Note: Main body font size 7pt/7.5pt File title: 9739_LF03519D_11020527_Solpadeine Max tabs PIL_v16 Item No.: 11020527 Do not take Solpadeine Max Tablets: Pregnancy and breast feeding When using this product you may experience: OPI No.: LF03519D • If you have ever had an allergic reaction to Talk to your doctor before taking Solpadeine Max • Constipation Last edit: 26th September 2017 paracetamol, codeine, other opioid painkillers or to Tablets if you are pregnant. Do not take Solpadeine Stop taking this medicine and tell your doctor any of the other ingredients (listed in Section 6) Max Tablets while you are breast-feeding. Codeine immediately if you experience: Brand: Solpadeine • If you are taking other medicines containing and morphine passes into breast milk. • Severe abdominal pain, nausea and vomiting if you Variant: MAX tablets 20 & 30s paracetamol or codeine have recently had your gall bladder removed Component: Leaet • For pain relief in children and adolescents (0-18 Driving and using machines This medicine can affect your ability to drive as it • Allergic reactions which may be severe such as skin years of age) after removal of their tonsils or rash and itching sometimes with swelling of the Market/s: UK Tablets adenoids due to obstructive sleep apnoea syndrome may make you sleepy or dizzy. Dimensions: 150 x 200mm Do not drive while taking this medicine until you mouth or face or shortness of breath • If you know that you metabolise very rapidly • Skin rash or peeling or mouth ulcers know how it affects you. Cutter guide: CG148_L607D008 codeine into morphine • Breathing problems. These are more likely if you • If you are breastfeeding. It is an offence to drive if this medicine affects your TSS le: TSS SOLP MAX_20_30_UK_AEN-v2 ability to drive. have experienced them before when taking other Ask your doctor before you take this painkillers such as ibuprofen and aspirin Printer: ... medicine: However, you would not be committing an offence • Unexplained bruising or bleeding Substrate: White paper 60g/m2 • This medicine is for the short term treatment of • If you have liver or kidney disease, including if: • Nausea, sudden weight loss, loss of appetite and acute moderate pain when other painkillers have EAN Code: N/A alcoholic liver disease • The medicine has been taken to treat a medical or yellowing of the eyes and skin. not worked. • If you have bowel problems including blockage of dental problem and Reporting of side effects: If you get any side effects, PharmaCode: 12804 • You should only take this product for a maximum your bowel • You have taken it according to the information talk to your doctor, pharmacist or nurse. This Replacement number: 11019723 of 3 days at a time. If you need to take it for • If you have had an operation to remove your gall provided with the medicine and includes any possible side effects not listed in this longer than 3 days you should see your doctor or Manufacturing Site: Aenova bladder • It was not affecting your ability to drive safely. leaflet. You can also report side effects directly via pharmacist for advice. No. of colour: 1 (Process Black) • If you have been told by your doctor that you have Talk to your doctor or pharmacist if you are not sure the Yellow Card Scheme at: • This medicine contains codeine which can cause an intolerance to some sugars. whether it is safe for you to drive while taking this www.mhra.gov.uk/yellowcard addiction if you take it continuously for more than Black medicine. By reporting side effects you can help provide more 3 days. This can give you withdrawal symptoms If you are taking other medicines Details regarding a new driving offence concerning information on the safety of this medicine. from the medicine when you stop taking it. Talk to your doctor or pharmacist before taking Cutter driving after drugs have been taken in the UK may How do I know if I am addicted? • If you take this medicine for headaches for more these tablets if you are taking any prescribed be found here: www.gov.uk/drug-driving-law than 3 days it can make them worse. medicines; particularly metoclopramide or If you take this medicine according to the Please read right through this leaflet before you domperidone (for nausea [feeling sick] or vomiting 3. How to take Solpadeine Max Tablets instructions on the pack, it is unlikely you will start using this medicine. [being sick]); colestyramine (to lower blood become addicted to the medicine. However, if the Adults: This medicine is available without prescription, but cholesterol); monoamine oxidase inhibitors (MAOIs) following apply to you it is important that you talk Swallow 2 tablets every 4-6 hours as needed. you still need to use Solpadeine Max Tablets carefully prescribed for depression or medicines that make to your doctor: Do not take more frequently than every 4 hours. to get the best results from them. you drowsy. If you take blood