Serc

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Betahistine dihydrochloride 4mg

זמין מ:

Russells Pharmaceuticals Ltd

INN (שם בינלאומי):

Betahistine dihydrochloride 4 mg

כמות:

4 mg

טופס פרצבטיות:

Tablet

הרכב:

Active: Betahistine dihydrochloride 4mg Excipient: Colloidal silicon dioxide Erythrosine Lactose monohydrate Magnesium stearate

יחידות באריזה:

Bottle, glass, 1x100, 100 tablets

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Custom Pharmaceuticals (Canada)

leaflet_short:

Package - Contents - Shelf Life: Bottle, glass, 1x100 - 100 tablets - 36 months from date of manufacture stored at or below 30°C

תאריך אישור:

1969-12-31

מאפייני מוצר

Page 1 of 6
NEW ZEALAND DATA SHEET
SERC
®
1. PRODUCT NAME
SERC, 8 mg, 16 mg tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 8 mg tablet contains 8 mg betahistine dihydrochloride
corresponding to 5.21mg betahistine,
Each
16 mg tablet
contains
16
mg betahistine
dihydrochloride
corresponding
to 10.42 mg
betahistine.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
8 mg tablet: round, flat, white to almost white tablet with bevelled
edges, one side inscribed with
‘256’.
16 mg: round, biconvex, scored, white to almost white tablet with
bevelled edges, one side inscribed
‘267’ on either side of the score.
SERC 16 mg tablets can be divided into equal doses. 4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Ménière’s Syndrome as defined by the following core symptoms:

Vertigo (with nausea/vomiting)

Hearing loss (hardness of hearing)

Tinnitus
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
The recommended starting dose is 8 to 16 mg taken three times a day.
The maximum recommended
daily dose is 48 mg.
The dosage should be individually adapted according to the response.
Improvement can sometimes
only be observed after a couple of weeks of treatment.
_SPECIAL POPULATIONS_
PAEDIATRIC
Due to lack of clinical experience, betahistine dihydrochloride should
not be used in children less
than 18 years (see section 4.3).
Page 2 of 6
METHOD OF ADMINISTRATION
The tablets may be taken with or without food. However, if
gastrointestinal upset occurs, it is
recommended that the tablets be taken with meals.
_4.3_
_CONTRAINDICATIONS_
Serc (betahistine dihydrochloride) Tablets are contraindicated as
follows:

During pregnancy and lactation

In children less than 18 years

In patients suffering from phaeochromocytoma

In patients with active peptic ulcer or a history of this condition

In patients with hypersensitivity to any component to the product (see
Section 6.1)
_4.4_
_SPECIAL WARNINGS AND PRECAUTIONS FOR USE_
Patients with bronchial asthma need to be carefu