Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Codeine phosphate; Paracetamol
Phoenix Labs Ltd
N02AJ06
Codeine phosphate; Paracetamol
30mg ; 500mg
Effervescent tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070100; GTIN: 5000283605119 5000283652892
420543 (alt 420419 ) GMID 772999 (alt 762057) PB Solpadol 500/30mg GB Operator S.Goette 148 x 210 DC Code 344 Pantone Reflex Blue min. 9pt Ocean San pro san - Version 4 Seite 3 Seite 1 1 3 PACKAGE INFORMATION LEAFLET SOLPADOL 30MG/500MG EFFERVESCENT TABLETS Codeine Phosphate and Paracetamol THIS MEDICINE CONTAINS CODEINE WHICH IS AN OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY. Is this leafl et hard to see or read? Phone 08453727101 for help READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Keep this leafl et. You may need to read it again. • If you have further questions, please ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effect not listed in this leafl et, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Solpadol is and what it is used for 2. What you need to know before you take Solpadol 3. How to take Solpadol 4. Possible side effects 5. How to store Solpadol 6. Further information 1. WHAT SOLPADOL IS AND WHAT IT IS USED FOR The name of your medicine is Solpadol 30mg/500mg Effervescent Tablets (called Solpadol throughout this leafl et). This medicine has been prescribed for you for the relief of severe pain. Solpadol can be used in children over 12 years of age for the short-term relief of moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. Solpadol contains codeine which belongs to a class of medicines called opioids, which are ‘pain relievers’. It also contains paracetamol, another analgesic to relieve pain. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is ap Perskaitykite visą dokumentą
OBJECT 1 SOLPADOL 30MG/500MG EFFERVESCENT TABLETS Summary of Product Characteristics Updated 26-Mar-2020 | SANOFI • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Solpadol 30mg/500mg Effervescent Tablets 2. Qualitative and quantitative composition ACTIVE CONSTITUENTS Paracetamol 500.0mg Codeine Phosphate Hemihydrate 30.0mg For excipients see 6.1. 3. Pharmaceutical form Effervescent Tablets. Solpadol Effervescent Tablets are white bevelled-edge tablets scored on one face. 4. Clinical particulars 4.1 Therapeutic indications For the relief of severe pain. Indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone). 4.2 Posology and method of administration Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with codeine in order to minimise the risk of addiction and dr Perskaitykite visą dokumentą