Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
buprenorphine hydrochloride,naloxone hydrochloride dihydrate
AA-Med Pty Ltd
Registered
ZUBSOLV® SUBLINGUAL TABLET 1 ZUBSOLV ® SUBLINGUAL TABLET _buprenorphine (as hydrochloride) / naloxone (as hydrochloride dihydrate)_ CONSUMER MEDICINE INFORMATION WARNING: HAZARDOUS AND HARMFUL USE ZUBSOLV poses risks of abuse and misuse which can lead to overdose and death. Your doctor will monitor you regularly during treatment. LIFE THREATENING RESPIRATORY DEPRESSION ZUBSOLV can cause life-threatening or fatal breathing problems (slow, shallow, unusual or no breathing) even when used as recommended. These problems can occur at any time during use, but the risk is higher when first starting ZUBSOLV and after a dose increase, if you are older or if you have an existing problem with your lungs. Your doctor will monitor you and change the dose as appropriate. USE OF OTHER MEDICINES WHILE USING ZUBSOLV Using ZUBSOLV with other medicines that can make you feel drowsy such as sleeping tablets (e.g. benzodiazepines), other pain relievers, antihistamines, antidepressants, antipsychotics, gabapentinoids (e.g. gabapentin and pregabalin), cannabis and alcohol may result in severe drowsiness, decreased awareness, breathing problems, coma and death. Your doctor will minimise the dose and duration of use; and monitor you for signs and symptoms of breathing difficulties and sedation. You must not drink alcohol while using ZUBSOLV. WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about ZUBSOLV. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ZUBSOLV against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT IS ZUBSOLV USED FOR? ZUBSOLV is used to treat dependence on opioids like heroin, morphine, oxycodone or codeine in patients who have agreed to be treated for their addiction, who are also receiving read_full_document
1 AUSTRALIAN PRODUCT INFORMATION ZUBSOLV ® (BUPRENORPHINE/NALOXONE) WARNINGS _HAZARDOUS AND HARMFUL USE _ Although ZUBSOLV is indicated for the treatment of opioid dependence it still poses risks of hazardous and harmful use which can lead to overdose and death. Monitor the patient’s ongoing risk of hazardous and harmful use regularly during opioid substitution therapy with ZUBSOLV (see _section 4.4. Special Warnings and Precautions for Use_). _LIFE THREATENING RESPIRATORY DEPRESSION _ Serious, life‐threatening or fatal respiratory depression may occur with the use of ZUBSOLV. Be aware of situations which increase the risk of respiratory depression, and monitor patients closely, especially on initiation or following a dose increase (see _section _ _4.4 Special Warnings and Precautions for Use_). _CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM (CNS) _ _DEPRESSANTS, INCLUDING ALCOHOL _ Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Patients and their caregivers should be made aware of the symptoms of respiratory depression. Patients and their caregivers should also be informed of the potential harms of consuming alcohol while taking ZUBSOLV. 1 NAME OF THE MEDICINE ZUBSOLV contains buprenorphine (as hydrochloride) and naloxone (as hydrochloride dihydrate) at a ratio of 4:1 buprenorphine:naloxone (ratio of free bases). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ZUBSOLV is intended for sublingual administration. It is available in six strengths: 0.7/0.18 mg, 1.4/0.36 mg, 2.9/0.71 mg, 5.7/1.4 mg, 8.6/2.1 mg and 11.4/2.9 mg. Each ZUBSOLV 0.7/0.18 sublingual tablet contains 0.7 mg buprenorphine (as hydrochloride) and 0.18 mg naloxone (as hydrochloride dihydrate). 2 Each ZUBSOLV 1.4/0.36 sublingual tablet contains 1.4 mg buprenorphine (as hydrochloride) and 0.36 mg nalox read_full_document