3. how to take senokot 7.5mg/5 ml syrup 12 years plus

• 6. Further information

1. What Senokot 7.5mg/5 ml Syrup 12 years plus is and what it is used ' for

constipation. Senokot 7.5mg/5 ml Syrup 12 years plus contains calcium sennosides. Constipation is a fairly common and uncomfortable complaint. । It usually involves difficult or irregular bowel movements, accompanied by j hard, dry motions which can be painful to pass. Laxatives do not help with 1 weightloss. !

What is constipation? ]

Normal and regular bowel movement is important for most people. '

However, what is “normal and regular’” varies from person to person. Some j may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. ।

• Constipation is an occasional problemfor some peopleFor others,"it may happen more often. It happens when the normal muscle actions in the bowel (laige intestine) slow down. This can mean that material is not easily eliminated from the body. The cause of constipation is often not known. It can be associated with: Sudden change of diet , A diet with not enough fibre ' Not drinking enough fluids
• ! Loss of’tone’ofthe­bowelmusclesi­nolderpeople
• ] Pregnancy
• Medicines such as morphine or codeine
• ; Having to stay in bed for alongtime
• Lack of exercise

Whatever the cause, constipation can be uncomfortable.

I may make you feel bloated and heavy or generally “off colour”.

Sometimes it causes headaches.It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

These healthy tips are recommended to try to prevent constipation '

happens

• Eat a balanced diet including fresh fruit and vegetables
• Drink enough water so that you do not become dehydrated
• Keep up your exercise and stay fit
• Make time to empty your bowels when your body tells you

This medicine does not help with weight loss.

2. what you need to know before you take senokot 7.5mg/5 ml syrup

12 years plus

Do not take if you:

– are allergic to any of the ingredients (for afulllistofin­gredients, see section 6)

– have blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or stenosis)

– have paralysis or a lack of muscle tone in the bowel (atony)

– have appendicitis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis

have severe dehydration '

’ p – bare persistent or undiagnosed abdominal complaints e.g pain, nausea, or vomiting

, – have faecal impaction or rectal bleeding for which you don’t know the

] cause, or blood in your stools

– have already taken a laxative and are still constipated

– have had a sudden change in bowel habit that has lasted for more than 2

। weeks

– are pregnant or breast-feeding

– have kidney or heart failure

– are under 12 years of age

Does this help with weight loss?

Stimulant laxatives (Senokot 7.5mg/5 ml Syrup 12 years plus) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives U—. may damage your health by:

• ' Causing disturbances of electrolyte and mineral balances.hodiiim, >

potassium, magnesium, and phosphorus are electrolytes and minerals that, are present in very specific amounts necessary for proper functioning of 1 the nerves and muscles, including those of the colon and heart. Upsetting । this delicate balance can causeincorrec­tfunctioningof­these vital organs. ]

– you are taking medicines for a heart condition (e.g. cardiac glycosides, । antiarrhythmic medicines e.g quinidine), medicines inducing QT ] elongation, diuretics, adrenocorticos­teroids or liquorice root preparations. । – are under 12 years of age ।

When administering this product to incontinent adults, pads should be 1 changed more frequently to prevent extended" skin contact with faeces. It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

Senokot Senokot 7.5mg/5 ml Syrup 12 years plus contains

This medicine contains maltitol liquid (E965). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. Caution should be taken if you are diabetic as each 5ml contains 3.2 kilocalories.

This medicinal product also contains:

– methyl (E218) and propyl (E216) parahydroxyben­zoate, which may cause । allergic reactions (possibly delayed)

– This medicine contains 6.9 mg of alcohol (ethanol) in each 5ml dose. The | amount in each dose ofthis medicine is equivalent to less than 1ml beer । or 1ml wine. The small amount of alcohol in this medicine will not have

Taking other medicines ~

You should consult your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, including those listed above and any medicines obtained without a prescription.

3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus, the elderly and children 12 years and over:

New users should start with the lowest dose and increase it to the maximum dose for each age group, if necessary, by one half of the initial dose each day. Once regularity hits been regained dosage should be reduced and can usually be stopped. One to two 5 ml spoonfuls at night, unless otherwise

Normally it is sufficient to take this medicinal product up to two to three times a week. Not to be used for more than one week. Tell a doctor, pharmacist or nurse if:

– the symptoms worsen or persist during the use of the medicinal product

– there is no bowel movement within 3 days of use

- you need to take laxatives every day or if abdomin al pain persists.

Donottakemore than theTeafleftHls you.

Overuse can beharmfuLlfyou take too much Syrup:

Consultyour doctor andtakethis leafletwithyou.

It may be harmful totaketoo much of this medicine ortakeitfortoo long. This is becauseitmayleadto:

– ‘lazybowel’,whe­rethemusclein­thebowelbecomes­toorelaxed.This­meansthat

। bowelemptyinghap­penslessoften­.Thiscanleadto­long-termconstipation.

