Medine.co.uk

Pholcodine Linctus

Document: label-leaflet MAH GENERIC_PL 00014-5718R change

*-

68MM

168MM

CARRIER:

•*


130.5MM


8MM6.5MM


Pholcodine Linctus B.P.


Do not give to children under 6 years.


ru


Please read and keep the attached leaflet for full instructions.

Uses: For relief of dry, tickly coughs.

IK Do not take:

If you have liver or kidney failure

If you have difficulty breathing

If you have long-term lung problems

or an infection which produces lots of

phlegm on the chest

If you are taking monoamine oxidase

inhibitors (for depression), or have taken

them in the last 14 days

If you are taking other cough and cold

medicines

If you are pregnant or breastfeeding,

unless your doctor tells you to


A.


f Talk to your doctor:

•    If you have a long-term cough or asthma (do not take if wheezing or if you are having an asthma attack)

•    If you have a cough which produces lots of phlegm

f Talk to your pharmacist or doctor

•    If you have other liver or kidney problems

This medicine can make you feel sleepy. Do not drive or operate machines until you are sure you are not affected. /How to take

Check the seal is not broken before first use. If it is, do not take the medicine. Adults and children of 12 years and oven Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to.

Children of 6 to 11 years: Give one 5 ml _ _spoonful 3 or 4 times a day, if you needto.


| Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless their doctor tells you to.

If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.

If symptoms do not go away, talk to your doctor.

Do not store above 25°C.

Keep all medicines out of the sight an<{ reach of children.

Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.

Also contains: sucrose.

If you need more advice ask your pharmacist, PL 00014/5718R    [P]

Use by the date on the label edge.

The Boots Company PLC Nottingham NG2 3AA    200 ml 0

_________________62-42.-138


u

CL


-1.5MM


TECH1M1CAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


60MM


RIGHT

EDGE LEADING

-►


ARTWORK ONLY


15MM


4MM


141MM


12MM


148MM


6 PAGE LEAFLET


Trident Reference No: BTC222547

Zen Ref:

TR1102040

Category:

Healthcare

Sub-Category:

Cough Cold

Brand:

Good

Pack Type:

Label/Leaflet

Variant:

Pholcodine Linctus BP 200ml

Action:

B

Date:

12/05/16

Country:

UK

Component Code:

PCNK2

Item Code:

62-42-138

CAD Ref No:

168 x 68mm

Printer:

N/A

Substrate:

White Plastic

Barcode Type:

EAN 13

Barcode Number:

5045096242137

Magnification:

80%

Barcode Truncated By: 7.3 mm

(smallest bar]

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical ft Non Printing Items Cutter    Guides


Braille position may be set in an alternative position as long as the cutter to Braille minimum of 2.5mm is adhered to.


136mm


133mm


133mm


PANTONE 280 C

PANTONE 2736 C

Overall Water Varnish

Braille

=

=

_3_

_4_


2.5mm ■


68mm


2.5mm ■


68mm


■ Please read and keep the attached

X Do not take:

If you have liver or kidney failure

{♦If you have difficulty breathing, long-term lung problems or an infection with phlegm on the chest

•    If you are taking other cough and cold medicines, or monoamine oxidase inhibitors (for depression)

•    If you are pregnant or breastfeeding, unless your doctor tells you to

f Talk to your doctor:

•    If you have a long-term cough or asthma

•    If you have a cough which produces lots of phlegm

f Talk to your pharmacist or doctor:

•    If you have other liver or kidney problems This medicine can make you feel sleepy.

Do not drive or operate machines until you are sure you are not affected.

/How to take

Check the seal is not broken before first use. Jf lie, dQjioUake.themedicine. _ _


leaflet for full instructions.

Adults and children of 12 years and over: Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to. Children of 6 to 11 years: Give one 5 ml spoonful 3 or 4 times a day, if you need to.

Do not give to children under 6 years._

I Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless tneir doctor tells you to.

If a child's symptoms worsen at any time, talk to a pharmacist or doctor.

If symptoms do not go away, talk to your doctor.

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

Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.

Also contains: sucrose. „

PL 00014/5718R    0

Use by the date on the label edge.

The Boots Company PLC Nottingham NG2 3AA



Pholcodine

Linctus B.P.



