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Spar Paracetamol Extra Pain Relief Tablets

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Paracetamol Plus Caplets

Paracetamol, 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

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

These tablets are for the relief of mild to moderate pain including headache, migraine, toothache, nerve pain, sore throat and period pains. They are also for symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, flu, feverishness and feverish colds.

2.    Is this medicine suitable for you?

Do not take this medicine if you:

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

•    have high blood pressure or are taking any medication for high blood pressure, such as beta blockers

•    your heart beat is too fast, too slow or irregular

•    are recovering from alcoholism and are taking the medicine disulfiram

•    are taking any medication to treat anxiety, this includes antidepressants (e.g. lithium carbonate or monoamine oxidase inhibitors), anxiolytics or sedatives (e.g. diazepam)

•    are currently taking the medicine ephedrine (a decongestant) or theophylline, which is used to treat asthma.

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

•    are pregnant or breast feeding

•    suffer from kidney or liver problems, including alcoholic liver 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 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 used during hospital tests for heart conditions such as adenosine and dipyridamole

•    medicines used to treat the skin condition psoriasis, such as methoxsalen

•    medicines to treat epilepsy, such as phenytoin

•    medicines used to treat thyroid conditions, such as levothyroxine

•    medicines used to treat infections, such as pipemidic acid.

•    Contains paracetamol.

•    Do not take with any other paracetamol-containing products.

Taking this medicine with food and drink:

Each tablet contains 65 mg of caffeine and up to 8 tablets (or 520 mg of caffeine) may be taken per day. If you are also consuming other medicines or food that contains caffeine (coffee, tea, cola drinks, chocolate) reduce the number of these tablets you take in a day.    Please turn over

The amount of caffeine in a drink of coffee and tea depends on how they are made, but you can use the table below as a guide:

Food

Amount*

Caffeine content

Filter coffee

100 ml

50- 100 mg

Instant coffee

100 ml

20 - 73 mg

Tea

100 ml

20 - 73 mg

Cola drink

100 ml

Up to 20 mg

Chocolate

100 g

5 - 20 mg

Your tablets

1 tablet

65 mg

*100 mi is a small cup / glass.


2729190


Maximum recommended caffeine intake per day: 520 mg.

3.    How to take this medicine

Swallow the tablets whole with water. Do not chew. Adults, the elderly and children over 12 years:

2 tablets every 4 hours as required.

Do not take more than 4 doses (8 tablets) in any 24 hour period.

Do not take more often than every 4 hours.

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. Paracetamol side effects:

Rare side effects are:

• allergic reactions such as skin rash.

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. Caffeine side effects:

If you do not take more than the recommended 520 mg of caffeine per day side effects are unlikely, but you must remember to take into account caffeine from coffee, tea, other medicines, etc. Some people are more sensitive to caffeine and can get side effects at lower doses, especially if they have never had caffeine before or have not had caffeine for some time.

Side effects may include tremor, insomnia, nervousness, irritability, anxiety, headache, tinnitus (ringing in the ears), and stomach complaints (e.g. nausea, vomiting and diarrhoea). You may also notice palpitations, changes in heartbeat, an increased need to pass water, and rapid breathing.

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 tablet contains the active ingredients: paracetamol 500 mg and caffeine 65 mg.

The other ingredients are: povidone, maize starch, methylcellulose, talc, calcium stearate and purified water.

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

7.    Who makes this medicine?

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

Text Revised: June 2011.

PL 12063/0007