Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Buprenorphine hydrochloride
DE Pharmaceuticals
N07BC01
Buprenorphine hydrochloride
2mg
Sublingual tablet
Sublingual
Schedule 3 (CD No Register)
Valid as a prescribable product
BNF: 04100300
21 PACKAGE LEAFLET: INFORMATION FOR THE USER SUBUTEX 0.4 MG, 2 MG AND 8 MG SUBLINGUAL TABLETS buprenorphine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Subutex is and what it is used for 2. Before you take Subutex 3. How to take Subutex 4. Possible side effects 5. How to store Subutex 6. Further information 1. WHAT SUBUTEX IS AND WHAT IT IS USED FOR Subutex is used to treat dependence on opiate (narcotic) drugs, such as morphine and heroin in drug addicts who have agreed to be treated for their addiction. Subutex is used in adults and adolescents over 16 years of age who are also receiving medical, social and psychological support. 2. BEFORE YOU TAKE SUBUTEX DO NOT TAKE SUBUTEX: If you are a child under the age of 16 years. If you are allergic (hypersensitive) to buprenorphine or to any of the other ingredients of this medicine (listed in section 6). If you have SERIOUS BREATHING PROBLEMS. If you have SERIOUS PROBLEMS WITH YOUR LIVER. If you are intoxicated due to alcohol or have trembling, sweating, anxiety confusion or hallucinations caused by alcohol. If you are breast feeding a baby. TAKE SPECIAL CARE WITH SUBUTEX Tell your doctor before you start taking Subutex if you have: asthma or other breathing problems any liver disease such as hepatitis low blood pressure recently suffered head injury or brain disease a urinary disorder (especially linked to enlarged prostate in men) any kidney disease thyroid problems adrenocortical disorder (e.g. Addison’s disease) 22 IMPORTANT THINGS TO BE AWARE OF: Izlasiet visu dokumentu
OBJECT 1 SUBUTEX 2MG SUBLINGUAL TABLETS Summary of Product Characteristics Updated 23-Jul-2019 | Indivior UK Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Subutex 2mg sublingual tablets 2. Qualitative and quantitative composition Each tablet contains 2mg buprenorphine (as buprenorphine hydrochloride). Excipient(s) with known effect: lactose For a full list of excipients, see section 6.1 3. Pharmaceutical form Sublingual tablet Uncoated oval white flat bevelled edged tablet, nominal dimensions 10 mm x 5 mm, debossed with B2 on one side. 4. Clinical particulars 4.1 Therapeutic indications Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. 4.2 Posology and method of administration Posology Treatment with Subutex sublingual tablets is intended for use in adults and children aged 16 years or over who have agreed to be treated for opioid dependence. _Precautions to be taken before dosing_ Prior to treatment Izlasiet visu dokumentu