– imbalanceofflu­idsandsaltsin­thebody.Thisca­naffectthetig­htnessofmuscles

। suchasthosein­thebowel.Itca­nalsoafTectthe­saltsintheblo­od.

– low levels ofpotassium in the blood (calledhypo-kalaemia). This can make you

। tired,dizzy,ma­keyourmuscles­weakandcausea­nunevenheart-beat.

– dehydration,ma­kingyouthirsty,fe­elfaintandgivin­gyouheadaches­.Itcanalso

। meanthatyoucan­notpassenoughu­rine.

Ifyou forget to take Sirnokot7.5mg/5mlSy­rup 12 years plus

? Jf you miss a dose, take yournext doseatthe usual time.

?xDo not take orgiveadouble­dose,justcarry­onwiththerecom­mendeddose.If

'vouhaveanyfrther­qucstions ontheuseofthis­productasyourdoc­toror

S pharmacist. Always consult your doctor if you need further advice.

LPosabkadeeffects-------------------------

Like all medicines, this medicine can cause side effects, although not everybody gets them.If anyof the followingorany­olhersideeffec­tsoccur, stop taking thismedicine and consult a doctor or pharmacist:

– abdomtnalpain,spas­msanddianhoea,in­particularthe­seeffectsmaybe experienced by patients with irritable colon.

Jnthesecases,a­reductionindo­semaybenecessa­ry.

– hypersensitivity (allergic) reactions, hives (skin bumps), skin itchiness or local or more widespread rash, or asthma,

– canmakeyoumore­likelytocatchin­fections.

– chronicusemay­leadtoalbuminu­riaandhaematu­riawhichisalbu­minorredblood cellsintheurine.

– yeUoworred-browndiscolou­rationofurine­mayoccur,whichish­armless

– chronic use may cause pigmentation ofthe gastroin testinal tract whichusually recedes when the product is no longertaken.

– lowpotassiumle­velsinthebloo­dleadingtomus­cleweaknessan­d/orcramps

– severeweightloss

– changesinthesha­peoftheflngeran­dfingernai,mus­cularspasmsand

inflammatio n ofbones andjoints.

The frequency is not known.

Reportingofsi­deeffects

Ifyou getanyside effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Youcanalso report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more infoimation on the safety of this medicine.

5. how to store senokot 7.5 mg/5 ml syrup 12 years plus

Keep this medicine out ofthe sight and reach of children.

Store below 25°C, but donot freeze.

Donotuseafter­theexpiy dateshown onthepack(EXPmon­th/year).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

3. how to take senokot 7.5mg/5 ml syrup 12 years plus

• 6. Further information

1. What Senokot 7.5mg/5 ml Syrup 12 years plus is and what it is used ' for

constipation. Senokot 7.5mg/5 ml Syrup 12 years plus contains calcium sennosides. Constipation is a fairly common and uncomfortable complaint. । It usually involves difficult or irregular bowel movements, accompanied by j hard, dry motions which can be painful to pass. Laxatives do not help with 1 weightloss. !

What is constipation? ]

Normal and regular bowel movement is important for most people. '

However, what is “normal and regular’” varies from person to person. Some j may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. ।

• Constipation is an occasional problemTon some peopleFor others,"it may happen more often. It happens when the normal muscle actions in the bowel ("large intestine) slow down. This can mean that material is not easily eliminated from the body. The cause of constipation is often not known. It can be associated with: Sudden change of diet , A diet with not enough fibre ' Not drinking enough fluids
• ! Loss of’tone’ofthe­bowelmusclesi­nolderpeople
• ] Pregnancy
• Medicines such as morphine or codeine
• ; Having to stay in bed for alongtime
• Lack of exercise

Whatever the cause, constipation can be uncomfortable.

I may make you feel bloated and heavy or generally “off colour””.

Sometimes it causes headaches.It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

These healthy tips are recommended to try to prevent constipation '

happening:

• Eat a balanced diet including fresh fruit and vegetables
• Drink enough water so that you do not become dehydrated
• Keep up your exercise and stay fit
• Make time to empty your bowels when your body tells you

This medicine does not help with weight loss.

2. what you need to know before you take senokot 7.5mg/5 ml syrup

12 years plus

Do not take if you:

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

– have blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or stenosis)

– have paralysis or a lack of muscle tone in the bowel (atony)

– have appendicitis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis

have severe dehydration '

’ p – bare persistent or undiagnosed abdominal complaints e.g pain, nausea, or vomiting

, – have faecal impaction or rectal bleeding for which you don’t know the

] cause, or blood in your stools

– have already taken a laxative and are still constipated

– have had a sudden change in bowel habit that has lasted for more than 2

। weeks

– are pregnant or breast-feeding

– have kidney or heart failure

– are under 12 years of age

Does this help with weight loss?

