BLADURIL Film-coated tablet Ref.[50643] Active ingredients: Flavoxate

Source: Health Products Regulatory Authority (ZA)  Revision Year: 2022  Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, South Africa 0860 ADCOCK (232625)

Product name and form

BLADURIL 200 mg, film-coated tablets.

Pharmaceutical Form

Film-coated tablets.

White, homogeneous film-coated tablets with “F200” embossed.

Qualitative and quantitative composition

Each film-coated tablet contains 200 mg flavoxate hydrochloride.

Excipient with known effect:

Contains sugar (lactose monohydrate): 64 mg.

For full list of excipients, see section 6.1.

Active Ingredient Description
Flavoxate

Flavoxate is an antispasmodic selective to the urinary tract. Flavoxate has been shown to have a direct antispasmodic action on smooth muscle fibres.

List of Excipients

Core:

Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose (Avicel PH-102)
Povidone (Polyvinylpyrollidone K30)
Sodium starch glycolate (Type A)
Talc

Coating:

Macrogol 6000
Magnesium stearate
Sepifilm (coating consisting of: hypromellose, macrogol stearate, microcrystalline cellulose)
Titanium dioxide (CI 77891)

Pack sizes and marketing

Cartons of 15 tablets: Each carton contains 1 blister strip containing 15 tablets.

Cartons of 90 tablets: Each carton contains 6 blister strips containing 15 tablets per blister strip.

Not all pack sizes may be marketed.

Marketing authorization holder

Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, South Africa
0860 ADCOCK (232625)

Marketing authorization dates and numbers

56 0136

10 May 2022

Drugs

Drug Countries
BLADURIL Ecuador, Mexico, South Africa

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