Each 10 ml contains:
Bromhexine Hydrochloride BP…….......8 mg
Guaiphenesin BP……………………….200 mg
In flavored syrupy base.
Excipients: citric acid, ethyl maltol, Flavour, glycerol,
PEG-40 hydrogenated castor oil, potassium sorbate,
propylene glycol, purified water, saccharin sodium, xanthan gum.
Bromhexine Hydrochloride BP…….......8 mg
Guaiphenesin BP……………………….200 mg
In flavored syrupy base.
Excipients: citric acid, ethyl maltol, Flavour, glycerol,
PEG-40 hydrogenated castor oil, potassium sorbate,
propylene glycol, purified water, saccharin sodium, xanthan gum.
Therapeutic indications
Britussol Cough Linctus contains two active ingredients together to relieve chesty, mucus coughs. Guaiphenesin, an expectorant, and bromhexine hydrochloride, a mucolytic assists in loosening phlegm and eliminating mucus congestion from the chest.
Britussol Cough Linctusis a non-drowsy formula and has a pleasant strawberry flavour. It is free of added sugar, colour,alcohol, lactose, dairy products,gluten, benzoates and parabens.
Britussol Cough Linctuscontains the equivalent of 4g/10mL of maltitol solution. Products containing maltitol may have a laxative effect or cause diarrhoea.It also contains sodium saccharin and sorbic acid.
Britussol Cough Linctusis a non-drowsy formula and has a pleasant strawberry flavour. It is free of added sugar, colour,alcohol, lactose, dairy products,gluten, benzoates and parabens.
Britussol Cough Linctuscontains the equivalent of 4g/10mL of maltitol solution. Products containing maltitol may have a laxative effect or cause diarrhoea.It also contains sodium saccharin and sorbic acid.
Dosage and Administration
Shake bottle before use.
If coughing persists consult your doctor or pharmacist.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus. Ask your doctor or pharmacist about using this product safely
- Aged 2 to 6 years: Take 2.5ml, four times a day when necessary.
- Children aged 6 to 12 years: Take5ml, four times a day when necessary.
- Adults and children over 12 years: Take10ml, four times a day when necessary.
If coughing persists consult your doctor or pharmacist.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as emphysema, chronic bronchitis, asthma, smoker's cough), cough with blood or large amounts of mucus. Ask your doctor or pharmacist about using this product safely
Contraindications
Patients with a history of hypersensitivity to bromhexine, guaiphenesin and any of the other listed ingredients in the product.
Special warnings and Precautions for use
Bromhexine Hydrochloride: Since mucolytics may disrupt the gastric mucosal barrier, bromhexine should be used with caution in patients with a history of gastric ulceration.
Clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.
Guaiphenesin: Guaiphenesin may cause gastro-intestinal discomfort. Very large doses cause nausea and vomiting.
· If symptoms persist consult your doctor.
· Keep out of the reach of children.
· Not to be given to children under 6 years of age unless directed by a doctor or pharmacist.
Clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic or renal impairment.
Guaiphenesin: Guaiphenesin may cause gastro-intestinal discomfort. Very large doses cause nausea and vomiting.
· If symptoms persist consult your doctor.
· Keep out of the reach of children.
· Not to be given to children under 6 years of age unless directed by a doctor or pharmacist.
Interaction with other drugs, other forms interactions
No clinically relevant unfavourable interactions with other medicines have been reported.
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination may counteract each other and patients may be exposed to unnecessary adverse effects.
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination may counteract each other and patients may be exposed to unnecessary adverse effects.
Interaction with other drugs, other forms interactions
No clinically relevant unfavourable interactions with other medicines have been reported.
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination may counteract each other and patients may be exposed to unnecessary adverse effects.
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination may counteract each other and patients may be exposed to unnecessary adverse effects.
Interaction with other drugs, other forms interactions
No clinically relevant unfavourable interactions with other medicines have been reported.
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination may counteract each other and patients may be exposed to unnecessary adverse effects.
If urine is collected within 24 hours of a dose of this product a metabolite of guaifenesin may cause a colour interference with laboratory determinations of urinary 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination may counteract each other and patients may be exposed to unnecessary adverse effects.
Pregnancy and Lactation
Safety in pregnancy and lactation has not been established.
Effects on ability to drive and operate machine
None known
Undesirable Effects
Bromhexine: Gastrointestinal side effects may occur occasionally with bromhexine and a transient rise in serum aminotransferase values has been reported. Other reported adverse effects include headache, vertigo (dizziness), sweating and allergic reactions.
Guaiphenesin: Gastro-intestinal discomfort has been reported. Very large doses cause nausea and vomiting.
