ZANAFLEX Tablet Ref.[8261] Active ingredients: Tizanidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2016  Publisher: Teva Pharma B.V., Swansweg 5, 2031GA, Haarlem, Netherlands

Product name and form

Zanaflex 2 mg Tablets.

Pharmaceutical Form

Tablet.

White to off-white, biconvex, round, tablets, 6 mm in diameter, debossed “T2” on one side and score line on the other.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

Each tablet contains 2 mg of tizanidine (as hydrochloride).

Excipient(s) with known effect: Each tablet contains 57.910 mg of lactose, anhydrous.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tizanidine

Tizanidine is a centrally acting skeletal muscle relaxant. Polysynaptic signal transmission at spinal interneuron level, which is responsible for excessive muscle tone, is inhibited and muscle tone reduced.

List of Excipients

Lactose, anhydrous
Cellulose, microcrystalline
Silica, colloidal anhydrous
Stearic acid

Pack sizes and marketing

Blister PVC/PVDC/Aluminium.

Blister packs of 15, 20, 30, 50, 100, 120 and clinical pack 500 (10x 50) tablets.

Not all pack-sizes may be marketed.

Marketing authorization holder

Teva Pharma B.V., Swansweg 5, 2031GA, Haarlem, Netherlands

Marketing authorization dates and numbers

PA0749/054/001

Date of first authorisation: 25th January 2008
Date of last renewal: 28th December 2010

Drugs

Drug Countries
ZANAFLEX Ireland, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.