Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Tolvaptan
Otsuka Pharmaceuticals (U.K.
C03XA01
Tolvaptan
15mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06050200; GTIN: 5038256000036
1 PACKAGE LEAFLET: INFORMATION FOR THE USER SAMSCA 15 MG TABLETS SAMSCA 30 MG TABLETS tolvaptan READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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, please ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IN THIS LEAFLET: 1. What Samsca is and what it is used for 2. What you need to know before you take Samsca 3. How to take Samsca 4. Possible side effects 5. How to store Samsca 6. Contents of the pack and other information 1. WHAT SAMSCA IS AND WHAT IT IS USED FOR Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists. Vasopression is a hormone that helps prevent the loss of water from the body by reducing urine output. Antagonist means that it prevents vasopressin having its effect on water retention. This leads to a reduction in the amount of water in the body by increasing urine production and as a result it increases the level or concentration of sodium in your blood. Samsca is used to treat low serum sodium levels in adults. You have been prescribed Samsca because you have a lowered sodium level in your blood as a result of a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH) where the kidneys retain too much water. This disease causes an inappropriate production of the hormone vasopressin which has caused the sodium levels in your blood to get too low (hyponatraemia). That can lead to difficulties in concentration and memory, or in keeping your balance. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SAMSCA DO NOT TAKE SAMSCA if you are allergic to tolvaptan or any of the other ingredien Přečtěte si celý dokument
SAMSCA 15 MG AND 30 MG TABLETS Summary of Product Characteristics Updated 05-Aug-2014 | Otsuka Pharmaceuticals (UK) Ltd 1. Name of the medicinal product Samsca 15 mg tablets Samsca 30 mg tablets 2. Qualitative and quantitative composition Samsca 15 mg tablets: Each tablet contains 15 mg tolvaptan. Excipient with known effect: Each tablet contains approximately 35 mg lactose (as monohydrate). Samsca 30 mg tablets: Each tablet contains 30 mg tolvaptan. Excipients with known effect: Each tablet contains approximately 70 mg (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Samsca 15 mg tablets: Tablet Blue, triangular, shallow-convex, debossed with OTSUKA and 15 on one side. Samsca 30 mg tablets: Tablet Blue, round, shallow-convex, debossed with OTSUKA and 30 on one side. 4. Clinical particulars 4.1 Therapeutic indications Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH). 4.2 Posology and method of administration Due to the need for a dose titration phase with close monitoring of serum sodium and volume status (see section 4.4), treatment with Samsca should be initiated in hospital. _Posology _ Treatment with tolvaptan should be initiated at a dose of 15 mg once daily. The dose may be increased to a maximum of 60 mg once daily as tolerated to achieve the desired level of serum sodium. During titration, patients should be monitored for serum sodium and volume status (see section 4.4). In case of inadequate improvement in serum sodium levels, other treatment options should be considered, either in place of or in addition to tolvaptan. Use of tolvaptan in combination with other options may increase the risk of overly rapid correction of serum sodium (see sections 4.4 and 4.5). For patients with an appropriate increase in serum sodium, the underlying disease and serum sodium levels should be monitored at regular intervals to evaluate further need of tolvaptan treatment. In the setti Přečtěte si celý dokument