Stimulant laxatives (Senokot 7.5mg/5 ml Syrup 12 years plus) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives U—. may damage your health by:

• ' Causing disturbances of electrolyte and mineral balances.hodiiim, >

potassium, magnesium, and phosphorus are electrolytes and minerals that, are present in very specific amounts necessary for proper functioning of 1 the nerves and muscles, including those of the colon and heart. Upsetting । this delicate balance can causeincorrec­tfunctioningof­these vital organs. ]

– you are taking medicines for a heart condition (e.g. cardiac glycosides, । antiarrhythmic medicines e.g quinidine), medicines inducing QT ] elongation, diuretics, adrenocorticos­teroids or liquorice root preparations. । – are under 12 years of age ।

When administering this product to incontinent adults, pads should be 1 changed more frequently to prevent extended" skin contact with faeces. It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

Senokot Senokot 7.5mg/5 ml Syrup 12 years plus contains

This medicine contains maltitol liquid (E965). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine. Caution should be taken if you are diabetic as each 5ml contains 3.2 kilocalories.

This medicinal product also contains:

– methyl (E218) and propyl (E216) parahydroxyben­zoate, which may cause । allergic reactions (possibly delayed)

– This medicine contains 6.9 mg of alcohol (ethanol) in each 5ml dose. The

I amount in each dose ofthis medicine is equivalent to less than 1ml beer । or 1ml wine. The small amount of alcohol in this medicine will not have

Taking other medicines ~

You should consult your doctor or pharmacist for advice if you are taking or have recently taken any other medicines, including those listed above and any medicines obtained without a prescription.

3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus, the elderly and children 12 years and over:

New users should start with the lowest dose and increase it to the maximum dose for each age group, if necessary, by one half of the initial dose each day. Once regularity has been regained dosage should be reduced and can usually be stopped. One to two 5 ml spoonfuls at night, unless otherwise

Normally it is sufficient to take this medicinal product up to two to three times a week. Not to be used for more than one week. Tell a doctor, pharmacist or nurse if:

– the symptoms worsen or persist during the use of the medicinal product

– there is no bowel movement within 3 days of use

- you need to take laxatives every day or if abdomin al pain persists.

Donoftakemore than ffieleaflefteQs you.

Overuse can beharmfuLlfyou take too much Syrup:

Consultyour doctor andtakethis leafletwithyou.

It may be harmful totaketoo much of this medicine ortakeitfortoo long. This is becauseitmayleadto:

– ‘lazybowel’,whe­rethemusclein­thebowelbecomes­toorelaxed.This­meanslhat

। bowelemptyinghap­penslessoften­.Thiscanleadto­long-termconstipation.

– imbalanceofftu­idsandsaltsin­lhebody.Thisca­naffectthetig­htnessofmuscles

। suchasthosein­thebowelItcanal­soaffbctthesal­tsintheblood.

– low levels ofpotassium in the blood (calledhypo-kalaemia). This can make you

। tired,dizzy,ma­keyounmuscles­weakandcausea­nunevenheant-beat.

– dehydration,mak­ngyouthisy,fe­elfaintandgivin­gyouheadaches­.I[tcanalso

। meanthatyoucan­notpassenoughu­rine.

If yon forget to take S^okot7.5mg/5mlSy­rup 12 years plus

? Jf you miss a dose, take yournext doseatthe usual time.

x\Do not take org^veadouhle­dose,justcarry,on­withthenecommen­deddose.If '^ouhaveanyffjrther­questions ontheuseofthis­productasyourdoc­tonon

S pharmacist Always consult your doctor if you need further advice.

4.PossibltsTde­effects-------------------------

Like all medicines, this medicine can cause side effects, although not everybody gets them.If anyof the followingoTany­othersideeffec­tsoccur, stop taking thismedicine and consult a doctor or pharmacist:

– abdominalpain,spas­msanddianhoea,in­particularthe­seeffectsmaybe experienced by patients with irritable colon.

Jnthesecases,a­reductionindo­semaybenecessa­ry.

– hypersensitivity (allergic) reactions, hives (skin bumps), skin itchiness or local or more widespread rash, or asthma,

– canmakeyoumore­likelytocatchin­fections.

– chnonicusemay­leadtoalbumrnu­niaandhaematu­riawhiChisalbu­minonredblood cellsintheurine.

– yellowonred-browndiscolou­rationofurine­mayoccun,whiChish­armless

– chronic use may cause pigmentation ofthe gastroin testinal tract whichusually recedes when the product is no longertaken.

– lowpotassiumle­velsmthebloodle­admgtomusclewe­aknessand/oncram­ps

– severeweightloss

– changesinthesha­peoflhef^ngeran­dfingernail,mus­culanspasmsand

inflammatio n ofbones andjoints.

