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BENYLIN CHESTY COUGHS (NON-DROWSY)

Active substance(s): GUAIFENESIN / LEVOMENTHOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
BENYLIN Chesty Coughs (Non-drowsy)
Benylin Mucus Cough

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml of product contains 100 mg guaifenesin and 1.1 mg levomenthol.

Also contains:
Ethanol
Glucose
Sucrose
Sodium
Ponceau 4R (E124)
3.

0.2595ml/5ml
3492 mg/5ml
999 mg/5ml
16.42 mg/5ml

For full list of excipients, see Section 6.1
PHARMACEUTICAL FORM
Clear red syrup

4.

CLINICAL PARTICULARS

4.1

Therapeutic Indications
BENYLIN Chesty Coughs (Non-drowsy) is indicated for the symptomatic
relief of cough.

4.2

Posology and method of administration
Adults and children aged 12 years and over:
Oral. Two 5 ml spoonfuls four times a day.

Children under 12 years:

This product is contraindicated in children under the age of 12 years (see
section 4.3).
The Elderly:
As for adults.

Hepatic/renal dysfunction
Experience with the use of this product suggests that normal adult dosage is
appropriate for mild to moderate dysfunction. Caution should be exercised in severe
hepatic and severe renal impairment. [See Pharmacokinetics].

Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3

Contraindications
This product is contraindicated in individuals with known hypersensitivity to the
product, or any of its components.

Not to be used in children under the age of 12 years.
4.4

Special warnings and precautions for use
This product should not be used for persistent or chronic cough, such as occurs with
asthma, or where cough is accompanied by excessive secretions, unless directed by a
physician.
Caution should be exercised when using the product in the presence of severe renal or
severe hepatic impairment, [See Pharmacokinetics].
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5ml
dose, equivalent to approximately 5 ml beer, 2 ml wine per 5 ml dose. This can be
harmful for those suffering from alcoholism. The ethanol content should be taken into
account in pregnant or breast-feeding women, children and high-risk groups such as
patients with liver disease or epilepsy.

This product contains 16.42mg of sodium per 5ml. This should be taken into
consideration by those on a controlled sodium diet.
This product contains Ponceau 4R (E124) red colouring which may cause
allergic reactions.

4.5

Interaction with other medicinal products and other forms of interaction
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 5hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

4.6

Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of Guaifenesin in pregnant
women. Animal studies are insufficient with respect to reproductive toxicity (see
section 5.3). Insufficient information is available on the effects of administration of
this product during human pregnancy. This product is not recommended during
pregnancy and in women of childbearing potential not using contraception
Breastfeeding
Guaifenesin is excreted in breast milk in small amounts. There is insufficient
information on the effects of Guaifenesin in newborns/infants. A decision must be
made whether to discontinue breast-feeding or to discontinue/abstain from this
product, taking into account the benefit of breast feeding for the child and the benefit
of therapy for the woman.
Fertility
There is insufficient information available to determine whether guaifenesin has the
potential to impair fertility.

4.7

Effects on ability to drive and use machines
This product has no or negligible influence on the ability to drive or operate machinery.

4.8

Undesirable effects
The safety of guaifenesin/menthol is based on available data from clinical
trials and adverse drug reactions (ADRs) identified during post-marketing
experience are included.
The frequencies are provided according to the following convention:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000, including isolated reports

Not known (cannot be estimated from the available data)
ADRs are presented for frequency category based on 1) incidence in
adequately designed clinical trials or epidemiology studies if available or 2)
when incidence cannot be estimated, frequency category is listed as ‘Not
known’
Adverse Drug Reactions identified During Clinical trials, Epidemiology
studies and Post-Marketing Experience with Guaifenesin. Frequency Category
Estimated from Clinical Trials or Epidemiology Studies.
Body system

Incidence

Immune System
Disorders

Not known

Gastrointestinal
Disorders

Not known

Reported adverse
event
Hypersensitivity
reactions
(hypersensitivity,
pruritus and
urticaria)
Rash
Abdominal pain
upper
Diarrhoea
Nausea
Vomiting

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

4.9

Overdose
Symptoms and signs
The effects of acute toxicity from guaifenesin may include gastro-intestinal
discomfort, nausea and drowsiness.
When taken in excess, guaifenesin may cause renal calculi.

