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Non-Drowsy Decongestant With Paracetamol

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Document: document 3 change

139.7 mm

150 mm


I




Information for the user


Boots Cold & Flu Relief Capsules

(Caffeine, Paracetamol, Phenylephrine Hydrochloride)

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


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

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Paracetamol, an analgesic which relieves pain and reduces fever, Phenylephrine, a decongestant to relieve a blocked up nose and Caffeine, which helps the pain relieving effect of paracetamol and makes you more alert.

It can be used to relieve the symptoms of colds and flu including aches and pains, fever, headache, catarrh, nasal and sinus congestion and its associated pressure and pain.

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

XDo not take:

•    If you are allergic to any of the ingredients in this medicine (see "What is in this medicine")

•    If you have high blood pressure or have had a heart attack

•    If you have an overactive thyroid

•    If you are taking monoamine oxidase inhibitors

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

•    If you are taking tricyclic antidepressants

•    If vouareoreanant


! Talk to your pharmacist or doctor

•    If you have severe kidney or liver problems (including that due to drinking alcohol)

•    If you are dependent on alcohol

•    If you are breastfeeding

If you take other medicines

f This medicine contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Medicines to treat high blood pressure

•    Colestyramine (to reduce blood fat levels)

•    Metoclopramide or domperidone (for feeling sick or being sick)

•    Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.



2748857


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Trident Reference No: BTC171441

Zen Ref:

TR899152

Category:

Healthcare

Sub-Category:

Cough Cold

Brand:

Core

Pack Type:

Leaflet

Variant:

Boots Cold ft Flu Relief Capsules x16

Action:

A

Date:

11/12/14

Country:

UK

Component Code:

2749857

Item Code:

12-76-026

CAD Ref No:

139.7 mm width x 150 mm height

Printer:

N/A

Substrate:

White Paper

Barcode Type:

N/A

Barcode Number:

N/A

Magnification:

N/A

Barcode Truncated By: N/A

(smallest bar)

Edgemark Position:

n/a

Pharmacode No/NE:

111010100(979)

Technical ft Non Printing Items Cutter | Guides


/How to take this medicine

Check the foil is not broken before use. If it is, do not take that capsule.

Age

How many to take

How often to take

Adults and children of 12 years and over

Two capsules

Every 4 to 6 hours, if you need to, up to 6 times in any 24 hours.

Don't take more than

12 capsules in any 24 hours.


Swallow each capsule whole with water. Do not chew.

Do not give to children under 12 years.

Do not take more medicine than the table tells you to.

If you do not get better, talk to your doctor.

! If you take too many capsules: Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

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 capsules. See a doctor at once:

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

•    Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin

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

•    Skin rash, tingling and coldness of the skin

•    Difficulty sleeping, feeling sick, being sick

•    Fast, slow or regular heart beat, palpitations, headache caused by an increase in blood pressure

•    Unusual bruising or infections such as sore throats - this may be a sign of very rare changes in the blood


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: www.mhra.aoy.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton or on the foil edge.

What is in this medicine

Each capsule contains Caffeine 25 mg,

Paracetamol 300 mg, Phenylephrine Hydrochloride 5 mg, which are the active ingredients.

As well as the active ingredients, the capsules also contain maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate. The capsule shell contains gelatin and colours, which are titanium dioxide (E171), iron oxide yellow (E172), patent blue V (E131), quinoline yellow (E104).

The pack contains 16 green and yellow hard gelatin capsules.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Limited Braunton Devon EX33 2DL Leaflet prepared December 2014 If you would like any farther information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


ARTWORK ONLY


ARTWORK TEXT SIZE


Colours

PANTONE 280 C

=


Main Headings:

lOpt

Sub Headings:

9pt

Body Copy:

8pt


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.


PACK 1VIOCK LIP

Product Name: Cold ft Flu Reflief Capsules Product Licence No.: 12063/0003 Wording Ref: MHRA Approved v 1 dated 04/04/2013 (BTC116387v D)

Status: Internally approved Pack Details: White/opaque UPVC/aluminium foil blisters. 30 micron pyramidaly embossed hard temper aluminium (with 250 micron FVC blisters)

Pack Size: 16

Version No.

