BRICANYL SA 7.5 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TERBUTALINE SULFATE

Available from:

AstraZeneca UK Limited

INN (International Name):

TERBUTALINE SULFATE

Dosage:

7.5 Milligram

Pharmaceutical form:

Tablets

Authorization status:

Withdrawn

Authorization date:

2006-10-24

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bricanyl
®
SA 7.5mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 7.5 mg of terbutaline sulphate.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film-coated prolonged-release tablets.
A white to faintly yellow, circular, biconvex tablet engraved
with ‘
B
A
D
’ on one side.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
Terbutaline is a selective 
2
-adrenergic agonist recommended for relief and prevention
of bronchospasm in bronchial 
asthma and in chronic bronchitis and other bronchopulmonary
disorders in which bronchospasm is a complicating 
factor.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults: 1 tablet morning and evening.
The inactive components in Bricanyl SA form a matrix which
is insoluble in the digestive juices. The empty matrix 
may sometimes pass through the digestive system unchanged and
be excreted.
The tablet may not be divided or chewed, but must be swallowed
whole together with liquid. 
Elderly:
Dosage as for adults.
4.3 CONTRAINDICATIONS
Bricanyl oral preparations are contra-indicated in patients with
a history of hypersensitivity to any of their constituents.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Care should be taken with patients suffering
from myocardial insufficiency or thyrotoxicosis.
Due to the hyperglycaemic effects of 
2
-stimulants, additional blood glucose measurements are initially
recommended 
when Bricanyl therapy is commenced in diabetic patients.
If a previously effective dosage regime no
longer gives the same symptomatic relief, the patient should
urgently seek 
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 26/09/2005_
_CRN 2015116_
_page number: 1_
further medical advice. Consideration should be gi