients include: 18 _Tablet core:_ Croscarmellose sodium (300 mg tablet only), magnesium stearate and 19 microcrystalline cellulose. 20 _Film coat:_ Hydroxypropyl cellulose, hydroxypropyl methylcellulose 2910 and titanium 21 dioxide (E171). 22 Sugar-free. 23 24 G LAXO S MITH K LINE S OUTH A FRICA (P TY ) L IMITED Submission Date 14/05/2018 Type A ZANTAC O RAL R ANGE Implementation 15/05/2018 Category 10(b) T ABLETS /S YRUP 150 mg OR 300 mg Reference GDSv45 - v0005 CONFIDENTIAL 1.3 SOUTH AFRICAN LABELLING AND PACKAGING 1.3.1 SOUTH AFRICAN PACKAGE INSERT 1.3.1.1 PACKAGE INSERT (CLEAN) Page 2 of 14 GDS-045 ZANTAC EFFERVESCENT 150 TABLETS: Each effervescent tablet contains ranitidine 150 mg (as 25 the hydrochloride). 26 Contains sugar (sorbitol): 1,14 mg/tablet. 27 These tablets contain aspartame as a sweetening agent and sodium benzoate. 28 ZANTAC EFFERVESCENT 300 TABLETS: Each effervescent tablet contains ranitidine 300 mg (as 29 the hydrochloride). 30 Contains sugar (sorbitol): 1,71 mg/tablet. 31 These tablets contain aspartame as a sweetening agent and sodium benzoate. 32 The other excipients include grapefruit flavour IFF 18 C222, monosodium citrate anhydrous, 33 orange flavour IFF 6, povidone K30 and sodium bicarbonate. 34 35 ZANTAC SYRUP: Baca dokumen lengkapnya