País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
Tolvaptan
Accord Healthcare S.L.U.
C03XA01
tolvaptan
Diuretics,
Inappropriate ADH Syndrome
Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Authorised
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TOLVAPTAN ACCORD 7.5 MG TABLETS TOLVAPTAN ACCORD 15 MG TABLETS TOLVAPTAN ACCORD 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 Tolvaptan Accord is and what it is used for 2. What you need to know before you take Tolvaptan Accord 3. How to take Tolvaptan Accord 4. Possible side effects 5. How to store Tolvaptan Accord 6. Contents of the pack and other information 1. WHAT TOLVAPTAN ACCORD IS AND WHAT IT IS USED FOR Tolvaptan Accord, 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. Tolvaptan Accord 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, Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tolvaptan Accord 7.5 mg tablets Tolvaptan Accord 15 mg tablets Tolvaptan Accord 30 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tolvaptan Accord 7.5 mg tablets Each tablet contains 7.5 mg tolvaptan. _Excipient with known effect_ _ _ 17.5 mg lactose (as monohydrate) per tablet Tolvaptan Accord 15 mg tablets Each tablet contains 15 mg tolvaptan. _Excipient with known effect_ _ _ 35 mg lactose (as monohydrate) per tablet Tolvaptan Accord 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 Tolvaptan Accord 7.5 mg tablets Light blue to blue coloured, round, biconvex, uncoated tablets, debossed with "MT" on one side and "18" on other side with approximate dimension of 5.0 mm. Tolvaptan Accord 15 mg tablets Light blue to blue coloured, triangle, biconvex, uncoated tablets, debossed with '"MT" on one side and "7" on other side with approximate dimension of 6.7 x 6.3 x 3.3 mm. Tolvaptan Accord 30 mg tablets Light blue to blue coloured, round, biconvex, uncoated tablets, debossed with "MT" on one side and "8" on other side with approximate dimension of 8.1 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). 3 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 tolvaptan has to be initiated in hospital. 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 Llegiu el document complet