The frequency is not known.

Reportingofsi­deeffects

Ifyou getanyside effects, talkto your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Youcanalso report side effects directly via the Yellow Card Scheme at: http://ww.mhna.gov.ukye"llowcard or search for MhRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store senokot 7.5 mg/5 ml syrup 12 years plus

Keep this medicine out ofthe sight and reach of children.

Store below 25°C, but donot freeze.

Donotuseafter­theexpiy dateshown onthepack(EXPmon­th/year).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Senoko t 7.5mg/5 ml Svrup 12 Years Plus contains

Each3ml ofSenokoTOmg/fml Syiup'12Years”Plus_con­tains calmumsennosides" 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.

What Senokot 7.5 mg/5 ml Syrup 12 Years Plus looks like and the contents ofthe pack

Senokot Syrup is an amber coloured liquid available in150mland 500ml glass bottles.

Marketing Authorisation Holder and Manufacturer

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS.

Leaflet last revised September 2020.

Senokot is atrade mark ofthe RB group ofcompanies

500ml

FACE PAGE

i Sd PACKAGE LEAFLET:

• [Z-J INFORMATION FOR THE USER

1 Senokot 7.5mg/5 ml Syrup 12 years plus

| sennosides (Senna)

Read this leaflet carefully because it contains important [information for you.

i" Keep this leaflet. You may need to read it again.

• ! Always take this medicine exactly as described in this leaflet or

• 1 as your doctor or pharmacist have told you.

i" Ask your pharmacist if you need more information or advice.

• [ If any of the side effects get 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/5 ml Syrup 12 years plus is and what

1 it is used for

,2. What you need to know before you take Senokot 7.5mg/

1 5 ml Syrup 12 years plus

i3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus

[4. Possible side effects

i5. How to store Senokot 7.5mg/5 ml Syrup 12 years plus

[6. Further information

'1. What Senokot 7.5mg/5 ml Syrup 12 years plus is and what it as used for

[Senokot 7.5mg/5 ml Syrup 12 years plus contains iSenna/Sennosides which work as a stimulant laxative for the [short-term relief of occasional constipation. Senokot 7.5mg/ '5 ml Syrup 12 years plus contains calcium sennosides.

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. Laxatives do not help with weight loss.

What is constipation?

Normal and regular bowel movement is important for most people. However, what is “normal and regular” varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. Constipation is an occasional problem for some people. For others, it may happen more often. It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body. The cause of constipation is often not known. It can be associated with:

• Sudden change of diet
• A diet with not enough fibre
• Not drinking enough fluids
• Loss of ‘tone’ of the bowel muscles in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time Lack of exercise

Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally “off colour”. Sometimes it causes headaches.It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

These healthy tips are recommended to try to prevent constipation happening:

Eat a balanced diet including fresh fruit and vegetables

Drink enough water so that you do not become dehydrated

Keep up your exercise and stay fit

Make time to empty your bowels when your body tells you

This medicine does not help with weight loss.

2. what you need to know before you take senokot 7.5mg/

5 ml Syrup 12 years plus

Do not take if you:

• – are allergic to any of the ingredients (for a full list of ingredients, see section 6)

• – have blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or stenosis)

• – have paralysis or a lack of muscle tone in the bowel (atony)

• – have appendicitis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis

• – have severe dehydration

• – have persistent or undiagnosed abdominal complaints e.g pain, nausea, or vomiting

• – have faecal impaction or rectal bleeding for which you don’t know the cause, or blood in your stools

• – have already taken a laxative and are still constipated

• – have had a sudden change in bowel habit that has lasted for more than 2 weeks

• – are pregnant or breast-feeding

• – have kidney or heart failure

• – are under 12 years of age

Does this help with weight loss?

• Stimulant laxatives (Senokot 7.5mg/5 ml Syrup 12 years plus) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives may damage your health by: Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
• Laxative dependency occurs from overuse and can cause the colon to stop reacting to usual doses of laxatives so that larger amounts of laxatives may be needed to produce bowel movements.

Tell your doctor, pharmacist or nurse if: – you suffer from kidney disorders

• – you are taking medicines for a heart condition (e.g. cardiac glycosides, antiarrhythmic medicines e.g quinidine), medicines inducing QT elongation, diuretics, adrenocorticos­teroids or liquorice root preparations.

• – are under 12 years of age

When administering this product to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. It is recommended to use changes in diet and bulk forming

PAGE TWO

"'medicines to control constipation before using this medicine. S "Senokot Senokot 7.5mg/5 ml Syrup 12 years plus contains T This medicine contains maltitol liquid (E965). If you have been

। told by your doctor that you have intolerance to some sugars, contact [your doctor before taking this medicine. Caution should be taken if 'you are diabetic as each 5ml contains 3.2 kilocalories.

