국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen; Pseudoephedrine hydrochloride
Reckitt Benckiser Healthcare (UK) Ltd
M01AE51
Ibuprofen; Pseudoephedrine hydrochloride
200mg ; 30mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
CUSTOMER INFO: Minimum Point Size = 9.50pt RB00000 RB00000 INFORMATION FOR THE USER Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, you still need to use Nurofen Sinus & Blocked Nose 200mg/5mg Tablets carefully to get the best results from it. Keep this leaflet. You may want to read it again. If you have any further questions after you have read it, ask your doctor or pharmacist. YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE AFTER 10 DAYS. If any side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1- What is this medicine and what is it used for? 2- Before taking this medicine 3- How to take this medicine 4- Possible side-effects 5- How to store 6- Further information 1. WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR? Nurofen Sinus & Blocked Nose 200mg/5mg Tablets contains ibuprofen and phenylephrine hydrochloride, which are effective in relieving the symptoms associated with colds and flu, including relief of aches and pains, sore throats, headache, nasal congestion (blocked nose) and lowering of temperature. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) and is effective against aches and pains (including headache), swelling and can also reduce a fever. Phenylephrine hydrochloride (nasal decongestant) reduces swelling in the passages of the nose, relieving nasal congestion and reducing the pressure which may cause a headache. 2. BEFORE TAKING THIS MEDICINE DO NOT TAKE THIS MEDICINE IF YOU: • are allergic to ibuprofen, phenylephrine hydrochloride or any other ingredients of this medicine (see section 6) or to aspirin or other painkillers • have ever had 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 gast 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Nurofen Sinus Pain Relief 200mg/5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients Quantity Ibuprofen 200.0mg Phenylephrine hydrochloride 5.0mg For full list of excipients, see Section 6.1 Excipients with known effect: Sunset Yellow E 110. 3 PHARMACEUTICAL FORM Yellow film coated tablet, printed with an identifying motif (IPE) in black ink 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms of cold and ‘flu with associated congestion, including aches and pains, headache, fever, sore throat, blocked nose and sinuses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. 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). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days. Two tablets up to 3 times a day. Leave at least four hours between doses and do not take more than 6 tablets in any 24hour period. NOT TO BE GIVEN TO CHILDREN UNDER 12 YEARS. 4.3 CONTRAINDICATIONS Hypersensitivity to ibuprofen, phenylephrine or any of the excipients in the product. Hypertension and severe coronary heart disease. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes or proven ulceration or bleeding). History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see Section 4.4). Last trimester of pregnancy. Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors (see Section 4.5). Hyperthyroidism. Contraindicated in patients currently 전체 문서 읽기