Inform your doctor side effects encountered during the treatment.
Guaiphenesin: Gastro-intestinal discomfort has been reported. Very large doses cause nausea and vomiting.
Inform your doctor side effects encountered during the treatment.
Overdosage
Very large doses of Guaiphenesin cause nausea and vomiting.
Treatment: Symptomatic and supportive, Gastric lavage may be used. A B2-antagonist may be given to reduce the effects of terbutaline, but should be given with care because of the possibility of inducing bronchoconstriction and may not be given to asthmatics.
Treatment: Symptomatic and supportive, Gastric lavage may be used. A B2-antagonist may be given to reduce the effects of terbutaline, but should be given with care because of the possibility of inducing bronchoconstriction and may not be given to asthmatics.
Pharmacodynamic
Bromhexine thins airway secretions, improving breathing and discomfort associated with thick mucus in airways associated with a variety of respiratory conditions. Bromhexine aids in mucus clearance by reducing the viscosity of mucus and activating the ciliary epithelium, allowing secretions to be expelled from the respiratory tract
Guaifenesin is categorized as an expectorant that acts by enhancing the output of phlegm (sputum) and bronchial secretions via decreasing the adhesiveness and surface tension of such material. Furthermore, guaifenesin elicits an increased flow of less viscous gastric secretions that subsequently promote ciliary action - all actions that ultimately change dry, unproductive coughing to coughs that are more productive and less frequent. Essentially, by decreasing the viscosity and adhesiveness of such secretions, guaifenesin enhances the efficacy of mucociliary activity in removing accumulated secretions from the upper and lower airway
Guaifenesin is categorized as an expectorant that acts by enhancing the output of phlegm (sputum) and bronchial secretions via decreasing the adhesiveness and surface tension of such material. Furthermore, guaifenesin elicits an increased flow of less viscous gastric secretions that subsequently promote ciliary action - all actions that ultimately change dry, unproductive coughing to coughs that are more productive and less frequent. Essentially, by decreasing the viscosity and adhesiveness of such secretions, guaifenesin enhances the efficacy of mucociliary activity in removing accumulated secretions from the upper and lower airway
Pharmacokinetic
Bromhexine
Absorption
Following oral administration, bromhexine shows dose linear pharmacokinetics in the dose range of 8-32 mg. It is rapidly and completely absorbed from the gastrointestinal tract. The bioavailability after oral administration is substantially reduced by an extensive first-pass effect in the range of 75-80%. The absolute bioavailability of bromhexine hydrochloride is about 26.8 ± 13.1 %
Concomitant food intake leads to an increase of bromhexine plasma concentrations.
Distribution
After administration, bromhexine was rapidly and widely distributed throughout the body. The distribution of bromhexine in lung tissue (bronchial and parenchymal) was investigated after oral administration of 32 mg and 64 mg bromhexine. Bromhexine lung tissue concentrations two hours post-dose were 1.5 to 3.2 times higher in bronchiolo-bronchial tissues and between 3.4 and 5.9 times higher in pulmonary parenchyma compared to plasma concentrations.
Bromhexine crosses the blood-brain barrier and only a small amount crosses the placenta.
Unchanged bromhexine is 95% bound to plasma proteins.
Metabolism and Excretion
After administration of radiolabelled bromhexine, about 97.4 ± 1.9% of the dose was recovered in the urine, with less than 1% as the parent compound. Bromhexine plasma concentrations showed a multi-exponential decline. After administration of single oral doses between 8 and 32 mg, the terminal half-life of bromhexine ranged between 6.6 and 31.4 hours. The relevant half-life to predict the multiple dose pharmacokinetics is about 1 hour. No accumulation was observed after multiple dosing (accumulation factor 1.1).
Bromhexine is almost completely metabolised to a variety of hydroxylated metabolites and to dibromanthranilic acid. Ambroxol is a metabolite of bromhexine.
There is no pharmacokinetic data available in the elderly or in patients with renal or liver insufficiency. Extensive clinical experience did not give rise to relevant safety concerns in these populations. However, reduced clearance of bromhexine parent substance may be expected in the case of severe liver disease; in the case of severe renal insufficiency accumulation of metabolites cannot be ruled out.
Guaiphenesin
Absorption
Guaifenesin is well absorbed from the gastro-intestinal tract following oral administration,
Distribution
No information is available on the distribution of guaifenesin in humans.
Biotransformation and elimination
Guaifenesin appears to undergo both oxidation and demethylation followed by excretion in the urine. Approximately 40% of a dose is excreted as the metabolite beta-2-methoxyphenoxy-lactic acid in the urine within 3 hours.
