Paracetamol Plus Capsules

Pack Copy Specification	Paracetamol Plus Capsules
Marketing Authorisation number	PL 12063/0008

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 capsules 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 drug 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

• are pregnant or breastfeeding

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

• 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 and other

Pack Copy Specification	Paracetamol Plus Capsules
Marketing Authorisation number	PL 12063/0008

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

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
Your medicine	1 capsule	65 mg

*100 ml is a small cup/glass

Maximum recommended caffeine intake per day: 520 mg.

3. How to take this medicine

Swallow the capsules whole with water.

Do not chew.

Adults, the elderly and children over 12 years: 2 capsules every 4 hours as required. Do not take more than 4 doses (8 capsules) 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.

Pack Copy Specification	Paracetamol Plus Capsules
Marketing Authorisation number	PL 12063/0008

Go to your nearest hospital casualty department. Take your medicine and this leaflet with you.

4. Possible 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.

Very rare cases of serious skin reactions have been reported.

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

Reporting of side effects

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 your medicine

Keep out of the sight and reach of children.

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

Do not store above 25^oC.

6. What is in this medicine?

Each capsule contains:

Paracetamol EP 500 mg and caffeine EP 65 mg as the active ingredients.

They also contain:

Maize starch, croscarmellose sodium, sodium lauryl sulphate and magnesium stearate.

Pack Copy Specification	Paracetamol Plus Capsules
Marketing Authorisation number	PL 12063/0008

The capsule shell is made from gelatin and contains the colours E171, E132 and D127.

Each carton contain 8 capsules per blister either 1 or 2 strips per carton, or 12 capsules per blister either 1, 2, 4, or 8 strips per carton.

Each drum contains either 25, 50 or 100 capsules.

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.