[This medicinal product also contains:

'- methyl (E218) and propyl (E216) parahydroxyben­zoate, which may । cause allergic reactions (possibly delayed)

[This medicine contains 6.9 mg of alcohol (ethanol) in each 5ml dose. iThe amount in each dose of this medicine is equivalent to less than [1 ml beer or 1 ml wine.

iThe small amount of alcohol in this medicine will not have any [noticeable effects.

'This medicine contains 0.09 mmol (or 3.51 mg) potassium per 5 ml. [To be taken into consideration by patients with reduced kidney 'function or patients on a controlled potassium diet.

[Taking other medicines

[You should consult your doctor or pharmacist for advice if you are itaking or have recently taken any other medicines, including those [listed above and any medicines obtained without a prescription.

'3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus, [the elderly and children 12 years and over:

'New users should start with the lowest dose and increase it to the imaximum dose for each age group, if necessary, by one half of the [initial dose each day. Once regularity has been regained dosage ishould be reduced and can usually be stopped. One to two 5 ml [spoonfuls at night, unless otherwise advised by a medical practitioner.

Duration of use

Normally it is sufficient to take this medicinal product up to two to three times a week. Not to be used for more than one week.

Tell a doctor, pharmacist or nurse if:

• – the symptoms worsen or persist during the use of the medicinal product

• – there is no bowel movement within 3 days of use

• – you need to take laxatives every day or if abdominal pain persists.

Do not take more than the leaflet tells you.

Overuse can be harmful. If you take too much Syrup: Consult your doctor and take this leaflet with you.

It may be harmful to take too much of this medicine or take it for too long. This is because it may lead to:

• – ‘lazy bowel’, where the muscle in the bowel becomes too relaxed. This means that bowel emptying happens less often. This can lead to long-term constipation.

• – imbalance of fluids and salts in the body. This can affect the tightness of muscles such as those in the bowel. It can also affect the salts in the blood.

• – low levels of potassium in the blood (called hypo-kalaemia). This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat.

• – dehydration, making you thirsty, feel faint and giving you headaches. It can also mean that you cannot pass enough urine.

If you forget to take Senokot 7.5mg/5 ml Syrup 12 years plus If you miss a dose, take your next dose at the usual time.

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 as your doctor or pharmacist. Always consult your

doctor if you need further advice.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following or any other side effects occur, stop taking this medicine and consult a doctor or pharmacist:

• – abdominal pain, spasms and diarrhoea, in particular these effects may be experienced by patients with irritable colon.

In these cases, a reduction in dose may be necessary.

• – hypersensitivity (allergic) reactions, hives (skin bumps), skin itchiness or local or more widespread rash, or asthma,

• – can make you more likely to catch infections.

• – chronic use may lead to albuminuria and haematuria which is albumin or red blood cells in the urine.

• – yellow or red-brown discolouration of urine may occur, which is harmless

• – chronic use may cause pigmentation of the gastroin testinal tract which usually recedes when the product is no longer taken.

• – low potassium levels in the blood leading to muscle weakness and/or cramps

• – severe weight loss

• – changes in the shape of the finger and fingernail, muscular spasms and inflammation of bones andjoints.

The frequency is not known.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store senokot 7.5 mg/5 ml syrup 12 years plus keep this medicine out of the sight and reach of children.

Store below 25°C, but do not freeze.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other infromation:

What Senokot Senokot 7.5mg/5 ml Syrup 12 years plus contains Each 5 ml of syrup contains sennosides, as calcium salts, equivalent to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B. The other ingredients are potassium sorbate (E202), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), maltitol liquid (E965), xanthan gum, anti-foam emulsion, prune flavour (caramel colour E150a, ethanol, prime juice concentrate, vanilla bean extract, water), citric acid anhydrous and purified water

Senokot Syrup is available in 150ml and 500 ml glass bottle.

Manufacturer and PL Holder: Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS

PL 00063/0129 Leaflet last revised September 2020.

Senokot is a trade mark of the RB group of companies

500ml

FACE PAGE

[ Sd PACKAGE LEAFLET:

• [Z-J INFORMATION FOR THE USER

। Senokot 7.5mg/5 ml Syrup 12 years plus

| sennosides (Senna)

Read this leaflet carefully because it contains important [information for you.

i" Keep this leaflet. You may need to read it again.

• [ Always take this medicine exactly as described in this leaflet or

• 1 as your doctor or pharmacist have told you.

i" Ask your pharmacist if you need more information or advice.

• [ If any of the side effects get 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/5 ml Syrup 12 years plus is and what

1 it is used for

,2. What you need to know before you take Senokot 7.5mg/

1 5 ml Syrup 12 years plus

i3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus

[4. Possible side effects

i5. How to store Senokot 7.5mg/5 ml Syrup 12 years plus

[6. Further information

'1. What Senokot 7.5mg/5 ml Syrup 12 years plus is and what it as used for

[Senokot 7.5mg/5 ml Syrup 12 years plus contains iSenna/Sennosides which work as a stimulant laxative for the [short-term relief of occasional constipation. Senokot 7.5mg/ '5 ml Syrup 12 years plus contains calcium sennosides.

