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SOLPADEINE MAX SOLUBLE TABLETS

Active substance(s): CAFFEINE / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL / CAFFEINE / CODEINE PHOSPHATE HEMIHYDRATE / PARACETAMOL

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2.0

LEADING EDGE

• This medicine is for the short term
treatment of acute moderate pain
when other painkillers have not
worked.
• You should only take this product for
a maximum of 3 days at a time. If
you need to take it for longer than 3
days you should see your doctor or
pharmacist for advice.
• This medicine contains codeine
which can cause addiction if you take
it continuously for more than 3 days.
This can give you withdrawal
symptoms from the medicine when
you stop taking it.
• If you take this medicine for
headaches for more than 3 days it
can make them worse.
Please read right through this leaflet
before you start using this medicine.
This medicine is available without
prescription, but you still need to use
Solpadeine Max Soluble Tablets carefully to
get the best results from them.
• Keep this leaflet you may need to read it
again.
• If you have any questions, or if there is
anything you do not understand, ask your
pharmacist.
In this leaflet:
1. What Solpadeine Max Soluble Tablets do
2. Check before you take Solpadeine Max
Soluble Tablets
3. How to take Solpadeine Max Soluble
Tablets
4. Possible side effects
5. How to store Solpadeine Max Soluble
Tablets
6. Further information

Talk to your doctor before taking
Solpadeine Max Soluble Tablets if you are
pregnant. Do not take Solpadeine Max
Soluble Tablets while you are
breast-feeding. Codeine and morphine
passes into breast milk.

• If you have ever had an allergic reaction
to paracetamol, codeine, caffeine or to
any of the other ingredients (listed in
Section 6)
• If you are taking other medicines
containing paracetamol.
• If you are under 12 years:
• For pain relief in children and adolescents
(0-18 years of age) after removal of their
tonsils or adenoids due to obstructive
sleep apnoea syndrome
• If you know that you metabolise very
rapidly codeine into morphine
• If you are breastfeeding.

Driving and using machines

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Paracetamol, Codeine,
Caffeine

This medicine can affect your ability to
drive as it may make you sleepy or dizzy.
Do not drive while taking this medicine
until you know how it affects you. It is an
offence to drive if this medicine affects
your ability to drive.
However, you would not be committing an
offence if:
• The medicine has been taken to treat a
medical or dental problem and
• You have taken it according to the
information provided with the medicine
and
• It was not affecting your ability to drive
safely.
Talk to your doctor or pharmacist if you are
not sure whether it is safe for you to drive
while taking this medicine.
Details regarding a new driving offence
concerning driving after drugs have been
taken in the UK may be found here:
www.gov.uk/drug-driving-law

Ask your doctor before you take
this medicine:
• If you have liver or kidney disease,
including alcoholic liver disease
• If you have bowel problems including
blockage of your bowel
• If you have had an operation to remove
your gall bladder
• If you have been told by your doctor that
you have an intolerance to some sugars
• If you are on a controlled sodium diet.
Each tablet contains 427 mg of sodium.

If you are taking other medicines
Talk to your doctor or pharmacist before
taking these tablets if you are taking any
prescribed medicines; particularly
metoclopramide or domperidone (for
nausea [feeling sick] and vomiting [being
sick]); cholestyramine (to lower blood
cholesterol); monoamine oxidase inhibitors
(MAOIs) prescribed for depression in the
last 2 weeks or substances that make you
drowsy (e.g. sedatives, antidepressants or
alcohol). If you take blood thinning drugs
(anticoagulants e.g. warfarin) and you
need to take a pain reliever on a daily
basis, talk to your doctor because of the
risk of bleeding. But you can still take
occasional doses of Solpadeine Max
Soluble Tablets at the same time as
anticoagulants.

3. How to take Solpadeine Max
Soluble Tablets
Adults:
Take 2 tablets dissolved in a full
tumbler of water (200ml), every 4-6
hours as needed.
• Do not take more frequently than
every 4 hours.
• Do not take more than 8 tablets in
24 hours.
Children aged 16 – 18 years:
Take 1-2 tablets dissolved in a full
tumbler of water (200ml), every 6
hours as needed.
• Do not take more frequently than
every 6 hours.
• Do not take more than 8 tablets in
24 hours.
Children aged 12 – 15 years:
Take 1 tablet dissolved in a full
tumbler of water (200ml), every 6
hours as needed.
• Do not take more frequently than
every 6 hours.
• Do not take more than 4 tablets in
24 hours.
• Do not take more than the recommended
dose.
• Avoid too much caffeine in drinks
likecoffee and tea. High caffeine intake
can cause difficulty sleeping, shaking and
an uncomfortable feeling in the chest.
• Solpadeine Max Soluble Tablets should
not be taken by children below the age
of 12 years, due to the risk of severe
breathing problems
• This medicine should not be taken for
more than 3 days. If the pain does not
not improve after 3 days, talk to your
doctor for advice.

