Medine.co.uk

Senokot Syrup

Document: label-leaflet MAH BRAND_PL 00063-0123 change

Marketing Authorisation Holder and Manufacturer

[UK Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited,

Sansom Lane, Hull, HU8 7DS.

£ Marketing Authorisation Holder: Reckitt Benckiser Ireland Ltd., 7 Riverwalk, pitywest Business Campus, Dublin 24.

Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Dansom lane, Hull, tiU8 7DS, UK.

Consumer Services: UK-PO Box 4044,Slough, SL1 ONS Tel. 0500 455456; llE-Citywest Business Campus Dublin 24 Tel. 01-6305429.

Leaflet last revised January 2012.

Senokot,® are trademarks


RBH and Print


Artwork

Specification


o ■ o

CM


Trident Reference No: Action / Version: Brand:

Brand Platform:

Sub Platform:

Sub Brand:

Format:

Delivery:

Pack Size:

Country:

Date Created:

Date Modified:


TR314417

S

Senokot

Stimulant Laxative Senna

Regular Syrup

Liquid

Bottle

150ml

UK

99/99/99

26/01/12


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' OO CM


O ' O*

CM


O - ^

CM


O

- LO CM


RBH Contact:


Lisa Butterworth


UILI


Artwork Type: Submission Only

Component Code (2D if applicable):    RB002214

Parent Technical Packaging    .

Specification:    As current


O - M-

CM


O

- CO CM


PAGE 1


____

Senokot 7.5mg/5ml Syrup contains calcium sennosides equivalent to 7.5 mg/5 ml total sennosides. It works as a laxative for the predictable relief of occasional or non-persistent constipation.

HOW TO TAKE SENOKOT 7.5ma/5mllSiVlRUP^

Adults and children over 12 years old: The usual dose is two 5 ml spoonfuls. You should take Senokot 7.5mg/5ml Syrup at bedtime. Not to be given to children under 12 years old without medical advice.


Gentle effective constipation


relief


SENOKOT 7.5mg/5ml SYRUP


&


Ml


Peel

L=S Jie


contains methyl (E218) and propyl (E216) parahydroxybenzoate and maltitol liquid E(965). See leaflet for further information. Keep out of reach and sight of children. Do not store above 25°C. Do not freeze. Do not use after the expiry date.

MA Holder in the UK: Reckitt Benckiser


Healthcare (UK) Limited, Hull HU8 7DS. PA Holder in Ireland: Reckitt Benckiser Ireland Ltd., Citywest, Dublin 24. PLQDQ63/0123, JA 970/16/2___RBQ02214.



Pharmacode Reads This Way <-


Last Bar    First Bar


PAGE 5


PAGE 6


Bulk Code (if applicable):

xxxx


CAD Cam Ref: G-lbl-D0285437-60x154mm_6_page Printer:    Clondalkin Pharma ft Glasnevin (Dublin, Ireland)

Substrate:    Paper - White


Edgemark Position: na Pharmacode No/NE: N/A


Senokot 7.3mg/5mTSyrup usually works in"8-12 hours. New users should"start with the

[lowest dose and if needed increase by half the initial dose each day. When you feel the

medicine is working, gradually reduce the dose and stop.

tf you take more Senokot 7.5mg/5ml Syrup than you should

If you take too much, you may experience diarrhoea. If this occurs, you should drink

lots of liquid, especially fruit juice.

Jf you forget to take Senokot 7.5mg/5ml Syrup If a dose is missed do not take or give a double dose, just carry on with the recommended dose. If you have any further questions on the use of this product ask your doctor or pharmacist.

4. Possible side effects

^ike all medicines, Senokot 7.5mg/5ml Syrup can cause side effects, although not everybody gets them. While you’re adjusting to the dose that’s best for you, you may Experience some mild pain in your abdomen for a short time. Allergic reactions to some of the ingredients may occur. If any of the side effects gets serious or you notice any other side effects, please tell your doctor or pharmacist.


5.    How to store Senokot 7.5mg/5ml Syrup

[Keep all medicines out of reach and sight of children.

o not store above 25°C. Do not freeze, o not use after the expiry date shown on the pack.

[Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

teach 5ml of Senokot 7.5mg/5ml Syrup contains calcium sennosides equivalent to [7.5mg total sennosides (calculated as Sennoside B). The other ingredients are potassium sorbate (E202), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), maltitol liquid (E965), xanthan gum, anti-foam (Medical C) emulsion, prune flavour, citric acid anhydrous and purified water. This medicinal product also contains small amounts of ethanol (Alcohol) less than lOOmg per dose. yVhat Senokot 7.5mg/5ml Syrup looks like and the contents of the pack Senokot 7.5mg/5ml Syrup is an amber coloured liquid available in 150ml bottle.

