Medine.co.uk

Senokot Tablets

Document: leaflet MAH BRAND_PL 00063-5000R change

200mm


148mm


1    SENOKOTTABLETS    1

i    Senna Frdiit (pods)    I

I PATIENT INFORMATION LEAFLET I

Read this leaflet carefully because it contains important in ormation for you.

[This medicine is available without prescription. However, you s ill need to take jSenokot tablets carefully to get the best results from it.

!• Keep this leaflet. Vou may need to read1 it again.

!■ Ask your pharmacist if you need more Information or advice!

!• You must contact a doctor if your symptoms worsen or ilo not improve after 3 days. 1    1    1

If any of the side Effects get serious or If you notice any side Effect not listed in this leaflet, pleasC tell your doctor or pharmacist.    1

I    I    I

In this leaflet:    |    |    |

1. What Senokot Tablets is and what it is ijsed for    |

2. Before taking Sepokot Tablets    |    |

3.    How to take Sencjkot Tablets

4.    Possible side effects

. How to store Senpkot Tablets    j

l6. Further informatipn

j1. What Senokot Tablets is and what iti is used for    i

jSenokot is used for Che short term relief df occasional constipation.

[This medicine does 'not help with weight loss.    1

i    I    I    I

2. Before taking Senokot Tablets    |    ,

Do not take if you!    I    I

are allergic to any of the ingredients (fbr a full list of ingrediehts, see section 6)

-    have blockage oil narrowing of the gastro-intestinal tract or bowel (ileus,

intestinal obstruction or stenosis)    I    I

-    have paralysis or b lack of muscle tone in the bowel (atony) I

have appendicitis, inflammatory bowel disease such as Crohh's disease or ulcerative colitis.i    I    I

have severe dehydration    |    |

have persistent pr undiagnosed abdominal complaints e.g ppin, nausea, or vomiting    |    |    |

-    have faecal impaption or rectal bleeding for which you don't| know the cause, or

r    n    r


I    blbodin your stbols    I    P"

-    have already takfen a laxative and are Still constipated I

-    have had a suddfen change in bowel htibit that has lasted fot more than

2 weeks l    l    l

-    are pregnant or breast-feeding    |    |

-    have kidney or hpart failure    |    |

-    are under 12 yeairs of age unless advised by a medical professional

Tell your doctor, plharmacist or nurse it:    1

- you suffer from Sidney disorders 1    1

-    you are taking rrledicines for a heart condition (e.g. cardiac glycosides, antiarrhythmic rhedicines e.g quinidinle), medicines inducing QT prologation, diuretics, adrendcorticosteroids or liqiliorice root preparatiohs.

-    you have been tbld you have an intolerance to some sugarslbecause this medicine also cdntains lactose monohydrate (15.82mg per tablet)

When administering this product to incohtinent adults, pads should be changed more frequently to prevent extended skih contact with faecesJlt is recommended to use changes in diet and bulk forming tnedicines to control donstipation before using this medicine.    I    I

Taking other medjdnes    |    |

You should consult^our doctor or pharmacist for advice if you^re taking or have recently taken any pther medicines, including medicines obtaiped without a

I    I    I


prescription.


3. How to take Senokot Tablets    i    i

Adults, the elderljjr and children over i2 years: swallow ortato two tablets at night    *    '    '

Children over 6 ye^rs: Not recommended unless advised by a ntadical professional.

Children 6 years aind under: Not recommended    1

Do not exceed the1 stated dose    1    1

New users should start with the lowest dose and increase it to the maximum dose

if necessary. Once Regularity has been regained dosage should be reduced and

can usually be stopped.    ^    |

Duration of use |    |    |

Normally it is sufficient to take this medicinal product up to two tq three times a week.

Use for more than 11-2 weeks requires medical supervision, i nnni nr,

____________j_____________^____________^____RBJ2J12Q1


RB Artwork

3

and Print Specification

=

Trident Reference No: RB121120

3_

ZEN Ref:

TR665685

==

Action:

J

==-

Brand:

Senokot

==

Category:

Stimulant Laxative

-

Segment Group:

Senna

Segment:

Regular Tablet

33

Pack Size:

N/Aunit

—=

Market/Country:

UK

==

Date:

15/02/16

=1

RBH Contact:

Bernadette Ritscherle

Artwork Type: Submission

==

Component Code (2D if applicable): RB121120

=—

Parent Technical Packaging

33

Specification:

