PRO-BANTHINE Tablet Ref.[27547] Active ingredients: Propantheline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

Product name and form

Pro-Banthine tablets 15 mg.

Pharmaceutical Form

Tablets.

Qualitative and quantitative composition

Propantheline Bromide 15 mg.

Excipients with known effect: This medicinal product contains lactose (31 mg) and sucrose (26.74 mg), see section 4.4 for further details.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Propantheline

Propantheline inhibits parasympathetic activity by blocking the action of the neurohormone, acetylcholine, on the neuroeffector cell. This blocking action of propantheline is instrumental in reducing gastric acid secretion and gastrointestinal motor activity.

List of Excipients

In the tablet core: lactose monohydrate, talc, maize starch, magnesium stearate and light liquid paraffin.

In the coating: sucrose, calcium carbonate, saccharin sodium, titanium dioxide (E171), magnesium carbonate light, castor oil virgin, talc, ferric oxide red (E172), ferric oxide yellow (E172), and carnauba wax.

Pack sizes and marketing

Foil/PVC-PVdC strips of 100 or 112 tablets.

HDPE bottles of the appropriate size to accommodate 1000 or 5000 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Kyowa Kirin Limited, Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

Marketing authorization dates and numbers

PL 16508/0050

28 February 1998

Drugs

Drug Countries
PRO-BANTHINE Australia, Japan, New Zealand, United Kingdom

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