L___________________________________________RB002214


Print and Technical Colours

PANTONE 375 C

PANTONE Reflex Blue C

Varnish Generic

1

FLX

2

FLX

3

FLX

PANTONE 356 C

356 C TONE

Braille

4

FLX

5

FLX

6

FLX

PANTONE 107 C

7

FLX


COLOURS TO MATCH RECOGNISED STANDARDS


BARCODE 11MFO


O

- CM CM


O

CM


O

-o

CM


O

- cn


o

- OO


o

-


o

- LD


o

- LO


o

- CO


== O ==-CN


PAGE 2


PAGE 3


PAGE 4


_    SENOKOT 7.5 mg/SThUSYRUP

[    Sennosides

i    PATIENT INFORMATION LEAFLET

plead all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Senokot teyrup carefully to get the best results from it.

* Keep this leaflet. You may need to read it again.

[• Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after 3 days, i* If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

|1. What Senokot 7.5mg/5ml Syrup is and what it is used for 2. Before taking Senokot 7.5mg/5ml Syrup How to take Senokot 7.5mg/5ml Syrup 4. Possible side effects [5. How to store Senokot 7.5mg/5ml Syrup

6 JEuither Information______________________________________


irWhatls Sendkof 7.5mg/5mrSyrup“ and whaf is It usedTor?

^Senokot Syrup contains calcium sennosides, which work as a laxative for the relief of occasional or non persistent constipation. Constipation is a fairly common and uncomfortable complaint. It usually involves difficult or irregular bowel movements, accompanied by hard, dry motions which can be painful to pass.

2. Before taking Senokot 7.5mg/5ml Syrup

[Do not take Senokot 7.5mg/5ml Syrup if:

i* your abdomen is tender to the touch or hurts when you move

|* you have sharp or persistent stomach pain

* you are allergic to calcium sennosides, senna or the other ingredients

Consult your doctor if:

|* you have persistent constipation and need laxatives everyday, i* you have persistent abdominal pain or diarrhoea.

|* you have other symptoms such as bleeding in the stools or a feeling of incomplete ' emptying of the bowels.

!• there is no bowel movement after 3 days of taking this medicine.


[Fregnancy and breast-feeding

Talk to your doctor before taking any medicine.

[important information about some of the ingredients of Senokot 7.5mg/5ml Syrup

[This medical product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

[This medicine contains maltitol liquid (E965). If you have been told by your doctor that jyou have an intolerance to some sugars, contact your doctor before taking this medicinal product.

[Caution if you are diabetic as each 5ml contains 3.2 kilocalories.

3. How to take Senokot 7.5mg/5ml Syrup

[For oral use. Adults, including the elderly and children 12 years old and over:

The usual dose is two 5 ml spoonfuls at bedtime.

[Children under 12 years old: Not to be given except on medical advice. Where Senokot Syrup has been recommended it should be given as follows:

Children 6 years old and over: One 5 ml spoonful in the morning.

[Children aged 2 to 6 years old: Half to one 5 ml spoonful in the morning. Give only onceinMhours.____________________________________RBDD2I14


Barcode Type: Barcode Number: Magnification: BWR:


EAN 13

0000000000000

80%

20 microns


Truncated by (smallest Bar): 2.3 mm Encoded Data:_N/A


All other aspects of the bar code to conform to the current GS1 Operating Manual or other agreed commercial standard.


TRIDENT

Connaught House, Connaught Road, Xiugswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


STUDIO USE ONLY Claire Jackson    vU>

Sm»Art check results: G-1; 0-0; R-0; - CJ - 26/01/12 15:40:11


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READS

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ARTWORK APPROVAL


_o

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na - English Alphabet

• •

• •

• •

• •

• •

• • • •

• •

• •

• •

• • •

• •

• •

• • ••

• •

• •

• •

• •

• •


CUSTOMER INFO:

Front Minimum Point Size = 7 pt Leaflet Minimum Point Size = 9 pt


Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________


O

CM


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.

Tel. Alan Smith: +44 (0)1482 710304


==_o


Senokot

Number -j Number Sign / . Sign

Syrup


5 mg/“e,5 ml


Marketing Authorisation Holder and Manufacturer

[UK Marketing Authorisation Holder: Reckitt Benckiser Healthcare (UK) Limited,

Sansom Lane, Hull, HU8 7DS.

£ Marketing Authorisation Holder: Reckitt Benckiser Ireland Ltd., 7 Riverwalk, pitywest Business Campus, Dublin 24.

