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URISPAS 200MG TABLETS

Active substance(s): FLAVOXATE HYDROCHLORIDE

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APPROVED 23/03/2018
TCK
0015: To update the labelling to be in line with
the UK labelling text and guidelines.
Label Summary
PLPI Number: 15184/0642
(a) Enter the relevant pack sizes in the grey boxes and place a

where appropriate

Product name: Urispas 200mg Tablets
Packs to be Marketed(1)
Pack sizes 60’s
90’s
Over-labels
Re-cartons
Product name: Uronid 200mg Tablets
Packs to be Marketed(1)
Pack sizes 60’s
90’s
Over-labels
Re-cartons
(1) Add/Delete table depending on the number of product names approved on the licence

(b) Variable Text
Imported
Pack Size
60’s

ECMA number
53032

Manufacturer
(as stated on the label)
Recordati, S.p.A., Milan, Italy

(c) Statements of Assurance
relating to the variable text(2)

Agree

Not
Applicable

The layout and formatting of the labels shall not change
when using variable text
The label mock-ups will include the manufacturer with
the longest piece of text
The label mock-ups will include the re-packager(3) with
the longest piece of text
(2) These assurances relate to the variable text only. Other assurances (if applicable) should
be stated where appropriate.
(3) The re-packager must be granted on the licence.

The following page(s) is/are representative mock-up labelling of the
current granted and proposed overlabels, recartons and Braille

Urispas 200mg Tablets

Uronid 200mg Tablets

Carton Label:
Size 65mm x 75mm
Self adhesive backed
Printed Black

Carton Label:
Size 65mm x 75mm
Self adhesive backed
Printed Black

Urispas ® 200mg Tablets

Uronid ® 200mg Tablets

(flavoxate hydrochloride)

(flavoxate hydrochloride)

60 Tablets

60 Tablets

Each film-coated tablet contains 200mg
Flavoxate Hydrochloride.
Also contains lactose.

Each film-coated tablet contains 200mg
Flavoxate Hydrochloride.
Also contains lactose.

Please read the enclosed Patient Information Leaflet.
Take as directed by your doctor. Swallow with water.
Do not store above 30°C. Store in original package.
Keep out of the sight and reach of children.

Please read the enclosed Patient Information Leaflet.
Take as directed by your doctor. Swallow with water.
Do not store above 30°C. Store in original package.
Keep out of the sight and reach of children.

Manufactured by Recordati, S.p.A, Milan Italy and procured from
within the EU and re-packaged by the Product Licence Holder,
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
Urispas is a registered trademark of Recordati Ireland Limited.

Manufactured by Recordati, S.p.A, Milan Italy and procured from
within the EU and re-packaged by the Product Licence Holder,
Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
Uronid is a registered trademark of Recordati Ireland Limited.

Ref: 0642/241117/CL/01

Ref: 0642/241117/CL/02

Blank space provided on the carton label for the
introduction of the 2D barcode and human readable

Blank space provided on the carton label for the
introduction of the 2D barcode and human readable

POM PL No: 15184/0642
ECMA No: 53032

POM

Batch No:
Expiry date:

PL No: 15184/0642
ECMA No: 53032

Batch No:
Expiry date:

Urispas 200mg Tablets

Uronid 200mg Tablets

Over Silver Blister Label :
Size: 64mm x 78mm
Material Specifications of label:
Facestock: A frangible matt cast PVC film.
Adhesive: A permanent solvent acrylic based adhesive.
Liner:
BG50 white, a supercalendered glassine paper.
Printed 1 colour: Black

Over Silver Blister Label :
Size: 64mm x 78mm
Material Specifications of label:
Facestock: A frangible matt cast PVC film.
Adhesive: A permanent solvent acrylic based adhesive.
Liner:
BG50 white, a supercalendered glassine paper.
Printed 1 colour: Black

Blister design does not show perforations for removal of
tablets as the tablets can be pushed straight through the
label material with ease due to the nature of the
material.
Please accept this as written assurance that the blister
label will not hinder removal of the tablets

Blister design does not show perforations for removal of
tablets as the tablets can be pushed straight through the
label material with ease due to the nature of the
material.
Please accept this as written assurance that the blister
label will not hinder removal of the tablets

0642/241117/BL/01

(flavoxate hydrochloride)

BN:

Lexon (UK) Ltd., B98 0RE.

