TRAMADOL HYDROCHLORIDE/PARACETAMOL 37.5 MG / 325 MG FILM-COATED TABLETS

Active substance: TRAMADOL HYDROCHLORIDE

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Ref:
Version:

1

08 February 2013

231-30-32116-B LEA TRAMADOL/PARACETAMOL 32.5mg/325mg TAB 60 TUK
Trackwise Parent:

180694

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

231-10-07691
N/A
106 (101011)
N/A
N/A
Univers

Base Font Size:

180698

PL 00289/1731. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann 1030.
QRD update; multiple text updates throughout.

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

Child:

9 Pt

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

323 mm
200 mm
N/A
N/A

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

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

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

PAGE 1: FRONT FACE (INSIDE OF REEL)

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

The risk of side effects increases:

1. What Tramadol hydrochloride/Paracetamol is and what
it is used for
2. What you need to know before you take Tramadol
hydrochloride/Paracetamol
3. How to take Tramadol hydrochloride/Paracetamol
4. Possible side effects
5. How to store Tramadol hydrochloride/Paracetamol
6. Contents of the pack and other information
The risk of side effects increases, if you also take:

1 WHAT TRAMADOL HYDROCHLORIDE/

PARACETAMOL IS AND WHAT IT IS USED FOR

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE

TRAMADOL HYDROCHLORIDE/PARACETAMOL

Do not take Tramadol hydrochloride/Paracetamol

The effectiveness of Tramadol hydrochloride/Paracetamol
may be altered if you also take:

Tramadol hydrochloride/Paracetamol with food, drink and
alcohol

Warnings and precautions

Pregnancy, breast-feeding and fertility

Driving and using machines

3 HOW TO TAKE TRAMADOL

HYDROCHLORIDE/PARACETAMOL

Other medicines and Tramadol hydrochloride/Paracetamol

Important

Top of page cut-off to middle of registration mark: 44 mm.

TRAMADOL HYDROCHLORIDE/PARACETAMOL
37.5 mg/325 mg
FILM-COATED TABLETS

Ref:
Version:

1

08 February 2013

231-30-32116-B LEA TRAMADOL/PARACETAMOL 32.5mg/325mg TAB 60 TUK
Trackwise Parent:

180694

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

231-10-07691
N/A
106 (101011)
N/A
N/A
Univers

Base Font Size:

180698

PL 00289/1731. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann 1030.
QRD update; multiple text updates throughout.

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

Child:

9 Pt

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

323 mm
200 mm
N/A
N/A

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

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

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

PAGE 2: REAR FACE (OUTSIDE OF REEL)

The following are recognised side effects which have been
reported

Use in children
Elderly patients

Severe liver or kidney disease (insufficiency)/dialysis patients

Method of administration:

If you take more Tramadol hydrochloride/Paracetamol than
you should

If you forget to take Tramadol hydrochloride/Paracetamol

If you stop taking Tramadol hydrochloride/Paracetamol

5 HOW TO STORE TRAMADOL HYDROCHLORIDE/
PARACETAMOL

Keep out of the sight and reach of children.

4 POSSIBLE SIDE EFFECTS

6 CONTENTS OF THE PACK AND OTHER
INFORMATION

What Tramadol hydrochloride/Paracetamol contains
Very common:
Common:

Uncommon:
What Tramadol hydrochloride/Paracetamol looks like and
contents of the pack

Marketing Authorisation Holder and Manufacturer
Rare:

This leaflet was last revised in January 2013.

Ref:

231-30-19083-B LEA TRAMADOL/PARACETAMOL 37.5mg/325mg TAB 60 TUK
Version:

1

Trackwise Parent:

180694

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

231-10-07691
N/A
TBC
N/A
TBC
Univers

Base Font Size:

180698

PL 00289/1731. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Teva Zagreb.
QRD Update - multiple text updates throughout.

F. P. Code:
EAN Code:
Pharma Code:
(GJH &RGH
Third party code:
Fonts:

Child:

13 January 2013

9 Pt

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

450 mm
155 mm
N/A
N/A
N/A

Colours:
3$1721(Š LV D UHJLVWHUHG
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

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

TRAMADOL HYDROCHLORIDE/
PARACETAMOL
37.5 mg/325 mg
FILM-COATED TABLETS

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

The risk of side effects increases:

1. What Tramadol hydrochloride/
Paracetamol is and what it is used for
2. What you need to know before you take
Tramadol hydrochloride/Paracetamol
3. How to take Tramadol hydrochloride/
Paracetamol
4. Possible side effects
5. How to store Tramadol hydrochloride/
Paracetamol
6. Contents of the pack and other information

1 WHAT TRAMADOL

HYDROCHLORIDE/
PARACETAMOL IS AND
WHAT IT IS USED FOR
The risk of side effects increases, if you
also take:

2 WHAT YOU NEED TO KNOW

BEFORE YOU TAKE
TRAMADOL HYDROCHLORIDE/
PARACETAMOL

Do not take Tramadol hydrochloride/
Paracetamol

The effectiveness of Tramadol
hydrochloride/Paracetamol may be altered
if you also take:

Tramadol hydrochloride/Paracetamol with
food, drink and alcohol

Warnings and Precautions
Talk to your doctor or pharmacist
Pregnancy, breast-feeding and fertility

Driving and using machines

3 HOW TO TAKE

TRAMADOL HYDROCHLORIDE/
PARACETAMOL

Other medicines and
Tramadol hydrochloride/Paracetamol

Important

Neutralna uputa-155 x 450mm.indd 1

6/17/10 8:52:50 AM

Ref:

231-30-19083-B LEA TRAMADOL/PARACETAMOL 37.5mg/325mg TAB 60 TUK
Version:

1

Trackwise Parent:

180694

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

231-10-07691
N/A
TBC
N/A
TBC
Univers

Base Font Size:

180698

PL 00289/1731. TEVA UK Limited Licence, Teva Regulatory Team.
Packed at Teva Zagreb.
QRD Update - multiple text updates throughout.

F. P. Code:
EAN Code:
Pharma Code:
(GJH &RGH
Third party code:
Fonts:

Child:

13 January 2013

9 Pt

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

450 mm
155 mm
N/A
N/A
N/A

Colours:
3$1721(Š LV D UHJLVWHUHG
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

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

Use in children

Elderly patients

Severe liver or kidney disease
(insufficiency)/dialysis patients

Method of administration:

If you take more Tramadol hydrochloride/
Paracetamol than you should

If you forget to take Tramadol
hydrochloride/Paracetamol

If you stop taking Tramadol
hydrochloride/Paracetamol

5 HOW TO STORE

TRAMADOL HYDROCHLORIDE/
PARACETAMOL

Keep out of the sight and reach of
children.

4 POSSIBLE SIDE EFFECTS
6 CONTENTS OF THE PACK AND
OTHER INFORMATION

What Tramadol hydrochloride/
Paracetamol contains

Very common:

Common:

Uncommon:

What Tramadol hydrochloride/
Paracetamol looks like and contents of the
pack

Marketing Authorisation Holder and
Manufacturer

Rare:

This leaflet was last revised in January 2013.

The following are recognised side effects
which have been reported

Neutralna uputa-155 x 450mm.indd 1

6/17/10 8:52:50 AM

Expand view ⇕

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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