PANTOPRAZOLE 20 MG GASTRO-RESISTANT TABLETS

Active substance: PANTOPRAZOLE SODIUM SESQUIHYDRATE

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BEFORE YOU TAKE PANTOPRAZOLE
TABLETS

Do not take Pantoprazole Tablets

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)
L:
W:
D:
Foil Width:
Perforated:

Dimensions:

231-10-01210
N/A
N/A
N/A
N/A
Univers
8.75 Pt

PL 00289/1496. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Belmac, Zaragoza
Additional pack sizes

233922
Trackwise Parent:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
:H PXVW UHFHLYH D FRS\ RI DQ\ UG 3DUW\ 6XSSOLHU·V 3URRI EHIRUH DSSURYDO WR SULQW ZLOO EH JUDQWHG

2

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
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Base Font Size:

Pregnancy and breast-feeding

PL Number(s),
MA Holder & Packer:
Reason for revision:

Adults:

320 mm
170 mm
mm
N/A
N/A

Child:

Pantoprazole Tablets are used for:
Adults and adolescents 12 years of age and
above:

1

Taking other medicines

231-30-88146-D LEA PANTOPRAZOLE 20MG TAB TUK
WHAT PANTOPRAZOLE TABLETS ARE
AND WHAT THEY ARE USED FOR

Version:

1. What Pantoprazole Tablets are and what they
are used for
2. Before you take Pantoprazole Tablets
3. How to take Pantoprazole Tablets
4. Possible side effects
5. How to store Pantoprazole Tablets
6. Further information

1

PANTONE® BLACK C

PANTONE® GREEN C

4 November 2013

Tell your doctor immediately

233932

Read all of this leaflet carefully before you start
taking this medicine.

Ref:

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
:H PXVW UHFHLYH D FRS\ RI DQ\ UG 3DUW\ 6XSSOLHU·V 3URRI EHIRUH DSSURYDO WR SULQW ZLOO EH JUDQWHG

320 mm
170 mm
mm
N/A
N/A
L:
W:
D:
Foil Width:
Perforated:

Dimensions:

231-10-01210
N/A
N/A
N/A
N/A
Univers
8.75 Pt
F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:
Base Font Size:

PL 00289/1496. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Belmac, Zaragoza
Additional pack sizes
PL Number(s),
MA Holder & Packer:
Reason for revision:

Trackwise Parent:

PANTONE® BLACK C

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C

4 November 2013
233932
Child:

1
Version:

233922

231-30-88146-D LEA PANTOPRAZOLE 20MG TAB TUK Ref:

PANTOPRAZOLE 20 mg
GASTRO-RESISTANT TABLETS
Pantoprazole (as pantoprazole sodium
sesquihydrate)

Very Rare
taking one tablet daily
For long-term management and for preventing
the return of reflux oesophagitis

Not known

Adults:
To prevent duodenal and stomach ulcers in
patients who need to take NSAIDs continuously
Special patient groups:

If you take more Pantoprazole Tablets than you
should

If you forget to take Pantoprazole Tablets

Side effects identified through blood tests:
Uncommon
Rare
Very Rare

If you stop taking Pantoprazole Tablets

4

POSSIBLE SIDE EFFECTS

5

HOW TO STORE PANTOPRAZOLE TABLETS

Keep out of the reach and sight of children.

6
If you get any of the following side effects, stop
taking these tablets and tell your doctor
immediately, or contact the casualty department
at your nearest hospital:
Serious allergic reactions (frequency rare)

FURTHER INFORMATION

What Pantoprazole Tablets contain

Driving and using machines
Take special care with Pantoprazole Tablets
Serious skin conditions (frequency not known):
Important information about some of the
ingredients of Pantoprazole Tablets

3

HOW TO TAKE PANTOPRAZOLE TABLETS

When and how should you take Pantoprazole
Tablets ?

What Pantoprazole Tablets look like and contents
of the pack

Other serious conditions (frequency not known):

Other side effects are:
Uncommon

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

Manufacturer
Adults and adolescents 12 years of age and
above:
To treat symptoms (e.g. heartburn, acid
regurgitation, pain on swallowing) associated to
gastro-oesophageal reflux disease

Rare

This leaflet was last approved in October 2013

Ref:

231-30-88146-D LEA PANTOPRAZOLE 20MG TAB TUK
Version:

1

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

231-10-01210
N/A
N/A
N/A
N/A
Univers
8.75 Pt

Child:

233932

PL 00289/1496. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Belmac, Zaragoza
Additional pack sizes

F. P. Code:
EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:
Base Font Size:

233922

4 November 2013

Artwork Originator;
Sign & Date:

Digitally signed by
Elizabeth Morgan
DN: cn=Elizabeth
Morgan, o=Teva UK Ltd,
ou=Origination Dept,
email=elizabeth.morga
n@tevauk.com, c=GB
Date: 2013.11.04
15:06:42 Z

Artwork Checker;
Sign & Date:

Dimensions:
L:
W:
D:
Foil Width:
Perforated:

Digitally signed by
Simon Wilkinson
DN: cn=Simon
Wilkinson, o=Teva UK
Ltd, ou=Artwork
Origination,
email=SWilkinson@tev
auk.com, c=GB
Date: 2013.11.04
16:24:26 Z

320 mm
170 mm
mm
N/A
N/A

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

Poonam
Shelar

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

PANTONE® GREEN C
PANTONE® BLACK C

Packing Site Approval (where not TEVA UK Limited)
Sign & Date:

Digitally signed by
Poonam Shelar
DN: cn=Poonam Shelar, o,
ou=Teva UK Ltd Harlow,
email=poonam.
shelar@tevauk.com, c=GB
Date: 2013.11.04 16:58:50
Z

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
:H PXVW UHFHLYH D FRS\ RI DQ\ UG 3DUW\ 6XSSOLHU·V 3URRI EHIRUH DSSURYDO WR SULQW ZLOO EH JUDQWHG

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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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