Date Issued

Reason For Change

1

28/11/2014

Redesign and addition of statutory warnings


E3

TRIDENT

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


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


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


STUDIO USE ONLY Philip Ives    v1.0

Sm»Art check results: G=1; 0=0; R=0; - Pi-11/12/1411:11:44


f


linn


Information for the user


Boots Cold & Flu Relief Capsules

(Caffeine, Paracetamol, Phenylephrine Hydrochloride)

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

1


This medicine is available without prescription to treat minor conditions. However, you still need to take it careful^ to get the best results from it.

•    Keep this leaflet, you may need to read it again

•    Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Paracetamol, an analgesic which relieves pain and reduces fever, Phenylephrine, a decongestant to relieve a blocked up nose and Caffeine, which helps the pain relieving effect of paracetamol and makes you more alert.

It can be used to relieve the symptoms of colds and flu including aches and pains, fever, headache, catarrh, nasal and sinus congestion and its associated pressure and pain.

Before you take this medicine

This medicine can be taken by adults and children of 12 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

*Do not take:

•    If you are allergic to any of the ingredients in this medicine (see "What is in this medicine")

•    If you have high blood pressure or have had a heart attack

•    If you have an overactive thyroid

•    If you are taking monoamine oxidase inhibitors

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

•    If you are taking tricyclic antidepressants

•    If ypu_are_pregnant___________________

f Talk to your pharmacist or doctor:

•    If you have severe kidney or liver problems (including that due to drinking alcohol)

•    If you are dependent on alcohol

•    If you are breastfeeding

If you take other medicines

! This medicine contains paracetamol.

Do not take anything else containing paracetamol while taking this medicine.

Before you take these capsules, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

•    Medicines to treat high blood pressure

•    Colestyramine (to reduce blood fat levels)

•    Metoclopramide or domperidone (for feeling sick or being sick)

•    Warfarin or other blood thinners - if you take warfarin you can take occasional amounts of this medicine, but talk to your doctor first before you take it on a regular basis

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

/How to take this medicine

Check the foil is not broken before use. If it is, do not lake that capsule.

Age

How many to lake

How often to take

Adults and children of 12years and over

Two capsules

Every 4 to 6 hours, if you need to, up to 6 times in any 24 hours.

Don’t take more than

12 capsules in any 24 hours.

Swallow each capsule whole with water. Do not chew.

Do not give to children under 12 years.

Do not take more medicine than the table tells you to.

If you do not get better, talk to your doctor, f If you take too many capsules: Talk to a doctor at once if you take too much of this medicine even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage. Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

Possible side effects

Most people will not have problems, but some may get some, f If you get any of these serious side effects, slop taking the capsules. See a doctor at once:

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

•    Very rare cases of serious skin reactions have been reported. This may include peeling, blistering and lesions of the skin

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

•    Skin rash, tingling and coldness of the skin

•    Difficulty sleeping, feeling sick, being sick

•    Fast, slow or irregular heart beat, palpitations, headache caused by an increase in blood pressure

•    Unusual bruising or infections such as sore throats - this may be a sign of very rare changes in the blood

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: www.mhra.aoy.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store this medicine

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton or on the foil edge.

What is in this medicine

Each capsule contains Caffeine 25 mg,

Paracetamol 300 mg, Phenylephrine Fiydrochloride 5 mg, which are the active ingredients.

As well as the actve ingredients, the capsules also contain maize starch, croscarmellose sodium, sodium laurilsulfate, magnesium stearate. The capsule shell contains gelatin and colours, which are titanium dioxide (E171), iron oxide yellow (E172), patent blue V (E131), quinoline yellow (E104).

The pack contains 16 green and yellow hard gelatin capsules.

Who makes this medicine

Manufactured for The Boots Company PLC Nottingham NG2 3AA by the Marketing Authorisation holder Wrafton Laboratories Umited Braunton Devon EX33 2DL Leaflet prepared December 2014 If you would like any further information about this medicine, please contact The Boots Company PLC Nottingham NG2 3AA


2749857


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