Date:...... Date:...... 11019723 Aenova 9739_LF03519D_11020527_Solpadeine Max tabs PIL_v16 11020527 LF03519D 26th September 2017 Solpadeine tablets 20 & 30s MAX Leaet UK 150 x 200mm 1 (Process Black) 1 (Process ... paper 60g/m2 White N/A 12804 CG148_L607D008 SOLP MAX_20_30_UK_AEN-v2 TSS Black Cutter Sign:...... Name (please print):...... email:...... Contact Sign:...... Name (please print):...... email:...... Contact Marketing Approval: Regulatory Approval: File title: File Item No.: OPI No.: Last edit: Brand: Variant: Component: Market/s: Dimensions: 81 Rivington Street, Shoreditch, London, EC2A 3AY, UK +44 (0)20 3008 6040 [email protected] Printer: Substrate: Replacement number:Replacement Manufacturing Site: of colour: No. Cutter guide: Cutter le: TSS EAN Code: PharmaCode: Page 1 of 1 Page

First Bar Ph Code 12804 Code Ph

Note: Note: 7pt/7.5pt size Main body font LF03519D 11020527 LF03519D . have recently had your gall bladder removed have recently had your gall with swelling of the rash and itching sometimes of breath mouth or face or shortness before when taking other have experienced them and aspirin painkillers such as skin. yellowing of the eyes and of time. dose. you start taking the unwell but you feel better if medicine again. Starch pregelatinised, povidone, Other ingredients maize starch, talc, magnesium stearate, stearic acid, microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, hypromellose, macrogol, quinoline yellow (E 104), erythrosine (E 127) and titanium dioxide (E 171). contain 20 or 30 Packs of Solpadeine Max Tablets tablets with MAX embossed one side or plain on both sides. The marketing authorisation holder is Omega Road, London, SW1V Bridge Pharma Ltd, 32 Vauxhall 2SA, United Kingdom and all enquiries should be sent to this address. is Omega Pharma Manufacturing The manufacturer GmbH & Co. KG, Benzstraße 25, 71083, Herrenberg, Germany or SmithKline Beecham S.A. Carretera de Ajalvir Km 2500, Alcala de Henares, 28806 Madrid, Spain or Swiss Caps GmbH Grassingerstraβe 9, 83043 Bad Aibling, Germany (Aenova Group). This leaflet was last revised in September 2017. 500 mg and Phosphate Hemihydrate 12.8 mg 500 mg and Codeine Phosphate Hemihydrate 12.8 When using this product you may experience: you When using this product • Constipation doctor Stop taking this medicine and tell your you experience: immediately if you and vomiting if • Severe abdominal pain, nausea as skin which may be severe such • Allergic reactions mouth ulcers • Skin rash or peeling or you . These are more likely if problems • Breathing or bleeding • Unexplained bruising , loss of appetite and • Nausea, sudden weight loss If you get any , Reporting of side effects: pharmacist or nurse. This talk to your doctor, not listed in this includes any possible side effects directly via can also report side effects leaflet. You Card Scheme at: the Yellow www.mhra.gov.uk/yellowcard you can help provide more By reporting side effects information on the safety of this medicine. I am addicted? How do I know if If you take this medicine according to the instructions on the pack, it is unlikely you will the if become addicted to the medicine. However, following apply to you it is important that you talk to your doctor: to take the medicine for longer periods need • You the recommended than to take more need • You • When you stop taking the medicine you feel very Solpadeine Max Tablets 5. How to store . and sight of children Keep out of the reach Do not use this medicine after the ‘EXP’ date shown on the pack. 6. Further information Each tablet contains Active ingredients dental problem and with the medicine and provided children below the age of 12 years, due to the risk of severe breathing problems. days. If the pain does not improve after 3 days, talk to your doctor for advice. Possible withdrawal effects This medicine contains codeine and can cause than 3 you take it continuously for more addiction if days. When you stop taking it you may get should talk to your withdrawal symptoms. You you think you are suffering doctor or pharmacist if from withdrawal symptoms. you take too much of this to a doctor at once if Talk you feel well. This is because too medicine, even if much paracetamol can cause delayed, serious liver damage. If your symptoms continue or your headache becomes persistent, see your doctor 4. Possible side effects when using this Some people may have side effects you medicine. If you have any unwanted side effects pharmacist or should seek advice from your doctor, other healthcare professional. Pregnancy and breast feeding and breast Pregnancy Max to your doctor before taking Solpadeine Talk Do not take Solpadeine you are pregnant. if Tablets . Codeine breast-feeding while you are Max Tablets breast milk. and morphine passes into Driving and using machines as it your ability to drive This medicine can affect dizzy. may make you sleepy or until you Do not drive while taking this medicine you. know how it affects your this medicine affects to drive if It is an offence ability to drive. you would not be committing an offence However, if: taken to treat a medical or • The medicine has been to the information taken it according have • You your ability to drive safely. • It was not affecting you are not sure to your doctor or pharmacist if Talk whether it is safe for you to drive while taking this medicine. concerning Details regarding a new driving offence driving after drugs have been taken in the UK may be found here: www.gov.uk/drug-driving-law 3. How to take Solpadeine Max 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. dose. the recommended than • Do not take more should not be taken by • Solpadeine Max Tablets 3 • This medicine should not be taken for more than

