Serc
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
14-03-2022
Summary of Product characteristics
(SPC)
14-03-2022
Active ingredient:
Betahistine dihydrochloride 16mg;
Available from:
Viatris Limited
INN (International Name):
Betahistine dihydrochloride 16 mg
Dosage:
16 mg
Pharmaceutical form:
Tablet
Composition:
Active: Betahistine dihydrochloride 16mg Excipient: Citric acid monohydrate Colloidal silicon dioxide Mannitol Microcrystalline cellulose Purified talc
Units in package:
Blister pack, physician sample pack, 10 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Finorga SA
Product summary:
Package - Contents - Shelf Life: Blister pack, physician sample pack - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 25 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 30°C
Authorization date:
1998-08-03
Patient Information leaflet
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
SERC
®
_BETAHISTINE DIHYDROCHLORIDE 16 MG TABLET_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Serc.
This leaflet answers some common
questions about Serc.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Serc against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT SERC IS USED
FOR
Serc is used to treat a disorder of
your inner ear. This disorder may
include one or more of the following
symptoms, in one or both ears:
ringing in the ears (tinnitus)
loss of clear hearing
problems with balance
(vertigo)
These symptoms may also be
associated with nausea, vomiting
and headache. Often these
symptoms together are referred to
as Meniere's Syndrome.
Serc contains the active ingredient
betahistine dihydrochloride. It
belongs to a group of medicines to
help treat vertigo.
Serc works by improving the blood
flow of the inner ear and restoring it
to normal. It also acts on the nerve
endings in the inner ear to
normalise the way in which the
nerves respond to outside
influences.
Your doctor may have prescribed
this medicine for another reason.
This medicine is not addictive.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE SERC
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE SERC IF YOU HAVE AN
ALLERGY TO:
any medicine containing
betahistine dihydrochloride
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash
Read the complete document
Summary of Product characteristics
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
Read the complete document
