Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Cariprazine Hydrochloride
Mitsubishi Tanabe Pharma Malaysia Sdn. Bhd.
Cariprazine Hydrochloride
28 Capsules
Gedeon Richter Plc.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ SYMVENU ® _ _ Cariprazine 1.5 mg hard capsules Cariprazine 3 mg hard capsules Cariprazine 4.5 mg hard capsules Cariprazine 6 mg hard capsules _ _ 1 WHAT IS IN THIS LEAFLET 1. What Symvenu is used for 2. How Symvenu works 3. Before you use Symvenu 4. How to use Symvenu 5. While you are using it 6. Side Effects 7. Storage and Disposal of Symvenu 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT SYMVENU IS USED FOR Symvenu contains the active substance cariprazine and belongs to a group of medicines called antipsychotics. It is used: • to treat adults with schizophrenia. Schizophrenia is a disease characterised by symptoms such as hearing, seeing or sensing things which are not there (hallucination), suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious, tense, or not being able to start or keep up planned activities, unwillingness to speak, lack of emotional response to a situation that would normally stimulate feelings in others. • for short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder. The duration of the treatment depends on the clinical response and tolerability, and should be determined based on the clinical judgement of the treating physician. • to treat depressive episodes that happen with bipolar I disorder. Bipolar I disorder is a condition that causes periods of severe changes in your mood, activity levels, energy, and ability to carry out everyday tasks. These changes are commonly called “mood episodes.” HOW SYMVENU WORKS The mechanism of action of cariprazine is not fully known. However, the therapeutic effect of cariprazine may be mediated through a combination of partial agonist activity at dopamine D 3 , D 2 and serotonin 5-HT 1A receptors, and antagonist activity at serotonin 5-HT 2B , 5-HT 2A and histamine H 1 receptors. BEFORE YOU Baca dokumen lengkap
1 SYMVENU ® cariprazine hydrochloride 1. QUALITATIVE AND QUANTITATIVE COMPOSITION Symvenu ® 1.5 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 1.5 mg cariprazine. Symvenu ® 3 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 3 mg cariprazine. Excipients with known effect Each hard capsule contains 0.0003 mg Allura red AC (E 129). Symvenu ® 4.5 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 4.5 mg cariprazine. Excipients with known effect Each hard capsule contains 0.0008 mg Allura red AC (E 129). Symvenu ® 6 mg hard capsules Each hard capsule contains cariprazine hydrochloride corresponding to 6 mg cariprazine. Excipients with known effect Each hard capsule contains 0.0096 mg Allura red AC (E 129). For the full list of excipients, see section 5.1. 2. PHARMACEUTICAL FORM Hard capsule Symvenu ® 1.5 mg hard capsules ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with white opaque cap and white opaque body imprinted with “GR 1.5” on the capsule body with black ink. The capsules are filled with white to yellowish white powder mixture. Symvenu ® 3 mg hard capsules ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and white opaque body imprinted with “GR 3” on the capsule body with black ink. The capsules are filled with white to yellowish white powder mixture. Symvenu ® 4.5 mg hard capsules 2 ‘Size 4’ (approximately 14.3 mm in length) hard gelatin capsule with green opaque cap and green opaque body imprinted with “GR 4.5” on the capsule body with white ink. The capsules are filled with white to yellowish white powder mixture. Symvenu ® 6 mg hard capsules ‘Size 3’ (approximately 15.9 mm in length) hard gelatin capsule with purple opaque cap and white opaque body imprinted with “GR 6” on the capsule body with black ink. The capsules are filled with white to yellowish white powder mixture. 3. CLINICAL PARTICULARS 3 Baca dokumen lengkap