_ 6242-138 .


Relieves dry, tickly coughs


200 ml e


141mm


4mm


Pholcodine Linctus B.P.


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


Keep this leaflet, you may need to read it again p Ask your pharmacist if you need more information ' or advice

^This medicine is for minor conditions Uses: This medicine contains Pholcodine, a cough suppressant. It can be used to relieve dry and tickly coughs that do not produce phlegm or mucus on the chest.

For children, simple treatments should be tried first before you give this medicine. Further information on "Treating coughs and colds in children"

is provided at the end of this leaflet.

pefore you take this medicine

This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

_P_CNKH___________________________


XDo not take:

•    If you are allergic to any of the ingredients

•    If you have liver or kidney failure

•    If you have difficulty breathing

•    If you have long-term lung problems or an infection which produces lots of phlegm on the chest

•    If you are taking monoamine oxidase inhibitors

(for depression), or have taken them in the last 14 days

•    If you are taking any other cough and cold medicines

•    If you have an intolerance to some sugars,

unless your doctor tells you to (this medicine contains sucrose)

•If you are pregnant or breastfeeding, unless your doctor tells you to


|f Talk to your doctor:

• If you have a long-term cough or asthma (do not take if you are wheezing or if you are having an asthma attack)

If you have a cough which produces lots of phlegm

if Talk to your pharmacist or doctor:

]• If you have other liver or kidney problems (see “Do not take”)

If you take other medicines:

-    Water tablets (diuretics), medicines to treat high blood pressure

-    Medicines that may make you sleepy or feel drowsy such as strong painkillers or medicines for epilepsy

-    Medicines for depression or other mental health conditions

(Other important information

If you are going into hospital for an operation, tell the doctor that you are taking this medicine. Do not drink a!p°h_o[(e.g. wjne,_beer,spirits) whitettaWn^Jhjs medicine.


This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.

■ Do not drive or use machines while taking this medicine until you are sure you are not affected

•    It is an offence to drive if this medicine affects your ability to drive

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account by people with diabetes.


2.5mm


60mm


Es

TRIDENT


Connaught House, Connaught Road, Kingswood Business Park, Hull, HU7 3AF, 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.


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


FACE PAGE 1


138mm

PAGE 2


138mm

PAGE 3


STUDIO USE ONLY Michael Woodhead    vl.O

Sm»Art check results: G=1; 0=0; R=0; - MW - 12/05/1614:56:20


ARTWORK TEXT SIZE


•+


133mm


-*


133mm


-*■


136mm


/How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Age

How much

How often

Adults and children of 12 years and over

Two 5 ml SDOonfuls

3 or 4 times a day, if you needto

Children of 6 to 11 years

One 5 ml spoonful

3 or 4 times a day, if you needto


Swallow this medicine.

Do not give to children under 6 years.

Do not take more than the amount recommended above.

Do not give to a child for more than 5 days, unless their doctor tells you to.

If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.

If symptoms do not go away talk to your doctor.

? If you take too much: Talk to a doctor straight away.


Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these serious side effects, stop taking the medicine. See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If you get any of the following side effects see your pharmacist or doctor:

•    Other allergic reactions such as skin rash

•    Feeling sick, being sick, constipation

•    Feeling drowsy, dizzy, excited or confused

•    Phlegm on the chest 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 on this label. You can also report side effects directly via the Yellow Card scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on _ _the_s_afety_of thjs_meajqhe^ _


Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children.

Use by the date on the label edge.

What is in this medicine

Each 5 ml of oral solution contains Pholcodine 5 mg. Also contains: sucrose, purified water, citric acid, glycerol (E422), sodium benzoate, domiphen bromide.

This bottle contains a colourless to pale yellow solution. A gradual yellowing of the solution on storage is a characteristic of this product.

Who makes this medicine Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA Leaflet prepared April 2016 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


Treating coughs and colds in children

It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.

Follow these simple steps, which may help your child overcome their cough or cold:

1. If your child is hot or has a fever. Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).

Your pharmacist will be able to help you find a suitable product if in doubt.


[2. For coughs: Although it may be distressing to bear your child cough, the coughing itself serves an 'important purpose. It helps to clear phlegm on the ichest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may [help loosen the phlegm and relax the airways.

£. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.


Base/Pages 2-6

Main Headings:

lOpt

Sub Headings:

9pt

Body Copy:

8pt

Page 1

Main Headings:

9.5pt

Sub Headings:

8.5pt

Body Copy:

7.5pt

Product Name:

Pholcodine Linctus BP


2.5mm


60mm


PACK 1VIOCK LIP


Product Licence No.: PL00014/5718R Wording Ref:    Type IA 'do and tell'vl 27/1/2015 (BTCl 73887 B)

Status:    Type IA ‘do and tell'

Pack Details:    Amber coloured glass bottle fitted with a roll-on

piIfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.

Pack Size:    200 m|


Version No. Date Issued


Reason For Change


27/1/2015


01/04/2016


11/05/2016


Reformulation, removal of driver warning flash, addition of yellow card statement


Addition of colour statement and update to PL number following RFI


Additional wording added to the description of the product following email correspondence from the MHRA


138mm

PAGE 4


4mm


138mm

PAGE5


->~4-


141mm

PAGE6


•*


130.5MM


8MM6.5MM


Pholcodine Linctus B.P.


Do not give to children under 6 years.


ru


Please read and keep the attached leaflet for full instructions.

Uses: For relief of dry, tickly coughs.

IK Do not take:

If you have liver or kidney failure

If you have difficulty breathing

If you have long-term lung problems

or an infection which produces lots of

phlegm on the chest

If you are taking monoamine oxidase

inhibitors (for depression), or have taken

them in the last 14 days

If you are taking other cough and cold

medicines

If you are pregnant or breastfeeding,

unless your doctor tells you to


A.


f Talk to your doctor:

•    If you have a long-term cough or asthma (do not take if wheezing or if you are having an asthma attack)

•    If you have a cough which produces lots of phlegm

f Talk to your pharmacist or doctor

•    If you have other liver or kidney problems

This medicine can make you feel sleepy. Do not drive or operate machines until you are sure you are not affected. /How to take

Check the seal is not broken before first use. If it is, do not take the medicine. Adults and children of 12 years and oven Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to.

Children of 6 to 11 years: Give one 5 ml _ _spoonful 3 or 4 times a day, if you needto.


| Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless their doctor tells you to.

If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.

If symptoms do not go away, talk to your doctor.

Do not store above 25°C.

Keep all medicines out of the sight an<{ reach of children.

Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.

Also contains: sucrose.

If you need more advice ask your pharmacist, PL 00014/5718R    [P]

Use by the date on the label edge.

The Boots Company PLC Nottingham NG2 3AA    200 ml 0

_________________62-42.-138


u

CL


-1.5MM


TECH1M1CAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


60MM


RIGHT

EDGE LEADING

-►


BRAILLE CONVERSION


• •

• •

• •

• •

• •

• •

• •

• •

• •

• •


ARTWORK ONLY


15MM


4MM


141MM


12MM


Boots

Pholcodine


148MM


Linctus B.P.


6 PAGE LEAFLET


Braille position may be set in an alternative position as long as the cutter to Braille minimum of 2.5mm is adhered to.


136mm


133mm


133mm


Trident Reference No: BTC222547

Zen Ref:

TR1102040

Category:

Healthcare

Sub-Category:

Cough Cold

Brand:

Good

Pack Type:

Label/Leaflet

Variant:

Pholcodine Linctus BP 200ml

Action:

B

Date:

12/05/16

Country:

UK

Component Code:

PCNK2

Item Code:

62-42-138

CAD Ref No:

168 x 68mm

Printer:

N/A

Substrate:

White Plastic

Barcode Type:

EAN 13

Barcode Number:

5045096242137

Magnification:

80%

Barcode Truncated By: 7.3 mm

(smallest bar]

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical ft Non Printing Items Cutter | Guides


Colours

PANTONE 280 C

PANTONE 2736 C

Overall Water Varnish

Braille

=

=

_3_

_4_


2.5mm ■


68mm


2.5mm ■


68mm


■ Please read and keep the attached X Do not take:

If you have liver or kidney failure {♦If you have difficulty breathing, long-term lung problems or an infection with phlegm on the chest

•    IfJ ju an. takin„ other cc gh ar,

coil medicir. s, or *)n®i#ne»xidase inhibitors ftor dep sssior)    •

•    If you are pregnant or breastfeeding,

urAsayos doct» tells fDu to • • •    •

?Ta.kto,OurdOwtc.:    •

•    If have a longterm Ibugh or asthBa

•    If you have a cough which produces lots of

pfUgm • •• ••    • •

f Ta.< to fbur pharmacist oi doctor:

•    IfyouhaveothemerorkidneiTSrobldB* • This medicine can make you feel sleepy.

