Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Tolvaptan
Otsuka Pharmaceutical Netherlands B.V.
C03XA01
tolvaptan
Diuretics,
Inappropriate ADH Syndrome
Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH).,
Revision: 15
Authorised
2009-08-02
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE USER SAMSCA 7.5 MG TABLETS 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, 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 signs of illness 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. WHAT IS 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. Vasopressin 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 this medicine 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 (hyponatremia). 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 y Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Samsca 7.5 m g tablets Each tablet contains 7.5 mg tolvaptan. Excipient with known effect 51 mg lactose (as monohydrate) per tablet Samsca 15 mg tablets Each tablet contains 15 mg tolvaptan. Excipient with known effect 35 mg lactose (as monohydrate) per tablet Samsca 30 mg tablets Each tablet contains 30 mg tolvaptan. Excipient with known effect 70 mg lactose (as monohydrate) per tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Samsca 7.5 mg tablets Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side. Samsca 15 mg tablets Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side. Samsca 30 mg tablets Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Samsca is indicated in adults for the treatment of hyponatremia secondary to the 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 has to be initiated in hospital. 3 Posology Tolvaptan has to 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. For patients at risk of overly rapid correction of sodium e.g., patients with oncological conditions, very low baseline serum sodium, taking diuretics, or taking sodium supplementation a dose of 7.5 mg should be considered (see section 4.4). During titration, patients must be monitored for serum sodium and volume status (se Lesen Sie das vollständige Dokument