দেশ: মাল্টা
ভাষা: ইংরেজি
সূত্র: Malta Medicines Authority
TRAMADOL HYDROCHLORIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N02AX02
TRAMADOL HYDROCHLORIDE 50 mg
HARD CAPSULE
TRAMADOL HYDROCHLORIDE 50 mg
POM
ANALGESICS
Authorised
2012-12-17
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER TRAMADOL AUROBINDO 50 MG CAPSULES, HARD tramadol hydrochloride 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, 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 Tramadol Aurobindo is and what it is used for 2. What you need to know before you take Tramadol Aurobindo 3. How to take Tramadol Aurobindo 4. Possible side effects 5. How to store Tramadol Aurobindo 6. Contents of the pack and other information 1. WHAT TRAMADOL AUROBINDO IS AND WHAT IT IS USED FOR Tramadol hydrochloride - the active substance in Tramadol Aurobindo - is a painkiller belonging to the class of opioids that acts on the central nervous system. It relieves pain by acting on specific nerve cells of the spinal cord and brain. Tramadol Aurobindo is used for the treatment of moderate to severe pain. You must talk to a doctor if you do not feel better or if you feel worse after number of days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRAMADOL AUROBINDO DO NOT TAKE TRAMADOL AUROBINDO - if you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6). - if you are under the influence of alcohol or sedative drugs including sleeping pills, other pain-killers or tranquiliser medicines - if you are taking, or have taken in the last two weeks, certain medicines called “monoamine oxidase inhibitors” or MAOIs (used to treat e.g. depression, and the antibiotic linezolid). The combination could result in a serious, potentially life threatening interaction - if you have epilepsy that is n সম্পূর্ণ নথি পড়ুন
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tramadol Aurobindo 50 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg tramadol hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard Green/ Yellow, size ‘4’ hard gelatin capsules filled with white to off-white powder and imprinted with ‘T’ on green cap and ‘02’ on yellow body with black ink. 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. Unless otherwise prescribed, Tramadol should be administered as follows: ADULTS AND CHILDREN AGED 12 YEARS AND OVER Oral administration ACUTE PAIN: An initial dose is 50-100 mg depending on the intensity of pain. This can be followed by doses of 50 or 100 mg 4-6 hours later, and duration of therapy should be matched to clinical need need (see section 5.1). A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. PAIN ASSOCIATED WITH CHRONIC CONDITIONS: Use an initial dose of 50 mg and then titrate dose according to pain severity. The initial dose may be followed if necessary by 50-100 mg every 4-6 hours. The recommended doses are intended as a guideline. Patients should always Page 2 of 13 receive the lowest dose that provides effective pain control. A total daily dose of 400 mg should not be exceeded except in special clinical circumstances. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported (see section 4.4). The capsules are to be taken whole, not divided or chewed, with sufficient liquid, independent of meals. Tramadol should under no circumstances be administered for longer than absolutely necessary. If long-term সম্পূর্ণ নথি পড়ুন