Do not drive or operate machines until you are sure you are not affected.

/How to take

Check the seal is not broken before first use. Jf it is, dQjioUake.themedicine.___


leaflet for full instructions.

Adults and children of 12 years and over: Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to. Children of 6 to 11 years: Give one 5 ml spoonful 3 or 4 times a day, if you need to.

Do not give to children under 6 years._

I Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless tneir doctor tells you to.

"a chi|d's ^mptoms worsen at any time,

Ik to a pllrmacEur doctor    _

symptong ao not go away, talk to your doctor.

Keep all ngedicines or r* the sight and reacted ch 'd in • •

Active ingredient: Cadt5 ml of Aral

solution contains Pholcodine 5 mg.

Also contains: sucrose. „

PL 00014/5718R 0 Use by the date on the label edge.

The Boots Company PLC Nottingham NG2 3AA



Pholcodine

Linctus B.P.


Pholcodine Linctus B.P.


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



_ 6242-138 .


Relieves dry, tickly coughs


200 ml e


|» Keep this leaflet, you may need to read it again p Ask your pharmacist if you need more information ' or advice

^This medicine is for minor conditions Uses: This medicine contains Pholcodine, a cough suppressant. It can be used to relieve dry and tickly coughs that do not produce phlegm or mucus on the chest.

For children, simple treatments should be tried first before you give this medicine. Further information on "Treating coughs and colds in children"

is provided at the end of this leaflet.

pefore you take this medicine

This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

_P_CNKH___________________________


XDo not take:

•    If you are allergic to any of the ingredients

•    If you have liver or kidney failure

•    If you have difficulty breathing

•    If you have long-term lung problems or an infection which produces lots of phlegm on the chest

•    If you are taking monoamine oxidase inhibitors

(for depression), or have taken them in the last 14 days

•    If you are taking any other cough and cold medicines

•    If you have an intolerance to some sugars,

unless your doctor tells you to (this medicine contains sucrose)

•If you are pregnant or breastfeeding, unless your doctor tells you to


|f Talk to your doctor:

• If you have a long-term cough or asthma (do not take if you are wheezing or if you are having an asthma attack)

If you have a cough which produces lots of phlegm

if Talk to your pharmacist or doctor:

]• If you have other liver or kidney problems (see “Do not take”)

If you take other medicines:

-    Water tablets (diuretics), medicines to treat high blood pressure

-    Medicines that may make you sleepy or feel drowsy such as strong painkillers or medicines for epilepsy

-    Medicines for depression or other mental health conditions

(Other important information

If you are going into hospital for an operation, tell the doctor that you are taking this medicine. Do not drink a!p°h_o[(e.g. wjne,_beer,spirits) whitettaWn^Jhjs medicine.


This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.

■ Do not drive or use machines while taking this medicine until you are sure you are not affected

•    It is an offence to drive if this medicine affects your ability to drive

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account by people with diabetes.


2.5mm


60mm


E3

TRIDENT

Connaught Bouse, Connaught Road, Kingswood Business Park, Bull, Hll7 3AF, 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.


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


141mm


4mm


FACE PAGE 1


138mm

PAGE 2


138mm

PAGE 3


STUDIO USE ONLY Michael Woodhead    v1.0

Sm»Art check results: G=1; 0=0; R=0; - MW - 12/05/1614:56:20


ARTWORK TEXT SIZE


•*


133mm


-*


133mm


-A


136mm


/How to take this medicine

Check the seal is not broken before first use. If it is, do not take the medicine.

