SOLPADEINE PLUS SOLUBLE TABLETS

Active substance: CODEINE PHOSPHATE

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2. Check before you take Solpadeine Plus Soluble 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.

Do not take Solpadeine Plus Soluble 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 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.

• 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.

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 dose contains 854 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.

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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 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.

3. How to take Solpadeine Plus Soluble Tablets
Adults and children aged 12 years and over:
Take 2 tablets dissolved in a full tumbler of water (200ml),
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.
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.

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.

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, dry mouth, nausea and vomiting if you have recently had your
gall bladder removed
• Nervousness, dizziness, irritability, drowiness or restlessness
• 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, itching or sweating
• 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, upset stomach, sudden weight loss, loss of appetite and yellowing of the
eyes and skin
• Difficulty in urinating.
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 Plus Soluble Tablets
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, sodium carbonate, polyvinylpyrrolidone and silicone fluid.
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 November 2013.

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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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