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SOLPADEINE PLUS SOLUBLE TABLETS

Active substance: PARACETAMOL

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File title:

25th February 2015

Brand:

Solpadeine

Variant:

LEADING EDGE

LF03521A

Last edit:

LEADING EDGE

62000000001721

OPI No.:

2.0

9459_62000000001721_Solpadeine Plus Sol tabs PIL-UK_v9

Item No.:

Plus Soluble tablets

Component: Leaflet

8.8

Market/s:

1. What Solpadeine Plus Soluble
Tablets do
Solpadeine Plus 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,
headache, dental pain, period pain,
strains & sprains, backache, 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 Plus Soluble Tablets

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.

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 Plus
Soluble Tablets at the same time as
anticoagulants.

Soluble Tablets

• 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 Plus 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.

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.

Possible withdrawal effect
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.

Children and adolescents
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

TRAILING EDGE
12.0

150.0

12.0

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:...............................................................................

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

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

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

Regulatory Approval:
Sign:...............................................................................

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

Page 1 of 1

Keep out of the reach and sight of
children.
Do not use this medicine after the ‘EXP’
date shown on the pack.
Store below 30°C.

6. Further information
Active ingredients Each capsule contains
Paracetamol 500 mg, Codeine Phosphate
Hemihydrate 8 mg and Caffeine 30 mg.
Other ingredients Sodium bicarbonate,
sorbitol powder (E 420), saccharin
sodium, sodium lauryl sulfate, citric acid,
2.0
sodium carbonate, polyvinylpyrrolidone
and silicone fluid.

8.0

Packs of Solpadeine Plus 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.
LF03521A - 62000000001721

TRAILING EDGE
150.0

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

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

5. How to store Solpadeine Plus
Soluble Tablets

Some people may have side effects when

12.0

No. of colour: 1

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.

4. Possible side effects

LF03521A - 62000000001721

Manufacturing Site: GSK Dungarvan

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.

Warnings and precautions

Replacement number: 40L528D

30.0

In this leaflet:
1. What Solpadeine Plus Soluble Tablets
do
2. Check before you take Solpadeine Plus
Soluble Tablets
3. How to take Solpadeine Plus Soluble
Tablets
4. Possible side effects
5. How to store Solpadeine Plus Soluble
Tablets
6. Further information

• 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 dose contains 854 mg of
sodium.

Reel Unwind Direction: No. 5 Inside and No. 1 outside
PharmaCode: 534

Right
hand bar

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 Plus 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.

Ask your doctor before you take
this medicine:

60gsm whitepaper

Specification: OTC.LT.SPEC.010

Left
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.

Chesapeake Tewkesbury

Substrate:

using this medicine. If you have any
unwanted side effects you should seek
advice from your doctor, pharmacist or
other healthcare professional.
Pregnancy and breast feeding
When using this product you may
experience:
Talk to your doctor before taking
• Constipation
Solpadeine Plus Soluble Tablets if you are Stop taking this medicine and tell your
pregnant. Do not take Solpadeine Plus
doctor immediately if you experience:
Soluble Tablets while you are
• Severe abdominal pain, dry mouth,
breast-feeding. Codeine and morphine
nausea and vomiting if you have
passes into breast milk.
recently had your gall bladder removed
• Nervousness, dizziness, irritability,
Driving and using machines
drowsiness or restlessness
• Allergic reactions which may be severe
This medicine can affect your ability to
such as skin rash and itching sometimes
drive as it may make you sleepy or dizzy.
with swelling of the mouth or face or
Do not drive while taking this medicine
shortness of breath
until you know how it affects you. It is
• Skin rash or peeling or mouth ulcers,
an offence to drive if this medicine
itching or sweating
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
are not sure whether it is safe for you to side effects, talk to your doctor,
pharmacist or nurse. This includes any
drive while taking this
possible side effects not listed in this
medicine.
leaflet. You can also report side effects
Details regarding a new driving offence
concerning driving after drugs have been directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
taken in the UK may be found here:
By reporting side effects you can help
www.gov.uk/drug-driving-law
provide more information on the safety
of this medicine.
3. How to take Solpadeine Plus

8.2

Paracetamol, Codeine,
Caffeine

• If you have ever had an allergic
reaction to paracetamol, caffeine,
codeine, other opioid painkillers or to
any of the other ingredients (listed in
Section 6)
• If you are taking other medicines
containing paracetamol or codeine
• 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:

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

8.2

8.2

Do not take Solpadeine Plus
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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