Benylin Phlegm Cough plus Decongestant Syrup
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through pharmacy onlyActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 02 August 2024
File name
ie-pl-benylin-phlegm-cough-plus-decon-2546.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 02 August 2024
File name
ie-spc V18-benylin-phlegm-cough-plus-decon-2546.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 11 October 2021
File name
ie-spc V17-benylin phlegm cough plus decon 2093.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 03 May 2021
File name
ie-leaflet-proposed-benylin phlegm cough plus decon 2094.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 03 May 2021
File name
ie-spc V16 benylin phlegm cough plus decon 2094.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 23 October 2020
File name
ie-pl-benylin-phlegmcough+decon-2058.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 13 August 2020
File name
ie-pl-benylin phlegm cough plus decon 2071.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 13 August 2020
File name
ie-spc V15 benylin phlegm cough plus decon 2071.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 04 November 2019
File name
ie-pl-benylin phlegm cough plus decon 1929.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 04 November 2019
File name
ie-spc V14 Benylin Phlegm Cough plus Decongestant 1929.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 21 March 2019
File name
ie-pl-benylin phlegm cough plus decongestant BV 1829.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 March 2019
File name
ie-spc V13 Benylin Phlegm Cough plus Decongestant 1829.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Updated on 16 August 2018
File name
LN514801-PIL BENYLIN PHLEGM COUGH PLUS DECONGESTANT 100MLv4_6_v2_FVID488837.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 16 August 2018
File name
ie-spc V12 Benylin Phlegm Cough plus Decon 1826.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Supply through pharmacy only
Updated on 20 July 2018
File name
ie-pl-benylin phlegm cough plus decon clean BV 1811.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 20 July 2018
File name
ie-spc Benylin Phlegm Cough plus Decon clean BV 1811.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Supply through pharmacy only
Updated on 25 January 2018
File name
PIL_10740_897.pdf
Reasons for updating
- New PIL for new product
Updated on 25 January 2018
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 23 January 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 23 January 2018
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 31 August 2016
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Correction of spelling/typing errors
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Changed from:
Each 5ml of syrup contains 30mg Pseudoephedrine hydrochloride and 100 mg Guaifenesin
to
Each 5ml of syrup contains 100 mg Guaifenesin and 30mg Pseudoephedrine hydrochloride.
Updated on 18 July 2016
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
4.2 Posology and Method of Administration
For oral administration
Posology
Adults and children over 12 years:
10 ml every 4-6 hours, up to four times a day
Children under 12 years:
Not recommended (see section 4.3)
The ElderlyOlder people
:
There have been no specific studies of Benylin Phlegm Cough plus Decongestant Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate, although it may be advisable to monitor renal and/or hepatic function. If there is serious impairment then caution should be exercised.
Method of Administration
For oral use
4.3 Contraindications
Benylin Phlegm Cough plus Decongestant Syrup is contra-indicated in individuals who have previously exhibited intolerance to
Pseudoephedrine, Guaifenesin or any of its excipients it or to any of its constituents (See Section 4.4 for warnings on excipients and section 6.1 for list of excipients8).
Benylin Phlegm Cough plus Decongestant Syrup is contra-indicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. The concomitant use of pseudoephedrine and this type of product may
occasionally cause a rise in blood pressure or hypertensive crisis (See Section 4.5).
Benylin Phlegm Cough plus Decongestant Syrup is contra-indicated in patients with severe hypertension or severe coronary artery disease.
The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of Benylin Phlegm Cough plus Decongestant Syrup and furazolidone, they should not be taken together.
Benylin Phlegm Cough plus Decongestant Syrup is contraindicated for use in children under 12 years.
4.4 Special warnings and Precautions for use
Although pseudoephedrine has virtually no pressor effects in normotensive patients, Benylin Phlegm Cough plus Decongestant Syrup should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants or other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose of Benylin Phlegm Cough plus Decongestant Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.
As with other sympathomimetic agents, Benylin Phlegm Cough plus Decongestant Syrup should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.Patients with the following conditions should be advised to consult a physician before using this product: pre-existing cardiovascular disease in particular those with coronary heart disease and hypertension; diabetes; thyroid disease; increased intra-ocular pressure, glaucoma; difficulty in urination due to enlargement of the prostate; a respiratory condition such as emphysema, chronic bronchitis or acute or chronic bronchial asthma, [see section 4.3 and section 4.5].
