Negara: Malta
Bahasa: Inggris
Sumber: Medicines Authority
DIHYDROCODEINE TARTRATE
Napp Pharmaceuticals Limited Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom
N02AA08
DIHYDROCODEINE TARTRATE 60 mg
PROLONGED-RELEASE TABLET
DIHYDROCODEINE TARTRATE 60 mg
POM
ANALGESICS
Withdrawn
2007-02-22
2640-7 _DHC_ _®_ _CONTINUS_ _®_ 60 MG, 90 MG AND 120 MG PROLONGED-RELEASE TABLETS Dihydrocodeine tartrate PACKAGE LEAFLET: INFORMATION FOR THE USER 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 any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What _DHC_ _CONTINUS_ tablets are and what they are used for 2. Before you take _DHC_ _CONTINUS_ tablets 3. How to take _DHC_ _CONTINUS_ tablets 4. Possible side effects 5. How to store _DHC_ _CONTINUS_ tablets 6. Further information 1. WHAT _DHC_ _CONTINUS_ TABLETS ARE AND WHAT THEY ARE USED FOR These tablets have been prescribed for you to relieve severe pain over a period of 12 hours. They contain the active ingredient dihydrocodeine which belongs to a group of medicines called strong analgesics or ‘painkillers’. 2. BEFORE YOU TAKE _DHC_ _CONTINUS_ TABLETS DO NOT TAKE _DHC_ _CONTINUS_ TABLETS IF YOU: • are allergic (hypersensitive) to dihydrocodeine or any of the other ingredients of the tablets (see section 6 ‘Further Information’); • have breathing problems, such as obstructive airways disease or respiratory depression. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; • are having an asthma attack; • have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus); • have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease). This is because the tablets may make these symptoms worse or hide t Baca dokumen lengkapnya
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DHC CONTINUS prolonged release tablets 60 mg. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Dihydrocodeine Tartrate 60 mg. 3 PHARMACEUTICAL FORM Prolonged release tablet. White capsule-shaped tablet marked DHC 60. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of severe pain in cancer and other chronic conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children over 12 years: One or two tablets 12-hourly. Elderly: Dosage should be reduced. Children 12 years or under: Not recommended. Method of administration Oral. 4.3 CONTRAINDICATIONS Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; paralytic ileus; head injury; raised intracranial pressure; acute alcoholism. As dihydrocodeine may cause the release of histamine, it should not be given during an asthma attack and should be given with caution to asthmatics. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Page 2 of 6 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Dosage should be reduced in the elderly, in hypothyroidism, chronic hepatic disease and renal insufficiency. Dihydrocodeine should be administered with caution to patients with a history of opioid abuse, biliary tract disorders, prostatic hypertrophy, pancreatitis, constipation, obstructive bowel disorder and severe cor pulmonale. Dihydrocodeine has a recognised abuse and addiction profile similar to other opioids. Tolerance to analgesic effects may develop upon repeated administration. The risk-benefit of continued use should be assessed regularly by the Baca dokumen lengkapnya