Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
BETAHISTINEDIHYDROCHLORIDE 16 mg/stuk SAMENSTELLING overeenkomend met ; BETAHISTINE 10,4 mg/stuk
Sandoz B.V. Veluwezoom 22 1327 AH ALMERE
N07CA01
BETAHISTINEDIHYDROCHLORIDE 16 mg/stuk SAMENSTELLING overeenkomend met ; BETAHISTINE 10,4 mg/stuk
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CITROENZUUR 0-WATER (E 330) ; MANNITOL (D-) (E 421) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B), CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 0-WATER (E 330) ; MANNITOL (D-) (E 421) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B),
Oraal gebruik
Betahistine
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 0-WATER (E 330); MANNITOL (D-) (E 421); SILICIUMDIOXIDE (E 551); TALK (E 553 B);
1900-01-01
Sandoz B.V. Page 1/6 Betahistine Sandoz 8 mg/16 mg/24 mg, tabletten RVG 118846-7-8 1311-V1 1.3.1.2 Bijlsuiter Januari 2018 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Betahistine Sandoz ® 8 mg, tabletten Betahistine Sandoz ® 16 mg, tabletten Betahistine Sandoz ® 24 mg, tabletten betahistinedihydrochloride 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 {[nationally completed name]} is and what it is used for 2. What you need to know before you take {[nationally completed name]} 3. How to take {[nationally completed name]} 4. Possible side effects 5. How to store {[nationally completed name]} 6. Contents of the pack and other information 1. WHAT {NATIONALLY COMPLETED NAME} IS AND WHAT IT IS USED FOR {Nationally completed name} contains the active substance betahistine that is similar to histamine, a substance which occurs naturally in the human body. {Nationally completed name} is used to treat MÉNIÈRE’S SYNDROME, a disorder characterised by symptoms which may include: dizziness - often associated with feeling sick and/or vomiting ringing in the ears hearing loss 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE {NATIONALLY COMPLETED NAME} DO NOT TAKE {NATIONALLY COMPLETED NAME} if you are allergic to betahistine dihydrochloride or any of the other ingredients of this medicine (listed in section 6 ) if you suffer from a tumour of the adrenal gland (phaeochromocytoma) Sandoz B.V. Page 2/6 Betahistine Sandoz 8 mg/16 mg/24 mg, tabletten RVG 118846-7-8 1311-V1 1.3.1 Lees het volledige document
Sandoz B.V. Page 1/8 Betahistine Sandoz 8 mg/16 mg/24 mg, tabletten RVG 118846-7-8 1311-V2 1.3.1.1 Samenvatting van de Productkenmerken November 2022 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Betahistine Sandoz 8 mg, tabletten Betahistine Sandoz 16 mg, tabletten Betahistine Sandoz 24 mg, tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <{[NATIONALLY COMPLETED NAME] 8 MG TABLETS}>_ _ Each tablet contains 8 mg of betahistine dihydrochloride. <{[NATIONALLY COMPLETED NAME] 16 MG TABLETS}>_ _ Each tablet contains 16 mg of betahistine dihydrochloride. <{[NATIONALLY COMPLETED NAME] 24 MG TABLETS}>_ _ Each tablet contains 24 mg of betahistine dihydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM <{[NATIONALLY COMPLETED NAME] 8 MG TABLETS}>_ _ White colour, round and flat uncoated tablet plain on both sides. Diameter: approximately 7 mm _ _ <{[NATIONALLY COMPLETED NAME] 16 MG TABLETS}>_ _ White colour, round and biconvex uncoated tablet scored on one side with embossing “I” on the either sides of the score and plain in the other side. Diameter: approximately 8.7 mm The tablet can be divided into equal doses. <{[NATIONALLY COMPLETED NAME] 24 MG TABLETS}>_ _ White colour, round and biconvex uncoated tablet scored on one side with the embossing "II" on either sides of the score and plain on the other side. Diameter: approximately 10 mm The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sandoz B.V. Page 2/8 Betahistine Sandoz 8 mg/16 mg/24 mg, tabletten RVG 118846-7-8 1311-V2 1.3.1.1 Samenvatting van de Productkenmerken November 2022 Betahistine is indicated for the treatment of Menière’s syndrome, symptoms of which may include vertigo (often associated with nausea and/or vomiting), tinnitus and hearing loss. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ The dose should be individually adapted according to the response. 8 and 16 mg tablets The usual daily dose is 24 - 48 mg betahistine dihydroc Lees het volledige document