Treatment
Treatment should be symptomatic and supportive.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic Group: Cough and cold preparations, Expectorants. ATC Code:
R05CA10
Guaifenesin is thought to exert its pharmacological action by stimulating receptors in the
gastric mucosa. This increases the output from secretory glands of the gastrointestinal
system and in reflex increases the flow of fluids from glands lining the respiratory tract.
The result is an increase in volume and decrease in viscosity of bronchial secretions.
Other actions may include stimulating vagal nerve endings in bronchial secretory glands
and stimulating certain centres in the brain which in turn enhance respiratory fluid flow.
Guaifenesin produces its expectorant action within 24 hours.
Menthol has mild local anaesthetic and decongestant properties.

5.2

Pharmacokinetic properties
Absorption
Guaifenesin is well absorbed from the gastro-intestinal tract following oral
administration, although limited information is available on its pharmacokinetics. After
the administration of 600 mg guaifenesin to healthy adult volunteers, the Cmax was
approximately 1.4 ug/ml, with tmax occurring approximately 15 minutes after drug
administration.
Menthol is well absorbed from the gastrointestinal tract following oral administration.

Distribution
No information is available on the distribution of guaifenesin or menthol in humans.

Metabolism and elimination
Guaifenesin appears to undergo both oxidation and demethylation. 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.
Menthol is hydroxylated in the liver by microsomal enzymes to p-methane -3,8 diol.
This is then conjugated with glucuronide and excreted both in urine and bile as the
glucuronide.

Pharmacokinetics in Renal/Hepatic Impairment
There have been no specific studies of this product, menthol or guaifenesin in hepatic or
renal impairment.

Pharmacokinetics in the Elderly
There have been no specific studies in the use of this product, menthol or guaifenesin in
the elderly.

5.3

Pre-clinical Safety Data
Carcinogenicity
There is insufficient information available to determine whether Guaifenesin
or menthol have carcinogenic potential.
Mutagenicity
There is insufficient information available to determine whether Guaifenesin
has mutagenic potential.
The results of a range of tests suggest that menthol does not have a mutagenic
potential.
Teratogenicity
There is insufficient information available to determine whether Guaifenesin
has teratogenic potential.
The results of a number of studies suggest that the administration of menthol
does not produce any statistically significant teratogenic effects in rats, rabbits
and mice.
Fertility
There is insufficient information available to determine whether Guaifenesin
or menthol have the potential to impair fertility.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Sodium benzoate (E211)
Sucrose
Liquid glucose
Glycerol
Citric acid monohydrate

Sodium citrate
Saccharin sodium
Ethanol 96%
Caramel T12
Ponceau 4R (E124)
Concentrated raspberry essence double strength
Natural sweetness enhancer
Carbomer
Purified water

6.2.

Incompatibilities
None known

6.3

Shelf life
3 years

6.4.

Special precautions for storage
Do not store above 30°C.

6.5

Nature and contents of container
125, 150, 200 or 300ml amber glass bottles with a 2 piece or a 3 piece plastic child
resistant, tamper evident closure fitted with a polyterephtalate ethylene faced
aluminium/expanded polyethylene laminated wad

6.6

Special precautions for disposal
No special requirements.
Any unused product or waste material should be disposed of in accordance with local
requirements.

7

MARKETING AUTHORISATION HOLDER
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead

Berkshire SL6 3UG
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 15513/0056

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15th December 1997

10

DATE OF REVISION OF THE TEXT
09/05/2016

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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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