Age

How much

How often

Adults and children of 12vearsandover

Two 5 ml spoonfuls

3 or 4 times a day, if you needto

Children of 6 to 11 years

One 5 ml spoonful

3 or 4 times a day, if you needto


Swallow this medicine.

Do not give to children under 6 years.

Do not take more than the amount recommended above.

Do not give to a child for more than 5 days, unless their doctor tells you to.

If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.

If symptoms do not go away talk to your doctor.

? If you take too much: Talk to a doctor straight away.


Possible side effects

Most people will not have problems, but some may get some.

f If you get any of these serious side effects, stop taking the medicine. See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck, tongue or throat (severe allergic reactions)

If you get any of the following side effects see your pharmacist or doctor:

•    Other allergic reactions such as skin rash

•    Feeling sick, being sick, constipation

•    Feeling drowsy, dizzy, excited or confused

•    Phlegm on the chest 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 on this label. You can also report side effects directly via the Yellow Card scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on _ _the_s_afety_of thjs_meajqhe^ _


Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children.

Use by the date on the label edge.

What is in this medicine

Each 5 ml of oral solution contains Pholcodine 5 mg. Also contains: sucrose, purified water, citric acid, glycerol (E422), sodium benzoate, domiphen bromide.

This bottle contains a colourless to pale yellow solution. A gradual yellowing of the solution on storage is a characteristic of this product.

Who makes this medicine Manufactured by the Marketing Authorisation holder The Boots Company PLC Nottingham NG2 3AA Leaflet prepared April 2016 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


Treating coughs and colds in children

It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.

Follow these simple steps, which may help your child overcome their cough or cold:

1. If your child is hot or has a fever. Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).

Your pharmacist will be able to help you find a suitable product if in doubt.


[2. For coughs: Although it may be distressing to bear your child cough, the coughing itself serves an 'important purpose. It helps to clear phlegm on the ichest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may [help loosen the phlegm and relax the airways.

£. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies with blocked noses who are having trouble feeding.


Base/Pages 2-6

Main Headings:

lOpt

Sub Headings:

9pt

Body Copy:

8pt

Page 1

Main Headings:

9.5pt

Sub Headings:

8.5pt

Body Copy:

7.5pt


2.5mm


60mm


PACK MOCK LIP


Product Name:    Pholcodine Linctus BP

Product Licence No.: PL00014/5718R

Wording Ref:    Type IA 'do and tell'vl 27/1/2015 (BTC173887 B)


138mm

PAGE 4


4mm


138mm

PAGE5


->~4-


141mm

PAGE6


Type IA 'do and tell'

Amber coloured glass bottle fitted with a roll-on pilfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.

200 ml

Status:

Pack Details:

Pack Size:

Version No.

Date Issued

Reason For Change

1

27/1/2015

Reformulation, removal of driver warning flash, addition of yellow card statement

2

01/04/2016

Addition of colour statement and update to PL number following RFI

3

11/05/2016

Additional wording added to the description of the product following email correspondence from the MHRA


•*


130.5MM


8MM6.5MM


1.5MM


TECHNICAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


BRAILLE CONVERSION


• •

• •

• •

• •

• •

• •

• •

• •

• • •

• •

• •


ARTWORK ONLY


◄-►


148MM


Boots

Pholcodine


Linctus B.P.


Trident Reference No: BTC222547

Zen Ref:

TR1102040

Category:

Healthcare

Sub-Category:

Cough Cold

Brand:

Good

Pack Type:

Label/Leaflet

Variant:

Pholcodine Linctus BP 200ml

Action:

B

Date:

12/05/16

Country:

UK

Component Code:

PCNK2

Item Code:

62-42-138

CAD Ref No:

168 x 68mm

Printer:

N/A

Substrate:

White Plastic

Barcode Type:

EAN 13

Barcode Number:

5045096242137

Magnification:

80%

Barcode Truncated By: 7.3 mm

(smallest bar]

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical Et Non Printing Items Cutter    Guides


136mm


133mm


133mm


PANTONE 280 C

PANTONE 2736 C

Overall Water Varnish

Braille

=

=

_3_

_4_



4mm

FACE PAGE 1


PAGE 2


PAGE 3


Ea

TRIDENT


Connaught Bouse, Connaught Road, Kingswood Business Park, Bull, 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.


