देश: यूनाइटेड किंगडम
भाषा: अंग्रेज़ी
स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)
Naproxen
Orion Pharma (UK) Ltd
M01AE02
Naproxen
25mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 6432100027184
1 PACKAGE LEAFLET: INFORMATION FOR THE USER NAPROXEN 25 MG/ML ORAL SUSPENSION Naproxen 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 Naproxen is and what it is used for 2. What you need to know before you take Naproxen 3. How to take Naproxen 4. Possible side effects 5. How to store Naproxen 6. Contents of the pack and other information 1. WHAT NAPROXEN IS AND WHAT IT IS USED FOR Naproxen oral solution contains as an active substance naproxen which is a ‘Non-Steroidal Anti Inflammatory Drug’ or NSAID. Naproxen alleviates inflammation and pain by reducing the formation of mediators causing pain and inflammation in the body . Therapeutic uses of this medicine Naproxen is used in the treatment of inflammation and pain in the following diseases and conditions: rheumatoid arthritis, ankylosing spondylitis, osteoarthrosis, acute gout, acute musculoskeletal disorders, and menstrual pain. This medicine may also have been prescribed by a doctor for some other diseases than those mentioned in this package leaflet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAPROXEN DO NOT TAKE NAPROXEN, IF YOU • have a history of asthma, rhinitis, nasal polyps or rashes associated with the use of acetylsalicylic acid (aspirin) or other NSAIDs • you are allergic to naproxen, acetylsalicylic acid or other anti-inflammatory analgesics or any of the other ingredients of this medicine (listed in section 6). • have gastric or duodenal ulcer • have a history of gastric or duodenal ulcer or bleeding that have recurred पूरा दस्तावेज़ पढ़ें
OBJECT 1 NAPROXEN ORION 25 MG/ML ORAL SUSPENSION Summary of Product Characteristics Updated 26-Apr-2016 | Orion Pharma (UK) Limited 1. Name of the medicinal product Naproxen Orion 25 mg/ml oral suspension 2. Qualitative and quantitative composition One milliliter contains 25 mg naproxen. Excipients with known effect: Sorbitol 400 mg/ml Methyl parahydroxybenzoate 1 mg/ml Propyl parahydroxybenzoate 0.2 mg/ml For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral suspension. White or off-white, homogeneous suspension. 4. Clinical particulars 4.1 Therapeutic indications Adults: • Rheumatoid arthritis, spondyloarthropathies (including ankylosing spondylitis) • Osteoarthrosis • Acute gout • Acute musculoskeletal disorders with pain • Dysmenorrhoea Children: • Juvenile rheumatoid arthritis 4.2 Posology and method of administration Posology Adverse drug reactions may be reduced by using the lowest effective dose for the shortest duration possible to manage the symptoms (see section 4.4). Adults: Usually, 250500 mg (1020 ml) twice a day based on the individual need. If the predominant symptom in rheumatoid arthritis is morning stiffness, a single dose of 500750 mg (2030 ml) in the evenings may be adequate. In the treatment of acute gout, the recommended dose is 750 mg at once then 250 mg every 8 hours until the attack has passed. In the treatment of acute musculoskeletal disorders and dysmenorrhoea the recommended dose is 500 mg initially followed by 250mg at 68 hour intervals as needed, with a maximum daily dose after the first day of 1250 mg. Paediatric population (over 5 years): For juvenile rheumatoid arthritis: in children aged over 5 years, the recommended daily dose is 10 mg/kg divided into two doses. Dosing as per the table below. Patients weighing over 50 kg may be administered the adult dosage. body weight daily dose body weight daily dose 2024 kg 4 ml x 2 3540 kg 7 ml x 2 2529 kg 5 ml x 2 4044 kg 8 ml x 2 3034 kg 6 ml x 2 4549 kg 9 ml x 2 Elderly patients पूरा दस्तावेज़ पढ़ें