FRONT LEADING EDGE File title: 9034_SOLPM00890812v1_Solpadeine Max Soluble tabs PIL v5F Item No.: 40L564D(OPI) Last edit: 22nd November 2013 8.2mm  This medicine is for the short term Brand: Solpadeine treatment of acute moderate pain Do not take Solpadeine Max Soluble Tablets: when other painkillers have not If you have ever had an allergic reaction Variant: MAX soluble tablets worked.  You should only take this product for taking other medicines containing . Component: Leaflet a maximum of 3 days at a time. If under 12 years: you need to take it for longer than 3 For pain relief in children and adolescents (0-18 years of age) after removal Market/s: UK of their tonsils or adenoids due to obstructive sleep apnoea syndrome days you should see your doctor Dimensions: 150 x 105mm (Drw No. OTC.LT.008) or pharmacist for advice. If you know that you metabolise very rapidly into morphine If you are breastfeeding.  This medicine contains codeine, which can cause addition if you take it 64.2mm Copy position: 1 OUTSIDE, 5 INSIDE print continuously for more than 3 days. This can give you withdrawal Ask your doctor before you take this medicine: symptoms from the medicine when you stop taking it. Printer: Chesapeake St Pierre  If you take this medicine for headaches for more than 3 days, it can make liver kidney disease alcoholic liver disease them worse. bowel problems Substrate: Paper Please read right through this leaflet before you start using this medicine. operation to remove your gall bladder intolerance to EAN Code: N/A some sugars controlled sodium diet. 854 mg PharmaCode: 413 of sodium. Replacement number: 40L564C If you are taking other medicines Manufacturing Site: Dungarvan In this leaflet: metoclopramide Spec Ref: OTC.LT.SPEC.008 domperidone nausea vomiting No. of colour: 1 105mm colestyramine blood cholesterol monoamine oxidase inhibitors depression drowsy blood thinning drugs anticoagulants warfarin Process Black talk to your doctor 1. What Solpadeine Max Soluble Tablets do occasional Solpadeine Max Soluble Tablets can be used in patients over 12 years of age for Eye mark 8mm the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or alone. Warnings and precautions high x 2mm wide. They can be used for migraine, dental pain, strains & sprains, backache, arthritic & Codeine is transformed to morphine in the liver by an enzyme. Morphine is the Front panel only RHS rheumatic pain and sciatica. The tablets contain three active ingredients; substance that produces pain relief. Some people have a variation of this enzyme of web, centred in a paracetamol, codeine and . Codeine and paracetamol are both painkillers. and this can affect people in different ways. In some people, morphine is not Codeine belongs to a group of medicines called opioid which act to produced or produced in very small quantities, and it will not provide enough clear margin. Centre 81 Rivington Street relieve pain. It can be used on its own or in combination with other painkillers. pain relief. Other people are more likely to get serious because a very of eye mark to be Caffeine acts to further help the effectiveness of paracetamol. high amount of morphine is produced. If you notice any of the following side Shoreditch 2. Check before you take Solpadeine Max effects, you must stop taking this medicine and seek immediate medical advice: 64.2mm from London EC2A 3AY slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being leading edge. Soluble Tablets sick, constipation, lack of appetite. UK awk contact: contains codeine cause addiction Children and adolescents more than 3 days. withdrawal symptoms There is to be a 2mm Phil Hinckley Use in children and adolescents after surgery: Codeine should not be used for clear (print free) [email protected] more than 3 days, make them pain relief in children and adolescents after removal of their tonsils or adenoids +44 (0)7710 521027 worse. due to Obstructive Sleep Apnoea Syndrome. 40L564D(OPI) gap between eye +44 (0)203 008 6041 mark and text. 5.8mm

TRAILING EDGE Regulatory Approval: 150mm

Sign:...... Date:...... 11mm 12mm Name (please print):......

Contact email:......

Marketing Approval: BACK LEADING EDGE

Sign:...... 8.2mm Use in children with breathing problems: Allergic reactions Name (please print):...... Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children. Skin rash peeling mouth ulcers itching sweating

Pregnancy and breast feeding Breathing problems. Contact email:...... Talk to your doctor bruising bleeding pregnant. Do not take Solpadeine Max Soluble Tablets while you are breast-feeding. Nausea, upset stomach, weight loss, loss of appetite yellowing of Codeine and morphine passes into breast milk. the eyes and skin Difficulty urinating. 3. How to take Solpadeine Max Soluble Tablets 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. Take 2 tablets dissolved in a full tumbler of water You can also report side effects directly via the Yellow Card Scheme at: Profile Keys: (200 ml), every 4 hours as needed. www.mhra.gov.uk/yellowcard every 4 hours. By reporting side effects you can help provide more information on the safety of 8 tablets in 24 hours. this medicine. more than the recommended dose. How do I know if I am addicted? Avoid too much caffeine in drinks like coffee and tea. First bar difficulty sleeping, shaking Copy/Text Free Pharma Code uncomfortable feeling in the chest. Solpadeine Max Soluble Tablets should not be taken by children below talk to your doctor: the age of 12 years, due to the risk of severe breathing problems longer periods of time. PHARMACODE: This medicine should not be taken for more than 3 days. If the pain does more than the recommended dose. Code 8mm high. On back, not improve after 3 days, talk to your doctor for advice. 105mm feel code on LHS of web, last better if you start taking the medicine again. Possible withdrawal effects bar to be 30mm from trailing PAGE 1 OF 1 contains codeine cause addiction 5. How to store Solpadeine Max Soluble Tablets more than 3 days. edge. First bar to be nearest withdrawal symptoms. talk to your doctor or pharmacist Keep out of the reach and sight of children. to leading edge. Reading from right to left. 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. 6. Further information There is to be 1mm gap a see your doctor. Active ingredients between pharmacode and Other ingredients text . 4. Possible side effects Last bar 30mm The marketing authorisation holder is Omega Pharma Ltd., 32 Vauxhall Bridge When using this product you may experience: Road, London, SW1V 2SA, United Kingdom and all enquiries should be sent to this address. Stop taking tell your doctor immediately The manufacturer abdominal pain, dry mouth, nausea vomiting This leaflet was last revised in November 2013.

40L564D(OPI) SOLPM00890812v1 5.8mm

TRAILING EDGE 150mm

12mm 11mm