IBC

—=

Finished Goods Code: N/A

-3

Pharmacode No/NE:

N/A

==

Edgemark Position:

N/A

=1

CAD Cam Ref:

Skt-Lflt- D0001241-148x200mm

w~

—=

Substrate:

Paper White

~~=

Technical ft Non Printing Items

3

|~| Cutter

1 Cutter 2 (if applicable)

33

|~H Guides

| | Guides 2 (if applicable)

O ' OO

CN

O

CM

O - CO

CM

O

- LD CM

O

- ,id-CN

O

- m

CM

o

- CN CN

o

CN

o

-o

CN


O

■ 0*1 CM


Colours (Leaflet)

PANTONE 347 C

1

OH


O - CO


[lelT a” doctor, pharm^cfsfor nurselfT “ the symptoms worsen, or persist during|the use of the medicinal product there is no bowel piovement within 3 dqys of use    |

you need to take laxatives every day or ijf abdominal pain persists.

If you take too mahy tablets:    I    I

Consult your doctor bnd take this leaflet with you.    1

I'll

,lt may be harmful to| take too much of this [medicine or take it for ^oo long. This is jbecause it may lead |to:

A'lazy bowel', whgre the muscle in the bpwel becomes too relaxed.This means that bowel emptying happens less ofteiji.This can lead to long|-term constipation. Imbalance of fluicjs and salts in the body.This can affect the tightness of muscles such as those in t(ie bowel. It can also afjfect the salts in the blgod.

Low levels of potassium in the blood (cabled hypo-kalaemia).T|iis can make you tired, dizzy, make your muscles weak anpl cause an uneven he^rt-beat. Dehydration, making you thirsty, feel faipt and giving you headaches. It can also mean that you capnot pass enough uripe.    |

jlf you miss a dose: I    I    I

jlf you miss a dose, tcfke your next dose at the usual time. Do not tbke two doses at jthe same time to malke up for the missed dose.    I

Always consult yourdoctor if you need further advice.    I

4. Possible side effects

;    i    i    i

Like all medicines, tf|is medicine can causeiside effects, although pot everybody gets them.    |    |    |

if any of the following or other side effects pccur, stop taking this imedicine and consult a doctor qr pharmacist:    |    |

abdominal pain, spasms and diarrhoea, jn particular these effects may be experienced by patients with irritable cqlon. In these cases,    |

a reduction in do^e may be necessary. |    |

hypersensitivity (qllergic) reactions, hivep (skin bumps), skin itcfiiness or local or more widespread rash, or asthma.    |    |

can make you mgre likely to catch infectjions.    ^

chronic use may Igad to albuminuria anijf haematuria which is plbumin or red blood cells in the grine.    ^    ^

j- yellow or red-bro^vn discolouration of ugne may occur, whichjs harmless


chronic use may (jTause prgmehtatTon of-the gastrointestinal tr^ct whicKusually “ recedes when thg product is no longer jaken.    |

-    low potassium leyels in the blood leading to muscle weaknes^ and/or cramps

-    severe weight losp

-    changes in the shape of the finger and fingernail, muscular spasms and

inflammation of llrones and joints    '    '

The frequency is noj known.    J    |

Reporting of side effects    |    |

If you get any side effects, talk to your doctor, pharmacist or nursp.This includes any possible side effectsi not listed in this leaflet You can also report sjide effects directly via the Yellow Card ‘jcheme at: www.mhraigov.uk/yellowcard. Byireporting side effects you can help provide more information on the safety of tips medicine.

5.    How to store Sefiokot Tablets    1    1

Keep this medicing out of the sight antj reach of children. |

Store below 25°C. Stjore in the original package.    |

Do not use after the^xpiry date shown on|the pack (EXP month/year).

Return any unused ijnedicine to your pharmacist fbr safe disposaj.

6.    Further information    I    I

Each tablet containsl powdered Alexandrian Senna fruit (pods) {Cassia senna L (C. acutifolia Delile)) and Tinnevelly Senna fruit (pods) (Cassia angustifolia Vahl) equivalent to 7.5mcj hydroxyanthracene glycosides, calculated at sennoside B.

This medicine also cbntains: calcium phosphate, maize starch, magnesium stearate and lactose monohjidrate.    I    I

Senokot Tablets are Available in blister packs in pack sizes of 6,8, h 0,12,20,40,60,80 and 100 tablets andlin containers in pack Pzes of 50,100,200,50b or 1000 tablets. Not all pack sizes miy be marketed. Product Licence Holder and Manufacturer!

