Vertigo tablets

Country: Հայաստան

language: անգլերեն

source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

active_ingredient:

betahistine (betahistine dihydrochloride)

MAH:

Medochemie Ltd (Factory AZ)

ATC_code:

N07CA01

INN:

betahistine (betahistine dihydrochloride)

dosage:

16mg

pharmaceutical_form:

tablets

units_in_package:

(30/3x10/) in blister

prescription_type:

Prescription

authorization_status:

Registered

authorization_date:

2021-12-21

PIL

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VERTIGO 8MG TABLETS
VERTIGO 16MG TABLETS
VERTIGO 24MG TABLETS
Betahistine dihydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 illnessare 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 Vertigo is and what it is used for
2.
What you need to know before you take Vertigo
3.
How to takeVertigo
4.
Possible side effects
5.
How to store Vertigo
6.
Contents of the pack and other information
1.
WHAT VERTIGO IS AND WHAT IT IS USED FOR
WHAT VERTIGO IS
Vertigo contains betahistine. It belongs to a type of medicines called
histamine analogues.
WHAT IS VERTIGO USED FOR
Vertigo is used to treat Meniere’s disease symptoms which include:

dizziness (vertigo) and nausea or vomiting;

ringing in the ears (tinnitus);

hearing loss.
The feeling of dizziness is caused by the situation in which, part of
the inner ear, which controls your
balance, does not work correctly (called vestibular vertigo).
2
HOW VERTIGO WORKS
Vertigo works by improving the blood flow to your inner ear. This
reduces the pressure in the inner
ear.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VERTIGO
DO NOT TAKE VERTIGO
-
if you are allergic to betahistine dihydrochloride or any of the other
ingredients of this medicine
(listed in section 6);
-
if your doctor has told you that you suffer from a tumour of the
adrenal gland (known as
phaeochromocytoma).
Do not take this medicine if any of the above applies to you. If you
are not sure, ask your doctor or
pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Verti

SPC

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vertigo 8mg tablets
Vertigo 16mg tablets
Vertigo 24mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_2.1 GENERAL DESCRIPTION _
Vertigo 8mg tablets:
White, round, flat tablets with bevelled edge, and line bossing,
diameter 6.5 mm.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
Vertigo 16mg tablets:
White, flat round tablet with bevelled edges with a breakline,
diameter 9.0 mm
The tablet can be divided into equal doses.
Vertigo 24mg tablets:
White, flat round tablet with bevelled edges with a breakline;
diameter 10.0 mm
The tablet can be divided into equal doses.
_2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION _
Vertigo 8mg tablets:
Each tablet contains 8 mg betahistine dihydrochloride
Vertigo 16mg tablets:
Each tablet contains 16 mg betahistine dihydrochloride
Vertigo 24mg tablets:
Each tablet contains 24 mg betahistine dihydrochloride
Excipient with known effect: lactose monohydrate.
Vertigo 8mg tablets: Each tablet contains 50 mg lactose monohydrate.
Vertigo 16mg tablets: Each tablet contains 100 mg lactose monohydrate.
Vertigo 24mg tablets: Each tablet contains 150 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
2
3.
PHARMACEUTICAL FORM
Tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Symptomatic treatment of Meniere’s disease.

Symptomatic treatment of vestibular vertigo.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
24 mg – 48 mg betahistine dihydrochloride daily, in divided doses.
8 mg tablets
16 mg tablets
24 mg tablets
1-2 tablets 3 times daily
½-1 tablet 3 times daily
1 tablet 2 times daily
The dosage is individualised. Sometimes the improvement of the
condition can only be observed after
a few weeks of treatment.
The best treatment result is achieved after a few months.
When the treatments is started in early stages, it can prevent the
progression of the disease and/or
hearing loss in the lates stages of the dise