Font Size 9pt /9pt FRONT BACK File title: 9460_LF03517G_11020562_Solpadeine Max Sol tabs PIL_UK_v12 Item No.: 11020562 OPI No.: LF03517G Replacement No.: 11019646 2.0 Last edit: 8th August 2017 LEADING EDGE LEADING EDGE Brand: Solpadeine Variant: Max Soluble tablets 16 & 32s Component: Lea et Market/s: UK Dimensions: 150 x 305mm Cutter Guide: CG175_OTC.LT.010_v3 Do not take Solpadeine Max Pregnancy and breast feeding 4. Possible Reel Unwind: No. 5 Inside and No. 1 outside Soluble Tablets: TSS le: TSS SOLP 16_32SOLTABMAX_UK_AEN-v1 Talk to your doctor before taking Some people may have side effects when Substrate: 60gsm whitepaper • If you have ever had an allergic reaction using this medicine. If you have any PharmaCode: 12820

8.2 Solpadeine Max Soluble Tablets if you are to , , or to unwanted side effects you should seek EAN Code: N/A pregnant. Do not take Solpadeine Max Other Code/Spec.: ... any of the other ingredients (listed in Soluble Tablets while you are advice from your doctor, pharmacist or Paracetamol, Codeine, Section 6) other healthcare professional. Manufacturing Site: Aenova Caffeine breast-feeding. Codeine and morphine Printer: ... • If you are taking other medicines passes into breast milk. When using this product you may No. of Colours: 1 containing paracetamol. experience: • If you are under 12 years: Driving and using machines • Constipation • For pain relief in children and adolescents Stop taking this medicine and tell your • This medicine is for the short term Black (0-18 years of age) after removal of their 80.0 This medicine can affect your ability to doctor immediately if you experience: treatment of acute moderate pain tonsils or adenoids due to obstructive drive as it may make you sleepy or dizzy. • Severe abdominal pain, dry mouth, when other painkillers have not sleep apnoea syndrome Do not drive while taking this medicine nausea and vomiting if you have recently Cutter worked. • If you know that you metabolise very until you know how it affects you. It is an had your gall bladder removed • You should only take this product for rapidly codeine into morphine offence to drive if this medicine affects • Nervousness, dizziness, irritability, a maximum of 3 days at a time. If • If you are breastfeeding. your ability to drive. drowsiness or restlessness 81 Rivington Street you need to take it for longer than 3 However, you would not be committing an • Allergic reactions which may be severe Shoreditch days you should see your doctor or London EC2A 3AY Ask your doctor before you take offence if: such as skin rash and itching sometimes United Kingdom pharmacist for advice. • The medicine has been taken to treat a with swelling of the mouth or face or awk contact:

this medicine: 120.0 • This medicine contains codeine medical or dental problem and Phil Hinckley • If you have liver or kidney disease, shortness of breath [email protected] which can cause addiction if you take • You have taken it according to the • Skin rash or peeling or mouth ulcers, +44 (0)7710 521027 including alcoholic liver disease +44 (0)203 008 6041 it continuously for more than 3 days. information provided with the medicine itching or sweating This can give you withdrawal • If you have bowel problems including and blockage of your bowel • Nervousness, dizziness, irritability, symptoms from the medicine when • It was not affecting your ability to drive drowsiness or restlessness you stop taking it. • If you have had an operation to remove safely. your gall bladder • Breathing problems. These are more • If you take this medicine for Talk to your doctor or pharmacist if you are likely if you have experienced them Marketing Approval: headaches for more than 3 days it • If you have been told by your doctor that not sure whether it is safe for you to drive you have an intolerance to some sugars before when taking other painkillers such can make them worse. while taking this medicine. as and aspirin • If you are on a controlled sodium diet. Details regarding a new driving offence Each tablet contains 427 mg of sodium. • Unexplained bruising or bleeding Please read right through this leaflet concerning driving after drugs have been • Nausea, upset stomach, sudden weight Sign:...... Date:...... before you start using this medicine. taken in the UK may be found here: loss, loss of appetite and yellowing of This medicine is available without If you are taking other medicines www.gov.uk/drug-driving-law the eyes and skin Name (please print):...... prescription, but you still need to use Talk to your doctor or pharmacist before • Difficulty in urinating. Solpadeine Max Soluble Tablets carefully to taking these tablets if you are taking any 3. How to take Solpadeine Max Reporting of side effects: If you get any get the best results from them. prescribed medicines; particularly Soluble Tablets Contact email:...... • Keep this leaflet you may need to read it side effects, talk to your doctor, pharmacist metoclopramide or domperidone (for Adults: or nurse. This includes any possible side again. nausea [feeling sick] and vomiting [being • If you have any questions, or if there is Take 2 tablets dissolved in a full effects not listed in this leaflet. You can sick]); cholestyramine (to lower blood tumbler of water (200ml), every 4-6 also report side effects directly via the anything you do not understand, ask your cholesterol); monoamine oxidase inhibitors pharmacist. hours as needed. Yellow Card Scheme at: Regulatory Approval: (MAOIs) prescribed for depression in the • Do not take more frequently than www.mhra.gov.uk/yellowcard last 2 weeks or substances that make you every 4 hours. By reporting side effects you can help In this leaflet: drowsy (e.g. sedatives, antidepressants or 1. What Solpadeine Max Soluble Tablets do • Do not take more than 8 tablets in provide more information on the safety of alcohol). If you take blood thinning drugs 24 hours. this medicine. Sign:...... Date:...... 2. Check before you take Solpadeine Max (anticoagulants e.g. warfarin) and you Soluble Tablets Children aged 16 – 18 years: need to take a pain reliever on a daily How do I know if I am addicted? Name (please print):...... 3. How to take Solpadeine Max Soluble basis, talk to your doctor because of the Take 1-2 tablets dissolved in a full Tablets risk of bleeding. But you can still take tumbler of water (200ml), every 6 If you take this medicine according to the 4. Possible side effects occasional doses of Solpadeine Max hours as needed. instructions on the pack, it is unlikely you Contact email:...... 5. How to store Solpadeine Max Soluble Soluble Tablets at the same time as • Do not take more frequently than will become addicted to the medicine. Tablets anticoagulants. every 6 hours. However, if the following apply to you it is 6. Further information • Do not take more than 8 tablets in important that you talk to your doctor: Warnings and precautions 24 hours. • You need to take the medicine for longer 1. What Solpadeine Max Soluble periods of time. Page 1 of 1 Tablets do Codeine is transformed to morphine in the Children aged 12 – 15 years: • You need to take more than the liver by an enzyme. Morphine is the Take 1 tablet dissolved in a full Solpadeine Max Soluble Tablets can be recommended dose. substance that produces pain relief. Some tumbler of water (200ml), every 6 • When you stop taking the medicine you used in patients over 12 years of age for people have a variation of this enzyme and hours as needed. the short-term relief of moderate pain that feel very unwell but you feel better if you this can affect people in different ways. In • Do not take more frequently than start taking the medicine again. is not relieved by other painkillers such as some people, morphine is not produced or every 6 hours. paracetamol or ibuprofen alone. produced in very small quantities, and it • Do not take more than 4 tablets in 5. How to store Solpadeine Max They can be used for migraine, dental pain, 24 hours. Soluble Tablets To fit additional text the font has remained will not provide enough pain relief. Other 9pt with 10pt headings but is now 95% strains & sprains, backache, arthritic & people are more likely to get serious side Keep out of the reach and sight of rheumatic pain and sciatica. The tablets • Do not take more than the recommended effects because a very high amount of dose. children. condensed. contain three active ingredients; morphine is produced. If you notice any of Do not use this medicine after the ‘EXP’ paracetamol, codeine and caffeine. • Avoid too much caffeine in drinks the following side effects, you must stop likecoffee and tea. High caffeine intake date shown on the pack. Codeine and paracetamol are both taking this medicine and seek immediate Protect from light and moisture painkillers. Codeine belongs to a group of can cause difficulty sleeping, shaking and medical advice: slow or shallow breathing, an uncomfortable feeling in the chest. medicines called opioid which confusion, sleepiness, small pupils, feeling 6. Further information act to relieve pain. It can be used on its • Solpadeine Max Soluble Tablets should Active ingredients Each effervescent tablet or being sick, constipation, lack of not be taken by children below the age own or in combination with other appetite. contains Paracetamol 500 mg, Codeine painkillers. Caffeine acts to further help the of 12 years, due to the risk of severe Phosphate Hemihydrate 12.8 mg and effectiveness of paracetamol. breathing problems Caffeine 30 mg. Children and adolescents • This medicine should not be taken for more than 3 days. If the pain does not Other ingredients Sorbitol (E 420), sodium 2. Check before you take Use in children and adolescents after saccharin, sodium bicarbonate, sodium surgery: Codeine should not be used for not improve after 3 days, talk to your Solpadeine Max Soluble Tablets doctor for advice. lauryl sulfate, citric acid, sodium carbonate, pain relief in children and adolescents after polyvidone and dimeticone • This medicine contains codeine which can removal of their tonsils or adenoids due to Possible withdrawal effects cause addiction if you take it Obstructive Sleep Apnoea Syndrome. This medicine contains codeine and can Packs of Solpadeine Max Soluble Tablets continuously for more than 3 days. This Use in children with breathing problems: cause addiction if you take it continuously contain 16 or 32 effervescent tablets. can give you withdrawal symptoms from Codeine is not recommended in children for more than 3 days. When you stop The marketing authorisation holder is the medicine when you stop taking it. with breathing problems, since the taking it you may get withdrawal • If you take a painkiller for headaches for Omega Pharma Ltd., 32 Vauxhall Bridge symptoms of morphine toxicity may be symptoms. You should talk to your doctor Road, London, SW1V 2SA, United Kingdom more than 3 days it can make them worse in these children. or pharmacist if you think you are suffering worse. and all enquiries should be sent to this from withdrawal symptoms. address. Talk to a doctor at once if you take too The manufacturer is GlaxoSmithKline much of this medicine, even if you feel Dungarvan Ltd., Co. Waterford, Ireland well. This is because too much paracetamol or can cause delayed, serious liver damage. Swiss Caps GmbH Grassingerstraße 9, 8.2 8.2 If your symptoms continue or your 83043 Bad Aibling, Germany (Aenova Group). headache becomes persistent, see your This leaflet was last revised in July 2017. LF03517G 11020562 doctor. LF03517G 11020562

TRAILING EDGE 12.0 12.0 TRAILING EDGE 12.0 12.0 150.0 150.0