Land: Europeiska unionen
Språk: engelska
Källa: EMA (European Medicines Agency)
Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate
Accord Healthcare S.L.U.
N07BC51
buprenorphine, naloxone
Other nervous system drugs
Opioid-Related Disorders
Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment.The intention of the naloxone component is to deter intravenous misuse. Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction.
Revision: 10
Authorised
2017-11-10
48 B. PACKAGE LEAFLET 49 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZUBSOLV 0.7 MG/0.18 MG SUBLINGUAL TABLETS ZUBSOLV 1.4 MG/0.36 MG SUBLINGUAL TABLETS ZUBSOLV 2.9 MG/0.71 MG SUBLINGUAL TABLETS ZUBSOLV 5.7 MG/1.4 MG SUBLINGUAL TABLETS ZUBSOLV 8.6 MG/2.1 MG SUBLINGUAL TABLETS ZUBSOLV 11.4 MG/2.9 MG SUBLINGUAL TABLETS buprenorphine/naloxone 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 Zubsolv is and what it is used for 2. What you need to know before you take Zubsolv 3. How to take Zubsolv 4. Possible side effects 5. How to store Zubsolv 6. Contents of the pack and other information 1. WHAT ZUBSOLV IS AND WHAT IT IS USED FOR Zubsolv contains the active substances buprenorphine and naloxone. Zubsolv is used to treat dependence on opioid (narcotic) drugs such as heroin or morphine in drug addicts who have agreed to be treated for their addiction. Zubsolv is used in adults and adolescents over 15 years of age, who are also receiving medical, social and psychological support. HOW ZUBSOLV WORKS The tablet contains buprenorphine which is responsible for the treatment of opioid (narcotic) dependence. It also contains naloxone which is used to deter intravenous abuse of the product. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZUBSOLV DO NOT TAKE ZUBSOLV IF YOU: - are allergic to buprenorphine, naloxone or any of the other ingredients of this medicine (listed in section 6) - have SERIOUS BREATHING PROBLEMS - have SERIOUS LIVER PROBLEMS - are intoxicated due to alcohol or have trembling, sweating, anxiety Läs hela dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zubsolv 0.7 mg/0.18 mg sublingual tablets Zubsolv 1.4 mg/0.36 mg sublingual tablets Zubsolv 2.9 mg/0.71 mg sublingual tablets Zubsolv 5.7 mg/1.4 mg sublingual tablets Zubsolv 8.6 mg/2.1 mg sublingual tablets Zubsolv 11.4 mg/2.9 mg sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Zubsolv 0.7 mg/0.18 mg sublingual tablets Each 0.7 mg/0.18 mg sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate). Zubsolv 1.4 mg/0.36 mg sublingual tablets Each 1.4 mg/0.36 mg sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg naloxone (as hydrochloride dihydrate). Zubsolv 2.9 mg/0.71 mg sublingual tablets Each 2.9 mg/0.71 mg sublingual tablet contains 2.9 mg buprenorphine (as hydrochloride) and 0.71 mg naloxone (as hydrochloride dihydrate). Zubsolv 5.7 mg/1.4 mg sublingual tablets Each 5.7 mg/1.4 mg sublingual tablet contains 5.7 mg buprenorphine (as hydrochloride) and 1.4 mg naloxone (as hydrochloride dihydrate). Zubsolv 8.6 mg/2.1 mg sublingual tablets Each 8.6 mg/2.1 mg sublingual tablet contains 8.6 mg buprenorphine (as hydrochloride) and 2.1 mg naloxone (as hydrochloride dihydrate). Zubsolv 11.4 mg/2.9 mg sublingual tablets Each 11.4 mg/2.9 mg sublingual tablet contains 11.4 mg buprenorphine (as hydrochloride) and 2.9 mg naloxone (as hydrochloride dihydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet Zubsolv 0.7 mg/0.18 mg sublingual tablets A white to off-white, oval tablet, length 6.8 mm and width 4.0 mm, debossed with “.7” on one side. Zubsolv 1.4 mg/0.36 mg sublingual tablets A white to off-white, triangular tablet, base 7.2 mm and height 6.9 mm, debossed with “1.4” on one 3 side. Zubsolv 2.9 mg/0.71 mg sublingual tablets A white to off-white, D-shaped tablet, height 7.3 mm and width 5.65 mm, debossed with “2.9” on one side. Zubsolv 5.7 mg/1.4 mg sublingual tablets A white to off-whit Läs hela dokumentet