Betahistine Sandoz 16 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

BETAHISTINEDIHYDROCHLORIDE 16 mg/stuk SAMENSTELLING overeenkomend met ; BETAHISTINE 10,4 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

N07CA01

INN (Algemene Internationale Benaming):

BETAHISTINEDIHYDROCHLORIDE 16 mg/stuk SAMENSTELLING overeenkomend met ; BETAHISTINE 10,4 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Betahistine

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CITROENZUUR 0-WATER (E 330); MANNITOL (D-) (E 421); SILICIUMDIOXIDE (E 551); TALK (E 553 B);

Autorisatie datum:

1900-01-01

Bijsluiter

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. A
-
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

Productkenmerken

Sandoz B.V.
Page 1/8
Betahistine Sandoz 8 mg/16 mg/24 mg, tabletten
RVG 118849-50-51
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 118849-50-51
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 dihy