Vertimed 24mg

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

BETAHISTINE DIHYDROCHLORIDE

Disponibil de la:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Codul ATC:

N07CA01

INN (nume internaţional):

BETAHISTINE DIHYDROCHLORIDE 24 mg

Forma farmaceutică:

TABLET

Compoziție:

BETAHISTINE DIHYDROCHLORIDE 24 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

OTHER NERVOUS SYSTEM DRUGS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2012-08-27

Prospect

Page 1 of 6 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

VERTIMED 8MG 
VERTIMED 16MG 
VERTIMED 24MG 
Active substance: 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 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. 

WHAT IS IN THIS LEAFLET:  
1. 
What Vertimed is and what it is used for 
2. 
What you need to know before you use Vertimed 
3. 
How to use Vertimed 
4. 
Possible side effects 
5.

  How to store Vertimed 
6. 
Contents of the pack and other information 

1.

WHAT VERTIMED IS AND WHAT IT IS USED FOR 
Betahistine,  the  active  substance  of  Vertimed,  is  similar  to  histamine,  a  substance  which  is  found 
naturally in th ehuman body. Betahistine works by reducing signals in the balance centre of the brain 
which lead to dizziness. 

Vertimed is used for the treatment of Menière’s syndrome, symptoms of which may include dizziness 
(often associated with feeling sick and / or being sick), ringing in the ear (tinnitus) and hearing loss. 

Page 2 of 6 
2.

WHAT YOU NEED TO KNOW BEFORE YOU USEVERTIMED 
DO NOT USE VERTIMED 
- 
if you are allergic (hypersensitive) to betahistine dihydrochloride or any of the other ingredients 
of Vertimed (see section 6 Further information) 
- 
if

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Vertimed 8mg tablets
Vertimed 16mg tablets
Vertimed 24mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vertimed 8mg tablets:
Each tablet contains 8 mg betahistine dihydrochloride
Vertimed 16mg tablets:
Each tablet contains 16 mg betahistine dihydrochloride
Vertimed 24mg tablets:
Each tablet contains 24 mg betahistine dihydrochloride
Excipient with known effect: lactose monohydrate.
Vertimed 8mg tablets: Each tablet contains 50 mg lactose monohydrate.
Vertimed 16mg tablets: Each tablet contains 100 mg lactose
monohydrate.
Vertimed 24mg tablets: Each tablet contains 150 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Vertimed 8mg tablets:
White, round, flat tablets with bevelled edge, breakline on one side,
diameter 6.6 mm.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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Vertimed 16mg tablets:
White, round, flat tablets with bevelled edge, breakline on one side,
diameter 9.0 mm.
The tablet can be divided into equal doses.
Vertimed 24mg tablets:
white, round, flat tablets with bevelled edge, breakline on one side,
diamter 10.0 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Symptomatic treatment of Meniére’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 disease.
_Paediatric pop