PL No: 15184/0642

Uronid ® 200mg Tablets

Exp:

Lexon (UK) Ltd., B98 0RE.

(flavoxate hydrochloride)

BN:

Exp:

PL No: 15184/0642

Urispas® 200mg Tablets

0642/241117/BL/02

Urispas 200mg Tablets
Braille Label
Size 40mm x 75mm
Please accept this as written assurance for the Braille code: the imprint of the
Braille code will not affect the legibility of labels/cartons by sighted people and that
the labels will be the same (material, etc) as those already approved by the
MRHA.
Braille= Urispas 200 mg

urispas
# bjj mg
The Braille label will be applied over the carton over-label

Uronid 200mg Tablets
Braille Label
Size 40mm x 75mm
Please accept this as written assurance for the Braille code: the imprint of the
Braille code will not affect the legibility of labels/cartons by sighted people and that
the labels will be the same (material, etc) as those already approved by the
MRHA.
Braille= Uronid 200 mg

Uronid
# bjj mg
The Braille label will be applied over the carton over-label

Urispas 200 mg Tablets
Carton design
Size:40x70x86mm
cut, creased & glued
Printed two colours: PC702 & Black
Bar Code Ref: 5037015002847
Braille will be embossed onto the carton

Area to be clear of
varnish/print

Carton
Batch/Expiry date
over tab Label
Size:38x21mm
Printed Black,self
adheive backed
Batch No:
Expiry date:
PL No: 15184/0642
ECMA No: 53032

Urispas® 200mg Tablets
(flavoxate hydrochloride)

90 Tablets
Manufactured by Recordati, S.p.A., Milan, Italy and procured
from within the EU and repackaged by the Product Licence
Holder, Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
Urispas is a registered trademark of Recordati Ireland Limited.

Urispas 200mg
urispas
Tablets
®

# bjj mg

(flavoxate hydrochloride)

90 Tablets
Each film-coated tablet contains 200mg
flavoxate hydrochloride.
Also contains lactose.
POM

Urispas® 200mg Tablets
(flavoxate hydrochloride)

90 Tablets
Please read the enclosed Patient Information Leaflet.
Take as directed by your doctor.
Swallow with water. Do not store above 30°C.
Store in original package.
Keep out of the sight and reach of children.

Ref: 0642/241117/CT/01

Urispas® 200mg Tablets

(flavoxate hydrochloride)

90 Tablets

Blank space provided on the carton label for the
introduction of the 2D barcode and human readable data.

Uronid 200 mg Tablets
Carton design

Area to be clear of
varnish/print

Size:40x70x86mm
cut, creased & glued
Printed two colours: PC702 & Black
Bar Code Ref: 5037015002847

Carton
Batch/Expiry date
over tab Label
Size:38x21mm
Printed Black,self
adheive backed

Braille will be embossed onto the carton
Batch No:
Expiry date:
PL No: 15184/0642
ECMA No: 53032

Uronid ® 200mg Tablets
(flavoxate hydrochloride)

90 Tablets
Manufactured by Recordati, S.p.A., Milan, Italy and procured
from within the EU and repackaged by the Product Licence
Holder, Lexon (UK) Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
Urispas is a registered trademark of Recordati Ireland Limited.

Uronid 200mg
Uronid
Tablets
®

# bjj mg

(flavoxate hydrochloride)

90 Tablets
Each film-coated tablet contains 200mg
flavoxate hydrochloride.
Also contains lactose.
POM

Uronid ® 200mg Tablets
(flavoxate hydrochloride)

90 Tablets
Please read the enclosed Patient Information Leaflet.
Take as directed by your doctor.
Swallow with water. Do not store above 30°C.
Store in original package.
Keep out of the sight and reach of children.

Ref: 0642/241117/CT/02

Uronid ® 200mg Tablets

(flavoxate hydrochloride)

90 Tablets

Blank space provided on the carton label for the
introduction of the 2D barcode and human readable data.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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