Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TRAMADOL HYDROCHLORIDE; DEXKETOPROFEN TROMETAMOL
A. MENARINI SINGAPORE PTE. LTD.
TRAMADOL HYDROCHLORIDE; DEXKETOPROFEN TROMETAMOL
4 Tablets; 15 Tablets; 20 Tablets
Menarini - Von Heyden Gmbh, Leipziger
SKUDEXA (TRAMADOL HYDROCHLORIDE 75MG / DEXKETOPROFEN 25MG) FILM-COATED TABLETS Tramadol Hydrochloride 75mg Dexketoprofen 25mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What SKUDEXAis used for 2. How SKUDEXA works 3. Before you use SKUDEXA 4. How to use SKUDEXA 5. While you are using it 6. Side effects 7. Storage and Disposal of SKUDEXA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 1.WHAT SKUDEXA IS USED FOR SKUDEXA is used for the symptomatic short term treatment of moderate to severe acute pain in adults. 2. HOW SKUDEXA WORKS SKUDEXA contains the active substances tramadol hydrochloride and dexketoprofen. Tramadol hydrochloride is a pain killer belonging to a group of medicines called opioids that act on the central nervous system. It relieves pain by acting on specific nerve cells of the brain and spinal cord. Dexketoprofen is a pain killer and it belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). 3. BEFORE YOU USE SKUDEXA _- When you must not use it _ • If you are allergic to dexketoprofen, to tramadol hydrochloride or to any of the other ingredients of this medicine • If you are allergic to acetylsalicylic acid or to other NSAID • If you have suffered attacks of asthma, acute allergic rhinitis (a short period of inflamed lining of the nose), nasal polyps (lumps in the nose due to allergy), urticaria (skin rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking acetylsalicylic acid or other non- steroidal anti-inflammatory medicines • If you have had photo allergic or phototoxic reactions (reddening and/or blistering of the skin exposed to sunlight) while taking ketoprofen (a NSAID) or fibrates (drugs used to lower the level of fats in the blood) • If you have a peptic ulcer, stomach or bowel bleeding or if you have suffered in the past from stomach or bowel bleeding, ulceration or perforation, including that due to previ Read the complete document
PACKAGE INSERT SKUDEXA TABLETS 1. NAME OF THE MEDICINAL PRODUCT Skudexa (Tramadol hydrochloride 75mg / Dexketoprofen 25mg) Film-Coated Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen. Excipients with known effects: each tablet contains 33.07 mg croscarmellose sodium and 1.83 mg sodium stearyl fumarate For the full list of excipients, see section 6.1. 3. PRODUCT DESCRIPTION Film-coated tablet. Skudexa: almost white to slightly yellow, oblong, film-coated tablets with a break-mark on one side and a debossed “M” on the other side. The dimension of the film-coated tablet is ca. 14 mm lengths and ca. 6 mm width. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic short term treatment of moderate to severe acute pain in adult patients whose pain is considered to require a combination of tramadol and dexketoprofen. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults: _ The recommended dosage is one film-coated tablet (corresponding to 75 mg of tramadol hydrochloride and 25 mg of dexketoprofen). Additional doses can be taken as needed, with a minimum dosing interval of 8 hours. The total daily dose should not exceed three film- coated tablets per day (corresponding to 225 mg of tramadol hydrochloride and 75 mg of dexketoprofen). Skudexa is intended for short term use only and the treatment must be strictly limited to the symptomatic period and in any case not more than 5 days. Switching to a single agent analgesia should be considered according to pain intensity and response of the patient. Undesirable effects may be minimised by using the lowest number of doses for the shortest duration necessary to control symptoms. (see section 4.4). _Elderly: _ In elderly patients the starting recommended dosage is one film-coated tablet; additional doses can be taken as needed with the minimum dose interval of 8 hours and n Read the complete document