देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Tramadol hydrochloride
Grunenthal Ltd
N02AJ13
Paracetamol; Tramadol hydrochloride
325mg ; 37.5mg
Oral tablet
Oral
Schedule 3 (CD No Register Exempt Safe Custody)
Valid as a prescribable product
BNF: 04070200; GTIN: 4032129026735
1 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAMACET ® 37.5MG/325MG FILM-COATED TABLETS Tramadol hydrochloride/Paracetamol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. 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). WHAT IS IN THIS LEAFLET: 1. What TRAMACET is and what it is used for 2. What you need to know before you take TRAMACET 3. How to take TRAMACET 4. Possible side effects 5. How to store TRAMACET 6. Contents of the pack and other information 1. WHAT TRAMACET IS AND WHAT IT IS USED FOR TRAMACET is used to treat moderate to severe pain when your doctor recommends that a combination of tramadol hydrochloride and paracetamol is needed. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMACET DO NOT TAKE TRAMACET if you are allergic to tramadol hydrochloride, paracetamol or any of the other ingredients of this medicine (listed in section 6) in cases of acute alcohol poisoning if you are taking sleeping pills, pain relievers or medicines that affect mood and emotions if you are also taking medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the last 14 days before treatment with TRAMACET. MAOIs are used in the treatment of depression or Parkinson’s disease. if you have a severe liver disorder if you have epilepsy that is not adequately controlled by your current medicine. WARNINGS AND PRECAUTIONS 2 TALK TO YOUR DOCTOR BEFORE TAKING TRAMACET if you take other medicines containing paracetamol or tramadol if you have liver problems or disease as your eyes and skin may turn yellow, which may suggest jaund पूरा दस्तावेज़ पढ़ें
OBJECT 1 TRAMACET 37.5 MG/ 325 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 25-Jul-2017 | Grunenthal Ltd 1. Name of the medicinal product TRAMACET 37.5mg/325mg Film coated tablets Tramadol hydrochloride/Paracetamol 37.5 mg/325 mg film-coated tablets 2. Qualitative and quantitative composition One film-coated tablet contains 37.5 mg tramadol hydrochloride and 325 mg paracetamol Excipients: One film coated tablet contains 1.878 mg lactose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Pale yellow film-coated tablet, marked with the manufacturer's logo on one side and 'T5' on the other side. 4. Clinical particulars 4.1 Therapeutic indications Tramadol hydrochloride/Paracetamol tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Tramadol hydrochloride/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol (see also Section 5.1). 4.2 Posology and method of administration _Posology_ The use of Tramadol Hydrochloride/Paracetamol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol. The dose should be adjusted to intensity of pain and the sensitivity of the individual patient. The lowest effective dose for analgesia should generally be selected. The total dose of 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day should not be exceeded. The dosing interval should not be less than six hours. Adults and adolescents (12 years and older) An initial dose of two tablets of Tramadol hydrochloride/Paracetamol is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600 mg paracetamol) per day. The dosing interval should not be less than six hours. Tramadol hydrochloride/Paracetamol should under no circumstances be administered for longer than is strictly necessary (see पूरा दस्तावेज़ पढ़ें