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PARACETAMOL PLUS CAPSULES

Active substance(s): CAFFEINE / PARACETAMOL / CAFFEINE / PARACETAMOL / CAFFEINE / PARACETAMOL

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1.3

PRODUCT INFORMATION

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET

Particulars to appear on the outer packaging
Package leaflet

Package leaflet: Information for the patient
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Paracetamol, Caffeine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has
told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse.
What is in this leaflet
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information

1. What this medicine is and what it is 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. What you need to know before you take this medicine


Do not take this medicine if you:
are allergic to paracetamol, caffeine or any of the other ingredients of this medicine (listed in section
6)
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SPC, LABELLING AND PACKAGE LEAFLET

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
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine, if you
 suffer from kidney or liver problems, including alcoholic liver disease.
Other medicines and <>
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, like











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
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.
Do not take anything else containing paracetamol while taking this medicine.

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

Amount*
100 ml
100 ml

Caffeine Content
50 – 100 mg
20 – 73 mg
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PRODUCT INFORMATION

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SPC, LABELLING AND PACKAGE LEAFLET

Tea
Cola Drink
Chocolate
Your medicine
*100 ml is a small cup/glass

100 ml
100 ml
100 g
1 capsule

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 16 years: 2 capsules to be taken every 4 to 6 hours as
required. Do not take more than 4 doses (8 capsules) in any 24 hour period.
Children aged 12 to 15 years:
1 capsule to be taken every 4 to 6 hours, as required. Do not take more than 4 doses (4 capsules) in
any 24 hour period.
Do not give to children under 12 years.
Do not take more often than every 4 hours. Do not continue to take for longer than 3 days, unless
instructed by your doctor. Do not take more medicine than the label tells you to. If you do not get
better, talk to your doctor.
Talk to a doctor at once if you take too much of this medicine even if you feel well. This is
because too much paracetamol can cause delayed, serious liver damage. Go to your nearest
hospital casualty department. Take your medicine and this leaflet with you.
If your symptoms continue or your headache becomes persistent, see your doctor.
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:
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SPC, LABELLING AND PACKAGE LEAFLET

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 this medicine
Keep this medicine 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. Contents of the pack and other information
What this medicine contains
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.
The capsule shell is made from gelatin and contains the colours E171, E132 and D127.
Each carton contains 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.
The marketing authorisation holder and manufacturer is Wrafton Laboratories Limited,
Braunton, Devon, EX33 2DL, UK.
Last revised July 2017.
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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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