Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dihydrocodeine tartrate
Mawdsley-Brooks & Company Ltd
N02AA08
Dihydrocodeine tartrate
30mg
Oral tablet
Oral
Schedule 5 (CD Inv)
Valid as a prescribable product
BNF: 04070200
PACKAGE LEAFLET: INFORMATION FOR THE USER DIHYDROCODEINE 30MG TABLETS (DIHYDROCODEINE TARTRATE BP) 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Dihydrocodeine Tablets are and what they are used for 2. What you need to know before you take Dihydrocodeine Tablets 3. How to take Dihydrocodeine Tablets 4. Possible side effects 5. How to store Dihydrocodeine Tablets 6. Contents of the pack and other information 1. WHAT DIHYDROCODEINE TABLETS ARE AND WHAT THEY ARE USED FOR Dihydrocodeine Tablets are used as a strong pain killer (known as an opioid) for the relief of moderate to severe pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIHYDROCODEINE TABLETS DO NOT TAKE DIHYDROCODEINE TABLETS IF: • You know that you are allergic to dihydrocodeine tartrate, or any of the other ingredients (listed in section 6 ) • You suffer from breathing problems, for example chronic bronchitis or if you are having an asthma attack (both are conditions of shortness of breath, wheezing and chest tightness) •You suffer from paralytic ileus (paralysis of the gut which stops the movement of food through the intestine) • You have a head injury or suffer from increased pressure on the brain. Children Dihydrocodeine Tablets are not recommended for children under 12 years. WARNINGS AND PRECAUTIONS • Do not take for longer than directed by your prescriber • Taking dihydrocodeine (DHC) regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dihydrocodeine Tablets 30mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dihydrocodeine tartrate BP 30mg. Excipients with known effect: Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For 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). 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 (30mg) every 4 to 6 hours when necessary after food. Maximum dose in 24 hours 180mg (6 tablets). _Paediatric population: _ Not recommended for children under 12 years old. _Elderly: _ The dosage may have to be reduced in elderly patients. See also sub-section 4.4 Special warnings and special precautions for use. Method of administration For oral use. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Respiratory depression. Obstructive airways disease. Acute alcoholism. Risk of paralytic ileus. Head injuries or conditions in which intracranial pressure is raised. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Drug dependence, tolerance and potential use for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. The risks are increased in individuals with current or past history of substance misuse disorder (including alcohol misuse) or mental health disorder (e.g. major depression). Additional support and monitoring may be necessary when prescribing for patients at ris Izlasiet visu dokumentu