REGURIN XL Prolonged-release capsule, hard Ref.[9721] Active ingredients: Trospium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Regurin XL 60 mg prolonged-release capsule, hard.

Pharmaceutical Form

Prolonged-release capsule, hard.

The Regurin XL 60 mg prolonged-release capsule, hard has an opaque orange cap and an opaque white body imprinted with SAN 60 and contains white to off-white pellets.

Qualitative and quantitative composition

Each prolonged-release capsule, hard contains 60 mg trospium chloride.

Excipients with known effect: Each prolonged-release capsule, hard contains 154.5 mg sucrose.

For the 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

Capsule content:

Sucrose
Maize starch
Methyl acrylate-methyl methacrylate-methacrylic acid-copolymer
Ammonium hydroxide
Triglycerides, medium chain
Oleic acid
Ethylcellulose
Titanium dioxide (E171)
Hypromellose
Macrogol 400
Polysorbate 80
Triethyl citrate
Talc

Capsule shell:

Gelatin
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)

Printing ink:

Shellac (20% esterified)
Iron oxide black (E172)
Propylene glycol

Pack sizes and marketing

Polyvinylchloride (PVC)/aluminium blister, Polyvinylchloride/Polyvinylidenchloride (PVC/PVDC)/aluminium blister or PVC/Aclar/aluminium blister.

Packs of 4, 7, 10, 14, 28, 30, 56, 60, 84, 90, 100 and 10x28 capsules.

Sample packs of 4.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0194

06.11.2008

Drugs

Drug Countries
REGURIN Ireland, United Kingdom

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