Betahistine Dihydrochloride Tablets 8mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BETAHISTINE DIHYDROCHLORIDE

Available from:

Generics UK Limited Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

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Withdrawn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:

2006-09-28

Patient Information leaflet

 
COLOURS:
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PL 4569/0348 +
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Marketing
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Quality Assurance
Generics [UK] Limited, Design Department
Albany Gate, Darkes Lane, Potters Bar, Herts, EN6 1AG
CUSTOMER:
  GUK/ANY OLS
DESIGNER:
 Maria Toumazou
PRODUCT:
  Betahistine tablets 8 & 16 mg x 84 & 120's 
ITEM CODE:
  (BU-I) 302131
PHARMACODE:
 204 supplied
DIMENSIONS:
  110 x 210 mm
PROOF NO & DATE:
  5   09/11/04
REVISION:
  Further text changes from MDSG.
SUPERSEDES:
  BG-I31 & 32  
ARTWORK FOR SUBMISSION
KEEP ALL MEDICATION OUT OF THE REACH AND SIGHT OF CHILDREN. 
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ THIS LEAFLET 
CAREFULLY. This leaflet contains a summary of the information about your 
medicine, Betahistine Dihydrochloride Tablets.

YOUR MEDICINE
Your medicine is in the form of a tablet. There are two strengths of Betahistine 
Dihydrochloride Tablets. Each tablet contains either 8 mg of the active ingredient 
Betahistine Dihydrochloride (marked BH 8) or 16 mg of the active ingredient 
Betahistine Dihydrochloride (marked BH 16). Each tablet also contains 
microcrystalline cellulose, mannitol, citric acid, colloidal silica and talc. Betahistine 
Dihydrochloride Tablets are available in blister packs of 84 or 120 tablets. Your 
pharmacist will dispense the number of tablets prescribed by your doctor.
Product Licence Holder and Manufacturer: Generics [UK] Limited, Station Close, 
Potters Bar, Hertfordshire, EN6 1TL.
WHY DO YOU NEED TO TAKE YOUR MEDICINE ?
Your doctor will prescribe Betahistine Dihydrochloride Tablets for you to help treat 
the symptoms of Ménière's syndrome such as feeling sick, vertigo (dizziness), tinnitus 
(ringing or buzzing in the ears) and hearing loss. The exact way in which Betahistine 
Dihydrochloride works i

Summary of Product characteristics

Page 1 of 5 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
TRADE NAME OF THE MEDICINAL PRODUCT 

Betahistine Dihydrochloride Tablets 8mg 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Betahistine dihydrochloride 8 mg 

3. PHARMACEUTICAL 
FORM 

Tablet. 

White, 7.0mm, round, flat bevel edged tablet marked “BH 8” on
one side and “G” on the reverse. 

CLINICAL PARTICULARS 

4.1. THERAPEUTIC 
INDICATIONS 

Betahistine is indicated for the treatment of vertigo, tinnitus,
hearing loss and nausea associated with 
Ménière's syndrome. 

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 24 - 48 MG DAILY. Dosage can be adjusted to
suit individual patient needs. 

Children: 

Betahistine tablets are not recommended for use in
children._ _Betahistine efficacy and safety have not 
been studied in children and adolescents below the age of 18
years. 

4.3. CONTRA-INDICATIONS 

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:  Known hypersensitivity to
betahistine dihydrochloride 
and/or any other excipient;  Concurrent use with antihistamines. 
Page 2 of 5 
4.4. 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Caution is advised in the treatment of patients with peptic ulcer
or a history of peptic ulceration, 
because of the occasional dyspepsia encountered in patients on
betahistine. 

Caution should be exercised in patients with bronchial asthma. 

Caution is advised in prescribing betahistine to patients with either
urticaria, rashes or allergic 
rhinitis, because of the possibility of aggravating these
symptoms.