Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Asenapine maleate
Lundbeck Ltd
N05AH05
Asenapine maleate
10mg
Sublingual tablet
Sublingual
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020300; GTIN: 5702157141586
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 of this medicine (lis Preberite celoten dokument
OBJECT 1 SYCREST 10MG SUBLINGUAL TABLETS Summary of Product Characteristics Updated 18-Dec-2018 | Lundbeck 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 Fertility, 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 Sycrest ® 5 mg and 10 mg sublingual tablets 2. Qualitative and quantitative composition Each sublingual tablet contains 5 mg or 10 mg asenapine (as maleate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Sublingual tablet 5 mg: Round, white to off-white, sublingual tablets debossed with “5” on one side. 10 mg: Round, white to off-white, sublingual tablets debossed with “10” 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 Preberite celoten dokument