Note: File title: 10667_LF03513G_CR04256_Solpadeine Plus Capsules PIL UK v02 Main body font size 7pt Item No.: 11024222 OPI No.: LF03513G Last edit: 1st July 202 Brand: Solpadeine Variant: Plus Capsules 32 Component: Leaflet Market/s: UK Dimensions: 150 x 200mm Cutter guide: CG148_L607D008 Do not take Solpadeine Plus Capsules: Pregnancy and breast feeding When using this product you may experience: • If you have ever had an allergic reaction to Talk to your doctor before taking Solpadeine Plus • Constipation TSS file: TSS SOLP 32CAP_PLUS_UK_AEN-v2 paracetamol, caffeine, codeine, other opioid Capsules if you are pregnant. Do not take Stop taking this medicine and tell your doctor Printer: N/A painkillers or to any of the other ingredients (listed Solpadeine Plus Capsules while you are immediately if you experience: Substrate: Uncoated paper, white, 60g/m2 • Severe abdominal pain, dry mouth, nausea and in Section 6) breast-feeding. Codeine and morphine passes EAN Code: N/A into breast milk. vomiting if you have recently had your gall bladder • If you are taking other medicines containing Driving and using machines PharmaCode: 15372 paracetamol or codeine removed This medicine can affect your ability to drive as it • Nervousness, dizziness, irritability, drowsiness or Replacement number: 11019721 If you are under 12 years: may make you sleepy or dizzy. restlessness Manufacturing Site: Aenova Paracetamol, Codeine, • For pain relief in children and adolescents (0-18 Do not drive while taking this medicine until you • Allergic reactions which may be severe such as skin Caffeine years of age) after removal of their tonsils or know how it affects you. It is an offence to drive if rash and itching No. of colour: 1 adenoids due to obstructive sleep apnoea this medicine affects your ability to drive. • Skin rash or peeling or mouth ulcers; itching or syndrome However, you would not be committing an offence if: sweating Black Cutter • This medicine is for the short term treatment of • If you know that you metabolise very rapidly • The medicine has been taken to treat a medical or • Breathing problems. These are more likely if you acute moderate pain when other painkillers have codeine into morphine dental problem and have experienced them before when taking other not worked. If you are breastfeeding. 80mm • You have taken it according to the information painkillers such as ibuprofen and aspirin • You should only take this product for a maximum Ask your doctor before you take this medicine: provided with the medicine and • Unexplained bruising or bleeding of 3 days at a time. If you need to take it for • If you have liver or kidney disease, including • It was not affecting your ability to drive safely. • Nausea, upset stomach, sudden weight loss, loss of longer than 3 days you should see your doctor or alcoholic liver disease Talk to your doctor or pharmacist if you are not sure appetite and yellowing of the eyes and skin pharmacist for advice. • If you have bowel problems including blockage of whether it is safe for you to drive while taking this • Difficulty urinating. your bowel medicine. Reporting of side effects: If you get any side effects, • This medicine contains codeine which can cause talk to your doctor, pharmacist or nurse. This addiction if you take it continuously for more than • If you have had an operation to remove your gall Details regarding a new driving offence concerning

includes any possible side effects not listed in this 120mm 3 days. This can give you withdrawal symptoms bladder. driving after drugs have been taken in the UK may 81 Rivington Street, Shoreditch, be found here: www.gov.uk/drug-driving-law leaflet. You can also report side effects directly via from the medicine when you stop taking it. If you are taking other medicines the Yellow Card Scheme at: London, EC2A 3AY, UK • If you take this medicine for headaches for more Talk to your doctor or pharmacist before taking 3. How to take Solpadeine Plus Capsules www.mhra.gov.uk/yellowcard +44 (0)20 3008 6040 than 3 days it can make them worse. [email protected] these capsules if you are taking any prescribed Adults: By reporting side effects you can help provide more Please read right through this leaflet before you medicines; particularly metoclopramide or Swallow 2 capsules every 4-6 hours as needed. information on the safety of this medicine. start using this medicine. domperidone (for nausea [feeling sick] or vomiting Do not take more than 8 capsules in 24 hours. How do I know if I am addicted? This medicine is available without prescription, but [being sick]); colestyramine (to lower blood For the elderly a reduced dose may be required. If you take this medicine according to the you still need to use Solpadeine Plus Capsules cholesterol); monoamine oxidase inhibitors (MAOIs) instructions on the pack, it is unlikely you will carefully to get the best results from them. prescribed for depression in the last 2 weeks or Children aged 16 – 18 years: become addicted to the medicine. However, if the Marketing Approval: • Keep this leaflet you may need to read it again. substances that make you drowsy (e.g. sedatives, Swallow 1-2 capsules every 6 hours as needed. following apply to you it is important that you talk • If you have any questions, or if there is anything antidepressants or alcohol). If you take blood Children aged 12-15 years: to your doctor: you do not understand, ask your pharmacist. thinning drugs (anticoagulants e.g. warfarin) and Swallow 1 capsule every 6 hours as needed. • You need to take the medicine for longer periods In this leaflet: you need to take a pain reliever on a daily basis, talk Do not take more than 4 capsules in 24 hours. of time. Sign:...... Date:...... 