מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tramadol hydrochloride
CST Pharma Ltd
N02AX02
Tramadol hydrochloride
200mg
Modified-release capsule
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04070200; GTIN: 5055946801506
ZAMADOL SR 200MG PROLONGED-RELEASE HARD CAPSULES (tramadol hydrochloride) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE, BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. * 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. * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor or pharmacist. * 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. Your medicine is called Zamadol SR 200mg prolonged-release hard capsules and will be referred to as Zamadol SR prolonged-release hard capsules throughout the rest of this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Zamadol SR 50mg prolonged-release hard capsules, Zamadol SR 100mg prolonged-release hard capsules and Zamadol SR 150mg prolonged-release hard capsules. WHAT IS IN THIS LEAFLET: What Zamadol SR prolonged-release hard capsules is and what it is used for What you need to know before you take Zamadol SR prolonged-release hard capsules How to take Zamadol SR prolonged-release hard capsules Possible side effects How to store Zamadol SR prolonged-release hard capsules Contents of the pack and other information WHAT ZAMADOL SR PROLONGED-RELEASE HARD CAPSULES IS AND WHAT IT IS USED FOR Zamadol SR prolonged-release hard capsules belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. The active substance, tramadol hydrochloride, interrupts the pain messages being sent to your brain, and it also acts in your brain to stop pain messages from being felt. This means that Zamadol SR prolonged-release hard capsules does not stop the pain from happening, but you will not be able to feel the pain as much. Zamadol SR prolonged-release hard capsules is used to relieve moderate to severe pain. (for קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zamadol SR 200 mg prolonged-release hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One capsule contains 200mg of tramadol hydrochloride Excipients with known effect This product contains sucrose (37.5 mg/capsule). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release hard capsule The 200 mg capsules are yellow of about 19 – 19.5 mm, marked T200SR 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. _Dosage for adults and adolescents from 12 years of age: _ The usual initial dose is 50-100 mg twice daily, in the morning and in the evening. This dose may be titrated up to 150-200 mg twice daily according to pain severity. If long-term pain treatment with tramadol hydrochloride is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary. A total oral daily dose of 400 mg should not be exceeded except in special clinical circumstances. _Paediatric population: _ Zamadol SR prolonged-release hard capsules should not be used in children under 12 years of age since safety and efficacy have not been established. _Elderly patients:_ A dose adjustment is usually not necessary in patients up to 75 years of age without clinically manifest hepatic or renal insufficiency. In elderly patients over 75 years of age elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements. _Renal insufficiency/dialysis and hepatic impairment:_ In patients with renal and/or hepatic insufficiency the elimination of Zamadol SR prolonged- קרא את המסמך השלם