SERC betahistine dihydrochloride 16 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

betahistine dihydrochloride, Quantity: 16 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

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

Administration route:

Oral

Units in package:

25 tablets, 100 tablets, 10 tablets - sample pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: round, biconvex, scored, white to almost white tablet with bevelled edges, one side inscribed with "267" on either side of the score.; 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

Authorization status:

Licence status A

Authorization date:

1997-11-05

Patient Information leaflet

SERC
®
S
E
R
C
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SERC?
SERC contains the active ingredient betahistine dihydrochloride. 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 and
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.
For more information, see Section 1. Why am I using SERC? in the full
CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SERC?
Do not use if you have ever had an allergic reaction to betahistine
dihydrochloride or any of the ingredients listed at the end of the
CMI.
DO NOT TAKE THIS MEDICINE IF YOU HAVE PEPTIC ULCER OR A RARE
ABNORMALITY OF THE ADRENAL GLAND KNOWN AS
PHAEOCHROMOCYTOMA.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS (E.G.
PEPTIC ULCER, ASTHMA OR A HISTORY OF SKIN CONDITIONS), TAKE
ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SERC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SERC and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SERC?
•
The usual adult starting dose is half to one tablet taken three times
a day.
•
Take SERC at about the same time each day during or immediately after
a meal.
More instructions can be found in Section 4. How do I use SERC? in the
full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SERC?
THINGS YOU
SHOULD DO
•
Remind any doctor or pharmacist you visit that you are using SERC.
•
If you are going to have surgery, tell the surgeon that you are taking
this medicine.
THINGS YOU
SHOULD NOT

Summary of Product characteristics

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 8 mg or 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 recei