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SULPIRIDE 400MG TABLETS

Active substance(s): SULPIRIDE

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The following symptoms may occur in newborn babies, of mothers that have used Sulpiride
Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or
weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby
develops any of these symptoms you may need to contact your doctor.

1207615

Title: Art Work Approval Form

MEDREICH LIMITED
Product

Sulpiride Tablets - 200 mg / 400 mg - S/L - Eng - PIL

Customer

MEDREICH PLC, UK

Reason
for Issue

CC No.:
Change in text from UK. Old code: 1207615

Colours:

Single - Black

Dimensions:

240 x 280 mm (Open Size) , 140 x 40 mm (Folded size)

Layout No.

NA

No. of Folds

4

Item Code

XXXXXXX (WOA)

Dimensions & Colour Shade: Confirmed by PDC

Artwork No.:

NA

Specification: Printed on 56 - 60 GSM Maplitho paper

Artwork made to

75%

Check for all aspects

100% check
on text matter:

Check on design and
adequacy of text matter:

Check on Dimensions
& OPD aspects:

Check on Label claim, License, Codes aspects:

PDC

Regulatory :

IBD:

Technical services:

QC:

MED/SUL/PIL/01
Format No.: CO-QA005-F06-00

WIN\\192.168.1.32\pdc\Artworks\Medreich\UK Products\Sulpiride\PIL\Sulpiride Tablets 200 mg 400 mg SL Eng PIL.ai
Internal Approval issued on

CD issued on

CQA:
30.11.11(MA)

Sulpiride Tablets 200mg are white, circular tablets marked S200 on one face and plain on the reverse.
and plain on the reverse.

MA Holder & Batch Release site:
MEDREICH PLC
9, Royal Parade, Kew Gardens,
Surrey TW9 3QD, England

120XXXX

PL Numbers:
PL 21880/0058-Sulpiride 200mg Tablets
PL 21880/0059-Sulpiride 400mg Tablets
This leaflet was last approved in November 2011.

Printed on 56 - 60 GSM Maplitho paper
MEDREICH PLC, UK
CC No.:
Change in text from UK. Old code: 1207615

Single - Black

NA

4

XXXXXXX (WOA)

MED/SUL/PIL/01
Format No.: CO-QA005-F06-00

Artwork No.:

240 x 280 mm (Open Size) , 140 x 40 mm (Folded size)

Artwork made to

75%

NA

WIN\\192.168.1.32\pdc\Artworks\Medreich\UK Products\Sulpiride\PIL\Sulpiride Tablets 200 mg 400 mg SL Eng PIL.ai
Internal Approval issued on

CD issued on

30.11.11(MA)

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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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