Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SEMAGLUTIDE
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
SEMAGLUTIDE
30 Tablets; 60 Tablets; 90 Tablets
NOVO NORDISK A/S
RYBELSUS ® TABLET _ _ Semaglutide (3 mg, 7 mg, 14 mg) _ _ _Consumer Medication Information Leaflet (RiMUP) _ 1 WHAT IS IN THIS LEAFLET 1. What Rybelsus ® is used for 2. How Rybelsus ® works 3. Before you use Rybelsus ® 4. How to use Rybelsus ® 5. While you are using it 6. Side effects 7. Storage and disposal of Rybelsus ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT RYBELSUS ® IS USED FOR Rybelsus ® is used to treat adults (aged 18 years and older) with type 2 diabetes when diet and exercise is not enough: on its own – when you cannot use metformin (another diabetes medicine) or with other medicines for diabetes – when the other medicines are not enough to control your blood sugar levels. These may be medicines you take by mouth or inject such as insulin. It is important that you continue with your diet and exercise plan as agreed with your doctor, pharmacist or nurse. 2. HOW RYBELSUS ® WORKS Rybelsus ® contains the active substance semaglutide. It is a medicine that is used to lower blood sugar levels. 3. BEFORE YOU USE RYBELSUS ® _ _ _- WHEN YOU MUST NOT USE IT _ Do not take Rybelsus ® If you are allergic to semaglutide or any of the other ingredients of this medicine (listed in section 8. Product Description’). _- BEFORE YOU START TO USE IT _ Talk to your doctor, pharmacist or nurse before using Rybelsus ® . WARNINGS AND PRECAUTIONS This medicine is not the same as insulin and you should not use it if: you have type 1 diabetes (your body does not produce any insulin) you develop diabetic ketoacidosis. This is a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth. STOMACH AND GUT PROBLEMS AND DEHYDRATION During treatment with this medicine, you may feel sick (nausea) or be sick (vomiting), or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough Izlasiet visu dokumentu
Rybelsus ® Professional leaflet EN-Aug-2022_8-0503-00-004-1_Version 3.0 Based on EU text: 20220401_EN_08274_RYB_4-0 1 1. NAME OF THE MEDICINAL PRODUCT RYBELSUS ® 3 MG TABLETS RYBELSUS ® 7 MG TABLETS RYBELSUS ® 14 MG TABLETS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Rybelsus ® 3 mg tablets Each tablet contains 3 mg semaglutide*. Rybelsus ® 7 mg tablets Each tablet contains 7 mg semaglutide*. Rybelsus ® 14 mg tablets Each tablet contains 14 mg semaglutide*. *human glucagon-like peptide-1 (GLP-1) analogue produced in _Saccharomyces cerevisiae_ cells by recombinant DNA technology. Excipient with known effect Each tablet, regardless of semaglutide strength, contains 23 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Rybelsus ® 3 mg tablets White to light yellow, oval shaped tablet (7.5 mm x 13.5 mm) debossed with ‘3’ on one side and ‘novo’ on the other side. Rybelsus ® 7 mg tablets White to light yellow, oval shaped tablet (7.5 mm x 13.5 mm) debossed with ‘7’ on one side and ‘novo’ on the other side. Rybelsus ® 14 mg tablets White to light yellow, oval shaped tablet (7.5 mm x 13.5 mm) debossed with ‘14’ on one side and ‘novo’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Rybelsus ® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in combination with other medicinal products for the treatment of diabetes. Rybelsus ® Professional leaflet EN-Aug-2022_8-0503-00-004-1_Version 3.0 Based on EU text: 20220401_EN_08274_RYB_4-0 2 For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The starting dose of semaglutide is 3 mg once daily for one month. Izlasiet visu dokumentu