NEPHROTRANS Gastro-resistant capsule Ref.[27924] Active ingredients: Sodium bicarbonate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Medice Arzneimittel Pรผtter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany

Product name and form

Nephrotrans 500 mg gastro-resistant capsules, soft.

Pharmaceutical Form

Opaque, russet and white, elongated oval gastro-resistant capsule, soft with approximate size of 22 mm (length) and 7.8 mm (diameter).

Qualitative and quantitative composition

Each capsule contains 500 mg sodium hydrogen carbonate.

Excipients with known effect: sorbitol, soya-bean oil and propylene glycol.

Each capsule contains 50 mg sorbitol, 15 mg soya-bean oil and 8 mg propylene glycol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Sodium bicarbonate

Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

List of Excipients

Yellow beeswax, hydrogenated soya-bean oil, partially hydrogenated soya-bean oil, refined rapeseed oil, soya lecithin, iron oxide (E172), titanium dioxide (E171), glycerol 85%, gelatin, partially dehydrated liquid sorbitol, hydrochloric acid 25%, hypromellose, hydroxypropylcellulose, talc, polyethylene glycol, methacrylic acid – ethyl acrylate copolymer (1:1), polysorbate 80, sodium laurilsulfate, propylene glycol, glycerol monostearate, purified water.

Pack sizes and marketing

Boxes containing capsules in PVC/PVDC clear blisters sealed to aluminium foil.

Packs with 100 gastro-resistant capsules, soft.

Hospital packs with 500 gastro-resistant capsules, soft.

Not all pack sizes may be marketed.

Marketing authorization holder

Medice Arzneimittel Pรผtter GmbH & Co. KG, Kuhloweg 37, 58638 Iserlohn, Germany

Marketing authorization dates and numbers

PL 11243/0045

17/04/2020

Drugs

Drug Countries
NEPHROTRANS Austria, United Kingdom

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