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UKPAR for Sodium Bicarbonate 500 mg Capsules Hard PL …

UKPAR Sodium Bicarbonate 500 mg Capsules , Hard PL 30464/0063 1 Sodium Bicarbonate 500 MG Capsules , HARD PL 30464/0063 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 10 Summary of Product Characteristics Page 11 Product Information Leaflet Page 12 Labelling Page 13 UKPAR Sodium Bicarbonate 500 mg Capsules , Hard PL 30464/0063 2 Sodium Bicarbonate 500 MG Capsules , HARD PL 30464/0063 LAY SUMMARY On 6th September 2012, the MHRA granted Athlone Pharmaceuticals Limited a Marketing Authorisation (licence) for the medicinal product Sodium Bicarbonate 500 mg Capsules , Hard (PL 30464/0063). This is a Prescription-only medicine (POM). Sodium Bicarbonate 500 mg Capsules are part of a group of medicines called antacids which are used to reduce the effects of excess acid produced in the stomach. Sodium Bicarbonate 500 mg Capsules are used to treat indigestion and acidosis (too much acid produced by the body, or acid not removed by the kidneys).

UKPAR Sodium Bicarbonate 500 mg Capsules, Hard PL 30464/0063 6 Comparative dissolution profile has been presented for test and reference product.

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  Sodium, Capsule, Bicarbonate, Sodium bicarbonate 500 mg capsules

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