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SOLPADEINE PLUS SOLUBLE TABLETS

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

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BACK

LEADING EDGE

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 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.
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

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

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 Plus
Soluble Tablets at the same time as
anticoagulants.

Warnings and precautions
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.

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

8.2

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.

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
Driving and using machines
Stop taking this medicine and tell your
doctor immediately if you experience:
This medicine can affect your ability to
drive as it may make you sleepy or dizzy. • Severe abdominal pain, dry mouth,
nausea and vomiting if you have
Do not drive while taking this medicine
recently had your gall bladder removed
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.
• Allergic reactions which may be severe
However, you would not be committing
such as skin rash and itching sometimes
an offence if:
with swelling of the mouth or face or
• The medicine has been taken to treat a
shortness of breath
medical or dental problem and
• Skin rash or peeling or mouth ulcers,
• You have taken it according to the
itching or sweating
information provided with the
• Breathing problems. These are more
medicine and
likely if you have experienced them
• It was not affecting your ability to drive
before when taking other painkillers
safely.
such as ibuprofen and aspirin
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to • Unexplained bruising or bleeding
• Nausea, upset stomach, sudden weight
drive while taking this
loss, loss of appetite and yellowing of
medicine.
the eyes and skin
Details regarding a new driving offence
concerning driving after drugs have been • Difficulty in urinating.
taken in the UK may be found here:
Reporting of side effects: If you get any
www.gov.uk/drug-driving-law
side effects, talk to your doctor,
pharmacist or nurse. This includes any
3. How to take Solpadeine Plus
possible side effects not listed in this
Soluble Tablets
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
Adults:
www.mhra.gov.uk/yellowcard
Take 2 tablets dissolved in a full
By reporting side effects you can help
tumbler of water (200ml), every 4-6 provide more information on the safety
hours as needed.
of this medicine.
Do not take more frequently than
How do I know if I am addicted?
every 4 hours.
Do not take more than 8 tablets in
If you take this medicine according to
24 hours.
the instructions on the pack, it is unlikely
Children aged 16 – 18 years:
you will become addicted to the
Take 1-2 tablets dissolved in a full
medicine. However, if the following
tumbler of water (200ml), every 6
apply to you it is important that you talk
hours as needed.
to your doctor:
Do not take more frequently than
• You need to take the medicine for
every 6 hours.
longer periods of time.
Do not take more than 8 tablets in
• You need to take more than the
24 hours.
recommended dose.
Children aged 12 – 15 years:
• When you stop taking the medicine
Take 1 tablet dissolved in a full
you feel very unwell but you feel better
tumbler of water (200ml), every 6
if you start taking the medicine again.
hours as needed.
Do not take more frequently than
5. How to store Solpadeine Plus
every 6 hours.
Soluble Tablets
Do not take more than 4 tablets in
Keep out of the reach and sight of
24 hours.
children.
Do not take more than the
Do not use this medicine after the ‘EXP’
recommended dose.
date shown on the pack.
• Avoid too much caffeine in drinks like
Store below 30°C.
coffee and tea. High caffeine intake
6. Further information
can cause difficulty sleeping, shaking
Active ingredients Each effervescent
and an uncomfortable feeling in the
tablet contains Paracetamol 500 mg,
chest.
• Solpadeine Plus Soluble Tablets should Codeine Phosphate Hemihydrate 8 mg
not be taken by children below the age and Caffeine 30 mg.
Other ingredients Sodium bicarbonate,
of 12 years, due to the risk of severe
sorbitol powder (E 420), saccharin
breathing problems.
sodium, sodium lauryl sulfate, citric acid,
• This medicine should not be taken for
sodium carbonate, polyvinylpyrrolidone
more than 3 days. If the pain does not
and silicone fluid.
improve after 3 days, talk to your
doctor for advice.
Packs of Solpadeine Plus Soluble Tablets
contain 16 or 32 effervescent tablets.
Possible withdrawal effect
This medicine contains codeine and can
The marketing authorisation holder is
cause addiction if you take it
Omega Pharma Ltd., 32 Vauxhall Bridge
continuously for more than 3 days.
Road, London, SW1V 2SA, United
When you stop taking it you may get
Kingdom and all enquiries should be sent
withdrawal symptoms. You should talk
to this address.
to your doctor or pharmacist if you think
The manufacturer is GlaxoSmithKline
you are suffering from withdrawal
Dungarvan Ltd., Co. Waterford, Ireland
symptoms.
or
Talk to a doctor at once if you take too
Swiss Caps GmbH Grassingerstraβe 9,
much of this medicine, even if you feel
83043 Bad Aibling, Germany (Aenova
well. This is because too much
Group).
paracetamol can cause delayed, serious
This leaflet was last revised in July 2017.
liver damage.
If your symptoms continue or your
headache becomes persistent, see your
doctor.
LF03522E 11020526
Talk to your doctor before taking
Solpadeine Plus Soluble Tablets if you are
pregnant. Do not take Solpadeine Plus
Soluble Tablets while you are
breast-feeding. Codeine and morphine
passes into breast milk.

• 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.

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8.2

Paracetamol, Codeine,
Caffeine

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4. Possible side effects

Pregnancy and breast feeding

Do not take Solpadeine Plus
Soluble Tablets:

11020526

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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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