Betahistine Actavis 8mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAHISTINE DIHYDROCHLORIDE

Available from:

Actavis Group h.f. Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland

ATC code:

N07CA01

INN (International Name):

BETAHISTINE DIHYDROCHLORIDE 8 mg

Pharmaceutical form:

TABLET

Composition:

BETAHISTINE DIHYDROCHLORIDE 8 mg

Prescription type:

POM

Therapeutic area:

OTHER NERVOUS SYSTEM DRUGS

Authorization status:

Withdrawn

Authorization date:

2006-12-20

Patient Information leaflet

BETAHISTIN  ACTAVIS
Betahistine dihydrochloride, 8mg & 16mg tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
START TAKING THIS MEDICINE.
-  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. Do not pass it on to others. It may  
  harm them, even if their symptoms are  
  the same as yours.
-  If any of the side effects gets serious, or  
  if you notice any side effects not listed  
  in this leaflet, please tell your doctor or  
  pharmacist.
IN THIS LEAFLET: 
1.  What betahistine is and what it is used for
2.  Before you take betahistine
3.  How to take betahistine
4.  Possible side effects
5.  How to store betahistine
6.  Further information

1.  WHAT BETAHISTINE IS AND WHAT IT  
  IS USED FOR
Betahistine 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.  BEFORE YOU TAKE BETAHISTINE
DO NOT USE BETAHISTINE
•  if you are allergic (hypersensitive) to  
  betahistine or to any of the other  
  components of the tablet (see also  
  section 6 “Further information”)
•  if you have a phaeochromocytoma, a  
  rare tumour of the adrenal gland
•  if you are under the age of 18
•  if you are breast-feeding (see also the  
  section on “Pregnancy and breast- 
  feeding”).

TAKE SPECIAL CARE WITH BETAHISTINE
•  if you suffer or if you have suffered  
  from a stomach ulcer (peptic ulcer)
•  if you suffer from asthma
•  if you are suffering from 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.
If you suffer from any of the above 
conditions, consult your doctor about 
whether you may take betahistine.
The above group

Summary of Product characteristics

 
Page 1 of 5 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Betahistin Actavis 8mg Tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

One tablet contains 8 mg Betahistine dihydrochloride 

One tablet contains 70 mg lactose monohydrate. 

For a full list of excipients, see section 6.1 

3. 
PHARMACEUTICAL FORM 

Tablet. 

White or almost white, round tablet. Embossed B8 on one side. 

4.  
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Betahistine is indicated for the 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 (including the elderly): 

Initial oral treatment is 8 to 16 mg three times daily, taken with food. 

Maintenance doses are generally in the range of 24 - 48 mg daily. Dosage can be 
adjusted to suit individual patient needs. Sometimes improvement can be observed 
after only a couple of weeks of treatment. 

Children and adolescents: 

Betahistine tablets are not recommended for use in children and adolescents below the 
age of 18 years due to lack of data on safety and efficacy.  

4.3 
CONTRAINDICATIONS 

Page 2 of 5 

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

Also contraindicated in the cases of: 
•

hypersensitivity to the active substance or to any of the excipients. 

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Caution is advised in the treatment of patients with peptic ulcer or a history of peptic