URAPLEX Coated tablet Ref.[27636] Active ingredients: Trospium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishops Stortford, CM22 6PU, United Kingdom

Product name and form

Uraplex 20mg Coated Tablets.

Pharmaceutical Form

Coated tablet.

Brownish-yellow, glossy coated, biconvex tablets.

Qualitative and quantitative composition

The active ingredient is trospium chloride. Each coated tablet contains 20 mg trospium chloride.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Trospium

Trospium is an antispasmodic, antimuscarinic agent indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Receptor assays showed that trospium has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses. Trospium antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.
List of Excipients

Tablet core:

Wheat starch
Microcrystalline cellulose
Lactose monohydrate
Povidone
Croscarmellose sodium
Stearic acid
Silica colloidal anhydrous
Talc

Tablet coat:

Sucrose
Carmellose sodium
Talc
Silica colloidal anhydrous
Calcium carbonate E170
Macrogol 8000
Titanium dioxide E171
Iron oxide hydrate yellow E172
Beeswax white
Carnauba wax

Note for diabetics: one coated tablet corresponds to 0.06 g carbohydrate (equivalent to 0.005 bread units.

Pack sizes and marketing

PVC foiled aluminium blister.

Pack sizes approved: 2, 20, 28, 30, 40, 50, 56, 60, 90, 100, 120, 150, 200, 500, 600, 1000, 1200, 2000.

Not all pack sizes may be marketed.

Marketing authorization holder

Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road, Takeley, Bishop’s Stortford, CM22 6PU, United Kingdom

Marketing authorization dates and numbers

PL 15142/0287

14/03/2011

Drugs

Drug Countries
URAPLEX Spain, United Kingdom
 
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