Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
loxapine
Ferrer Internacional S.A.
N05AH01
loxapine
Nervous system
Schizophrenia; Bipolar Disorder
Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.
Revision: 14
Authorised
2013-02-20
45 B. PACKAGE LEAFLET 46 Package leaflet: Information for the user ADASUVE 4.5 mg inhalation powder, pre-dispensed loxapine Read all of this leaflet carefully before you start using 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What ADASUVE is and what it is used for 2. What you need to know before you use ADASUVE 3. How to use ADASUVE 4. Possible side effects 5. How to store ADASUVE 6. Contents of the pack and other information 1. What ADASUVE is and what it is used for ADASUVE contains the active substance loxapine, which belongs to a group of medicines called antipsychotics. ADASUVE works by blocking certain chemicals in the brain (neurotransmitters) such as dopamine and serotonin thus causing calming effects and relieving aggressive behaviour. ADASUVE is used to treat acute symptoms of mild-to-moderate agitation that may occur in adult patients who have schizophrenia or bipolar disorder. These are diseases characterised by symptoms such as: • (Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense. • (Bipolar disorder) Feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas, and sometimes severe irritability. 2. What you need to know before you use ADASUVE Do not use ADASUVE • if you are allergic to loxapine or amoxapine; • if you have symptoms of wheezing or shortness of breath; • if you have lung problems like asthma or chronic obstructive pulmonary disease (which your doctor may have called “COPD”). Warnings and precautions Your doctor or n Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ADASUVE 4.5 mg inhalation powder, pre-dispensed 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose inhaler contains 5 mg loxapine and delivers 4.5 mg loxapine. 3. PHARMACEUTICAL FORM Inhalation powder, pre-dispensed (inhalation powder). White device with a mouthpiece on one end and a pull-tab protruding from the other end. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms. 4.2 Posology and method of administration ADASUVE should be administered in a medical setting under the direct supervision of a healthcare professional. Patients should be observed during the first hour after each dose for signs and symptoms of bronchospasm. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm). Posology The recommended initial dose of ADASUVE is 9.1 mg. As this dose cannot be reach with this presentation (ADASUVE 4.5 mg), the presentation ADASUVE 9.1 mg should be used initially. A second dose can be given after 2 hours, if necessary. No more than two doses should be administered. A lower dose of 4.5 mg may be given if the 9.1 mg dose was not previously tolerated by the patient or if the physician decides a lower dose is more appropriate. Elderly The safety and efficacy of ADASUVE in patients older than 65 years of age have not been established. No data are available. Renal and/or hepatic impairment ADASUVE has not been studied in patients with renal or hepatic impairment. No data are available. 3 Paediatric population The safety and efficacy of ADASUVE in children (less than 18 years of age) have not been established. No data are available. Method of administration Inhalation use. The product is packaged in a sealed pouch. Wh Izlasiet visu dokumentu