There have been no specific studies of Benylin Phlegm Cough plus Decongestant Syrup in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of severe renal or hepatic impairment.
Benylin Phlegm Cough plus Decongestant Syrup should not be used for persistent or chronic cough such as occurs with smoking, asthma or emphysema or where cough is accompanied by excessive secretions unless directed by a physician.
Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
This product contains 5% v/v ethanol (alcohol), i.e. up to 190 mg per 5ml, 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 or kidney disease or epilepsy.
If cough tends to recur, or is accompanied by a fever, rash, or persistent headache, a physician should be consulted.
This product contains Ponceau 4R (E124) red colouring and sunset yellow (E110) which may cause allergic reactions.
This product contains Methyl Hydroxybenzoate (E 218) and Propyl Hydroxybenzoate (E 216) which may cause allergic reactions (Possibly delayed)
Do not take with any other cough and cold medicine.
If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician.
4.5 Interactions with other Medicaments and Other forms of Interaction
Concomitant use of Benylin Phlegm Cough plus Decongestant Syrup with other sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, may
occasionally cause a rise in blood pressure. (See section 4.8)
Because of its pseudoephedrine content, Benylin Phlegm Cough plus Decongestant Syrup may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.
Pseudoephedrine exerts its vasoconstricting properties by stimulating adrenergic receptors and displacing norepinephrine from neuronal storage sites. Since MAOIs impede the metabolism of sympathomimetic amines and increase the store of releasable norepinephrine in adrenergic nervous tissue, MAOIs may potentiate the pressor effect of pseudoephedrine. Acute hypertensive crises have been reported in the medical literature with the concomitant use of MAOIs and sympathomimetic amines.
4.6
Fertility, Ppregnancy and Lactation
This product should not be used during pregnancy or lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the developing foetus or nursing infant.
Pregnancy
Although pseudoephedrine and guaifenesin have been in widespread use for many years without apparent ill consequence, there are no specific data on their use during preganancy.
Caution should, therefore, be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus.
Breast-feeding
Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a mother will excrete in the breast milk over 24 hours.
Pseudoephedrine distributes into and is concentrated in breast milk. Up to 0.7% of a single 60 mg dose of pseudoephedrine may be distributed into breast milk over 24 hours. Pseudoephedrine concentrations in milk are from 2 to 3 fold higher than those in plasma. This milk/plasma drug concentration profile suggests low protein binding, although no plasma protein binding data in humans are available. Data from a study of lactating mothers taking 60 mg pseudoephedrine every 6 hours suggests that from 2.2 to 6.7% of the maximum daily dose (240 mg) may be available to the infant from a breastfeeding mother.
Guaifenesin is excreted in breast milk in small amounts with no effect on the infant.
4.7 Effects on Ability to Drive and Use Machines
Unlikely to produce an effect.It is not known if this product has an effect on the ability to drive or operate machinery.
4.8 Undesirable Effects
Serious adverse effects associated with the use of pseudoephedrine are rare. Symptoms of central nervous system excitation may occur, such as restlessness, tachycardia, sleep disturbance and, rarely, hallucinations.
Skin rashes, with or without irritation, have occasionally been reported.
Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement could have been an important predisposing factor.
Placebo-controlled studies with sufficient adverse event data were not available for the combination of guaifenesin and pseudoephedrine.
Adverse drug reactions identified during clinical trials and post-marketing experience with guaifenesin or pseudoephedrine or combination are listed below by System Organ Class (SOC).
The frequencies are defined 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
Not known (cannot be estimated from the available data).