Reckitt Benckiser Healthcare (UK) Limited, 'Hull, HU8 7DS PL 00063/5000R    [    [

Leaflet last revised February 2016    |

Senokot is a trademark.    |


BARCODE 11MFO


Barcode Type:    N/A

Barcode Number:    N/A

Magnification:    N/A

Truncated By:    N/A

Full Height:    N/A

Bar Height (Smallest Bar): N/A BWR:    N/A

Encoded Data:    N/A


Reckitt

Benckiser


Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 70S, U.K.


TRIDENT

Connaught House, Connaught Road, Kingswood 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 Ezra Hollingsworth    v2.o

Sm»Art check results: G=1; 0=0; R=0; - EH -15/02/1612.04:28


ARTWORK APPROVAL


.JLB12L12d


Approved by Sonoco Trident on behalf of Reckitt Benckiser

Signed:______________________

Date:_______________________


O

-


o

- kO


o

- LD


o

-


= o

==-m


^ o

==-CN


== O


o

-o


o

cn


o

OO


_o


.o

LD


==_o

== LD


==_o

-=


o

cn


CUSTOMER INFO: Minimum Point Size = 9.00pt


NOT APPROVED FOR COLOUR


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


==§_o

1- E a_E


If any of the side Effects get serious or If you notice any side Effect not listed in


:. Before taking Sepokot Tablets

3.    How to take Sengkot Tablets

4.    Possible side effects

. How to store Senpkot Tablets


1    SENQKOTTAffLETS    1

i    Senna Frdiit (pods)    I

I PATIENT INFORMATION LEAFLET I

Read this leaflet carefully because it contains important in ormation for you.

[This medicine is available without prescription. However, you s ill need to take [Senokot tablets carefully to get the best results from it.

!• Keep this leaflet. Vou may need to read1 it again.

!■ Ask your pharmacist if you need more Information or advice!

!• You must contact a doctor if your symptoms worsen or ilo not improve

after 3 days.

this leaflet, pleasC tell your doctor or pharmacist. I    I

In this leaflet: |    |

1. What Senokot Tablets is and what it is ijsed for 6. Further informatipn

,1. What Senokot Tablets is and what iti is used for    i

jSenokot is used for Che short term relief df occasional constipation.

[This medicine does 'not help with weight loss.    1

i    I    I    I

2. Before taking Senokot Tablets    |    ,

Do not take if you!    I    I

are allergic to any of the ingredients (fbr a full list of ingrediehts, see section 6)

-    have blockage oil narrowing of the gastro-intestinal tract or bowel (ileus,

intestinal obstruction or stenosis)    I    I

-    have paralysis or b lack of muscle tone in the bowel (atony) I

have appendicitis, inflammatory bowel disease such as Crohh's disease or ulcerative colitis.i    I    I

have severe dehydration    |    |

have persistent pr undiagnosed abdominal complaints e.g ppin, nausea, or vomiting    |    |    |

-    have faecal impaption or rectal bleeding for which you don't| know the cause, or

r    n    r

I    blood in your stbols    I    P "

-    have already takfen a laxative and are Still constipated I

-    have had a suddfen change in bowel htibit that has lasted fot more than

2 weeks l    l    l

-    are pregnant or breast-feeding    |    |

-    have kidney or hpart failure    |    |

-    are under 12 yeairs of age unless advised by a medical professional

Tell your doctor, plharmacist or nurse it:    1

- you suffer from Sidney disorders 1    1

-    you are taking rrledicines for a heart condition (e.g. cardiac glycosides, antiarrhythmic rhedicines e.g quinidinle), medicines inducing QT prologation, diuretics, adrendcorticosteroids or liqiliorice root preparatiohs.

-    you have been tbld you have an intolerance to some sugarslbecause this medicine also cdntains lactose monohydrate (15.82mg per tablet)

When administering this product to incohtinent adults, pads should be changed more frequently to prevent extended skih contact with faecesJlt is recommended to use changes in diet and bulk forming tnedicines to control donstipation before using this medicine.    I    I

Taking other medjdnes    |    |

You should consul^your doctor or pharmacist for advice if you^re taking or have recently taken any pther medicines, including medicines obtaiped without a prescription.    j    j

3. How to take Senokot Tablets    i    i

Adults, the elderljjr and children over i2 years: swallow one! to two tablets at night    *    '    '

Children over 6 yecirs: Not recommended unless advised by a Jiedical professional.

