מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dihydrocodeine tartrate
IVAX Pharmaceuticals UK Ltd
N02AA08
Dihydrocodeine tartrate
30mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200
HOW TO TAKE DIHYDROCODEINE Always take Dihydrocodeine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a glass of water and are best taken after food. The recommended dose is: ADULTS One tablet (30 mg) every 4 to 6 hours. However, your doctor may recommend a dosage individual to you. THE ELDERLY A reduced adult dose is recommended; your doctor will advise you. USE IN CHILDREN AND ADOLESCENTS CHILDREN FROM 4 TO 12 YEARS OF AGE Your doctor will calculate the appropriate dose of Dihydrocodeine for your child based on the child’s body weight. The dose should be taken every 4-6 hours. CHILDREN UNDER THE AGE OF 4 YEARS Dihydrocodeine is not recommended for use in children under 4 years of age. IF YOU TAKE MORE DIHYDROCODEINE THAN YOU SHOULD If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause difficulty in breathing, nausea, vomiting, fast heart rate, low blood pressure causing dizziness and a reduction in the size of the eye pupil which can all be exacerbated by also taking alcohol or other sedatives. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed. IF YOU FORGET TO TAKE DIHYDROCODEINE If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. IF YOU STOP TAKING DIHYDROCODEINE You should continue to take these tablets for as long as your doctor tells you to. When you stop taking your tablets, you may feel anxious, depressed and restless, and have difficulty sleeping. If this happens, ask your doctor for advice. If you have any further questions on the use of this product, ask your doctor or pharmacist. POSSIBLE SIDE EFFECTS Li קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dihydrocodeine 30mg Tablets BP. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dihydrocodeine tartrate 30 mg Also contains Lactose monohydrate 155 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White, flat, circular, bevel edged plain tablet with breakline. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dihydrocodeine 30mg Tablets BP (as an analgesic) are indicated for the relief of moderate to severe pain. Dihydrocodeine 30mg Tablets BP are indicated in all painful conditions where an alert patient is desired, e.g. sciatica, osteo- arthritis, chronic rheumatoid arthritis, arthritis of the spine, peripheral vascular disease, post-herpetic neuralgia, Paget’s disease, malignant disease, post- operative pain. Because Dihydrocodeine, in the recommended doses, causes little or no respiratory depression, its use in the treatment of post-operative pain may reduce the risk of chest complications. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _POSOLOGY: _ The analgesic effect is not materially enhanced by increasing the dose above that recommended below; in severe cases the interval between doses should be reduced to obtain the requisite analgesic cover. ADULTS AND CHILDREN OVER 12 YEARS: One tablet (30 mg) every 4 – 6 hours or at the discretion of the practitioner. Maximum dose in 24 hours 180mg (6 tablets) PAEDIATRIC POPULATION: A more suitable dosage form is recommended for children under 12 years (e.g. elixir) ELDERLY: Dosage should be reduced in the elderly 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). 4.3 CONTRAINDICATIONS • Hypersensitivity to dihydrocodeine or other opioid analgesics or to any of the excipients listed in section 6.1. • Respiratory depression • Obstructive airways disease • קרא את המסמך השלם