SERC betahistine dihydrochloride 8 mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

betahistine dihydrochloride, Quantity: 8 mg

Disponible des:

Viatris Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: colloidal anhydrous silica; microcrystalline cellulose; mannitol; citric acid monohydrate; purified talc

Vía de administración:

Oral

Unidades en paquete:

10 tablets, 120 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Meniere's Syndrome as defined by the following core symptoms: Vertigo (with nausea/vomiting): Hearing loss (hardness of hearing): Tinnitus.

Resumen del producto:

Visual Identification: round, flat, white to almost white tablet with bevelled edges, one side inscribed with '256'.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estat d'Autorització:

Licence status A

Data d'autorització:

1997-11-05

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
SERC
®
_Betahistine dihydrochloride tablets _
1
NAME OF THE MEDICINE
Betahistine dihydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient is betahistine dihydrochloride.
Each tablet contains 16 mg of Betahistine dihydrochloride.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Serc (betahistine dihydrochloride) 16 mg tablets: round, biconvex,
scored, white to almost white
uncoated tablet, one side inscribed with ‘267’ on either side of
the score.
Serc (betahistine dihydrochloride) *8 mg tablets: round, flat, white
to almost white uncoated tablet, one
side inscribed with ‘256’.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meniere’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
The recommended starting dose in adults is 8 to 16 mg three times a
day. The maximum recommended
daily dose is 48 mg.
The tablets may be taken with or without food. However, if
gastrointestinal upset occurs, it is
recommended that the tablets be taken with meals.
The dosage should be individually adapted according to the response.
Improvement in symptoms may
be observed in the first few days to weeks of treatment.
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 2 QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
AND
SECTION
6
PHARMACEUTICAL
PARTICULARS, 6.1 LIST OF EXCIPIENTS)
.
Serc
®
– PRODUCT INFORMATION
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients with bronchial asthma need to be carefully monitored during
therapy.
Caution should be taken in the treatment of patients receiving
ant