Vertigon 16 mg tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-07-2023
Summary of Product characteristics
(SPC)
19-06-2023
Active ingredient:
Betahistine dihydrochloride
Available from:
Aurobindo Pharma (Malta) Limited
ATC code:
N07CA; N07CA01
INN (International Name):
Betahistine dihydrochloride
Dosage:
16 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Antivertigo preparations; betahistine
Authorization status:
Not marketed
Authorization date:
2014-10-03
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
VERTIGON 8 MG TABLETS
VERTIGON 16 MG TABLETS
betahistine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vertigon is and what it is used for
2.
What you need to know before you take Vertigon
3.
How to take Vertigon
4.
Possible side effects
5.
How to store Vertigon
6.
Contents of the pack and other information
1.
WHAT VERTIGON IS AND WHAT IT IS USED FOR
Betahistine is a type of medicine called a “histamine analogue”.
Vertigon is used for:
Ménière’s disease – the signs of this include:
•
feeling dizzy (vertigo)
•
ringing in the ears (tinnitus)
•
hearing loss or hearing difficulty
How this medicine works
This medicine works by improving blood flow in the inner ear. This
lowers the build up of pressure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERTIGON
DO NOT TAKE VERTIGON
•
if you are allergic to betahistine or to any of the other ingredients
of this medicine (listed in
section 6)
•
if you have a pheochromocytoma, a rare tumour of the adrenal gland
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Vertigon
•
if you have or have had a stomach ulcer (peptic ulcer)
•
if you have asthma
•
if you have nettle rash, skin rash or a cold in the nose caused by an
allergy, since these complaints
may be exacerbated.
•
if you have low blood pressure
Vertigon is not the appropriate treatment for the following forms of
vertigo:
• attacks of benign positional vertigo,
• dizziness related to a disease of
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
19 June 2023
CRN00DD2J
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vertigon 16 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 16 mg Betahistine dihydrochloride.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White to off-white round (diameter 8.5 mm), uncoated tablets debossed
with ‘X’ and a break line on one side and ‘88’ on the
other side.
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Vertigon is indicated for treatment of Ménière's syndrome, symptoms
of which may include vertigo, tinnitus, hearing loss and
nausea
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Dosage _
Adults:
Initial oral treatment is 8 to 16 mg three times daily, taken
preferably with meals.
Maintenance doses are generally in the range 24 - 48 mg daily. . The
daily dose should be given in 2 or 3 divided doses
throughout the day. Daily dose should not exceed 48 mg. Dosage can be
adjusted to suit individual patient needs. Sometimes
improvement could be observed only after a couple of weeks of
treatment. The best results are sometimes obtained after a few
months. There are indications that treatment from the onset of the
disease prevents the progression of the disease and/or the
loss of hearing in later phases of the disease.
Vertigon 8 mg/16 mg:
8 mg tablets
16 mg tablets
1 - 2 tablets
3 times/day
½ - 1 tablet
3 times/day
Vertigon 24mg:
The recommended starting dose is 24 mg betahistine
If the maximum daily dose of 48 mg is indicated adults take one 24 mg
tablet twice daily (in the morning and in the evening)
24 mg tablets
1 tablet
2 times/day
_ _
_Renal impairment_
Health Products Regulatory Authority
19 June 2023
CRN00DD2J
Page 2 of 6
There are no specific clinical trials available in this patient group,
but according to post-marketing experience no dose
adjustment appears to be necessary.
_Hepatic impairment_
There are no specific clinical trials available in this
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