1. What Solpadeine Plus Capsules do to your doctor because of the risk of bleeding. But • Do not take more than the recommended dose • You need to take more than the recommended dose. 2. Check before you take Solpadeine Plus Capsules you can still take occasional doses of Solpadeine Plus • Avoid too much caffeine in drinks like coffee and • When you stop taking the medicine you feel very 3. How to take Solpadeine Plus Capsules Capsules at the same time as anticoagulants. tea. High caffeine intake can cause difficulty unwell but you feel better if you start taking the Name (please print):...... medicine again. 4. Possible side effects Warnings and precautions sleeping, shaking and an uncomfortable feeling in 5. How to store Solpadeine Plus Capsules Codeine is transformed to morphine in the liver by the chest 5. How to store Solpadeine Plus Capsules 6. Further information an enzyme. Morphine is the substance that produces • Solpadeine Plus Capsules should not be taken by Keep out of the reach and sight of children. Contact email:...... 1. What Solpadeine Plus Capsules do pain relief. Some people have a variation of this children below the age of 12 years, due to the risk Do not use this medicine after the ‘EXP’ date shown enzyme and this can affect people in different ways. of severe breathing problems on the pack. Store below 25°C. Solpadeine Plus Capsules can be used in patients • This medicine should not be taken for more than 3 over 12 years of age for the short-term relief of In some people, morphine is not produced or 6. Further information produced in very small quantities, and it will not days. If the pain does not improve after 3 days, moderate pain that is not relieved by other talk to your doctor for advice. Active ingredients Each capsule contains Paracetamol painkillers such as paracetamol or ibuprofen alone. provide enough pain relief. Other people are more 500 mg, Codeine Phosphate Hemihydrate 8 mg and Regulatory Approval: Possible withdrawal effect They can be used for migraine, headache, dental likely to get serious side effects because a very high Caffeine 30 mg. This medicine contains codeine and can cause pain, period pain, strains & sprains, backache, amount of morphine is produced. If you notice any addiction if you take it continuously for more than 3 Other ingredients Maize starch, magnesium stearate, rheumatic pain and sciatica. The capsules contain of the following side effects, you must stop taking this medicine and seek immediate medical advice: days. When you stop taking it you may get titanium dioxide (E 171), erythrosine (E 127), patent three active ingredients; paracetamol, codeine and Sign:...... Date:...... withdrawal symptoms. You should talk to your blue V (E 131), quinoline yellow (E 104), gelatin. caffeine. Codeine belongs to a group of medicines slow or shallow breathing, confusion, sleepiness, doctor or pharmacist if you think you are suffering Packs of Solpadeine Plus Capsules contain 16 or 32 called opioid analgesics which act to relieve pain. small pupils, feeling or being sick, constipation, lack from withdrawal symptoms. capsules, they have an opaque red cap and opaque Paracetamol is another analgesic to relieve pain. of appetite. Name (please print):...... Talk to a doctor at once if you take too much of this white body, plain on both halves. Caffeine acts to further help the effectiveness of Children and adolescents medicine, even if you feel well. This is because too paracetamol. Use in children and adolescents after surgery: The marketing authorisation holder is Omega Codeine should not be used for pain relief in much paracetamol can cause delayed, serious liver Pharma Ltd., 32 Vauxhall Bridge Road, London, Contact email:...... 2. Check before you take Solpadeine Plus damage. If your symptoms continue or your SW1V 2SA, United Kingdom and all enquiries Capsules children and adolescents after removal of their tonsils or adenoids due to Obstructive Sleep headache becomes persistent, see your doctor. should be sent to this address. • This medicine contains codeine which can cause Apnoea Syndrome. 4. Possible side effects The manufacturer is SmithKline Beecham S.A., addiction if you take it continuously for more than Use in children with breathing problems: Carretera de Ajalvir, Km 2500, 28806 Alcala De 3 days. This can give you withdrawal symptoms Some people may have side effects when using this Codeine is not recommended in children with Henares, Madrid, Spain or from the medicine when you stop taking it. medicine. If you have any unwanted side effects you breathing problems, since the symptoms of Swiss Caps GmbH Grassingerstraße 9 Page 1 of 1 • This medicine contains paracetamol. Do not take should seek advice from your doctor, pharmacist or morphine toxicity may be worse in these children. 83043 Bad Aibling, Germany (Aenova Group). anything else containing paracetamol while taking other healthcare professional. This leaflet was last revised in September 2019. this medicine. • If you take a painkiller for headaches for more than 3 days it can make them worse. LF03513G 11024222 LF03513G 11024222