thinning drugs • You need to take the medicine for longer periods Do not take more than 8 tablets in 24 hours. of time. • Keep this leaflet you may need to read it again. (anticoagulants e.g. warfarin) and you need to take 81 Rivington Street, Shoreditch, • If you have any questions, or if there is anything a pain reliever on a daily basis, talk to your doctor • You need to take more than the recommended Children aged 16 – 18 years: London, EC2A 3AY, UK you do not understand, ask your pharmacist. because of the risk of bleeding. But you can still take dose. Ph Code 12804 Code Ph +44 (0)20 3008 6040 First Bar First Swallow 1-2 tablets every 6 hours as needed. occasional doses of Solpadeine Max Tablets at the • When you stop taking the medicine you feel very Do not take more frequently than every 6 hours. [email protected] In this leaflet: same time as anticoagulants. unwell but you feel better if you start taking the 1. What Solpadeine Max Tablets do Do not take more than 8 tablets in 24 hours. medicine again. Warnings and precautions 2. Check before you take Solpadeine Max Tablets 5. How to store Solpadeine Max Tablets 3. How to take Solpadeine Max Tablets Codeine is transformed to morphine in the liver by Children aged 12 – 15 years: Keep out of the reach and sight of children. 4. Possible side effects an enzyme. Morphine is the substance that produces Swallow 1 tablet every 6 hours as needed. Do not use this medicine after the ‘EXP’ date shown 5. How to store Solpadeine Max Tablets pain relief. Some people have a variation of this Do not take more frequently than every 6 hours. Marketing Approval: 6. Further information enzyme and this can affect people in different ways. Do not take more than 4 tablets in 24 hours. on the pack. In some people, morphine is not produced or 6. Further information 1. What Solpadeine Max Tablets do produced in very small quantities, and it will not • Do not take more than the recommended dose. Active ingredients Each tablet contains Paracetamol Solpadeine Max Tablets can be used in patients over provide enough pain relief. Other people are more • Solpadeine Max Tablets should not be taken by 500 mg and Codeine Phosphate Hemihydrate 12.8 mg. 12 years of age for the short-term relief of moderate likely to get serious side effects because a very high children below the age of 12 years, due to the risk Sign:............................................................................... Date:............................... pain that is not relieved by other painkillers such as amount of morphine is produced. If you notice any of severe breathing problems. Other ingredients Starch pregelatinised, povidone, paracetamol or ibuprofen alone. They can be used of the following side effects, you must stop taking • This medicine should not be taken for more than 3 maize starch, talc, magnesium stearate, stearic acid, for migraine, headache, dental pain, period pain, this medicine and seek immediate medical advice: days. If the pain does not improve after 3 days, microcrystalline cellulose, croscarmellose sodium, Name (please print):.................................................................................................... strains & sprains, backache, arthritic & rheumatic lactose monohydrate, hypromellose, macrogol, 12804 Code Ph slow or shallow breathing, confusion, sleepiness, talk to your doctor for advice. Bar First pain and sciatica. The tablets contain two active small pupils, feeling or being sick, constipation, lack quinoline yellow (E 104), erythrosine (E 127) and ingredients; paracetamol and codeine are both of appetite. Possible withdrawal effects titanium dioxide (E 171). Contact email:................................................................................................................ painkillers. Codeine belongs to a group of medicines This medicine contains codeine and can cause Packs of Solpadeine Max Tablets contain 20 or 30 called opioid analgesics which act to relieve pain. It Children and adolescents addiction if you take it continuously for more than 3 tablets with MAX embossed one side or plain on can be used on its own or in combination with other Use in children and adolescents after surgery: days. When you stop taking it you may get both sides. painkillers. Codeine should not be used for pain relief in withdrawal symptoms. You should talk to your The marketing authorisation holder is Omega children and adolescents after removal of their doctor or pharmacist if you think you are suffering Pharma Ltd, 32 Vauxhall Bridge Road, London, SW1V 2. Check before you take Solpadeine Max tonsils or adenoids due to Obstructive Sleep from withdrawal symptoms. 2SA, United Kingdom and all enquiries should be Regulatory Approval: Tablets Apnoea Syndrome. Talk to a doctor at once if you take too much of this sent to this address. Use in children with breathing problems: medicine, even if you feel well.