Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Caffeine; Codeine phosphate; Paracetamol
Dendron Brands Ltd
N02BE51
Caffeine; Codeine phosphate; Paracetamol
30mg ; 8mg ; 500mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Never Valid To Prescribe As A VMP
BNF: 04070100; GTIN: 5000283657262 5000283657279
Package leaflet: Information for the patient SYNDOL ® HEADACHE RELIEF TABLETS Paracetamol, Codeine, Caffeine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • FOR THE SHORT TERM TREATMENT OF ACUTE MODERATE PAIN, WHICH IS NOT RELIEVED BY PARACETAMOL, IBUPROFEN OR ASPIRIN ALONE. • YOU SHOULD ONLY TAKE THIS PRODUCT FOR A MAXIMUM OF THREE DAYS AT A TIME. IF YOU NEED TO TAKE IT FOR LONGER THAN THREE DAYS YOU SHOULD SEE YOUR DOCTOR OR PHARMACIST FOR ADVICE. • THIS MEDICINE CONTAINS CODEINE WHICH CAN CAUSE ADDICTION IF YOU TAKE IT CONTINUOUSLY FOR MORE THAN THREE DAYS. THIS CAN GIVE YOU WITHDRAWAL SYMPTOMS FROM THE MEDICINE WHEN YOU STOP TAKING IT. • IF YOU TAKE THIS MEDICINE FOR HEADACHES FOR MORE THAN THREE DAYS IT CAN MAKE THEM WORSE. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR THIS MEDICINE CONTAINS: • CODEINE PHOSPHATE. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. • PARACETAMOL, another analgesic to relieve pain. • CAFFEINE which helps to increase the pain relief from paracetamol and makes you more alert. These tablets are for the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. This medicine is for the relief of m Citiți documentul complet
OBJECT 1 SYNDOL HEADACHE RELIEF TABLETS Summary of Product Characteristics Updated 17-Sep-2018 | 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 Co-Codamol Plus Caffeine Tablets Syndol Headache Relief Tablets 2. Qualitative and quantitative composition _INGREDIENT_ _QTY_ _UNIT_ _DOSE_ Paracetamol 500 mg Per tablet Caffeine 30 mg Per tablet Codeine Phosphate 8 mg Per tablet 3. Pharmaceutical form Tablet White, capsule–shaped with dimensions of 17.55 mm x 7.5 mm and debosed on one face to read PCC. 4. Clinical particulars 4.1 Therapeutic indications For the short term treatment of acute moderate pain which is not relieved by paracetamol, ibuprofen or aspirin alone. Suitable for migraine, headache, rheumatic pain, period pain, toothache and neuralgia. 4.2 Posology and method of administration For oral administration only Adults (including the elderly) 2 tablets every 4 to 6 hours up to four times daily. Maximum 8 tablets in 24 hours. The dose should not be repeated Citiți documentul complet