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Beechams Warmers Blackcurrant

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Document: leaflet MAH BRAND_PL 44673-0011 change

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Beechams

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HOT BLACKCURRANT

Paracetamol, Phenylephrine


Please read right through this leaflet before you start using this medicine. This medicine is available without prescription, but you still need to use Beechams Cold & Flu Hot Blackcurrant carefully to get the best results from it.

Keep this Ieaflet you may need to read it again.

If you have any questions, or if there is anything you do not understand, ask your pharmacist.

^^5 In this leaflet:

1.    What Beechams Cold & Flu does

2.    Check before you take Beechams Cold & Flu How to take Beechams Cold & Flu

4. Possible side effects

15. How to store Beechams Cold & Flu 6. Further information

1. What Beechams Cold & Flu does

Beechams Cold & Flu is used for the short term relief of the symptoms of flu, colds and chills. These symptoms include headache, shivers, aches and pains, blocked nose and painful sinuses, catarrh and sore throat.

The medicine contains two active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever.

Phenylephrine hydrochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily.

This product also contains 40 mg ascorbic acid (vitamin C).


2. Check before you take Beechams Cold & Flu
□ Do not take Beechams Cold & Flu:

•    if you have ever had an allergic reaction to paracetamol, phenylephrine hydrochloride or to any of the other ingredients (listed in Section 6)

•    if you have kidney or liver problems, overactive thyroid, diabetes, high blood pressure or heart or circulation disease

•    if you have phaeochromocytoma or glaucoma

•    if you are taking tricyclic antidepressants (e.g. imipramine or amitriptyline) or if you are taking or have taken within the last two weeks monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) prescribed for depression

•    if you are taking beta blockers.

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

Do not take with any other flu, cold or decongestant product.


Take special care with Beechams Cold & Flu

This product may cause dizziness. If affected, do not drive or operate machinery.

Ask your doctor before you take this medicine:

if you have a blood vessel disease such as Raynaud's Phenomenon.

if you have an enlarged prostate.

if you have diabetes mellitus. Each dose contains 4 g of sucrose. if you are on a controlled-sodium diet. Each dose contains 0.17 g of sodium.

If you are taking other medicines

Talk to your doctor or pharmacist before taking Beechams Cold & Flu if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]) or ergotamine or methylsergide (for migraine) or colestyramine

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TEXT SIZE CONTAINED IN THIS ARTWORK

Body text size: 6.0 pt Leading: 6.5 pt Horizontal Scale: 76 % Smallest text size: 6.0 pt Microtext: N

Alcala - Additional Artwork Information Panel

Component Name

PROSP BEECHAM BLACKCURRANT UK 1509

Dimensions

150 x 100 mm

Folded dimensions

N/A

Varnish Type

N/A

Reel Unwind Reference No

N/A

Glossiness / Matte printed side

N/A


IMPORTANT

GSK Market is responsible for this product, its design and content.

Ensure the artwork is thoroughly checked, all the text proof-read and approved.

RSC GSK is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise RSC in case changes required impact the followings:

Formulation, Tablet embossing. Storage conditions. Shelf Life

This PDF has been verified using PitStop 12 PDF is PDF/X-4 compliant and GSK compliant for Leaflet workflow

Page 1 of 2


Alcala - Additional Artwork Information Panel

Component Name

PROSP BEECHAM BLACKCURRANT UK 1509

Dimensions

150 x 100 mm

Folded dimensions

N/A

Varnish Type

N/A

Reel Unwind Reference No

N/A

Glossiness / Matte printed side

N/A


IMPORTANT

GSK Market is responsible for this product, its design and content.

Ensure the artwork is thoroughly checked, all the text proof-read and approved.

RSC GSK is responsible for site technical requirements and pre-press suitability.

GSK Market is responsible to advise RSC in case changes required impact the followings:

Formulation, Tablet embossing, Storage conditions, Shelf Life

This PDF has been verified using PitStop 12 PDF is PDF/X-4 compliant and GSK compliant for Leaflet workflow

Page 2 of 2


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(to lower blood cholesterol) or drugs to lower blood pressure; appetite supressants or stimulants; drugs to treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. digoxin) or if you take blood thinning drugs (anticoagulants e.g. warfarin).

Pregnancy and breast feeding

Do not take Beechams Cold & Flu if you are pregnant or breast feeding unless advised by a doctor.

3. How to take Beechams Cold & Flu

Adults and children aged 12 years and over:

Empty the contents of one sachet into a mug.

I Half fill with very hot water. Stir well.

Add cold water as necessary and sugar if desired.

Take one sachet every 4 hours as needed.

•    Do not take more frequently than every 4 hours.

•    Do not take more than 6 sachets in 24 hours.

•    Do not take more than the recommended dose.

~    • Do not take for more than 7 days without asking your doctor.

•    Do not give to children under 12 years.

If you take too many sachets

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.

If your symptoms persist, see your doctor.

14. Possible side effects

Like all medicines, Beechams Cold & Flu can have side effects, but not everybody gets them. A small number of people have had side effects.

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.

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

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.

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

5.    How to store Beechams Cold & Flu

Keep out of the sight and reach of children.

Do not use this medicine after the 'EXP' date shown on the pack.

Store below 25°C.

6.    Further information

Active ingredients Each dose contains Paracetamol 600 mg and Phenylephrine Hydrochloride 10 mg.

Other ingredients Ascorbic acid (vitamin C), sucrose, sodium citrate, citric acid, sodium cyclamate, saccharin sodium, blackcurrant juice, blackcurrant polvaromas, blackcurrant flavour, natural grapeskin (E 163).

Packs of Beechams Cold & Flu Hot Blackcurrant contain 5 or 10 sachets.

Not all pack sizes may be marketed.

The marketing authorisation holder is GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K. and all enquiries should be sent to this address.

The manufacturer is SmithKline Beecham SA, Ctra de Ajalvir, Km 2500,

28806 Alcala de Henares, Madrid, Spain.

This leaflet was last revised in November 2015.

Beechams is a registered trademark of the GSK group of companies.

11000010003286


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TEXT SIZE CONTAINED IN THIS ARTWORK


Body text size: 6.0 pt Leading: 6.5 pt Horizontal Scale: 76 % Smallest text size: 6.0 pt Microtext: N