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PARACETAMOL PLUS CAPLETS

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

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Package leaflet: Information for the patient

Health Essentials Pain Relief Plus Tablets
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 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. 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 (as listed in
section 6)
• 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
• are pregnant or breastfeeding.

3. How to take this medicine
Swallow the tablets whole with water.
Do not chew.

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.

Adults, the elderly and children over 16
years
2 tablets to be taken every 4 to 6 hours as
required. Do not take more than 4 doses
(8 tablets) in any 24 hour period.

Other medicines and Health Essentials
Pain Relief Plus Tablets
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
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.

Children aged 12 to 15 years
1 tablet to be taken every 4 to 6 hours, as
required. Do not take more than 4 doses
(4 tablets) in any 24 hour period.

Do not take anything else containing
paracetamol while taking this medicine.
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) you may have a high
caffeine intake and might have difficulty sleeping,
start shaking and/or have an uncomfortable
feeling in the chest. You should avoid too
much caffeine in drinks like coffee and tea.
Although the amount of caffeine in a drink of
coffee and tea depends on how they are
made, you can use the table below as a
guide to the amount of caffeine contained
within certain foods and drinks:
Amount* Caffeine content
Food
50 - 100 mg
100 ml
Filter coffee
20 - 73 mg
100 ml
Instant coffee
20 - 73 mg
100 ml
Tea
Up to 20 mg
100 ml
Cola drink
5 - 20 mg
100 g
Chocolate
65 mg
Your medicine 1 tablet
*100 ml is a small cup/glass.

Maximum recommended caffeine intake per
day: 520 mg.
Please turn over ➥

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
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.
Stop taking the medicine and tell your
doctor if you experience
• allergic reactions which may be severe
such as skin rash, or itching, sometimes
with shortness of breath or swelling of the
mouth, lips, tongue, throat or face.
• breathing problems. These are more likely if
you have experienced them before when
taking other painkillers such as aspirin or
ibuprofen (non-steroidal anti-inflammatories)
• severe rash or peeling of the skin which
may be accompanied by mouth ulcers.
Paracetamol side effects
Rare side effects are
• other allergic reactions (e.g. skin rash)
• yellowing of the skin or eyes, pale stools or
upper abdominal pain (these may be signs
of liver problems).
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 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.
If you experience any caffeine-related side
effects, stop taking all medicines containing
caffeine, including this medicine and stop
consuming food that contains caffeine
(coffee, tea, cola drinks, and chocolate).
If you stop taking caffeine after regular use
There are some people who may experience
unwanted side effects when they stop taking
tablets or foods containing caffeine after regular
use. The most common effect is headache but
also tiredness and feeling less alert can occur.
These effects are temporary and may last up
to a week but to minimize these effects it is
best to gradually reduce caffeine intake.
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.

6. Contents of the pack and
other information
What this medicine contains
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 pack sizes of 16
and 32 tablets. Not all pack sizes are available.
The Marketing Authorisation holder and
manufacturer is Wrafton Laboratories Limited,
Braunton, Devon, EX33 2DL, UK.
Text revised: January 2017.
PL 12063/0007

F6L73XCJA1

Package leaflet: Information for the patient

Health Essentials Pain Relief Plus Tablets
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 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. 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 (as listed in
section 6)
• 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
• are pregnant or breastfeeding.

3. How to take this medicine
Swallow the tablets whole with water.
Do not chew.

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.

Adults, the elderly and children over 16
years
2 tablets to be taken every 4 to 6 hours as
required. Do not take more than 4 doses
(8 tablets) in any 24 hour period.

Other medicines and Health Essentials
Pain Relief Plus Tablets
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
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.

Children aged 12 to 15 years
1 tablet to be taken every 4 to 6 hours, as
required. Do not take more than 4 doses
(4 tablets) in any 24 hour period.

Do not take anything else containing
paracetamol while taking this medicine.
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) you may have a high
caffeine intake and might have difficulty sleeping,
start shaking and/or have an uncomfortable
feeling in the chest. You should avoid too
much caffeine in drinks like coffee and tea.
Although the amount of caffeine in a drink of
coffee and tea depends on how they are
made, you can use the table below as a
guide to the amount of caffeine contained
within certain foods and drinks:
Amount* Caffeine content
Food
50 - 100 mg
100 ml
Filter coffee
20 - 73 mg
100 ml
Instant coffee
20 - 73 mg
100 ml
Tea
Up to 20 mg
100 ml
Cola drink
5 - 20 mg
100 g
Chocolate
65 mg
Your medicine 1 tablet
*100 ml is a small cup/glass.

Maximum recommended caffeine intake per
day: 520 mg.
Please turn over ➥

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
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.
Stop taking the medicine and tell your
doctor if you experience
• allergic reactions which may be severe
such as skin rash, or itching, sometimes
with shortness of breath or swelling of the
mouth, lips, tongue, throat or face.
• breathing problems. These are more likely if
you have experienced them before when
taking other painkillers such as aspirin or
ibuprofen (non-steroidal anti-inflammatories)
• severe rash or peeling of the skin which
may be accompanied by mouth ulcers.
Paracetamol side effects
Rare side effects are
• other allergic reactions (e.g. skin rash)
• yellowing of the skin or eyes, pale stools or
upper abdominal pain (these may be signs
of liver problems).
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 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.
If you experience any caffeine-related side
effects, stop taking all medicines containing
caffeine, including this medicine and stop
consuming food that contains caffeine
(coffee, tea, cola drinks, and chocolate).
If you stop taking caffeine after regular use
There are some people who may experience
unwanted side effects when they stop taking
tablets or foods containing caffeine after regular
use. The most common effect is headache but
also tiredness and feeling less alert can occur.
These effects are temporary and may last up
to a week but to minimize these effects it is
best to gradually reduce caffeine intake.
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.

6. Contents of the pack and
other information
What this medicine contains
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 pack sizes of 16
and 32 tablets. Not all pack sizes are available.
The Marketing Authorisation holder and
manufacturer is Wrafton Laboratories Limited,
Braunton, Devon, EX33 2DL, UK.
Text revised: January 2017.
PL 12063/0007

F6L73XCJB1

Expand Transcript

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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