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. Laxatives do not help with weight loss.

What is constipation?

Normal and regular bowel movement is important for most people. However, what is “normal and regular” varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. Constipation is an occasional problem for some people. For others, it may happen more often. It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body. The cause of constipation is often not known. It can be associated with:

• Sudden change of diet
• A diet with not enough fibre
• Not drinking enough fluids
• Loss of ‘tone’ of the bowel muscles in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time
• Lack of exercise

Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally “off colour”. Sometimes it causes headaches.It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

These healthy tips are recommended to try to prevent constipation happening:

Eat a balanced diet including fresh fruit and vegetables

Drink enough water so that you do not become dehydrated

Keep up your exercise and stay fit

Make time to empty your bowels when your body tells you

This medicine does not help with weight loss.

2. what you need to know before you take senokot 7.5mg/

5 ml Syrup 12 years plus

Do not take if you:

• – are allergic to any of the ingredients (for a full list of ingredients, see section 6)

• – have blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or stenosis)

• – have paralysis or a lack of muscle tone in the bowel (atony)

• – have appendicitis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis

• – have severe dehydration

• – have persistent or undiagnosed abdominal complaints e.g pain, nausea, or vomiting

• – have faecal impaction or rectal bleeding for which you don’t know the cause, or blood in your stools

• – have already taken a laxative and are still constipated

• – have had a sudden change in bowel habit that has lasted for more than 2 weeks

• – are pregnant or breast-feeding

• – have kidney or heart failure

• – are under 12 years of age

Does this help with weight loss?

• Stimulant laxatives (Senokot 7.5mg/5 ml Syrup 12 years plus) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives may damage your health by: Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
• Laxative dependency occurs from overuse and can cause the colon to stop reacting to usual doses of laxatives so that larger amounts of laxatives may be needed to produce bowel movements.

Tell your doctor, pharmacist or nurse if: – you suffer from kidney disorders

• – you are taking medicines for a heart condition (e.g. cardiac glycosides, antiarrhythmic medicines e.g quinidine), medicines inducing QT elongation, diuretics, adrenocorticos­teroids or liquorice root preparations.

• – are under 12 years of age

When administering this product to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. It is recommended to use changes in diet and bulk forming

PAGE TWO

"'medicines to control constipation before using this medicine. S "Senokot Senokot 7.5mg/5 ml Syrup 12 years plus contains

T This medicine contains maltitol liquid (E965). If you have been । told by your doctor that you have intolerance to some sugars, contact [your doctor before taking this medicine. Caution should be taken if 'you are diabetic as each 5ml contains 3.2 kilocalories.

[This medicinal product also contains:

'- methyl (E218) and propyl (E216) parahydroxyben­zoate, which may [ cause allergic reactions (possibly delayed)

[This medicine contains 6.9 mg of alcohol (ethanol) in each 5ml dose. iThe amount in each dose of this medicine is equivalent to less than [1 ml beer or 1 ml wine.

iThe small amount of alcohol in this medicine will not have any [noticeable effects.

'This medicine contains 0.09 mmol (or 3.51 mg) potassium per 5 ml. [To be taken into consideration by patients with reduced kidney 'function or patients on a controlled potassium diet.

[Taking other medicines

[You should consult your doctor or pharmacist for advice if you are itaking or have recently taken any other medicines, including those [listed above and any medicines obtained without a prescription.

'3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus, [the elderly and children 12 years and over:

'New users should start with the lowest dose and increase it to the imaximum dose for each age group, if necessary, by one half of the [initial dose each day. Once regularity has been regained dosage ishould be reduced and can usually be stopped. One to two 5 ml [spoonfuls at night, unless otherwise advised by a medical practitioner.

Duration of use

Normally it is sufficient to take this medicinal product up to two to three times a week. Not to be used for more than one week.

Tell a doctor, pharmacist or nurse if:

• – the symptoms worsen or persist during the use of the medicinal product

• – there is no bowel movement within 3 days of use

• – you need to take laxatives every day or if abdominal pain persists.

Do not take more than the leaflet tells you.

Overuse can be harmful. If you take too much Syrup: Consult your doctor and take this leaflet with you.

It may be harmful to take too much of this medicine or take it for too long. This is because it may lead to:

• – ‘lazy bowel’, where the muscle in the bowel becomes too relaxed. This means that bowel emptying happens less often. This can lead to long-term constipation.

• – imbalance of fluids and salts in the body. This can affect the tightness of muscles such as those in the bowel. It can also affect the salts in the blood.

