Betahistin Actavis 24mg, Tablets

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Medicines Authority

Ակտիվ բաղադրիչ:

BETAHISTINE DIHYDROCHLORIDE

Հասանելի է:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC կոդը:

N07CA01

INN (Միջազգային անվանումը):

BETAHISTINE DIHYDROCHLORIDE 24 mg

Դեղագործական ձեւ:

TABLET

Կազմը:

BETAHISTINE DIHYDROCHLORIDE 24 mg

Ռեկվիզորի տեսակը:

POM

Թերապեւտիկ տարածք:

OTHER NERVOUS SYSTEM DRUGS

Լիազորման կարգավիճակը:

Withdrawn

Հաստատման ամսաթիվը:

2012-02-01

Տեղեկատվական թերթիկ

dimensions: 
pharmacode: 
date sent:
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08.01.2014
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08.01.2014
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12.03.2014
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Dupnitsa
Item number: AAAG4215
Betahistine (PHARMAPACK TRANSFER) 24mg, PIL, Malta
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, pharmacist or nurse.
•  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, 
pharmacist or nurse. This includes any 
possible side effects not listed in this leaflet. 
WHAT IS IN THIS LEAFLET 
1. What Betahistin Actavis is and what it is 
used for
2. What you need to know before you take 
Betahistin Actavis
3. How to take Betahistin Actavis
4. Possible side effects
5. How to store Betahistin Actavis
6. Contents of the pack and other information
1. WHAT BETAHISTIN ACTAVIS IS AND WHAT IT IS 
USED FOR
Betahistin Actavis is a medicine that is used 
to treat symptoms of Ménière’s syndrome 
such as dizziness, ringing in the ears, loss of 
hearing and nausea. 
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE 
BETAHISTIN ACTAVIS
DO NOT USE BETAHISTIN ACTAVIS
•  if you are allergic to betahistine or any 
of the other ingredients of this medicine 
(listed in section 6)
•  if you have a phaeochromocytoma, a rare 
tumour of the adrenal gland
WARNINGS AND

Ապրանքի հատկությունները

Page 1 of 6

SUMMARY OF PRODUCTS CHARACHTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Betahistin Actavis 24 mg tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One tablet contains 24 mg Betahistine dihydrochloride 

Excipient with known effect: 
One tablet contains 210 mg lactose monohydrate. 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Tablet. 
White to off-white, circular, biconvex tablet, one face with a score line. 
The tablet can be divided into equal doses. 

4.  
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 
Betahistine 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 
_ _
_Posology _

Adults (including the elderly): 
12-24 mg twice a day, taken with food. 
Dosage can be adjusted to suit individual patient needs. Sometimes
improvement could be 
observed only after a couple of weeks of treatment. 

Paediatric population: 
Betahistine is not recommended for use in children below
18 yearsdue to insufficient data on safety 
and efficacy.  

4.3 
CONTRAINDICATIONS 

Betahistine is contraindicated in patients with phaeochromocytoma.
As betahistine is a 
synthetic analogue of histamine it may induce the release of
catecholamines from the tumour 
resulting in severe hypertension. 

Also contraindicated are the following: 


hypersensitivity to the active substance or to any of
the excipients listed in section 6.1. 

Page 2 of 6

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Patients with bronchial asthma, peptic ulcer or a 
history of peptic ulceration need to be carefully monitored
during the therapy. 

Caution should be exercised in patients with bronchial asthma. 

Caution is advised in prescribing betahistine to p