Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Macitentan
JOHNSON & JOHNSON SDN. BHD.
Macitentan
30 Tablets
Excella GmbH & Co.KG
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ OPSUMIT® 10MG FILM-COATED TABLETS Macitentan (10mg) 1 WHAT IS IN THIS LEAFLET 1. What Opsumit is used for 2. How Opsumit works 3. Before you use Opsumit 4. How to use Opsumit 5. While you are using it 6. Side effects 7. Storage and Disposal of Opsumit 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT OPSUMIT IS USED FOR Opsumit is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adults; it can be used on its own or with other medicines for PAH. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulmonary arteries). HOW OPSUMIT WORKS Opsumit contains the active substance macitentan, which belongs to the class of medicines called “endothelin receptor antagonists”. In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to feel tired, dizzy, and short of breath. Opsumit widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure, relieves the symptoms and improves the course of the disease. BEFORE YOU USE OPSUMIT - _When you must not take it _ • If you are allergic to macitentan, soya or any of the other ingredients of Opsumit. • If you are pregnant, if you are planning to become pregnant, or if you could become pregnant because you are not using reliable birth control (contraception). See section ‘Things you must do’. • If you are breastfeeding. See section ‘Things you must do’. • If you have liver disease or if you have very high levels of liver enzymes in your blood. Talk to your doctor, who will decide whether this medicine is suitable for you. If any of these apply to you, please tell your doctor. - _Before you start to use it_ Talk to your doctor or pharmacist before taking Opsumit. This medicine has been prescribed for you only. Do not pass it on to others. It may harm t Izlasiet visu dokumentu
1 1. NAME OF THE MEDICINAL PRODUCT Opsumit ® 10 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg macitentan. Excipients with known effect: Each film-coated tablet contains approximately 37 mg of lactose (as monohydrate) and approximately 0.06 mg of soya bean lecithin (E322). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). 5.5 mm, round, biconvex, white to off-white film-coated tablets, debossed with “10” on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Posology The recommended dose is 10 mg once daily. Special populations _Elderly _ No dose adjustment is required in patients over the age of 65 years (see section 5.2). _Hepatic impairment _ Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2). However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment. Opsumit must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (> 3 × ULN); see sections 4.3 and 4.4). 2 _Renal impairment _ Based on PK data, no dose adjustment is required in patients with renal impairment. There is no clinical experience with the use of macitentan in PAH patients with severe renal impairment. Th Izlasiet visu dokumentu