Serc
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
20-04-2024
Summary of Product characteristics
(SPC)
20-04-2024
Active ingredient:
Betahistine dihydrochloride
Available from:
Abbott Australasia Pty Ltd
Class:
Medicine Registered
Patient Information leaflet
SERC
®
_betahistine dihydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
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 or pharmacist
has weighed the risks of you taking
this medicine 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 tablets contain the active
ingredient betahistine
dihydrochloride. 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
This medicine is not addictive.
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 symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT.
It may affect your developing baby if
you take it during pregnancy.
DO NOT BREASTFEED
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Summary of Product characteristics
_Serc PI (marketed)_
_ _
_Version 3 _
_Page 1 _
PRODUCT INFORMATION
SERC
TABLETS
NAME OF THE DRUG
NON-PROPRIETARY NAME
Betahistine dihydrochloride
CHEMICAL STRUCTURE
Betahistine dihydrochloride is chemically identified as 2-[2-methylamino)ethyl]pyridine
dihydrochloride. Chemically, betahistine has a close resemblance to histamine. It has the
following chemical structure:
MW= 209.1
CAS NUMBER
5579-84-0
DESCRIPTION
Betahistine dihydrochloride is a white to almost white crystalline powder, which is very
hygroscopic. The product is very soluble in water, freely soluble in methanol and 96%
ethanol, and slightly soluble in isopropanol. The pKa values are
3.5 and 9.7.
Serc (betahistine dihydrochloride) is available in 16 mg tablets. The inactive ingredients in
Serc 16 mg tablets are: colloidal anhydrous silica, microcrystalline cellulose, mannitol, citric
acid monohydrate, and purified talc.
PHARMACOLOGY
PHARMACODYNAMICS
The mechanism of action of betahistine is not known. Pharmacological testing in animals
has shown that the blood circulation in the striae vascularis of the inner ear improves,
probably by means of a relaxation of the precapillary sphincters of the microcirculation of the
inner ear.
In further animal pharmacological studies, betahistine was found to have weak H1 receptor
agonistic and considerable H3 antagonistic properties in the CNS and autonomic nervous
system. Betahistine was also found to have a dose dependent inhibiting effect on spike
generation of neurons in lateral and medial vestibular nuclei in cats. The importance of this
obs
ervation in th
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