국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
Dihydrocodeine hydrorhodanide
Teofarma S.R.L.
N02AA; N02AA08
Dihydrocodeine hydrorhodanide
10 milligram(s)/gram
Oral drops, solution
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; dihydrocodeine
Marketed
1991-10-04
PACKAGE LEAFLET: INFORMATION FOR THE USER PARACODIN® 10 MG/G ORAL DROPS, SOLUTION (DIHYDROCODEINE HYDRORHODANIDE) 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. WHAT IS IN THIS LEAFLET : 1. What Paracodin Drops are and what they are used for 2. What you need to know before you take Paracodin Drops 3. How to take Paracodin Drops 4. Possible side effects 5. How to store Paracodin Drops 6. Contents of the pack and other information The information in this leaflet applies to both adults and children who have been prescribed the medicine. 1. WHAT PARACODIN DROPS ARE AND WHAT THEY ARE USED FOR Paracodin Drops are for oral administration. The active substance in Paracodin Drops is dihydrocodeine hydrorhodanide. Paracodin Drops belongs to a group of medicines called cough suppressants. Paracodin Drops are used to treat a dry (non-productive) cough. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACODIN DROPS DO NOT TAKE PARACODIN DROPS IF YOU: • are allergic to dihydrocodeine hydrorhodanide or to any of the ingredients in this medicine (see section 6) • suffer from breathing difficulties such as asthma • have addiction problems • suffer from confusion • have head injuries and are suffering from raised intracerebral pressure (an increase in the pressure of the fluid around the brain) • are suffering from hypotension (low blood pressure) • are suffering from a disorder of the blood called hypovolaemia (decrease in the volume of circulating blood in the body). • are taking an antidepressant of the mono-amine oxidase inhibitor (MAOI) g 전체 문서 읽기
Health Products Regulatory Authority 12 August 2020 CRN009SHY Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracodin 10 mg/g Oral Drops, Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each drop contains 0.5 mg of dihydrocodeine hydrorhodanide. 1 g of Paracodin drops (=20 drops) contains 10 mg of dihydrocodeine hydrorhodanide. Excipients: benzoic acid (E201) 2mg per 20-drop dose For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral drops, solution. Clear, brown solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracodin is indicated in the management of non-productive cough. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults: 14-20 drops taken up to three times daily. Children (aged 6-12 years): 6-12 drops taken up to three times daily. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Opiate addiction, mental clouding, disturbances of the breathing centre and respiratory function, head injuries and conditions in which intracerebral pressure is elevated (at high doses), hypotension and hypovolaemia. Do not give Paracodin to children below the age of 6 years. Do not give to patients who are receiving monoamine oxidase inhibitors or who have received these within the previous 14 days. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As dihydrocodeine may bring about histamine release, Paracodin should not be given during an attack of asthma and it should be administered with care to persons liable to such attacks. PARACODIN DROPS CONTAINS BENZOIC ACID This medicine contains 2 mg benzoic acid in each 20-drop dose Dosage should be reduced in the elderly, in hypothyroidism, in chronic hepatic disease and in renal insufficiency. Prolonged regular use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms such as restlessness and irritability, once the drug is stopped. Patients with pre-existing s 전체 문서 읽기