First Bar

Ph Code 12804 Code Ph LF03519D 11020527 LF03519D alcoholic liver disease your bowel bladder an intolerance to some sugars. Talk to your doctor or pharmacist before taking Talk you are taking any prescribed these tablets if medicines; particularly metoclopramide or domperidone (for nausea [feeling sick] or vomiting [being sick]); colestyramine (to lower blood (MAOIs) ); monoamine oxidase inhibitors cholesterol or medicines that make prescribed for depression . If you take blood thinning drugs you drowsy (anticoagulants e.g. warfarin) and you need to take a pain reliever on a daily basis, talk to your doctor take because of the risk of bleeding. But you can still at the occasional doses of Solpadeine Max Tablets same time as anticoagulants. and precautions Warnings by Codeine is transformed to morphine in the liver an enzyme. Morphine is the substance that produces pain relief. Some people have a variation of this ways. people in different enzyme and this can affect 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 because a very high likely to get serious side effects any amount of morphine is produced. If you notice you must stop taking of the following side effects, this medicine and seek immediate medical advice: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation, lack of appetite. and adolescents Children 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. : problems Use in children with breathing Codeine is not recommended in children with breathing problems, since the symptoms of morphine toxicity may be worse in these children. Do not take Solpadeine Max Tablets: Do not take Solpadeine to allergic reaction • If you have ever had an opioid painkillers or to paracetamol, codeine, other (listed in Section 6) any of the other ingredients containing • If you are taking other medicines paracetamol or codeine and adolescents (0-18 • For pain relief in children or of their tonsils years of age) after removal syndrome adenoids due to obstructive sleep apnoea • If you know that you metabolise very rapidly codeine into morphine . • If you are breastfeeding you take this Ask your doctor before medicine: , including • If you have liver or kidney disease including blockage of • If you have bowel problems your gall • If you have had an operation to remove have • If you have been told by your doctor that you taking other medicines If you are ablets T acute moderate pain when other painkillers have acute moderate pain when not worked. of 3 days at a time. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice. than you take it continuously for more addiction if 3 days. This can give you withdrawal symptoms from the medicine when you stop taking it. than 3 days it can make them worse. you do not understand, ask your pharmacist. 2. Check before you take Solpadeine Max 2. Check before Tablets • This medicine contains codeine which can cause than 3 you take it continuously for more addiction if days. This can give you withdrawal symptoms from the medicine when you stop taking it. • If you take a painkiller for headaches for more than 3 days it can make them worse. 1. What Solpadeine Max Tablets do 1. What Solpadeine Max Tablets can be used in patients over Solpadeine Max Tablets of moderate 12 years of age for the short-term relief by other painkillers such as pain that is not relieved paracetamol or ibuprofen alone. They can be used for migraine, headache, dental pain, period pain, strains & sprains, backache, arthritic & rheumatic pain and sciatica. The tablets contain two active ingredients; paracetamol and codeine are both painkillers. Codeine belongs to a group of medicines called opioid which act to relieve pain. It can be used on its own or in combination with other painkillers. • This medicine is for the short term treatment of • This medicine is for the only take this product for a maximum should • You • This medicine contains codeine which can cause • If you take this medicine for headaches for more you this leaflet before right through Please read start using this medicine. but This medicine is available without prescription, carefully you still need to use Solpadeine Max Tablets to get the best results from them. • Keep this leaflet you may need to read it again. there is anything • If you have any questions, or if In this leaflet: do 1. What Solpadeine Max Tablets 2. Check before you take Solpadeine Max Tablets 3. How to take Solpadeine Max Tablets 4. Possible side effects 5. How to store Solpadeine Max Tablets 6. Further information