Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
asenapine (as maleate)
N.V. Organon
N05AH05
asenapine
Psycholeptics
Bipolar Disorder
Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.
Revision: 21
Authorised
2010-09-01
38 B. PACKAGE LEAFLET 39 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SYCREST 5 MG SUBLINGUAL TABLETS SYCREST 10 MG SUBLINGUAL TABLETS asenapine 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Sycrest is and what it is used for 2. What you need to know before you take Sycrest 3. How to take Sycrest 4. Possible side effects 5. How to store Sycrest 6. Contents of the pack and other information 1. WHAT SYCREST IS AND WHAT IT IS USED FOR Sycrest contains the active substance asenapine. This medicine belongs to a group of medicines called antipsychotics. Sycrest is used to treat moderate to severe manic episodes associated with bipolar I disorder in adults. Antipsychotic medicines affect the chemicals that allow communication between nerve cells (neurotransmitters). Illnesses that affect the brain, such as bipolar I disorder, may be due to certain chemicals in the brain, such as dopamine and serotonin, being out of balance and these imbalances may cause some of the symptoms you may be experiencing. Exactly how this medicine works is unknown, however, it is believed to adjust the balance of these chemicals. Manic episodes associated with bipolar I disorder is a condition with symptoms such as 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 TAKE SYCREST DO NOT TAKE SYCREST If you are allergic to asenapine or any of the other ingredients Lire le document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Sycrest 5 mg sublingual tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sublingual tablet contains 5 mg asenapine (as maleate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Sublingual tablet Round, white to off-white, sublingual tablets debossed with “5” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended starting dose of Sycrest as monotherapy is 5 mg twice daily. One dose should be taken in the morning and one dose should be taken in the evening. The dose can be increased to 10 mg twice daily based on individual clinical response and tolerability. See section 5.1. For combination therapy a starting dose of 5 mg twice daily is recommended. Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily. Special populations _Elderly _ Sycrest should be used with care in the elderly. Limited data on efficacy in patients 65 years of age and older are available. Available pharmacokinetic data are described in section 5.2. _Renal impairment _ No dose adjustment is required for patients with renal impairment. There is no experience with asenapine in patients with severe renal impairment who have a creatinine clearance less than 15 mL/min. _Hepatic impairment _ No dose adjustment is required for patients with mild hepatic impairment. The possibility of elevated asenapine plasma levels cannot be excluded in some patients with moderate hepatic impairment (Child-Pugh B) and caution is advised. In subjects with severe hepatic impairment (Child-Pugh C), a 7-fold increase in asenapine exposure was observed. Thus, Sycrest is not recommended in patients with severe hepatic impairment. _Paediatric population _ A pharmacokinetic study and a short term Lire le document complet