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PARACETAMOL PLUS CAPSULES

Active substance(s): CAFFEINE / PARACETAMOL

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Pack Copy Specification
Marketing Authorisation
number

Paracetamol Plus Capsules
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
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Pack Copy Specification
Marketing Authorisation
number

Paracetamol Plus Capsules
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
Filter Coffee
Instant Coffee
Tea
Cola Drink
Chocolate
Your medicine
*100 ml is a small cup/glass

Amount*
100 ml
100 ml
100 ml
100 ml
100 g
1 capsule

Caffeine Content
50 – 100 mg
20 – 73 mg
20 – 73 mg
Up to 20 mg
5 – 20
65 mg

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.
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Pack Copy Specification
Marketing Authorisation
number

Paracetamol Plus Capsules
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 25oC.
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.
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Pack Copy Specification
Marketing Authorisation
number

Paracetamol Plus Capsules
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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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