• – low levels of potassium in the blood (called hypo-kalaemia). This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat.

• – dehydration, making you thirsty, feel faint and giving you headaches. It can also mean that you cannot pass enough urine.

If you forget to take Senokot 7.5mg/5 ml Syrup 12 years plus If you miss a dose, take your next dose at the usual time.

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 as your doctor or pharmacist. Always consult your

doctor if you need further advice.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following or any other side effects occur, stop taking this medicine and consult a doctor or pharmacist:

• – abdominal pain, spasms and diarrhoea, in particular these effects may be experienced by patients with irritable colon.

In these cases, a reduction in dose may be necessary.

• – hypersensitivity (allergic) reactions, hives (skin bumps), skin itchiness or local or more widespread rash, or asthma,

• – can make you more likely to catch infections.

• – chronic use may lead to albuminuria and haematuria which is albumin or red blood cells in the urine.

• – yellow or red-brown discolouration of urine may occur, which is harmless

• – chronic use may cause pigmentation of the gastroin testinal tract which usually recedes when the product is no longer taken.

• – low potassium levels in the blood leading to muscle weakness and/or cramps

• – severe weight loss

• – changes in the shape of the finger and fingernail, muscular spasms and inflammation of bones andjoints.

5. how to store senokot 7.5 mg/5 ml syrup 12 years plus keep this medicine out of the sight and reach of children.

Store below 25°C, but do not freeze.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other infromation:

What Senokot Senokot 7.5mg/5 ml Syrup 12 years plus contains Each 5 ml of syrup contains sennosides, as calcium salts, equivalent to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B. The other ingredients are potassium sorbate (E202), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), maltitol liquid (E965), xanthan gum, anti-foam emulsion, prune flavour (caramel colour E150a, ethanol, prime juice concentrate, vanilla bean extract, water), citric acid anhydrous and purified water

Senokot Syrup is available in 150ml and 500 ml glass bottle.

Manufacturer and PL Holder: Reckitt Benckiser Healthcare (UK) Limited, Hull, HU8 7DS

PL 00063/0129 Leaflet last revised September 2020.

Senokot is a trade mark of the RB group of companies

FACE PAGE

[ Sd PACKAGE LEAFLET:

• [Z-J INFORMATION FOR THE USER

। Senokot 7.5mg/5 ml Syrup 12 years plus

| sennosides (Senna)

Read this leaflet carefully because it contains important [information for you.

i" Keep this leaflet. You may need to read it again.

• [ Always take this medicine exactly as described in this leaflet or

• 1 as your doctor or pharmacist have told you.

i" Ask your pharmacist if you need more information or advice.

• [ If any of the side effects get 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/5 ml Syrup 12 years plus is and what

1 it is used for

,2. What you need to know before you take Senokot 7.5mg/

1 5 ml Syrup 12 years plus

i3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus

[4. Possible side effects

i5. How to store Senokot 7.5mg/5 ml Syrup 12 years plus

[6. Further information

'1. What Senokot 7.5mg/5 ml Syrup 12 years plus is and what it as used for

[Senokot 7.5mg/5 ml Syrup 12 years plus contains iSenna/Sennosides which work as a stimulant laxative for the [short-term relief of occasional constipation. Senokot 7.5mg/ '5 ml Syrup 12 years plus contains calcium sennosides.

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. Laxatives do not help with weight loss.

What is constipation?

Normal and regular bowel movement is important for most people. However, what is “normal and regular” varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. Constipation is an occasional problem for some people. For others, it may happen more often. It happens when the normal muscle actions in the bowel (large intestine) slow down. This can mean that material is not easily eliminated from the body. The cause of constipation is often not known. It can be associated with:

• Sudden change of diet
• A diet with not enough fibre
• Not drinking enough fluids
• Loss of ‘tone’ of the bowel muscles in older people
• Pregnancy
• Medicines such as morphine or codeine
• Having to stay in bed for a long time
• Lack of exercise

Whatever the cause, constipation can be uncomfortable. It may make you feel bloated and heavy or generally “off colour”. Sometimes it causes headaches.It is recommended to use changes in diet and bulk forming medicines to control constipation before using this medicine.

These healthy tips are recommended to try to prevent constipation happening:

Eat a balanced diet including fresh fruit and vegetables

Drink enough water so that you do not become dehydrated

Keep up your exercise and stay fit

Make time to empty your bowels when your body tells you

This medicine does not help with weight loss.

2. what you need to know before you take senokot 7.5mg/

5 ml Syrup 12 years plus

Do not take if you:

• – are allergic to any of the ingredients (for a full list of ingredients, see section 6)

• – have blockage or narrowing of the gastro-intestinal tract or bowel (ileus, intestinal obstruction or stenosis)

• – have paralysis or a lack of muscle tone in the bowel (atony)

• – have appendicitis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis

• – have severe dehydration

• – have persistent or undiagnosed abdominal complaints e.g pain, nausea, or vomiting

• – have faecal impaction or rectal bleeding for which you don’t know the cause, or blood in your stools

• – have already taken a laxative and are still constipated

• – have had a sudden change in bowel habit that has lasted for more than 2 weeks

• – are pregnant or breast-feeding

• – have kidney or heart failure

• – are under 12 years of age

Does this help with weight loss?

