Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Selexipag
Actelion Pharmaceuticals UK Ltd
B01AC27
Selexipag
800microgram
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050100; GTIN: 7640111931911
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT UPTRAVI 200 MICROGRAM FILM-COATED TABLETS UPTRAVI 400 MICROGRAM FILM-COATED TABLETS UPTRAVI 600 MICROGRAM FILM-COATED TABLETS UPTRAVI 800 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,000 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,200 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,400 MICROGRAM FILM-COATED TABLETS UPTRAVI 1,600 MICROGRAM FILM-COATED TABLETS Selexipag This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 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 have any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET 1. What Uptravi is and what it is used for 2. What you need to know before you take Uptravi 3. How to take Uptravi 4. Possible side effects 5. How to store Uptravi 6. Contents of the package and other information 1. WHAT UPTRAVI IS AND WHAT IT IS USED FOR Uptravi is a medicine that contains the active substance selexipag. It acts on blood vessels in a similar way to the natural substance prostacyclin, making them relax and widen. Uptravi is used for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients insufficiently controlled with other types of medicines for PAH known as endothelin receptor antagonists and phosphodiesterase type 5 inhibitors. Uptravi can be used on its own if the patient is not a candidate for these medicines. PAH is high blood pressure in the blood vessels that carry blood from the heart to the lungs (the pulm Izlasiet visu dokumentu
OBJECT 1 UPTRAVI Summary of Product Characteristics Updated 18-Apr-2018 | Actelion Pharmaceuticals UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Uptravi 200 microgram film-coated tablets. Uptravi 400 microgram film-coated tablets. Uptravi 600 microgram film-coated tablets. Uptravi 800 microgram film-coated tablets. Uptravi 1,000 microgram film-coated tablets. Uptravi 1,200 microgram film-coated tablets. Uptravi 1,400 microgram film-coated tablets. Uptravi 1,600 microgram film-coated tablets. 2. Qualitative and quantitative composition Uptravi 200 microgram film-coated tablets Each film-coated tablet contains 200 micrograms of selexipag. Uptravi 400 microgram film-coated tablets Each film-coated tablet contains 400 micrograms of selexipag. Uptravi 600 microgram film-coated tablets Each film-coated tablet contains 600 micrograms of selexipag. Uptravi 800 microgram film-coated tablets Each film-coated tablet contains 800 micrograms of selexipag. Uptravi 1,000 microgram film-coated tablets Each film-coated tablet contains 1,000 micrograms of selexipag. Uptravi 1,200 microgram film-coated tablets Each film-coated tablet contains 1,200 micrograms of selexipag. Uptravi 1,400 microgram film-coated tablets Each film-coated tablet contains 1,400 micrograms of selexipag. Uptravi 1,600 microgram film-coated tablets Each film-coated tablet contains 1,600 micrograms of selexipag. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Uptravi 200 microgram film-coated tablets Round, light-yellow, film-coated tablets with “2” debossed on one side. Uptravi 400 microgram film-coated tablets Round, red, film-coated tablets with “4” debossed on one side. Uptravi 600 microgram film-coated tablets Round, light-violet, film-coated tablets with “ Izlasiet visu dokumentu