Manufacturer: Reckitt Benckiser Healthcare (UK) Limited, Dansom lane, Hull, tiU8 7DS, UK.

Consumer Services: UK-PO Box 4044,Slough, SL1 ONS Tel. 0500 455456; llE-Citywest Business Campus Dublin 24 Tel. 01-6305429.

Leaflet last revised January 2012.

Senokot,® are trademarks


RBH and Print


Artwork

Specification


o

■ o

CM


Trident Reference No: Action / Version: Brand:

Brand Platform:

Sub Platform:

Sub Brand:

Format:

Delivery:

Pack Size:

Country:

Date Created:

Date Modified:


TR314417

S

Senokot

Stimulant Laxative Senna

Regular Syrup

Liquid

Bottle

150ml

UK

99/99/99

26/01/12


O

' OO CM


O ' O*

CM


O - ^

CM


O

- LO CM


RBH Contact:


Lisa Butterworth


UILI


Artwork Type: Submission Only

Component Code (2D if applicable):    RB002214

Parent Technical Packaging    .

Specification:    As current


O - M-

CM


O

- CO CM


PAGE 1


Pharmacode Reads This Way <-


Last Bar    First Bar


PAGE 5


PAGE 6


Bulk Code (if applicable):

xxxx


CAD Cam Ref: G-lbl-D0285437-60x154mm_6_page Printer:    Clondalkin Pharma ft Glasnevin (Dublin, Ireland)

Substrate:    Paper - White


Edgemark Position: na Pharmacode No/NE: N/A


CD    e 150ir»l J

SenokptJ

7.5mg/5m[ Syrup Jm \


• •• • • ••

S • •• Jpi . •    ••    •    •• Gentle


contains methyl (E218) and propyl (E216) parahydroxybenzoate and maltitol liquid E(965). See leaflet for further information. Keep out of reach and sight of children. Do not store above 25°C. Do not freeze. Do not use after the expiry date.

MA Holder in the UK: Reckitt Benckiser

Healthcare (UK) Limited, Hull HU8 7DS. PA Holder in Ireland: Reckitt Benckiser Ireland Ltd., Citywest, Dublin 24. PLQDQ63/0123, JA 970/16/2___RBQ02214.


____


SENOKOT 7.5mg/5ml SYRUP


Senokot 7.5mg/5ml Syrup contains calcium sennosides equivalent to 7.5 mg/5 ml total sennosides. It works as a laxative for the predictable relief of occasional or non-persistent constipation.


HOW TO TAKE SENOKOT 7.5mo/5ml IB


•dttts adl children o\€r 12 jiftrs old: The usinAdose is two 5 ml spoonfuls®'o#shoul®t®e Senokot 7.5mjpml Spup at bedtime. Not to be given to children under 12 years old without medical advice.



Senokot 7.3mg/5mTSyrup usually works in"8-12 hours. New users should"start with the

[lowest dose and if needed increase by half the initial dose each day. When you feel the

medicine is working, gradually reduce the dose and stop.

tf you take more Senokot 7.5mg/5ml Syrup than you should

If you take too much, you may experience diarrhoea. If this occurs, you should drink

lots of liquid, especially fruit juice.

Jf you forget to take Senokot 7.5mg/5ml Syrup If a dose is missed do not take or give a double dose, just carry on with the recommended dose. If you have any further questions on the use of this product ask your doctor or pharmacist.

4. Possible side effects

^ike all medicines, Senokot 7.5mg/5ml Syrup can cause side effects, although not everybody gets them. While you’re adjusting to the dose that’s best for you, you may Experience some mild pain in your abdomen for a short time. Allergic reactions to some of the ingredients may occur. If any of the side effects gets serious or you notice any other side effects, please tell your doctor or pharmacist.


5.    How to store Senokot 7.5mg/5ml Syrup

[Keep all medicines out of reach and sight of children.

o not store above 25°C. Do not freeze, o not use after the expiry date shown on the pack.

[Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Further information

teach 5ml of Senokot 7.5mg/5ml Syrup contains calcium sennosides equivalent to [7.5mg total sennosides (calculated as Sennoside B). The other ingredients are potassium sorbate (E202), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), maltitol liquid (E965), xanthan gum, anti-foam (Medical C) emulsion, prune flavour, citric acid anhydrous and purified water. This medicinal product also contains small amounts of ethanol (Alcohol) less than lOOmg per dose. yVhat Senokot 7.5mg/5ml Syrup looks like and the contents of the pack Senokot 7.5mg/5ml Syrup is an amber coloured liquid available in 150ml bottle.

