Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
N02AJ08
IBUPROFEN, CODEINE PHOSPHATE HEMIHYDRATE
200/12.8 Milligram
Film Coated Tablet
Product not subject to medical prescription
codeine and ibuprofen
Authorised
2012-03-09
Page 1 of 5 APFEN PLUS 200MG/12.8MG FILM COATED TABLETS IBUPROFEN/CODEINEPHOSPHATE HEMIHYDRATE PATIENT INFORMATIONLEAFLET. WHAT YOU SHOULD KNOW ABOUT THIS MEDICINE. READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without a prescription. However, you still need to use Apfen Plus Tablets carefully to get the best results from them. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact your doctor if your symptoms do not improve after three days. • If any of the 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 are Apfen Plus Tablets and what are they for 2. Before you take Apfen Plus Tablets 3. How to take Apfen Plus Tablets 4. Possible side-effects 5. How to store Apfen Plus Tablets 6. Further information 1. WHAT ARE APFEN PLUS TABLETS AND WHAT ARE THEY FOR Apfen Plus Tablets contain IBUPROFEN and CODEINE , which are both pain killing drugs. By working on your body in different ways ibuprofen and codeine combine to relieve pain. IBUPROFEN also helps to reduce swelling and inflammation in sore muscles etc. Apfen Plus Tablets provides effective relief from moderate pain , such as joint, muscle and back pain, arthritis, rheumatism, headaches (including migraine), toothache and severe period pains. Codeine can be used in children over 12 years of age for the short-termrelief or moderate pain that is not relieved by other painkillers such as paracetamol or ibuprofen alone. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. 2. CHECK BEFORE YOU TAKE APFEN PLUS TABLETS Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small increased risk of heart attack ‘myocardial infarction’ or st Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Apfen Plus 200mg / 12.8mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains ibuprofen 200mg and codeine phosphate hemihydrate 12.8 mg. Each tablet also contains 150mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White, film-coated, capsule-shaped tablets which are embossed on one side with "+". 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of acute moderate pain in such conditions as soft tissue injuries, including sprains, strains and musculo-tendonitis, backache, non-serious arthritic and rheumatic conditions rheumatic and muscular pain, migraine, dental pain, dysmenorrhoea, which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration and short-term use only. Adults (including the elderly) and children aged 12 years and over: One or two tablets, to be taken with water, three times daily. Apfen Plus should be used at the lowest effective dose for the shortest period of time. The dose should not be repeated more frequently than every six hours. Not more than six tablets should be taken in any 24-hour period. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Children under 12 years of age: Ibuprofen-codeine must not be given to children under 12 years of age because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). 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 c Прочетете целия документ