Document: label-leaflet MAH BRAND_PL 00079-0335 change

• label-leaflet MAH BRAND_PL 00079-0335
• leaflet MAH BRAND_PL 44673-0015
• leaflet MAH BRAND_PL 44673-0182

---

Like all medicines, Beechams Active Cold Relief Caplets can have side effects, but not everybody gets them. Stop taking the medicine and tell your doctor If you experience;

•Allergic reactions 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 • 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 or Irregular heart beat • Difficulty passing water. This Is more likely to occur in men with an enlarged prostate gland • Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea, or sickness.

If you do get any side effects, even those not mentioned, tell your doctor or pharmacist.

Active Ingredient 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 laurllsulfate, sunset yellow (E 110), stearic add, talc, microcrystalline cellulose, hypromellose, polyethylene glycol, titanium dioxide (E 171) and quinoline yellow lake (E 104). For more information about sunset yellow (E 110), please see section 2.

Beechams Active Cold Relief packs contain 14 caplets.

The manufacturer Is GlaxoSmithKline Dungarvan Ltd., Knockbrack, Co. Waterford, Republic of Ireland.

Market Authorisation Holder Is GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. All enquiries should be sent to this address.

This information was last revised In January 2011.    40U749E

BEECHAMS Is a registered trade mark of the GlaxoSmithKline group of companies.

	52.9 mm	21 mm	52.9 mm
E				E
E				E

cn    ai

'd¹    "d¹

WHAT ARE THEY FOR? Beed»ms Active Cold Relief Caplets provide relief from the symptoms of colds and fliif including fatigue and (frowsiness and the relief of sinus pain.

PLEASE READ THE ENCLOSED LEAFLET CAREFULLY BEFORE TAKING THIS MrDICINE.Q TAKE SPECIA- CARE

Do not take with 'iny ther flu, cold or decong stant products and avoid exce^ive intake of caffr'ie.

Do not take for more than 7 days except on medical advice.

CONTAINS PARACETAMOL. Do not taka ^{1 2}vith air¹ other paracetamol-containing products. Immediate medicial advice should be sou^l.e i.. the ever., of an overdose, ev«n if you feel well, because of the risk o. cLIayed, se. .ous liver Jamage.

CONSULT YOlIk DOCTOR

if you are under the care of your doctor if you have liver or kidney problem¹ if you a. e ^rwgnant or Least feed., ig If you are receiving presc. ,L.d medicines If ymi have a blood vessel disease such as Raynaud's phenomenon, heart or circr ’atory disease or an enlarged prost?‘e HOW TO TAKE Fororaluse.

Adults and children 12 years and over: 2 caplets to ^e taken every 4-6 hours as necessary. Do not take more than 8 caplets in 24 hours. Do not give to wiildren under 12 years unless your do¹.«or tells you to. Do not exceed the sta^-td dose.

INGREDIENTS Each ct-plet contains Paracetamol 500 mg.

Phenylephrine hydrochloridr 5 mg, and Caffeine 25 mg.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Store below 25°C in a dry place.

GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

40U749E D301081/05 PL 00079/0335

Beechams

CAPLETS

Paracetamol

Caffeine

Phenylephrine^\

• SORE THROAT

• blocked nose

• ACHES & PAINS ~ • HEADACHE < FEVER    ^

NON-DROWSY

Like all medicines, Beechams Active Cold Relief Caplets can have side effects, but not everybody gets them. Stop taking the medicine and tell your doctor If you experience:

•Allergic reactions such as skin rash and Itching sometimes with swelling of the mouth or face or shortness of breath •Sldn 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 • 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 or Irregular heart beat • Difficulty passing water. This Is more likely to occur in men with an enlarged prostate gland • Raised blood pressure, headache, dizziness, difficulty sleeping, nervousness, anxiety, diarrhoea, or sickness, if you do get any side effects, even those not mentioned, tell your doctor or pharmacist.

Active Ingredient 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 laurllsulfate, sunset yellow (E 110), stearic add, talc, microcrystalline cellulose, hypromellose, polyethylene glycol, titanium dioxide (E 171) and quinoline yellow lake (E 104). For more information about sunset yellow (E 110), please see section 2.

Beechams Active Cold Relief packs contain 14 caplets.

The manufacturer Is GlaxoSmithKline Dungarvan Ltd., Knockbrack, Co. Waterford, Republic of Ireland.

Market Authorisation Holder Is GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K. All enquiries should be sent to this address.

This information was last revised In January 2011.    40U749E

BEECHAMS Is a registered trade mark of the GlaxoSmithKline group of companies.

1

1. WHATBEECHAMS ACTIVE COLD RELIEF CAPLETS DO

Beechams Active Cold Relief Caplets provide effective relief from cold and flu symptoms, sinus pain and fatigue and drowsiness.

| 2. DO HOT TAKE BEECHAMS ACTIVE COLD REUEF TABLETS

□ • If you have ever had an allergic reaction to

paracetamol, phenylepherine hydrochloride, caffeine or any of the other ingredients (listed in Section 4). Colour sunset yellow (E 110) can cause allergic-type reactions Including asthma • If you have kidney or liver problems, overactive thyroid, diabetes, or are under the care of your doctor for high blood pressure or heart disease, taking i-blockers (e.g. atenolol), have glaucoma or phaeochromocytoma • If you are taking tricyclic antidepressants (e.g. imlpramlne or amitriptyline) or you have taken monoamine oxidase Inhibitors (MAOIs) prescribed for depression in the last two weeks

2

Consult your doctor before using this product If you suffer from an enlarged prostate gland, or Raynaud's phenomenon. I If you are taking other medicines | Talk to your doctor or pharmacist before taking Beechams Active Cold Relief Caplets if you are taking any prescribed medicines; particularly metodopramlde or domperldone (for nausea [feeling sick] or vomiting [being sick], or ergotamlne or methylserglde (for migraine) or colestyramlne (to lower blood cholesterol) or drugs to lower blood pressure; appetite suppressants (e.g. phentermlne) or stimulants (e.g. dexamfetamlne); drugs to treat depression such as tricyclic antidepressants (e.g. amitriptyline) or heart disease (e.g. dlgoxin) or If you take blood thinning drugs (anticoagulants e.g. warfarin). Do not take with other flu, cold and decongestant products and avoid excessive Intake of caffeine when taking this product.

I pregnancy and breast feeding This product Is not recommended for use In pregnancy. Ask your doctor before taking this product If you are breast feeding.