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BRONCHIAL MIXTURE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
‘Bronchial’ Mixture

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Anunonium Bicarbonate BP
Ipecacuanha Tincture BP
Squill Liquid Extract BP

3

117.500mg
0.0750ml
0.0475ml

PHARMACEUTICAL FORM
Dark Brown Oral Solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
A traditional remedy for the temporary relief of symptoms of catarrh and
irritating coughs.

4.2

Posology and method of administration
‘Bronchial’ Mixture is for oral administration.
Not recommended to children under 12 years
Adults (including the elderly):

Two 5ml spoonful diluted with an equal quantity of water, to be sipped slowly
three times a day.

4.3

Contraindications
Impaired renal function, impaired hepatic function, cardiac disorders,
moderate to severe respiratory insufficiency, alcoholism and raised intracranial
pressure or if hypersensitive to any ingredient.

4.4

Special warnings and precautions for use
The product labelling also contains the following warnings:
Do not exceed the stated dose.
Contact your doctor immediately if too much is taken.
If symptoms persist, consult your doctor.
Not to be taken by children under 12 years.
Store out of children’s reach.

4.5

Interaction with other medicinal products and other forms of interaction
An interaction between tricyclic antidepressants and ipecacuanha has been
described.

4.6

Fertility, Pregnancy and lactation
There is inadequate evidence of the safety of the active ingredients in human
pregnancy, but they have been widely used for many years without significant
reports of problems.

4.7

Effects on ability to drive and use machines
None known.

4.8

Undesirable effects
Large doses of ‘Bronchial’ Mixture may cause nausea and vomiting. A case of
gastric rupture caused by an emetic dose of ipecacuanah has been reported.

4.9

Overdose
No special procedures or antidotes are likely to be needed in healthy adults but
see ‘Contraindications’ (4.3).

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Ammonium bicarbonate and squill are expectorants.
Ipecacuanha is an emetic and expectorant.

5.2

Pharmacokinetic properties
None stated.

5.3

Preclinical safety data
No remarks.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Quantity per 5 ml dose
Preservatives:
Benzoic acid BP

6.0 mg

Other constituents:
Senga liquid extract BP
Sucrose BP

0.0238 ml
1.6250 g

Tolu solution (1980) BP
Capiscum tincture (1973) BPC
Anise Oil BP
Glycerol BP
Chloroform BP
Caramel BPC (1973)
Purified water, Ph.Eur.

0.06 ml
0.0625 ml
0.001 ml
0.005 ml
0.02 ml
0.0225 ml
TO 5.0 ml

6.2

Incompatibilities
None Known.

6.3

Shelf life
36 Months from date of manufacture.

6.4

Special precautions for storage
Store below 25°C.

6.5

Nature and contents of container
The product containers are round amber bottles with screw caps, containing
100 ml or 200 ml of product. The Rusco bottles are contained in cartons.
Carton: White backed folding box board printed on white.

6.6

Special precautions for disposal
For oral administration after dilution with an equal quantity of water.

7

MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited,
11 Boumpoulinas, 3rd Floor,

P.C. 1060
Nicosia.
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 28444/0043

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
31st January 1998

10

DATE OF REVISION OF THE TEXT
11/01/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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