• Stimulant laxatives (Senokot 7.5mg/5 ml Syrup 12 years plus) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss. Overuse of laxatives may damage your health by: Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.
• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.
• Laxative dependency occurs from overuse and can cause the colon to stop reacting to usual doses of laxatives so that larger amounts of laxatives may be needed to produce bowel movements.

Tell your doctor, pharmacist or nurse if: – you suffer from kidney disorders

• – you are taking medicines for a heart condition (e.g. cardiac glycosides, antiarrhythmic medicines e.g quinidine), medicines inducing QT elongation, diuretics, adrenocorticos­teroids or liquorice root preparations.

• – are under 12 years of age

When administering this product to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces. It is recommended to use changes in diet and bulk forming

PAGE TWO

"'medicines to control constipation before using this medicine. S "Senokot Senokot 7.5mg/5 ml Syrup 12 years plus contains

T This medicine contains maltitol liquid (E965). If you have been । told by your doctor that you have intolerance to some sugars, contact [your doctor before taking this medicine. Caution should be taken if 'you are diabetic as each 5ml contains 3.2 kilocalories.

[This medicinal product also contains:

'- methyl (E218) and propyl (E216) parahydroxyben­zoate, which may [ cause allergic reactions (possibly delayed)

[This medicine contains 6.9 mg of alcohol (ethanol) in each 5ml dose. iThe amount in each dose of this medicine is equivalent to less than [1 ml beer or 1 ml wine.

iThe small amount of alcohol in this medicine will not have any [noticeable effects.

'This medicine contains 0.09 mmol (or 3.51 mg) potassium per 5 ml. [To be taken into consideration by patients with reduced kidney 'function or patients on a controlled potassium diet.

[Taking other medicines

[You should consult your doctor or pharmacist for advice if you are itaking or have recently taken any other medicines, including those [listed above and any medicines obtained without a prescription.

'3. How to take Senokot 7.5mg/5 ml Syrup 12 years plus, [the elderly and children 12 years and over:

'New users should start with the lowest dose and increase it to the imaximum dose for each age group, if necessary, by one half of the [initial dose each day. Once regularity has been regained dosage ishould be reduced and can usually be stopped. One to two 5 ml [spoonfuls at night, unless otherwise advised by a medical practitioner.

Duration of use

Normally it is sufficient to take this medicinal product up to two to three times a week. Not to be used for more than one week.

Tell a doctor, pharmacist or nurse if:

• – the symptoms worsen or persist during the use of the medicinal product

• – there is no bowel movement within 3 days of use

• – you need to take laxatives every day or if abdominal pain persists.

Do not take more than the leaflet tells you.

Overuse can be harmful. If you take too much Syrup: Consult your doctor and take this leaflet with you.

It may be harmful to take too much of this medicine or take it for too long. This is because it may lead to:

• – ‘lazy bowel’, where the muscle in the bowel becomes too relaxed. This means that bowel emptying happens less often. This can lead to long-term constipation.

• – imbalance of fluids and salts in the body. This can affect the tightness of muscles such as those in the bowel. It can also affect the salts in the blood.

• – low levels of potassium in the blood (called hypo-kalaemia). This can make you tired, dizzy, make your muscles weak and cause an uneven heart-beat.

• – dehydration, making you thirsty, feel faint and giving you headaches. It can also mean that you cannot pass enough urine.

If you forget to take Senokot 7.5mg/5 ml Syrup 12 years plus If you miss a dose, take your next dose at the usual time.

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 as your doctor or pharmacist. Always consult your

doctor if you need further advice.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the following or any other side effects occur, stop taking this medicine and consult a doctor or pharmacist:

• – abdominal pain, spasms and diarrhoea, in particular these effects may be experienced by patients with irritable colon.

In these cases, a reduction in dose may be necessary.

• – hypersensitivity (allergic) reactions, hives (skin bumps), skin itchiness or local or more widespread rash, or asthma,

• – can make you more likely to catch infections.

• – chronic use may lead to albuminuria and haematuria which is albumin or red blood cells in the urine.

• – yellow or red-brown discolouration of urine may occur, which is harmless

• – chronic use may cause pigmentation of the gastroin testinal tract which usually recedes when the product is no longer taken.

• – low potassium levels in the blood leading to muscle weakness and/or cramps

• – severe weight loss

• – changes in the shape of the finger and fingernail, muscular spasms and inflammation of bones andjoints.