Benylin Phlegm Cough plus Decongestant Syrup

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (bottle) Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets Active Ingredients Loperamide Hydrochloride
1 - 0 of 65 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 4 November 2019 PIL

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 4 November 2019 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 16 August 2018 SmPC

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 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 January 2018 PIL

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 SmPC

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

PSE V3 CCDS update

Updated on 23 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 31 August 2016 SmPC

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 SmPC

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

Text that has been highlighted and underlined has been added, text that has been highlighted and struck through has been removed:

 

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 PIL

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 SmPC

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

Section 4.4:

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 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 25 June 2012 SmPC

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

New product name...'Benylin Phlegm Cough plus Decongestant'

Updated on 22 June 2012 PIL

Reasons for updating

  • Change to product name

Updated on 21 July 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 1 October 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 11 September 2009 SmPC

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 8 September 2009 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 7 October 2008 SmPC

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

Change from "Plastic" to "HDPE"

Updated on 9 September 2008 SmPC

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 4 July 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 24 June 2008 SmPC

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

Added to section 4.4;
 

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 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 March 2008 SmPC

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

Change to the name of the MAH from Pfizer Consumer Healthcare, Pottery Road Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24

Updated on 23 January 2008 SmPC

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

 
Additonal list of excipients has been included in this section:

Each 5ml of syrup contains 30mg  Pseudoephedrine hydrochloride and 100 mg Guaifenesin
 
 
            Excipients: Also includes Sucrose 3g per 5ml, Sunset yellow (E110) 0.25mg per 5ml, Ponceau 4R (E124) 0.25mg per 5ml. Methyl hydroxybenzoate (E218) 5.0mg per 5ml, Propyl hydroxybenzoate (E216) 0.5mg per 5ml and ethanol (96%) 0.25ml per 5ml.

Updated on 28 February 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 February 2006 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only