Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
metadonhydroklorid
2care4 Generics ApS
N07BC02
methadone hydrochloride
40 mg
Tablett
laktosmonohydrat Hjälpämne; metadonhydroklorid 40 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 25 tabletter
Godkänd
2018-09-13
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT METADON 2CARE4 20 MG TABLETS METADON 2CARE4 40 MG TABLETS methadone hydrochloride 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 {Invented name} is and what it is used for 2. What you need to know before you take {Invented name} 3. How to take {Invented name} 4. Possible side effects 5. How to store {Invented name} 6. Contents of the pack and other information 1. WHAT {INVENTED NAME} IS AND WHAT IT IS USED FOR {Invented name} is a morphine-like medicinal product which is used in adults for: - treating severe chronic pain which can be adequately managed only with opioid analgesics. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE {INVENTED NAME} DO NOT TAKE {INVENTED NAME}: - if you are allergic to methadone or any of the other ingredients of this medicine (listed in section 6). - if you use or have used a monoamino-oxidase inhibitor (MAO-inhibitor) within the last two weeks (medicine used in the treatment of depression and Parkinson's disease). - if you have respiratory depression with slow and shallow breathing, or other acute breathing difficulties (acute obstructive therapy). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking {Invented name}, if you: - get acute asthma attacks, - suffer from lung disease or breathing difficulties, - have a heart disorder or ischemic heart disease, - have a liver disease or impaired liver function (including gallstones), - have impaired kidney function (including kidney stones), - have an underactive Lue koko asiakirja
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Metadon 2care4 20 mg tablets Metadon 2care4 40 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 20 mg tablet contains 20 mg of methadone hydrochloride. Each 40 mg tablet contains 40 mg of methadone hydrochloride. Excipient with known effect Each 20 mg tablet contains 142 mg lactose monohydrate. Each 40 mg tablet contains 284 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet {Invented name} 20 mg tablets are white to almost white, round and flat 8 mm in diameter tablets with the marking ‘20’ on one side and score line on the other side. The tablet can be divided into equal doses. {Invented name} 40 mg tablets are white to almost white, round and flat 10 mm diameter tablets with the marking ’40’ on one side and score line on the other side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symtomatic treatment of severe chronic pain, which can be adequately managed only with opioid analgesics. {Invented name} is indicated in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage should be adjusted and evaluated based on the effect for the individual patient. The following dosage recommendations should only be considered as suggested approaches when treatment with {Invented name} is initiated and must be adjusted to the individual need for pain relief. In order to more rapidly achieve a full analgesic effect {Invented name} may initially be dosed with shorter dosage interval during a limited period. _Dose in opioid naive patient_ When oral methadone is used in patients who have not already been treated with opioids, the usual initial dose is 5 mg 1-3 times/day. {Invented name} 5 mg tablets are also available. This is followed by slow titration to effect. The titration should continue during several weeks. The initial dose should be carefully evaluated before increase of the dose is started. 3 Since the risk for ve Lue koko asiakirja