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


STUDIO USE ONLY Michael Woodhead    v1.0

Sm»Art check results: G=1; 0=0; R=0; - MW - 12/05/1614:56:20


ARTWORK TEXT SIZE


•+


-*■


Base/Pages 2-6

Main Headings:

lOpt

Sub Headings:

9pt

Body Copy:

8pt

Page 1

Main Headings:

9.5pt

Sub Headings:

8.5pt

Body Copy:

7.5pt


PACK 1VIOCK LIP


Product Name:


Pholcodine Linctus BP


Product Licence No.: PL00014/5718R Wording Ref:    Type IA 'do and tell'vl 27/1/2015 (BTC173887 B)

Status:    Type IA 'do and tell'

Pack Details:    Amber coloured glass bottle fitted with a roll-on

piIfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.

Pack Size:    200 m|


Version No. Date Issued


Reason For Change


27/1/2015


01/04/2016


11/05/2016


Reformulation, removal of driver warning flash, addition of yellow card statement


Addition of colour statement and update to PL number following RFI


Additional wording added to the description of the product following email correspondence from the MHRA


2.5mm


68mm


Pholcodine Linctus B.P.


1 Please read and keep the attached ! leaflet for full instructions.

1 Uses: For relief of dry, tickly coughs.

XDo not take:

| • If you have liver or kidney failure i • If you have difficulty breathing 1 • If you have long-term lung problems | or an infection which produces lots of i phlegm on the chest 1 • If you are taking monoamine oxidase ! inhibitors (for depression), or have taken i them in the last 14 days | • If you are taking other cough and cold i medicines

1 • If you are pregnant or breastfeeding,

| unless your doctor tells you to


f Talk to your doctor:

•    If you have a long-term cough or asthma (do not take if wheezing or if you are having an asthma attack)

•    If you have a cough which produces lots of phlegm

f Talk to your pharmacist or doctor

•    If you have other liver or kidney problems

This medicine can make you feel sleepy. Do not drive or operate machines until you are sure you are not affected. /How to take

Check the seal is not broken before first use. If it is, do not take the medicine. Adults and children of 12 years and oven Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to.

Children of 6 to 11 years: Give one 5 ml _ _spoonful 3 or 4 times a day, if you needto.


Do not givelo children under 6 years. 1 | Warning: Do not exceed the stated dose

Do not give to a child for more than 5 i days, unless their doctor tells you to. If a child’s symptoms worsen at any time, | talk to a pharmacist or doctor.

If symptoms do not go away, talk to your ] doctor.    i

Do not store above 25°C.

Keep all medicines out of the sight an<{ reach of children.    i

Active ingredient: Each 5 ml of oral solution contains Pholcodine 5 mg.

Also contains: sucrose.

If you need more advice ask your pharmacist. | PL 00014/5718R [P]

Use by the date on the label edge.    |

The Boots Company PLC    Nottingham '

NG2 3AA    200 mid

62-42.-138




RIGHT

EDGE LEADING

-►


6 PAGE LEAFLET


Braille position may be set in an alternative position as long as the cutter to Braille minimum of 2.5mm is adhered to.


■ Please read and keep the attached X Do not take:

•    If you have liver or kidney failure

•    If you have difficulty breathing, long-term lung problems or an infection with phlegm on the chest

•    If you are taking other cough and cold medicines, or monoamine oxidase inhibitors (for depression)

•    If you are pregnant or breastfeeding, unless your doctor tells you to

f Talk to your doctor:

•    If you have a long-term cough or asthma

•    If you have a cough which produces lots of phlegm

f Talk to your pharmacist or doctor:

•    If you have other liver or kidney problems This medicine can make you feel sleepy.

Do not drive or operate machines until you are sure you are not affected.

/How to take

Check the seal is not broken before first use. If lie, dQjiQUake.tlKmedi.cine. _ _


leaflet for full instructions.

Adults and children of 12 years and over: Swallow two 5 ml spoonfuls 3 or 4 times a day, if you need to. Children of 6 to 11 years: Give one 5 ml spoonful 3 or 4 times a day, if you need to.

Do not give to children under 6 years._

I Warning: Do not exceed the stated dose Do not give to a child for more than 5 days, unless tneir doctor tells you to.