ADRs are presented by 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’
|
System Organ Class (SOC)
|
Frequency
|
Adverse Drug Reaction (Preferred Term)
|
|
Immune System Disorders
|
Not Known Not Known
|
Hypersensitivity
1,2
Angioedema
3 |
|
Psychiatric Disorders
|
Common Common Rare
ly
Not Known Not Known Not Known Not Known Not Known
|
Insomnia
†,2
Nervousness
††,2
Hallucinations Agitation
3
Anxiety
2
Euphoric mood
2
Sleep
disturbance disorder
Restlessness
|
|
Nervous System Disorders
|
Common Not Known Not Known
|
Dizziness
†,2
Headache
2
Psychomotor hyperactivity (in the paediatric population)
2 |
|
Cardiac Disorders
|
Not Known Not Known Not Known
|
Arrhythmia
2
Palpitations
2
Tachycardia
2 |
|
Gastrointestinal Disorders
|
Common Common Not Known Not Known Not Known
|
Dry mouth
†2
Nausea
†1,2
Abdominal pain
1,3
Diarrhoea
1
Vomiting
1 |
|
Skin and Subcutaneous Tissue Disorders
|
Not Known Not Known Not Known
|
Pruritus
1,3
Skin rR
ashes with or without irritation1
Urticaria
1,3 |
|
Renal and Urinary Disorders
|
Not Known Not Known
|
Dysuria
2
Urinary Retention
2 |
|
General Disorders and Administration Site Conditions
|
Not Known
|
Feeling Jittery
2 |
|
Investigations
|
Not Known
|
Blood pressure increased
2 |
† Adverse events reported by ≥1% of subjects in randomised, placebo-controlled trials with single-ingredient pseudoephedrine.
1
ADRs associated with guaifenesin
2
ADRs associated with pseudoephedrine
3
Additional ADRs attributed to guaifenesin & pseudoephedrine in combination
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 online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
4.9 Overdose
Symptoms and signs
Symptoms
The effects of acute toxicity from Benylin Phlegm Cough plus Decongestant Syrup may include gastro-intestinal discomfort, nausea, vomiting, irritability, restlessness, tremor, convulsions, palpitations, hypertension, and difficulty with
mictufitionmicturition.
Guaifenesin
Somnolence (very rare) may be associated with guaifenesin overdose.
When taken in excess, guaifenesin may cause renal calculi.
Pseudoephedrine
Overdosage may result in nausea, vomiting, sympathomimetic symptoms including central nervous system stimulation, insomnia, tremor, mydriasis, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, hypertension, and reflex bradycardia.
Other effects may include dysrhythmias, hypertensive crisis, intracerebral haemorrhage, myocardial infarction, psychoses, rhabdomyolysis, hypokalaemia, and ischemic bowel infarction.
Drowsiness has been reported with overdose in children
TreatmentManagement
Necessary measures should be taken to maintain and support respiration and control convulsions. Gastric lavage should be performed if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.
6.6 Instructions for Use/handling
No special requirementsAny unused product or waste material should be disposed of in accordance with local requirements.
10. Date of (Partial) Revision of the Text
January 2014 July 2016
Updated on 13 July 2016
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 27 January 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.4 - Special precautions for storage
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Added:
This product contains 5% v/v ethanol (alcohol), i.e. up to 190 mg per 5ml, 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 or kidney disease or epilepsy.
Section 4.8:
Added:
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 online reporting option (preferred method) accessible from the IMB homepage (www.imb.ie). A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’ (see details below). Alternatively, the traditional post-paid ‘yellow card’ option may also be used.
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
Section 6.4:
Added:
'in order to protect from light.'
Updated on 27 January 2014
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 25 June 2012
Reasons for updating
- Change to product name
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 22 June 2012
Reasons for updating
- Change to product name
Updated on 21 July 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 01 October 2010
Reasons for updating
- Change due to user-testing of patient information
Updated on 11 September 2009
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 10 - Date of revision of the text
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.2:
Indication for use in children under 12 removed.
Section 4.3:
Contraindication not to use in children under 12 added.
Section 10:
Changed to July 2009
Updated on 08 September 2009
Reasons for updating
- Change to dosage and administration
Updated on 07 October 2008
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 09 September 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Update of section 4.4 of SPC - addition of sucrose / fructose warning
Update of section 5.1 of SPC - addition of ATC code.
Updated on 04 July 2008
Reasons for updating
- Change to warnings or special precautions for use
Updated on 24 June 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
Consult a pharmacist or other healthcare professional before use in children under 6 years.
Updated on 19 May 2008
Reasons for updating
- Change to marketing authorisation holder
Updated on 11 March 2008
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 23 January 2008
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Each 5ml of syrup contains 30mg Pseudoephedrine hydrochloride and 100 mg Guaifenesin
Updated on 28 February 2006
Reasons for updating
- New PIL for medicines.ie
Updated on 24 February 2006
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through pharmacy only