Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Paracetamol; Codeine phosphate hemihydrate
Haleon Ireland Limited
N02AJ06
Paracetamol; Codeine phosphate hemihydrate
500/12.8 milligram(s)
Film-coated tablet
Product not subject to medical prescription
codeine and paracetamol
Not marketed
2012-06-28
PANADEINE EXTRA STRENGTH TABLETS PARACETAMOL 500MG CODEINE PHOSPHATE HEMIHYDRATE 12.8MG PATIENT INFORMATION LEAFLET WHAT YOU SHOULD KNOW ABOUT THIS MEDICINE. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor or pharmacist. • 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 Panadeine Extra Strength Tablets and what are they for? 2. Before you take Panadeine Extra Strength Tablets 3. How to take Panadeine Extra Strength Tablets 4. Possible side-effects 5. How to store this medicine 6. Further information 1. WHAT ARE PANADEINE EXTRA STRENGTH TABLETS AND WHAT ARE THEY FOR? Panadeine Extra Strength Tablets contain paracetamol and codeine, which are both pain killing drugs. By working on your body in different ways paracetamol and codeine combine to relieve pain. Paracetamol also helps to reduce temperature when you have a fever. Panadeine Extra Strength Tablets provide effective relief for mild to moderate pain, including: • Joint, muscle and back pain. • Headaches, including migraine. • Toothache. • Sore throat. • Period pains. • Feverishness. • Colds and flu. Panadeine Extra Strength Tablets can be used in children over 12 years of age for the short-term relief of 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. 2. BEFORE YOU TAKE PANADEINE EXTRA STRENGTH TABLETS Do NOT take Panadeine Extra Strength Tablets: • if you are allergic to paracetamol, codeine, other opioid painkillers or any other ingredients (listed in section 6). • if you are under 12 years. • if you suffer from acute asthma (have suffered from recent asthma attacks). • if you suspect or know that you are pregnant. • Прочитать полный документ
Health Products Regulatory Authority 12 July 2023 CRN00DKWJ Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Panadeine Extra Strength Tablets Paracetamol 500 mg Codeine Phosphate hemihydrate 12.8 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol Ph Eur 500 mg and Codeine Phosphate Hemihydrate Ph Eur 12.8 mg. Excipient: Contains 5.9 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet Red, film-coated, capsule-shaped tablets. Embossed on one side with “Extra”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Panadeine Extra Strength Tablets is indicated in patients 12 years and older for the treatment of acute moderate pain (rheumatic pain, headaches, backache, musculoskeletal pain, migraine, toothache, sore throat, period pains, feverishness and the symptoms of colds and influenza) 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 use only. 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. Adults and children aged 16 years and over: One to two tablets to be taken with water three to four times daily as required. Paediatric population Children aged 12-15 years: One tablet to be taken with water three to four times daily as required. Panadeine Extra Strength is not recommended for use in children aged 12 years to 18 years with compromised respiratory function for the symptomatic treatment of cough or cold (see section 4.4). Panadeine Extra Strength Tablets 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, and not more than four doses should be given in any 24-hour period. Children aged less than 12 years: Codeine should not be used in children below the age of 12 years because of t Прочитать полный документ