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SOLPADEINE MAX TABLETS

Active substance: PARACETAMOL

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1. What Solpadeine Max Tablets do
Solpadeine Max 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, arthritic & rheumatic
pain and sciatica. The tablets contain two active
ingredients; paracetamol and codeine 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.

2. Check before you take Solpadeine Max
Tablets
• 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 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 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] or vomiting
[being sick]); colestyramine (to lower blood
cholesterol); monoamine oxidase inhibitors (MAOIs)
prescribed for depression or medicines that make
you drowsy. 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 Tablets at the
same time as anticoagulants.

Warnings and precautions

Driving and using machines
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

3. How to take Solpadeine Max Tablets
Adults and children aged 12 years and over:
Swallow 2 tablets every 4 hours as needed.
• 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.
• Solpadeine Max 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 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 effects

Children and adolescents

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.

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.

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

4. Possible side effects

When using this product you may experience:
• Constipation

Stop taking this medicine and tell your doctor
immediately if you experience:
• Severe abdominal pain, nausea and vomiting if you
have recently had your gall bladder removed

• 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
• 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, sudden weight loss, loss of appetite and
yellowing of the eyes and skin.
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 Tablets
Keep out of the reach and sight of children.
Do not use this medicine after the ‘EXP’ date shown
on the pack.

6. Further information
Active ingredients Each tablet contains Paracetamol
500 mg and Codeine Phosphate Hemihydrate 12.8
mg.
Other ingredients Starch pregelatinised, povidone,
potassium sorbate (E 202), maize starch, talc,
magnesium stearate, stearic acid, microcrystalline
cellulose, croscarmellose sodium, lactose
monohydrate, hypromellose, macrogol, quinoline
yellow (E 104), erythrosine (E 127) and titanium
dioxide (E 171).
Packs of Solpadeine Max Tablets contain 20 or 30
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 or Omega Pharma
Manufacturing GmbH & Co. KG, Benzstraße 25,
71083, Herrenberg, Germany or
SmithKline Beecham S.A. Carretera de Ajalvir Km
2,500, Alcala de Henares, 28806 Madrid, Spain.
This leaflet was last revised in March 2014.

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

Ask your doctor before you take this
medicine:

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

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• 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 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.

11000010001255

Tablets

Pregnancy and breast feeding

• If you have ever had an allergic reaction to
paracetamol, 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
• 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.

11000010001255

Do not take Solpadeine Max Tablets:

9407_11000010001255_Solpadeine Max tabs PIL UK V3

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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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