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SOLPADEINE MAX SOLUBLE TABLETS

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

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File title:

9460_62000000001746_Solpadeine Max Sol tabs PIL-UK_V7

Item No.:

62000000001746

OPI No.:

LF03516A

Last edit:

20th February 2015

Brand:

Solpadeine

Variant:

Max Soluble tablets

Component: Leaflet

8.8

Market/s:

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 2 tablet dose contains 854 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
In this leaflet:
cholesterol); monoamine oxidase
1. What Solpadeine Max Soluble Tablets
inhibitors (MAOIs) prescribed for
do
depression in the last 2 weeks or
2. Check before you take Solpadeine Max substances that make you drowsy (e.g.
Soluble Tablets
sedatives, antidepressants or alcohol). If
3. How to take Solpadeine Max Soluble
you take blood thinning drugs
Tablets
(anticoagulants e.g. warfarin) and you
4. Possible side effects
need to take a pain reliever on a daily
5. How to store Solpadeine Max Soluble
basis, talk to your doctor because of the
Tablets
risk of bleeding. But you can still take
6. Further information
occasional doses of Solpadeine Max
Soluble Tablets at the same time as
anticoagulants.
1. What Solpadeine Max Soluble

Tablets do

2. Check before you take
Solpadeine Max Soluble Tablets

Possible withdrawal effects

This medicine contains codeine and can
cause addiction if you take it
continuously for more than 3 days.
When you stop taking it you may get
withdrawal symptoms. You should talk
to your doctor or pharmacist if you think
you are suffering from withdrawal
symptoms.
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.
If your symptoms continue or your
headache becomes persistent, see your
doctor.

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

4. Possible side effects
8.2

8.2

• Do not take more frequently than
every 4 hours.
• Do not take more than 8 tablets in
24 hours.
• Do not take more than the
recommended dose.
• Avoid too much caffeine in drinks
like coffee 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.

Children and adolescents

• 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.

Some people may have side effects when
using this medicine. If you have any
unwanted side effects you should seek

LF03516A - 62000000001746

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12.0

150.0

Replacement number: 40L564D
Manufacturing Site: GSK Dungarvan
No. of colour: 1

Black
Cutter

81 Rivington Street
Shoreditch
London EC2A 3AY
United Kingdom
awk contact:
Phil Hinckley
phil@oneagency.co
+44 (0)7710 521027
+44 (0)203 008 6041

Marketing Approval:
Sign:...............................................................................

12.0

12.0

Date:...............................

Name (please print):....................................................................................................

Contact email:................................................................................................................

Regulatory Approval:

How do I know if I am addicted?

Adults and children aged 12 years
and over:
Take 2 tablets dissolved in a full
tumbler of water (200ml), every 4
hours as needed.

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.

60gsm whitepaper

PharmaCode: 535

Soluble Tablets

Warnings and precautions

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.

Chesapeake Tewkesbury

Substrate:

Reel Unwind Direction: No. 5 Inside and No. 1 outside

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.

Sign:...............................................................................

Contact email:................................................................................................................

Page 1 of 1

5. How to store Solpadeine Max
Soluble Tablets
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 capsule contains
Paracetamol 500 mg, Codeine Phosphate
Hemihydrate 12.8 mg and Caffeine 30
mg.
Other ingredients Sorbitol (E 420),
sodium saccharin, sodium bicarbonate,
2.0
sodium lauryl sulfate, citric acid, sodium
carbonate, polyvidone and dimeticone

8.0

Packs of Solpadeine Max Soluble Tablets
contain 16 or 32 effervescent tablets.
The marketing authorisation holder is
Omega Pharma Ltd., 32 Vauxhall Bridge
Road, London, SW1V 2SA, United
Kingdom and all enquiries should be sent
to this address.
The manufacturer is GlaxoSmithKline
Dungarvan Ltd., Co. Waterford, Ireland.
This leaflet was last revised in February
2015.
LF03516A - 62000000001746

TRAILING EDGE
150.0

Date:...............................

Name (please print):....................................................................................................

30.0

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.

• 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.

Printer:

Specification: OTC.LT.SPEC.010

Right
hand bar

• 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.

advice from your doctor, pharmacist or
other healthcare professional.
When using this product you may
experience:
Pregnancy and breast feeding
• Constipation
Stop taking this medicine and tell your
Talk to your doctor before taking
doctor immediately if you experience:
Solpadeine Max Soluble Tablets if you
• Severe abdominal pain, dry mouth,
are pregnant. Do not take Solpadeine
nausea and vomiting if you have
Max Soluble Tablets while you are
recently had your gall bladder removed
breast-feeding. Codeine and morphine
• Nervousness, dizziness, irritability,
passes into breast milk.
drowsiness or restlessness
• Allergic reactions which may be severe
Driving and using machines
such as skin rash and itching sometimes
with swelling of the mouth or face or
This medicine can affect your ability to
shortness of breath
drive as it may make you sleepy or dizzy. • Skin rash or peeling or mouth ulcers,
Do not drive while taking this medicine
itching or sweating
until you know how it affects you. It is
• Nervousness, dizziness, irritability,
an offence to drive if this medicine
drowsiness or restlessness
affects your ability to drive.
• Breathing problems. These are more
However, you would not be committing
likely if you have experienced them
an offence if:
before when taking other painkillers
• The medicine has been taken to treat a
such as ibuprofen and aspirin
medical or dental problem and
• Unexplained bruising or bleeding
• You have taken it according to the
• Nausea, upset stomach, sudden weight
information provided with the
loss, loss of appetite and yellowing of
medicine and
the eyes and skin
• It was not affecting your ability to drive • Difficulty in urinating.
safely.
Reporting of side effects: If you get any
Talk to your doctor or pharmacist if you
side effects, talk to your doctor,
are not sure whether it is safe for you to pharmacist or nurse. This includes any
drive while taking this medicine.
possible side effects not listed in this
Details regarding a new driving offence
leaflet. You can also report side effects
concerning driving after drugs have been directly via the Yellow Card Scheme at:
taken in the UK may be found here:
www.mhra.gov.uk/yellowcard
www.gov.uk/drug-driving-law
By reporting side effects you can help
provide more information on the safety
3. How to take Solpadeine Max
of this medicine.

Left
hand bar

Paracetamol, Codeine,
Caffeine

with breathing problems, since the
symptoms of morphine toxicity may be
worse in these children.

8.2

8.2

Do not take Solpadeine Max
Soluble Tablets:

UK

Dimensions: 150 x 305mm (ref: OTC.LT.010)

12.0

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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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