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Beechams*

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CAPLETS

Paracetamol, Phenylephrine, Caffeine 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 Flu-Plus Caplets carefully to get the best results from it.

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

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

In this leaflet:

1.    What Beechams Flu-Plus Caplets do

2.    Check before you take Beechams Flu-Plus Caplets

3.    How to take Beechams Flu-Plus Caplets

4.    Possible side effects

5.    How to store Beechams Flu-Plus Caplets

6.    Further information

1.    What Beechams Flu-Plus Caplets do

Beechams Flu-Plus Caplets provide effective relief from the major cold and flu symptoms. These symptoms include headache, shivers, aches and pains, blocked nose and painful sinuses, catarrh, sore throat, fatigue and tiredness.

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

Phenylephrine hydrochloride unblocks your nose and sinuses helping you to breathe more easily. Caffeine is present as a mild stimulant to relieve fatigue and tiredness.

2.    Check before you take Beechams Flu-Plus Caplets

□

Do not take Beechams Flu-Plus Caplets:

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

Colour sunset yellow (E 110) can cause allergic type reactions including asthma

•    if you have kidney or liver problems, overactive thyroid, diabetes, high blood pressure or heart 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 2 weeks monoamine oxidase inhibitors (MAOIs) (e.g. moclobemide) prescribed for depression.

•    if you are taking beta-blockers (e.g. atenolol).

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 Flu-Plus Caplets

■ 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 heart or circulation disease.

lf you are taking other medicines

Talk to your doctor or pharmacist before taking Beechams Flu-Plus Caplets if you are taking any prescribed medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]); ergotamine and methlysergide (for migraine) or colestyramine (to lower blood cholesterol) or drugs to lower blood pressure; appetite suppressants 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

Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.

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How to take Beechams Flu-Plus Caplets

I Adults and children aged 12 years and over:

Swallow 2 caplets every 4 hours as needed.

Do not take more than 8 caplets in 24 hours.

Do not take more frequently than every 4 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.

• 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.

If you take too much 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.

4. Possible side effects

Like all medicines, Beechams Flu-Plus Caplets 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.

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.

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 Flu-Plus Caplets

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 in a dry place.

6.    Further information Active ingredients Each caplet contains Paracetamol 500 mg, Phenylephrine Hydrochloride 5 mg and Caffeine 25 mg.

Other ingredients Starch pregel, maize starch, povidone, potassium sorbate (E 202), sodium laurilsulfate, sunset yellow (E 110), stearic acid, talc, microcrystalline cellulose, hypromellose, polyethylene glycol, titanium dioxide (E 171) and quinoline yellow lake (E 104). Packs of Beechams Flu-Plus Caplets contain 8,10,16 and 24 caplets.

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 GlaxoSmithKline Dungarvan Ltd., Knockbrack, Co. Waterford, Ireland or SmithKline Beecham SA, Ctra de Ajalvir, Km 2500,    ^

28806 Alcala de Henares, Madrid, Spain. This leaflet was last revised in November 2015.    g

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

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