País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
Sandoz Ltd
N07BC01
Buprenorphine hydrochloride
8mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300; GTIN: 5050650092035
Prefibin is used to treat • OPIOID DEPENDENCE. Prefibin is part of a medical, social and psychological treatment programme for patients addicted to opiate (narcotic) drugs. Treatment is prescribed and monitored by doctors who are specialists in the treatment of drug dependence. Treatment with Prefibin is intended for use in adults and adolescents aged 15 years and over. DO NOT TAKE PREFIBIN if you are/have • allergic to: - buprenorphine or - any of the other ingredients of this medicine (listed in section 6) • serious breathing problems • serious liver problems • intoxicated due to alcohol or have trembling, sweating, anxiety confusion or hallucinations caused by alcohol • under 15 years of age • breast-feeding a baby WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Prefibin if any of the following apply to you: • breathing problems such as asthma You must not use Prefibin if you have serious breathing problems. • recent head injury or brain disease • have had fits (seizures) • reduced kidney function • reduced liver function Acute liver problems have been reported which could be due to: - misuse, especially through administration into a vein and at a high dose - previous existing liver problems - viral infections, such as hepatitis B or hepatitis C - alcohol abuse - anorexia - liver damaging medicines Inform your doctor immediately if you experience symptoms of liver problem such as severe fatigue, itching and yellow skin or eyes. You can then receive the proper treatment. However, you must not use Prefibin if you have a serious liver disease. • certain heart rhythm conditions (long QT syndrome or prolonged QT interval) • low blood pressure • urinary disorders, especially due to enlarged prostate in men • thyroid problems • disorder of the kidney cortex (e.g. Addison’s disease) • bile problems • you are below 18 years or over 65 years old In general, all patients have to undergo a liver test prior to Prefibin therapy and your doctor may monitor your Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prefibin 8 mg sublingual tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 8 mg of buprenorphine (as hydrochloride). Excipient(s) with known effect: Each 8 mg sublingual tablet contains 278.1 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Sublingual tablet. White to off-white, oval tablet with a breaking notch on both sides (13.5 mm x 6.6 mm). The 2 mg and 8 mg tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 15 years and over who have agreed to be treated for addiction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction. The result of the treatment depends on the dose prescribed as well as on the combined medical, psychological, social and educational measures taken in monitoring the patient Precautions to be taken before dosing Prior to treatment induction, physicians should be aware of the partial agonist profile of buprenorphine to the opiate receptors, which may precipitate a withdrawal syndrome in opioid-dependent patients. Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy. Consideration should be given to the types of opioid dependence (i.e. long- or short- acting opioid), the time since last opioid use and the degree of opioid dependence. To avoid precipitating withdrawal, induction with buprenorphine should be undertaken when objective and clear signs of withdrawal are evident, , e.g. a score higher than 12 on the Clinical Opioid Withdrawal Scale (COWS). Posology The initial dose is from 0.8 mg to 4 mg, administered as a single daily dose. - For _patients _-dependent _on her Leer el documento completo