Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Morphine sulfate
Mundipharma Pharmaceuticals Limited
N02AA; N02AA01
Morphine sulfate
20 milligram(s)
Film-coated tablet
Product subject to prescription which may not be renewed (A)
Natural opium alkaloids; morphine
Marketed
1989-11-29
PACKAGE LEAFLET: INFORMATION FOR THE USER _SEVREDOL_ _®_ 10 MG, 20 MG AND 50 MG FILM-COATED TABLETS Morphine sulfate 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What _SEVREDOL _ tablets are and what they are used for 2. What you need to know before you take _SEVREDOL _ tablets 3. How to take _SEVREDOL _ tablets 4. Possible side effects 5. How to store _SEVREDOL _ tablets 6. Contents of the pack and other information 1. WHAT _SEVREDOL _TABLETS ARE AND WHAT THEY ARE USED FOR These tablets have been prescribed for you by your doctor to relieve severe pain. They contain the active ingredient morphine which belongs to a group of medicines called strong analgesics or ‘painkillers’. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _SEVREDOL_ TABLETS DO NOT TAKE _SEVREDOL _TABLETS IF: • you are allergic (hypersensitive) to morphine or any of the other ingredients of the tablets (see section 6 ‘Further Information’); • you have breathing problems, such as obstructive airways disease, respiratory depression or severe asthma. Your doctor will have told you if you have these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected; • you have a head injury that causes a severe headache or makes you feel sick. This is because the tablets may make these symptoms worse or hide the extent of the head injury; • you have a condition where the small bowel (part of your gut) does not work properly (paralytic ileus), your stomach empti Przeczytaj cały dokument
Health Products Regulatory Authority 13 March 2023 CRN00DFF9 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sevredol 20 mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg Morphine Sulfate. Also contains 197.5 mg lactose. Film-coating contains small amount (< 1 mg) Sunset yellow (E110). For a full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Pink, film coated, biconvex, capsule-shaped tablet, marked with a scoreline with ''IR'' to the left and ''20'' to the right with a plain reverse side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 12 years. The dosage of_ SEVREDOL_ tablets is dependent on the severity of pain and the patient's previous history of analgesic requirements. One tablet to be taken every four hours or as directed by a physician. Increasing severity of pain or tolerance to morphine will require increased dosage of _SEVREDOL_ tablets using 10 mg, 20 mg or 50 mg alone or in combination to achieve the desired relief. Patients receiving _SEVREDOL_ tablets in place of parenteral morphine should be given a sufficiently increased dosage to compensate for any reduction in analgesic effects associated with oral administration. Usually such increased requirement is of the order of 100%. In such patients, individual dose adjustments are required. Elderly A reduction in adult dosage may be advisable. Paediatric population 3-5 years 5mg 4-hourly 6-12 years 5-10mg 4-hourly Route of administration Oral. Discontinuation of therapy An abstinence syndrome may be precipitated if opioid administration is suddenly discontinued. Therefore, the dose should be gradually reduced prior to discontinuation. Health Products Regulatory Authority 13 March 2023 CRN00DFF9 Page 2 of 8 4.3 CONTRAINDICATIONS Mo Przeczytaj cały dokument