Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dihydrocodeine tartrate
Teva UK Ltd
N02AA08
Dihydrocodeine tartrate
30mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200; GTIN: 5017007054238 5017007054252
PACKAGE LEAFLET: INFORMATION FOR THE USER DIHYDROCODEINE 30 MG TABLETS THIS MEDICINE CONTAINS DIHYDROCODEINE TARTRATE WHICH IS AN OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY. 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. See section 4. WHAT IS IN THIS LEAFLET 1. What Dihydrocodeine is and what it is used for 2. What you need to know before you take Dihydrocodeine 3. How to take Dihydrocodeine 4. Possible side effects 5. How to store Dihydrocodeine 6. Contents of the pack and other information 1. WHAT DIHYDROCODEINE IS AND WHAT IT IS USED FOR This medicine has been prescribed for you for the relief of moderate to severe pain. It contains dihydrocodeine tartrate which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed to you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, and how to do this safely. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIHYDROCODEINE DO NOT TAKE DIHYDROCODEINE IF YOU: are allergic (hypersensitive) to dihydrocodeine, or any of the other ingredients of this medicine suffer from problems with your breathing suffer from alcoholism have suffered a significant head injury are at risk of paralytic ileus (an inactive bowel) which may cause a blockage of the gut are having an asthma attack Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dihydrocodeine 30 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 30 mg of Dihydrocodeine Tartrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, flat, bevel edged tablets, engraved 5B4 with a breakline. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Dihydrocodeine tablets are indicated for the relief of moderate to severe pain. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Prior to starting treatment with opioids, a discussion should be held with patients to put in place a strategy for ending treatment with dihydrocodeine in order to minimise the risk of addiction and drug withdrawal syndrome (see section 4.4). Dihydrocodeine tablets are best administered after food. _Adults _ 1 tablet (30 mg) every 4 to 6 hours or at the discretion of the physician. _ _ _Children 4 to 12 years of age _ 0.5 to 1 mg/kg body weight, every 4 to 6 hours. _Children under 4 years of age _ Dihydrocodeine is not recommended. Method of administration For oral administration 4.3 CONTRAINDICATIONS Hypersensitivity to dihydrocodeine or any of the tablet constituents; respiratory depression; obstructive airways disease; where there is a risk of paralytic ileus; acute alcoholism. Dihydrocodeine should also be avoided in patients with raised intracranial pressure or with significant head injury (in addition to interfering with respiration, it affects papillary response vital for neurological assessment). 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. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Dihydrocodeine should not be given during an attack of asthma, and should be administered with due care to persons liable to such attacks. Dihydrocodeine Les hele dokumentet