Wilko Non-Drowsy Decongestant With Paracetamol

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Document: leaflet BOOTS_PL 12063-0003 change

139.7 mm

150 mm

Information for the user

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, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read • it again. Ask your pharmacist if you need more •

information or advice.

.What is this medicine and what is it * used for? ,

This medicine contains: •

¹ paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever ¹ phenylephrine which is a decongestant to reduce •

swelling in the passages of the nose to help you breathe more easily .

' caffeine which helps to increase the pain relief from paracetamol and makes you more alert. •

These capsules are used for the relief of the symptoms of colds and flu, including headache, feverishness (high temperature), nasal and sinus congestion and its associated pressure and pain, catarrh, aches and pains. .

I. Is this medicine suitable for you?

Do not take this medicine if you:

¹ are allergic to paracetamol, phenylephrine, caffeine or any of the other ingredients ¹ are under 12 years of age

¹ have a serious heart condition or cardiovascular disorders)

' have high blood pressure (hypertension) 3.

> have an overactive thyroid ¹ are pregnant

' are taking antidepressant drugs called monoamine oxidase inhibitors (MAOIfe), or have taken them within the last 14 days - these are medicines such as phenelzine and isocarboxazid ¹ are taking tricyclic antidepressants, such as imipramine, amitriptyline.

Please see your doctor or pharmacist before taking this medicine if you:

are breastfeeding

suffer from kidney or liver problems, including alcoholic liver

disease or have alcohol dependence

have a blood vessel disease such as Raynaud's

phenomenon

have an enlarged prostate or other prostate problems have heart or circulation disease.

If you are taking any of the following medicines please see your doctor

medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine medicines to control feeling sick or being sick such as metodopramide or domperidone medicines called anti-coagulants, which are used to thin the blood such as warfarin or other coumarins - you may take occasional doses of paracetamol but should consult your doctor if you need to take it on a regular basis medicines to lower blood pressure, treat heart or circulatory problems such as beta blockers (for example atenolol), methyldopa, or ganglion blocking agents (for example trimetaphan camsylate).

Contains paracetamol.

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

How to take this medicine

Swallow the capsule whole with water. Do not chew. Adults, the elderly and children 12 years and oven

2 capsules every 4 to 6 hours, as required. Do not fake more than 12 capsules in any 24 hour period.

Do not give to children under 12 years.

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

|f you dqn_ot_get_better; talk toygur doctor_______

Avoid too much caffeine in drinks like coffee and tea. High caffeine intake can cause difficulty sleeping, shaking and an uncomfortable feeling in the chest.

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.

4 Possible side effects

Most people do not have any side effects while taking this medicine. However, if you experience any of the following side effects, or anything else unusual happens, stop faking the medicine immediately, and see your doctor or pharmacist.

Stop taking this medicine and tell your doctor immediately if you experience:

• Allergic reactions which may be severe such as skin rash and itching sometimes with swelling of the mouth or face or shortness of breath.

• Skin rash or peeling, or mouth ulcers.

• Breathing problems. These are more likely if you have experienced them before when taking other painkillers such as ibuprofen or aspirin.

• Unexplained bruising or bleeding.

• Reoccuring fevers or infections.

• Nausea, sudden weight loss, loss of appetite and yellowing of the eyes and skin.

• Visual disturbances. This is rare but is more likely in those with glaucoma.

• Unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat.

• Difiicu|ty passing water. This is more likely to occur in men with an enlarged prostate gland.

These reactions are rare.

The following side effects may occur.

Tell your doctor if you get them.

• Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea or sickness. Very rare cases of serious skin reactions have been reported.

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.

i. How to store your medicine Keep out of the sight and reach of children

Do not use this medicine after the expiry date printed on the pack.

Do not store above 25°C.

i. What is in this medicine?

Each green / yellow capsule contains the active ingredients: paracetamol 300 mg, caffeine 25 mg and phenylephrine hydrochloride 5 mg.

The other ingredients are: maize starch, croscarmellose sodium, sodium lauryl sulphate and magnesium stearate. The capsule shell is made of gelatin and contains the colours titanium dioxide (E171), iron oxide yellow (E172), patent blue V(E131) and quinoline yellow (E104).

The product is available in a pack size of 16 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, UK. Text revised: January 2016 If you would like any farther information about this medicine, please contact The Bools Company PLC Nottingham NG2 3AA Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Cold & Ru Relief Capsules Reference number: 12063/0003 This is a service provided by the Royal National Institute of Blind People.

2753142

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Trident Reference No: BTC209642
Zen Ref:	TR1052451
Category:	Healthcare
Sub-Category:	Cough Cold
Brand:	Core
Pack Type:	Leaflet
Variant:	Cold ft Flu Relief Capsules
Action:	c
Date:	28/01/16
Country:	UK
Component Code:	2753142
Item Code:	12-76-026
CAD Ref No:	139.7 mm width x 150 mm height
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Product Name:

Cold ft Flu Reflief Capsules

Product Licence No.: 12063/0003

WordingRef: Internally App roved v 1 dated 26/06/2015

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Status: Internally approved

Pack Details: White/opaque UPVC/aluminium foil blisters. 30

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Pack Size: 16

TRIDENT

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TECHNICAL INFO: PRINTER PLEASE NOTE

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Date Issued

27/11/2015

Reason For Change

Clinical updates in line with the brand leader, including storage conditions, new pharma code and new Perrigo code (leaflet now using A4 text of 3rd party MAH]

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Information for the user

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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, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice.

1. What is this medicine and what is it used for?

This medicine contains:

• paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever

• phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily

• caffeine which helps to increase the pain relief from paracetamol and makes you more alert.

2. Is this medicine suitable for you?

Do not take this medicine if you:

• are allergic to paracetamol, phenylephrine, caffeine or any of the other ingredients

• are under 12 years of age

• have a serious heart condition or cardiovascular disorders)

• have high blood pressure (hypertension)

• have an overactive thyroid

• are pregnant

• are taking antidepressant drugs called monoamine oxidase inhibitors (MAOIfe), or have taken them within the last 14 days - these are medicines such as phenelzine and isocarboxazid

• are taking tricyclic antidepressants, such as imipramine, amitriptyline.

Please see your doctor or pharmacist before | taking this medicine if you:

• are breastfeeding

• suffer from kidney or liver problems, including alcoholic liver i disease or have alcohol dependence

• have a blood vessel disease such as Raynaud's ,

phenomenon '

• have an enlarged prostate or other prostate problems ]

• have heart or circulation disease. i

If you are taking any of the following medicines; please see your doctor

• medicines to treat high cholesterol levels which reduce the j

amount of fat in the blood such as colestyramine i

• medicines to control feeling sick or being sick such as '

metodopramide or domperidone |

• medicines called anti-coagulants, which are used to thin i

the blood such as warfarin or other coumarins - you may ] take occasional doses of paracetamol but should consult i your doctor if you need to take it on a regular basis '

• medicines to lower blood pressure, treat heart or circulatory

problems such as beta blockers (for example atenolol), ' methyldopa, or ganglion blocking agents (for example trimetaphan camsylate). i

Contains paracetamol. '

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

3. How to take this medicine Swallow the capsule whole with water. Do not chew. ] Adults, the elderly and children 12 years and oven j

2 capsules every 4 to 6 hours, as required. Do not fake i more than 12 capsules in any 24 hour period. j

Do not give to children under 12 years. i

Do not take more medicine than the label tells you to. ¹

_ |f you do n_ot.get_better; talk toygur doctor________]