Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Caffeine
Omega Pharma Ltd
N02BE51
Paracetamol; Caffeine
500mg ; 65mg
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5000347005695
Artwork reference nr: FOR APPROVAL • Approval needs to be given within AMS. Please verify this proof carefully concerning lay-out, size, texts and bar code. For the PMS colours please refer to the latest PMS coulour guide. After your approval on the above we can proceed to the next stage of your project. Graphic Design Manufacturer: Folded size: Pharma code: UDI code: Serialization code: Barcode 1 type: Barcode 1 nr: Barcode 2 type: N/A N/A Barcode 2 nr: AMS Project nr: Techn. drawing ref: Languages on component: Component type: Size: Variant: Market: Component size (flat): Supplier component code: Perrigo component code: Application: Brand: CR06242 NEW English Leaflet 16 Headache United Kingdom palladio east PAPER Famar Anthoussa 150*210MM N/A N/A N/A N/A N/A 1931 N/A N/A 31051174 LF03514B Soluble Tablets Solpadeine 0 03/06/21 - - - - - - - - - - - - - - LF03514B - 02 Printer: 5: 8: 6: 9: 10: 7: 1: 4: 2: 3: - - - - - - Black - - - Specification ref: Reel Unwind ref: Substrate: 2. Check before you take Solpadeine Headache Soluble Tablets DO NOT TAKE SOLPADEINE HEADACHE SOLUBLE TABLETS: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, caffeine or to any of the other ingredients (listed in Section 6) • if you are TAKING OTHER MEDICINES CONTAINING PARACETAMOL. ASK YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE: • if you have LIVER or KIDNEY DISEASE, including ALCOHOLIC LIVER DISEASE • if you have been told by your doctor that you have an INTOLERANCE TO SOME SUGARS • if you are on a CONTROLLED SODIUM DIET. Each tablet contains 427mg of sodium. IF YOU ARE TAKING OTHER MEDICINES Talk to your doctor or pharmacist before taking these tablets if you are taking any pr escribed medicines; particularly METOCLOPRAMIDE or DOMPERIDONE (for NAUSE A [feeling sick] or VOMITING [being sick]) or COLESTYRAMINE (to lower BLOOD CHO LESTEROL). If you take BLOOD THINNING DRUGS (ANTICOAGULANTS e.g. WARFARIN) and you need to take a pain reliever on a daily basis, TALK TO YOUR DOCTOR because of the risk of bleeding. But yo Přečtěte si celý dokument
OBJECT 1 SOLPADEINE HEADACHE SOLUBLE TABLETS Summary of Product Characteristics Updated 19-Dec-2016 | Omega Pharma Ltd • 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 Solpadeine Headache Soluble Tablets SolpaPain 500mg_/_65mg Effervescent Tablets 2. Qualitative and quantitative composition Each tablet contains Paracetamol 500 mg and Caffeine 65 mg For excipients, see 6.1. 3. Pharmaceutical form Effervescent Tablet White bevel-edged scored tablets, one inch in diameter. 4. Clinical particulars 4.1 Therapeutic indications Solpadeine Headache Soluble Tablets are a mild analgesic and antipyretic formulated to give extra pain relief. The soluble tablets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, colds and influenza, sore throat, rheumatic pain and dysmenorrhoea. 4.2 Posology and method of administration Solpadeine Headache Soluble Tablets should be dissolved in at least half a tumble Přečtěte si celý dokument