AUROBEVERINE Modified-release capsule, hard Ref.[7479] Active ingredients: Mebeverine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

Aurobeverine MR 200 mg modified-release capsules, hard.

Pharmaceutical Form

Modified-release capsule, hard.

Creamy white body and creamy white cap, hard gelatin capsule (approximately 9.8 mm x 6.9 mm) filled with white to off white spherical pellets.

Qualitative and quantitative composition

Each capsule contains 200 mg mebeverine hydrochloride.

Excipient with known effect: Each capsule contains up to 23.81 mg sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mebeverine

Mebeverine is a musculotropic antispasmodic with a direct action on the smooth muscle of the gastrointestinal tract, relieving spasm without affecting normal gut motility.

List of Excipients

Capsule core:

Sugar spheres (sucrose, maize starch)
Povidone
Hypromellose

SR coating:

Ethylcellulose
Macrogol
Magnesium stearate

Capsule shell:

Gelatin
Titanium dioxide (E171)

Pack sizes and marketing

Blister pack: PVC/PVdC – Aluminium blisters in cartons.

Pack sizes of blister: 30 and 60 capsules.

HDPE container pack: HDPE bottles fitted with round white screw type continuous thread cap.

Pack sizes of HDPE container: 250 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0492

28/04/2017

Drugs

Drug Countries
AUROBEVERINE United Kingdom

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