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ssentials Cold Relief Capsules

Paracetamol, Phenylephrine, Caffeine

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you take this medicine because it contains important information you need to know.

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.

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

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 disorder(s)

» have high blood pressure (hypertension) _

•    have an overactive thyroid

•    are pregnant

•    are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI's), 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 disease

•    have alcohol dependence.

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 metoclopramide 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 with any other paracetamol-

containing products.    Please turn over ij

3.    How to take this medicine

Swallow the capsules whole with water.

Do not chew.

Adults, the elderly and children 12 years and over: 2 capsules every 4 to 6 hours, as required. Do not take more than 12 capsules in any 24 hour period.

Do not give to children under 12 years.

Do not exceed the stated dose.

If your symptoms persist or worsen, you must see a doctor or pharmacist.

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of 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 taking the medicine immediately, and see your doctor or pharmacist.

Rare side effects are:

•    allergic reactions such as skin rash

•    tingling and coolness of the skin

•    feeling sick (nausea)

•    difficulty sleeping (insomnia)

•    a faster or slower heart beat

•    a rise in blood pressure with headache, vomiting (being sick) and an irregular heart beat (palpitations).

More rarely, the following side effects can happen:

• you may become more prone to bleeding, bruising, fever and infections, such as sore throat and ulcers, due to changes in your blood.

5.    How to store your medicine

Keep all medicines out of the reach and sight of children.

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

6.    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).

This product is available in a pack size of 16 capsules.

7.    Who makes this medicine?

The Marketing Authorisation holder and manufacturer is Wrafton Laboratories Limited, Braunton, Devon, EX33 2DL, UK.

Text revised: July 2010.

PL 12063/0003