Patient Leaflet Updated 16-Jan-2017 | Omega Pharma Ltd
Solpadeine Plus Tablets
PATIENT INFORMATION LEAFLET
Solpadeine® PLUS TABLETS
Paracetamol, Codeine, Caffeine
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 Tablets carefully to get the best results from them.
In this leaflet:
1. What Solpadeine Plus Tablets do
2. Check before you take Solpadeine Plus Tablets
3. How to take Solpadeine Plus Tablets
4. Possible side effects
5. How to store Solpadeine Plus Tablets
6. Further information
1. What Solpadeine Plus Tablets do
Solpadeine Plus 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 Tablets
Do not take Solpadeine Plus Tablets:
Ask your doctor before you take this medicine:
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 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.
Pregnancy and breast feeding
Talk to your doctor before taking Solpadeine Plus Tablets if you are pregnant. Do not take Solpadeine Plus Tablets while you are breast-feeding. Codeine and morphine passes into breast milk.
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:
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 Plus Tablets
Adults:
Swallow 2 tablets every 4-6 hours as needed.
Do not take more frequently than every 4 hours.
Do not take more than 8 tablets in 24 hours.
Children aged 16 – 18 years:
Swallow 1-2 tablets every 6 hours as needed.
Do not take more frequently than every 6 hours.
Do not take more than 8 tablets in 24 hours.
Children aged 12 – 15 years:
Swallow 1 tablet every 6 hours as needed.
Do not take more frequently than every 6 hours.
Do not take more than 4 tablets in 24 hours.
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:
Stop taking this medicine and tell your doctor immediately if you experience:
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:
5. How to store Solpadeine Plus 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, Codeine Phosphate Hemihydrate 8 mg and Caffeine 30 mg.
Other ingredients Maize starch, Starch pregelatinised, potassium sorbate (E 202), povidone, purified talc, magnesium stearate, microcrystalline cellulose, stearic acid, hypromellose, carmoisine (E 122).
Carmoisine may cause allergic reactions.
Packs of Solpadeine Plus Tablets contain 16 or 32 tablets printed with Solpadeine in red on one side or plain both sides.
The marketing authorisation holder is
and all enquiries should be sent to this address.
The manufacturer is
or
This leaflet was last revised in November 2016.
LF03523C 11017639
Omega Pharma Ltd, 1st Floor, 32 Vauxhall Bridge Road, London, SW1V 2SA, UK
+44 (0)203 598 9603
+44 (0)1748 828 860