Warnings and precautions

1. What Solpadeine Max Soluble
Tablets do
Solpadeine Max Soluble Tablets can be
used in patients over 12 years of age for
the short-term relief of moderate pain that
is not relieved by other painkillers such as
paracetamol or ibuprofen alone.
They can be used for migraine, dental pain,
strains & sprains, backache, arthritic &
rheumatic pain and sciatica. The tablets
contain three active ingredients;
paracetamol, codeine and caffeine.
Codeine and paracetamol are both
painkillers. Codeine belongs to a group of
medicines called opioid analgesics which
act to relieve pain. It can be used on its
own or in combination with other
painkillers. Caffeine acts to further help the
effectiveness of paracetamol.

2. Check before you take
Solpadeine Max Soluble Tablets

Codeine is transformed to morphine in the
liver by an enzyme. Morphine is the
substance that produces pain relief. Some
people have a variation of this enzyme and
this can affect people in different ways. In
some people, morphine is not produced or
produced in very small quantities, and it
will not provide enough pain relief. Other
people are more likely to get serious side
effects because a very high amount of
morphine is produced. If you notice any of
the following side effects, you must stop
taking this medicine and seek immediate
medical advice: slow or shallow breathing,
confusion, sleepiness, small pupils, feeling
or being sick, constipation, lack of
appetite.
Use in children and adolescents after
surgery: Codeine should not be used for
pain relief in children and adolescents after
removal of their tonsils or adenoids due to
Obstructive Sleep Apnoea Syndrome.
Use in children with breathing problems:
Codeine is not recommended in children
with breathing problems, since the
symptoms of morphine toxicity may be
worse in these children.

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Some people may have side effects when
using this medicine. If you have any
unwanted side effects you should seek
advice from your doctor, pharmacist or
other healthcare professional.
When using this product you may
experience:
• Constipation
Stop taking this medicine and tell your
doctor immediately if you experience:
• Severe abdominal pain, dry mouth,
nausea and vomiting if you have recently
had your gall bladder removed
• Nervousness, dizziness, irritability,
drowsiness or restlessness
• Allergic reactions which may be severe
such as skin rash and itching sometimes
with swelling of the mouth or face or
shortness of breath
• Skin rash or peeling or mouth ulcers,
itching or sweating
• Nervousness, dizziness, irritability,
drowsiness or restlessness
• Breathing problems. These are more
likely if you have experienced them
before when taking other painkillers such
as ibuprofen and aspirin
• Unexplained bruising or bleeding
• Nausea, upset stomach, sudden weight
loss, loss of appetite and yellowing of
the eyes and skin
• Difficulty in urinating.
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.

How do I know if I am addicted?
If you take this medicine according to the
instructions on the pack, it is unlikely you
will become addicted to the medicine.
However, if the following apply to you it is
important that you talk to your doctor:
• You need to take the medicine for longer
periods of time.
• You need to take more than the
recommended dose.
• When you stop taking the medicine you
feel very unwell but you feel better if you
start taking the medicine again.

5. How to store Solpadeine Max
Soluble Tablets

To fit additional text the font has remained
9pt with 10pt headings but is now 95%
condensed.

Keep out of the reach and sight of
children.
Do not use this medicine after the ‘EXP’
date shown on the pack.
Protect from light and moisture

6. Further information

Active ingredients Each effervescent tablet
contains Paracetamol 500 mg, Codeine
Phosphate Hemihydrate 12.8 mg and
Caffeine 30 mg.
Other ingredients Sorbitol (E 420), sodium
saccharin, sodium bicarbonate, sodium
lauryl sulfate, citric acid, sodium carbonate,
polyvidone and dimeticone
Possible withdrawal effects
Packs of Solpadeine Max Soluble Tablets
This medicine contains codeine and can
contain 16 or 32 effervescent tablets.
cause addiction if you take it continuously
for more than 3 days. When you stop
The marketing authorisation holder is
taking it you may get withdrawal
Omega Pharma Ltd., 32 Vauxhall Bridge
symptoms. You should talk to your doctor
Road, London, SW1V 2SA, United Kingdom
or pharmacist if you think you are suffering and all enquiries should be sent to this
from withdrawal symptoms.
address.
The manufacturer is GlaxoSmithKline
Talk to a doctor at once if you take too
Dungarvan Ltd., Co. Waterford, Ireland
much of this medicine, even if you feel
well. This is because too much paracetamol or
Swiss Caps GmbH Grassingerstraße 9,
can cause delayed, serious liver damage.
83043 Bad Aibling, Germany (Aenova Group).
If your symptoms continue or your
This leaflet was last revised in July 2017.
headache becomes persistent, see your
doctor.
LF03517G 11020562

Children and adolescents

8.2

• This medicine contains codeine which can
cause addiction if you take it
continuously for more than 3 days. This
can give you withdrawal symptoms from
the medicine when you stop taking it.
• If you take a painkiller for headaches for
more than 3 days it can make them
worse.

4. Possible side effects

Pregnancy and breast feeding

Do not take Solpadeine Max
Soluble Tablets:

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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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