If a child's symptoms worsen at any time, talk to a pharmacist or doctor.



Pholcodine

Linctus B.P.



If symptoms do not go away, talk to your o doctor.

Keep all medicines out of the sight ° and reach of children.    ^

Active ingredient: Each 5 ml of oral ro solution contains Pholcodine 5 mg.    -e-

Also contains: sucrose. „

PL 00014/5718R    0    w

Use by the date on the label edge. ^

The Boots Company PLC Nottingham v N(32_3AA_________________62-42-138


Relieves dry, tickly coughs


200 ml e


Pholcodine Linctus B.P.


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


Keep this leaflet, you may need to read it again p Ask your pharmacist if you need more information ' or advice

^This medicine is for minor conditions Uses: This medicine contains Pholcodine, a cough suppressant. It can be used to relieve dry and tickly coughs that do not produce phlegm or mucus on the chest.

For children, simple treatments should be tried first before you give this medicine. Further information on "Treating coughs and colds in children"

is provided at the end of this leaflet.

pefore you take this medicine

This medicine can be taken by adults and children of 6 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

_P_CNKH___________________________


XDo not take:

•    If you are allergic to any of the ingredients

•    If you have liver or kidney failure

•    If you have difficulty breathing

•    If you have long-term lung problems or an infection which produces lots of phlegm on the chest

•    If you are taking monoamine oxidase inhibitors

(for depression), or have taken them in the last 14 days

•    If you are taking any other cough and cold medicines

•    If you have an intolerance to some sugars,

unless your doctor tells you to (this medicine contains sucrose)

•If you are pregnant or breastfeeding, unless your doctor tells you to


|f Talk to your doctor:

• If you have a long-term cough or asthma (do not take if you are wheezing or if you are having an asthma attack)

If you have a cough which produces lots of phlegm

if Talk to your pharmacist or doctor:

]• If you have other liver or kidney problems (see “Do not take”)

If you take other medicines:

-    Water tablets (diuretics), medicines to treat high blood pressure

-    Medicines that may make you sleepy or feel drowsy such as strong painkillers or medicines for epilepsy

-    Medicines for depression or other mental health conditions

(Other important information

If you are going into hospital for an operation, tell the doctor that you are taking this medicine. Do not drink afeohoKe.g.^ne.b^r.spintsJwhitettaWn^Jhjs medicine.


This medicine can affect your ability to drive or use machines as it may make you feel sleepy or dizzy.

■ Do not drive or use machines while taking this medicine until you are sure you are not affected

•    It is an offence to drive if this medicine affects your ability to drive

•    However, you would not be committing an offence if:

-    The medicine has been prescribed to treat a medical or dental problem and

-    You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and

-    It was not affecting your ability to drive safely Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

This medicine contains 3 g of sucrose per 5 ml spoonful. This should be taken into account by people with diabetes.


FACE PAGE 1

PAGE 2

PAGE 3

133mm

133mm

136mm


/’How to take this medicine

i Check the seal is not broken before first use. If it is, 1 do not take the medicine.

Age

How much

How often

Adults and children of 12 years and over

Two 5 ml SDOonfuls

3 or 4 times a day, if you needto

Children of 6 to 11 years

One 5 ml spoonful

3 or 4 times a day, if you needto


Swallow this medicine.

Do not give to children under 6 years.

Do not take more than the amount recommended above.

Do not give to a child for more than 5 days, unless their doctor tells you to.

If a child’s symptoms worsen at any time, talk to a pharmacist or doctor.

If symptoms do not go away talk to your doctor.

? If you take too much: Talk to a doctor straight away.


Possible side effects

Most people will not have problems, but some may , get some.    '

? If you get any of these serious side effects, ! stop taking the medicine. See a doctor at once:

•    Difficulty in breathing, swelling of the face, neck,

tongue or throat (severe allergic reactions)    ,

If you get any of the following side effects see | your pharmacist or doctor:

•    Other allergic reactions such as skin rash

•    Feeling sick, being sick, constipation

•    Feeling drowsy, dizzy, excited or confused

•    Phlegm on the chest 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 on this label. You can also report ' side effects directly via the Yellow Card scheme at: ] www.mhra.aov.uk/vellowcard. By reporting side i effects you can help provide more information on Jhe_s_afety_of thjs_meajcine^ _


] Do not store above 25°C. i Keep this medicine in a safe place out of the sight 1 and reach of children, i Use by the date on the label edge.