L___________________________________________RB002214


Print and Technical Colours

PANTONE 375 C

PANTONE Reflex Blue C

Varnish Generic

1

FLX

2

FLX

3

FLX

PANTONE 356 C

356 C TONE

Braille

4

FLX

5

FLX

6

FLX

PANTONE 107 C

7

FLX


COLOURS TO MATCH RECOGNISED STANDARDS


BARCODE 11MFO


O

- CM CM


O

CM


O

-o

CM


O

- cn


o

- OO


o

-


o

- LD


o

- LO


o

- CO


== O ==-CN


PAGE 2


PAGE 3


PAGE 4


_    SENOKOT 7.5 mg/SThUSYRUP

[    Sennosides

i    PATIENT INFORMATION LEAFLET

plead all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Senokot teyrup carefully to get the best results from it.

* Keep this leaflet. You may need to read it again.

[• Ask your pharmacist if you need more information or advice.

You must contact a doctor if your symptoms worsen or do not improve after 3 days, i* If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

|1. What Senokot 7.5mg/5ml Syrup is and what it is used for 2. Before taking Senokot 7.5mg/5ml Syrup How to take Senokot 7.5mg/5ml Syrup 4. Possible side effects [5. How to store Senokot 7.5mg/5ml Syrup

6 JEuither Information______________________________________


irWhatls Sendkof 7.5mg/5mrSyrup“ and whaf is It usedTor?

^Senokot Syrup contains calcium sennosides, which work as a laxative for the relief of occasional or non persistent constipation. Constipation is a fairly common and uncomfortable complaint. It usually involves difficult or irregular bowel movements, accompanied by hard, dry motions which can be painful to pass.

2. Before taking Senokot 7.5mg/5ml Syrup

[Do not take Senokot 7.5mg/5ml Syrup if:

i* your abdomen is tender to the touch or hurts when you move

|* you have sharp or persistent stomach pain

* you are allergic to calcium sennosides, senna or the other ingredients

Consult your doctor if:

|* you have persistent constipation and need laxatives everyday, i* you have persistent abdominal pain or diarrhoea.

|* you have other symptoms such as bleeding in the stools or a feeling of incomplete ' emptying of the bowels.

!• there is no bowel movement after 3 days of taking this medicine.


[Fregnancy and breast-feeding

Talk to your doctor before taking any medicine.

[important information about some of the ingredients of Senokot 7.5mg/5ml Syrup

[This medical product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

[This medicine contains maltitol liquid (E965). If you have been told by your doctor that jyou have an intolerance to some sugars, contact your doctor before taking this medicinal product.

[Caution if you are diabetic as each 5ml contains 3.2 kilocalories.

3. How to take Senokot 7.5mg/5ml Syrup

[For oral use. Adults, including the elderly and children 12 years old and over:

The usual dose is two 5 ml spoonfuls at bedtime.

[Children under 12 years old: Not to be given except on medical advice. Where Senokot Syrup has been recommended it should be given as follows:

Children 6 years old and over: One 5 ml spoonful in the morning.

[Children aged 2 to 6 years old: Half to one 5 ml spoonful in the morning. Give only onceinMhours.____________________________________RBDD2I14


Barcode Type: Barcode Number: Magnification: BWR:


EAN 13

0000000000000

80%

20 microns


Truncated by (smallest Bar): 2.3 mm Encoded Data:_N/A


All other aspects of the bar code to conform to the current GS1 Operating Manual or other agreed commercial standard.


TRIDENT

Connaught House, Connaught Road, Xiugswood Business Park, Hull, HU7 3AP, England. T: +44 (0) 1482 828100


Please note that any low resolution paper Canon colour copies associated with this job should be referred to for content, layout and colour separation only.


STUDIO USE ONLY Claire Jackson    vU>

Sm»Art check results: G-1; 0-0; R-0; - CJ - 26/01/12 15:40:11


== o


== o ==—o


==_o

== Oh


O

OO


O

r-.


o

to


o

Ln


El

S'

PRINTING

READS

to

to

OJ

This Way


ARTWORK APPROVAL


_o

M-


na - English Alphabet

• •

• •

• •

• •

• •

• • • •

• •

• •

• •

• • •

• •

• •

• • ••

• •

• •

• •

• •

• •


CUSTOMER INFO:

Front Minimum Point Size = 7 pt Leaflet Minimum Point Size = 9 pt


Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________


O

CM


UNDER NO CIRCUMSTANCES SHOULD THIS ARTWORK BE ALTERED WITHOUT PRIOR PERMISSION FROM TRIDENT.

Tel. Alan Smith: +44 (0)1482 710304


==_o


Senokot

Number -j Number Sign / . Sign

Syrup


5 mg/“e,5 ml


NOT APPROVED FOR COLOUR