Страна: ПАР
мова: англійська
Джерело: South African Health Products Regulatory Authority (SAHPRA)
Janssen Pharmaceutica (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS RABEPRAZOLE SODIUM 20,0 mg
Registered
2001-12-02
JANSSEN PHARMACEUTICA (PTY) LTD PARIET® range : 10 mg and 20 mg tablets (rabeprazole) CLEAN FINAL PATIENT INFORMATION LEAFLET Submitted: 18 August 2015 ref: RA/2015/07/080cp SUBMISSION TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015 _ _ _ _ CCDS: JUNE 2011 + JULY 2009 + CCDS JAN 2013 PAGE 1 OF 10 CLEAN FINAL PATIENT INFORMATION LEAFLET _(Clean version submitted 18 August 2015) _ SCHEDULING STATUS Schedule 4 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM PARIET ® 10 mg tablets PARIET ® 20 mg tablets RABEPRAZOLE SODIUM READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING PARIET. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. PARIET has been prescribed for you personally and you should not share it with other people. It may harm them, even if their symptoms are the same as yours. 1.0 WHAT PARIET CONTAINS The active substance is rabeprazole sodium. Each yellow PARIET tablet contains 20 mg rabeprazole sodium; and each pink PARIET tablet contains 10 mg of rabeprazole sodium. The other ingredients are: calcium carboxymethylcellulose, carnauba wax, diacetylated monoglycerides, ethylcellulose, ferric oxide, hydroxypropyl cellulose, hypromellose phthalate, low-substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, mannitol, talc, titanium dioxide. Ferric oxide red is used as an excipient in all 10 mg tablets and ferric oxide yellow is used as an excipient in all 20 mg tablets. JANSSEN PHARMACEUTICA (PTY) LTD PARIET® range : 10 mg and 20 mg tablets (rabeprazole) CLEAN FINAL PATIENT INFORMATION LEAFLET Submitted: 18 August 2015 ref: RA/2015/07/080cp SUBMISSION TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015 _ _ _ _ CCDS: JUNE 2011 + JULY 2009 + CCDS JAN 2013 PAGE 2 OF 10 2.0 WHAT PARIET IS USED FOR PARIET belongs to a group of medicines called “Proton Pump Inhibitors” (PPIs). They work by lowering the amount of acid that your stomach produces. PARIET tablets are used to treat the following conditions: Прочитайте повний документ
JANSSEN PHARMACEUTICA (PTY) LTD PARIET® range: 10 mg and 20 mg tablets (rabeprazole) CLEAN FINAL PACKAGE INSERT Submitted: 18 August 2015; Reference: RA/2015/07/080cp AMENDMENT TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015 CCDS January 2013 Page 1 of 16 CLEAN FINAL PACKAGE INSERT _(Clean version submitted 18 August 2015) _ SCHEDULING STATUS Schedule 4 PROPRIETARY NAME (AND DOSAGE FORM) PARIET ® 10 mg tablets PARIET ® 20 mg tablets COMPOSITION 10mg: Each enteric-coated delayed release tablet contains 10 mg of rabeprazole sodium, equivalent to 9,42 mg rabeprazole (racemate). 20 mg: Each enteric-coated delayed release tablet contains 20 mg of rabeprazole sodium, equivalent to 18,85 mg rabeprazole (racemate). Inactives: Calcium carboxymethylcellulose, carnauba wax, diacetylated monoglycerides, ethylcellulose, ferric oxide, hydroxypropyl cellulose, hypromellose phthalate, low-substituted hydroxypropyl cellulose, magnesium oxide, magnesium stearate, mannitol, talc, titanium dioxide. Ferric oxide red is used as an excipient in all 10 mg tablets and ferric oxide yellow is used as an excipient in all 20 mg tablets. PHARMACOLOGICAL CLASSIFICATION A 11.4.3 Medicines acting on gastro-intestinal tract. JANSSEN PHARMACEUTICA (PTY) LTD PARIET® range: 10 mg and 20 mg tablets (rabeprazole) CLEAN FINAL PACKAGE INSERT Submitted: 18 August 2015; Reference: RA/2015/07/080cp AMENDMENT TYPE: COMPLIANT RESPONSE TO CCC 04 JUNE 2015 CCDS January 2013 Page 2 of 16 PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Rabeprazole sodium is a gastric proton-pump inhibitor, blocking the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Animal studies indicate that after administration, rabeprazole sodium rapidly disappears from both the plasma and gastric mucosa. Anti-secretory Activity: After oral administration of a 20 mg dose of rabeprazole sodium the onset of the anti-secretory effect occurs within one hour, with the maximum effect oc Прочитайте повний документ