Following an oral dose of 600 mg guaifenesin to 3 healthy male volunteers, the t½ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.
Hepatic and renal impairment
No formal studies of guaifenesin in patients with hepatic or renal impairment have been conducted and no data are available for any grade of impairment.
Absorption
Following oral administration, bromhexine shows dose linear pharmacokinetics in the dose range of 8-32 mg. It is rapidly and completely absorbed from the gastrointestinal tract. The bioavailability after oral administration is substantially reduced by an extensive first-pass effect in the range of 75-80%. The absolute bioavailability of bromhexine hydrochloride is about 26.8 ± 13.1 %
Concomitant food intake leads to an increase of bromhexine plasma concentrations.
Distribution
After administration, bromhexine was rapidly and widely distributed throughout the body. The distribution of bromhexine in lung tissue (bronchial and parenchymal) was investigated after oral administration of 32 mg and 64 mg bromhexine. Bromhexine lung tissue concentrations two hours post-dose were 1.5 to 3.2 times higher in bronchiolo-bronchial tissues and between 3.4 and 5.9 times higher in pulmonary parenchyma compared to plasma concentrations.
Bromhexine crosses the blood-brain barrier and only a small amount crosses the placenta.
Unchanged bromhexine is 95% bound to plasma proteins.
Metabolism and Excretion
After administration of radiolabelled bromhexine, about 97.4 ± 1.9% of the dose was recovered in the urine, with less than 1% as the parent compound. Bromhexine plasma concentrations showed a multi-exponential decline. After administration of single oral doses between 8 and 32 mg, the terminal half-life of bromhexine ranged between 6.6 and 31.4 hours. The relevant half-life to predict the multiple dose pharmacokinetics is about 1 hour. No accumulation was observed after multiple dosing (accumulation factor 1.1).
Bromhexine is almost completely metabolised to a variety of hydroxylated metabolites and to dibromanthranilic acid. Ambroxol is a metabolite of bromhexine.
There is no pharmacokinetic data available in the elderly or in patients with renal or liver insufficiency. Extensive clinical experience did not give rise to relevant safety concerns in these populations. However, reduced clearance of bromhexine parent substance may be expected in the case of severe liver disease; in the case of severe renal insufficiency accumulation of metabolites cannot be ruled out.
Guaiphenesin
Absorption
Guaifenesin is well absorbed from the gastro-intestinal tract following oral administration,
Distribution
No information is available on the distribution of guaifenesin in humans.
Biotransformation and elimination
Guaifenesin appears to undergo both oxidation and demethylation followed by excretion in the urine. Approximately 40% of a dose is excreted as the metabolite beta-2-methoxyphenoxy-lactic acid in the urine within 3 hours.
Following an oral dose of 600 mg guaifenesin to 3 healthy male volunteers, the t½ was approximately 1 hour and the drug was not detectable in the blood after approximately 8 hours.
Hepatic and renal impairment
No formal studies of guaifenesin in patients with hepatic or renal impairment have been conducted and no data are available for any grade of impairment.
Preclinical safety data
Carcinogenicity
There is insufficient information available to determine whether guaifenesin has carcinogenic potential.
Mutagenicity
There is insufficient information available to determine whether guaifenesin has mutagenic potential.
Teratogenicity
There is insufficient information available to determine whether guaifenesin has teratogenic potential. In a study with limited
information guaifenesin showed developmental toxicity at therapeutic and higher doses.
Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.
There is insufficient information available to determine whether guaifenesin has carcinogenic potential.
Mutagenicity
There is insufficient information available to determine whether guaifenesin has mutagenic potential.
Teratogenicity
There is insufficient information available to determine whether guaifenesin has teratogenic potential. In a study with limited
information guaifenesin showed developmental toxicity at therapeutic and higher doses.
Fertility
There is insufficient information available to determine whether guaifenesin has the potential to impair fertility.
Incompatibilities
Not Applicable
Shelf life
24 months from date of manufacture
Special precautions for storage
Store below 30°C, Protect from light.
Keep out of reach of children.
DO NOT USE IF THE SECURITY SEAL ON THE CAP IS BROKEN OR MISSING.
Do not use expired drugs.
Keep out of reach of children.
DO NOT USE IF THE SECURITY SEAL ON THE CAP IS BROKEN OR MISSING.
Do not use expired drugs.
Marketing authorisation number
AUST R 93440
Marketing authorisation holder
BRIDGE HEALTHCARE PTY.LTD
Suite106/10 Edgeworth David Avenue, Hornsby NSW 2077, Australia
Suite106/10 Edgeworth David Avenue, Hornsby NSW 2077, Australia