SOLPADEINE MAX TABLETS

Active substance: CODEINE PHOSPHATE HEMIHYDRATE

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• If you take a painkiller for headaches for more than 3 days it can make
them worse.

Tablets
• 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.

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

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 opoid 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.

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.

Pregnancy and breast feeding
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.

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.

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

4. Possible side effects
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, nausea and vomiting if you have recently had your
gall bladder removed

Do not take Solpadeine Max Tablets:
• 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.

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 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
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.

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• 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 November 2013.

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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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