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 belongs to a group of medicines called opioid analgesics which act to relieve pain. Paracetamol is another analgesic to relieve pain. Caffeine acts to further help the effectiveness of paracetamol.
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 Swiss Caps GmbH Grassingerstra?e 9, 83043 Bad Aibling, Germany (Aenova Group).
Adults:
Take 2 tablets dissolved in a full tumbler of water (200ml), 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:
Take 1-2 tablets dissolved in a full tumbler of water (200ml), 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:
Take 1 tablet dissolved in a full tumbler of water (200ml), every 6 hours as needed. Do not take more frequently than every 6 hours. Do not take more than 4 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 improve after 3 days, talk to your doctor for advice.
Active ingredients: Each effervescent tablet 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.
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.
Do not take Solpadeine Plus Soluble Tablets:
- If you have ever had an allergic reaction to paracetamol, caffeine, codeine, other opioid painkillers or to any of the other ingredients listed in the ingredients section.
- 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.
Talk to your doctor or pharmacist before taking Solpadeine Plus Soluble Tablets:
- If you are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal substances Taking codeine (an active ingredient of this medicine) regularly for a long time can lead to addiction and misuse, which may result in overdose and/or death. Do not take this medicine longer than needed. Do not give this medicine to anyone else.
- 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 contains 427 mg of sodium
Children and adolescents
- Use in children and adolescents after surgery: Codeine should not be used for pain relief in children and adolescents after the 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 Breastfeeding
- 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.
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.
- 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.