Children 6 years aind under: Not recomLiended    1

Do not exceed the1 stated dose    1    1

New users should start with the lowest dose and increase it to the maximum dose

if necessary. Once Regularity has been regained dosage should be reduced and

can usually be stopped.    ^    |

Duration of use |    |    |

Normally it is sufficient to take this medicinal product up to two tq three times a week. Use for more than 1|- 2 weeks requires medical supervision,    i

r    n    r-

[lelf a” doctor, pharm^cfsfor nurselfT “ the symptoms worsen, or persist during|the use of the medicipal product there is no bowel piovement within 3 dqys of use    |

you need to take laxatives every day or ijf abdominal pain persists.

If you take too mahy tablets:    I    I

Consult your doctor bnd take this leaflet with you.    1

j    I    I    I

,lt may be harmful to| take too much of this piedicine or take it fbr poo long. This is

jbecause it may lead po:

A'lazy bowel', whgre the muscle in the bpwel becomes too relaxed.This means that bowel emptying happens less ofterp.This can lead to long|-term constipation. Imbalance of fluicjs and salts in the body.This can affect the tightness of muscles such as those in tjie bowel. It can also afjfect the salts in the bigod.

Low levels of potassium in the blood (cabled hypo-kalaemia).Tfiis can make you tired, dizzy, make your muscles weak anpl cause an uneven he^rt-beat. Dehydration, making you thirsty, feel faipt and giving you headaches. It can also mean that you capnot pass enough uripe.    |

jlf you miss a dose: I    I    I

jlf you miss a dose, tbke your next dose at the usual time. Do not tbke two doses at [the same time to malke up for the missed dose.    I

Always consult yourdoctor if you need further advice.    I

4. Possible side effects

j    i    i    i

Like all medicines, tf|is medicine can causeiside effects, although pot everybody gets them.    |    |    |

if any of the following or other side effects pccur, stop taking this imedicine and consult a doctor qr pharmacist:    |    |

abdominal pain, spasms and diarrhoea, jn particular these effects may be experienced by patients with irritable cqlon. In these cases,    |

a reduction in do^e may be necessary. |    |

hypersensitivity (qllergic) reactions, hivep (skin bumps), skin itcpiiness or local or more widespread rash, or asthma.    |    |

can make you mope likely to catch infections.    ^

chronic use may Igad to albuminuria anijf haematuria which is plbumin or red blood cells in the grine.    ^    ^

j- yellow or red-bro\gn discolouration of upine may occur, whichjs harmless

chronic use may gause pEgmentMonof-the gastrointestinal tgict whicPusuaTly “ recedes when thg product is no longer jaken.    |

-    low potassium leyels in the blood leading to muscle weaknes^ and/or cramps

-    severe weight losp

-    changes in the shape of the finger and fingernail, muscular spasms and

inflammation of leones and joints    '    '

The frequency is noj known.    J    |

Reporting of side effects    |    |

If you get any side effects, talk to your doctor, pharmacist or nursp.This includes any possible side effectsi not listed in this leaflet You can also report sjide effects directly via the Yellow Card ‘jcheme at: www.mhraigov.uk/yellowcard. Byireporting side effects you can help provide more information on the safety of tips medicine.

5. How to store Sefiokot Tablets    1    1

Keep this medicing out of the sight antj reach of children. |

Store below 25°C. Stjore in the original package.    |

Do not use after the^xpiry date shown on^he pack (EXP month/year).

Return any unused ijnedicine to your pharmacist fbr safe disposaj.

6. Further information    I    I

Each tablet contains! powdered Alexandrian Senna fruit (pods) {Cassiasenna L (C. acutifolia Delile)) and Tinnevelly Senna fruit (pods) (Cassia angustifolia Vahl) equivalent to 7.5mcj hydroxyanthracene glycosides, calculated at sennoside B.

This medicine also cbntains: calcium phosphate, maize starch, magnesium stearate and lactose monohjidrate.    I    I

Senokot Tablets are Available in blister packs in pack sizes of 6,8, h 0,12,20,40,60,80 and 100 tablets andiin containers in pack 4izes of 50,100,200,50b or 1000 tablets. Not all pack sizes miy be marketed.    I

Product Licence Holder and Manufacturer!

Reckitt Benckiser Healthcare (UK) Limited, 'Hull, HU8 7DS PL 00063/5000R    |    |

Leaflet last revised February 2016 Senokot is a trademark.

JLB12U2I

i