Bricanyl 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Terbutaline sulfate

Available from:

AstraZeneca UK Ltd

ATC code:

R03CC03

INN (International Name):

Terbutaline sulfate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010101; GTIN: 5014162002524

Patient Information leaflet

Profile
Technical Info
N/A
6121
AZL4004B
PS22706
28-07-2022
107444840/402942649 0020
Bricanyl Leaflet patient Bottle-5mg UK
SGK is a Matthews International Corporation
Black
BODY TEXT SIZE
12.0 pt
SMALLEST TEXT SIZE
12.0 pt
Package leaflet: Information for the patient
Bricanyl
®
Tablets 5 mg
terbutaline sulfate
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 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. See section 4.
What is in this leaflet
1. What Bricanyl Tablets are and what they are used for
2. What you need to know before you take Bricanyl Tablets
3. How to take Bricanyl Tablets
4. Possible side effects
5. How to store Bricanyl Tablets
6. Contents of the pack and other information
1. What Bricanyl Tablets are and what they are used for
Bricanyl Tablets contain a medicine called terbutaline sulfate.
This belongs to a group of medicines called beta-agonists.
These work by relaxing certain muscles. For example, they
open up the airways in the lungs.
•
Bricanyl Tablets are used for the regular treatment of breathing
disorders such as asthma. They help to relieve tightening of the
chest and difficulty breathing (bronchospasm). Bricanyl should
not be used alone for the regular treatment of asthma or other
breathing conditions. If you are using Bricanyl every day then
your doctor should have also prescribed you another type of
medication such as an “inhaled corticosteroid”, which helps
reduce the swelling and inflammation in your lungs.
2. What you need to know before you take Bricanyl Tablets
Do not take Bricanyl Tablets:
•
If you are allergic to terbutaline sulfate or

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bricanyl Tablets 5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg terbutaline sulfate.
Excipient(s) with known effect
Each Bricanyl Tablet contains 104 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Off white, circular, biconvex tablet, engraved A/BT and scored on one
side,
symbol ‘5’ on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For bronchodilation: Terbutaline is a selective beta
2
-adrenergic agonist
recommended for the relief and prevention of bronchospasm in bronchial
asthma and other bronchopulmonary disorders in which bronchospasm is a
complicating factor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
When used as maintenance therapy the patient should also receive
optimal
anti-inflammatory therapy, e.g. inhaled corticosteroids, leukotriene
receptor
antagonists.
Bricanyl Tablets have a duration of action of 7 to 8 hours. The
minimum
recommended dosage interval is therefore 7 hours.
Adults: During the first 1 - 2 weeks, 2.5mg (half a tablet) 3 times in
a 24-hour
period is recommended. The dose may then be increased to 5mg (1
tablet) 3
times in a 24-hour period to achieve adequate bronchodilation.
Elderly: Dosage as for Adults.
_Paediatric population (7 - 15 years)_: The starting dose should
normally be
2.5mg (half a tablet) 2 times in 24 hours. However, in some patients,
the dose
may need to be increased to 2.5mg 3 times in 24 hours.
Method of administration
For oral use.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As for all beta
2
-agonists caution should be observed in patients with
thyrotoxicosis.
Cardiovascular effects may be seen with sympathomimetic drugs,
including
Bricanyl. There is some evidence from post-marketing data and
published
literature of myocardial ischaemia associated with beta agonists.
Due to the