Ülke: Malezya
Dil: İngilizce
Kaynak: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Safinamide mesylate
EISAI (MALAYSIA) SDN BHD (18039-D)
Safinamide mesylate
28 Tablets
Meiji Seika Pharma Co., Ltd., Odawara Plant,
EQUFINA ® FILM COATED TABLET 50MG Safinamide 50mg 1 _CONSUMER MEDICATION INFORMATION LEAFLET _ _(RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Equfina is used for 2. How Equfina works 3. Before you use Equfina 4. How to use Equfina 5. While you are using it 6. Side effects 7. Storage and Disposal of Equfina 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT EQUFINA IS USED FOR Improvement of wearing-off phenomenon (effects of levodopa diminish before it is time for the next dose) in Parkinson's disease currently treated with levodopa-containing medicines. HOW EQUFINA WORKS Equfina acts to increase the level of a substance called dopamine in the brain, which is involved in the control of movement and is present in reduced amounts in the brain of patients with Parkinson’s disease. BEFORE YOU USE EQUFINA - _When you must not use it _ If you are allergic to safinamide or any of the ingredients of this medicine. If you are taking any of the following medicines: - Monoamine oxidase (MAO) inhibitors such as selegiline, rasagiline (e.g. for treatment of Parkinson’s disease or depression, or used for any other condition). - Tricyclic antidepressants such as amitriptylline, dosulepin, imipramine - Tetracyclic antidepressants such as mianserin, maprotiline - Selective serotonin reuptake inhibitors (SSRIs) typically used to treat anxiety disorders, and some personality disorders (e.g. fluvoxamine or escitalopram) - Serotonin–norepinephrine reuptake inhibitors (SNRIs), used in the treatment of major depression and other mood disorders, such as venlafaxine - Selective noradrenaline reuptake inhibitors such as atomoxetine - Noradrenergic and serotonergic antidepressant such as mirtazapine - Central nervous system stimulants such as methylphenidate - Pethidine, tramadol, tapentadol (strong painkiller). You must wait at least 14 days after stopping Equfina treatment before starting treatment with most of the group of medicines mentioned. If you have been Belgenin tamamını okuyun
1 Equfina ® FILM COATED TABLETS 50 mg 1. COMPOSITION AND PRODUCT DESCRIPTION 1.1 Composition Brand name Equfina® Film coated Tablets 50 mg Active ingredient Safinamide mesilate 65.88 mg (safinamide 50 mg) per tablet Inactive ingredients Lactose hydrate, corn starch, Sodium starch glycolate (Type A), hydroxypropylcellulose, light anhydrous silicic acid, magnesium stearate, hypromellose, D-mannitol, Macrogol 6000, talc, and carnauba wax 1.2 Product Description Description White film-coated tablets Appearance Surface Reverse Side Diameter (mm) Approximately 7.1 Thickness (mm) Approximately 3.5 Weight (mg) Approximately 130.0 2. INDICATION Improvement of wearing-off phenomenon in Parkinson's disease currently treated with levodopa-containing products. PRECAUTIONS CONCERNING INDICATIONS This drug should be used in patients with wearing-off phenomenon despite adjustment of the dose or frequency of levodopa-containing products. 3. DOSAGE AND ADMINISTRATION This drug is used in combination with levodopa-containing products. The usual adult dosage for oral use is 50 mg of safinamide once daily. The dosage for oral use may be administered at 100 mg once daily according to the patient’s condition. 2 4. PRECAUTIONS CONCERNING DOSAGE AND ADMINISTRATION 4.1 Coadministration with levodopa-containing products may cause adverse reactions of levodopa origin (dyskinesia, etc.). Therefore, patients should be closely monitored when the dosing of this drug is started or the dose of this drug is increased, and if such adverse reactions occur, the dose of this drug or levodopa-containing products should be adjusted. 4.2 The dose of Equfina should not exceed 50 mg daily for patients with moderate hepatic impairment (Child-Pugh B) [See 6.2.2 in PRECAUTIONS CONCERNING PATIENTS WITH SPECIFIC BACKGROUNDS and 11.6.2 in PHARMACOKINETICS: PATIENTS WITH SPECIFIC BACKGROUNDS]. 5. IMPORTANT PRECAUTIONS 5.1 This drug may induce daytime somnolence or sudden onset of sleep with no signs. Therefore, patients should be cautioned against engaging in Belgenin tamamını okuyun