What is in this medicine

] Each 5 ml of oral solution contains Pholcodine 5 mg. i Also contains: sucrose, purified water, citric acid,

| glycerol (E422), sodium benzoate, domiphen I bromide.

] This bottle contains a colourless to pale yellow i solution. A gradual yellowing of the solution on ] storage is a characteristic of this product.

Who makes this medicine ! Manufactured by the Marketing Authorisation holder i The Boots Company PLC Nottingham NG2 3AA ] Leaflet prepared April 2016 i If you would like any further information about this ' medicine, please contact The Boots Company PLC I Nottingham NG2 3AA


Treating coughs and colds in children

It’s normal for children to get 8 or more colds in a year, however gradually they build up immunity and get fewer colds. Most colds will get better within a few days and you may not need to do more than keep your child comfortable until they get over it. Antibiotics will not help to treat a cold as they are caused by viruses and not bacteria.

Follow these simple steps, which may help your child overcome their cough or cold:

1. If your child is hot or has a fever. Increase the amount of fluid your child normally drinks. Lower their temperature with a Paracetamol or Ibuprofen medicine, which is suitable for children. (Paracetamol is not suitable for children under 2 months. Ibuprofen is not suitable for children under 3 months).

Your pharmacist will be able to help you find a suitable product if in doubt.


[2. For coughs: Although it may be distressing to bear your child cough, the coughing itself serves an 'important purpose. It helps to clear phlegm on the ichest or mucus from the nose. Give your child plenty of lukewarm clear fluids to drink, which may [help loosen the phlegm and relax the airways.

£. To help with breathing: Plain saline nose drops, available from your pharmacy, can help babies with [blocked noses who are having trouble feeding.


2.5mm


60mm


TECH1M1CAL INFO: PRINTER PLEASE NOTE

Trident have created this artwork to a generic print process specification and repro has not been applied. Please call your Boots contact to discuss any amends or if anything falls beneath your print tolerances.


ARTWORK ONLY


Category:

Healthcare

Sub-Category:

Cough Cold

Brand:

Good

Pack Type:

Label/Leaflet

Variant:

Pholcodine Linctus BP 200ml

Action:

B

Date:

12/05/16

Country:

UK

Component Code:

PCNK2

Item Code:

62-42-138

CAD Ref No:

168 x 68mm

Printer:

Substrate:

White Plastic

Barcode Type:

EAN 13

Barcode Number:

5045096242137

Magnification:

80%

Barcode Truncated By: 7.3 mm

(smallest bar]

Edgemark Position:

N/A

Pharmacode No/NE:

N/A

Technical ft Non Printing Items Cutter    Guides


PAMONE280 C

PANTONE 2736 C

Overall Water Varnish

Braille

=

=

_3_

_4_


STUDIO USE ONLY


ARTWORK TEXT SIZE


Base/Pages 2-6

Main Headings:

lOpt

Sub Headings:

9pt

Body Copy:

8pt

Page 1

Main Headings:

9.5pt

Sub Headings:

8.5pt

Body Copy:

7.5pt

Product Name:

Pholcodine Linctus BP


PACK MOCK UP


Product Licence No.: PL00014/5718R Wording Ref:    Type IA 'do and tell'vl 27/1/2015 (BTC173887 B)

Status:    Type IA 'do and tell'

Pack Details:    Amber coloured glass bottle fitted with a roll-on

piIfer-proof aluminium cap with an expanded polyethylene liner or a flowed in PVC liner.

Pack Size:    200 m|


Version No. Date Issued


Reason For Change


27/1/2015


01/04/2016


11/05/2016


Reformulation, removal of driver warning flash, addition of yellow card statement


Addition of colour statement and update to PL number following RFI


Additional wording added to the description of the product following email correspondence from the MHRA


138mm

PAGE 4


4mm


138mm

PAGE5


141mm

PAGE6


Hinge is formed on right hand side of leaflet.

This is unconventional for left to right reading.