SOLPADEINE MIGRAINE IBUPROFEN & CODEINE TABLETS

Active substance: IBUPROFEN

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40L521K (OPI)

Unexplained bruising or bleeding, sore throat, mouth ulcers, fever, extreme paleness,
weakness or exhaustion. These can be signs of blood disorders such as anaemia, low white
blood cells, low platelet count, suppressed bone marrow function or reduction in
agranulocytes (a type of white blood cell).

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.

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.

This leaflet was last revised in November 2013.

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 pain killers.

Solpadeine Migraine 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.
It can be used for migraine, headaches, period and dental pain, muscle and joint pain, backache,
fibrositis, tennis elbow, sports injuries (e.g. sprains, strains) and for pain due to non-serious arthritis.

This medicine is for the short term treatment of acute
moderate pain when other painkillers have not worked.
You should only take this medicine 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.

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.
continued...
40L521K (OPI)

Children and adolescents

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.

Warnings and precautions

:
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.

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.

Do not take Solpadeine Migraine while you are breastfeeding. Codeine and morphine passes into
breast milk.

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.
Solpadeine Migraine should not be taken by children below the age of 12 years, due to
the risk of severe breathing problems.

If you take too many tablets contact your doctor or casualty department.

Severe abdominal pain, nausea and vomiting if you have recently had your gall bladder
removed.

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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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