দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
IBUPROFEN PH. EUR.
Bristol Laboratories Limited
M01AE; M01AE01
IBUPROFEN PH. EUR.
200 milligram(s)
Capsule, soft
Propionic acid derivatives; ibuprofen
Not marketed
2019-05-31
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBUPROFEN 200 MG SOFT CAPSULES IBUPROFEN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse. WHAT IS IN THIS LEAFLET 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR The active ingredient (which makes the medicine work) is Ibuprofen. lt belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain, swelling, and high temperature. Ibuprofen 200mg Liquid capsules is used for the relief of: • HEADACHES AND MIGRAINE PAIN • DENTAL PAIN AND NEURALGIA • PERIOD PAIN • RHEUMATIC, MUSCULAR AND BACK PAIN • FEVERISHNESS AND SYMPTOMS AT COLD AND FLU. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE DO NOT TAKE THIS MEDICINE: • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). Page 2 of 6 • have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding • have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines • have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs) • are taking other N সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 05 June 2019 CRN008LGZ Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ibuprofen 200 mg soft capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Ibuprofen 200 mg Excipients with known effect: Also contains 18.67 mg Potassium per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, soft. Transparent, oval shaped soft gelatin capsule, printed 'BL200' in white ink, containing clear solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults and children over 12 years: Ibuprofen 200mg liquid capsules are indicated as an anti-inflammatory, analgesic and antipyretic for short term management of mild to moderate pain, fever and inflammation associated with headache, dental pain, period pain, muscular strain, neuralgia, rheumatic pain and migraine and for the management of the symptoms of head colds and influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted. Adults should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. ADULTS, THE ELDERLY AND CHILDREN OVER 12 YEARS: 200 - 400mg taken with water up to three times a day as required. Leave at least four hours between doses with a maximum of 1200mg in any 24 hour period. NOT FOR USE BY CHILDREN UNDER 12 YEARS OF AGE. ELDERLY: NSAIDs should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed (See Section 4.4). Method of administration For oral administration and short-term use only. 4.3 CONTRAINDICATIONS - Hypersensitivity to the active su সম্পূর্ণ নথি পড়ুন