Non-Drowsy SUDAFED Decongestant 30mg/5ml Syrup

  • Name:

    Non-Drowsy SUDAFED Decongestant 30mg/5ml Syrup

  • Company:
    info
  • Active Ingredients:

    Pseudoephedrine Hydrochloride

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 30/09/19

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Summary of Product Characteristics last updated on medicines.ie: 30/9/2019

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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 30 September 2019 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 30 September 2019 PIL

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects

Updated on 11 December 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 December 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

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

Legal category: Supply through pharmacy only

Updated on 20 July 2018 SmPC

Reasons for updating

  • Other

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 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 23 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 23 January 2018 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • 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

PSE V3 CCDS update

Updated on 23 March 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 23 March 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 5.3 - Preclinical safety data
  • 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

Section 4.2 removed text “Oral”

Added Text “Posology”

Replaced text “over” with “aged” added text “and over” and “Maximum daily dose: 40 ml (240 mg pseudoephedrine)”

Added text “(120 mg pseudoephedrine)

Removed text “Use for more than five consecutive days is not recommended”

Replaced text “Not recommended” with “This medicine is contraindicated in children under the age of 6 years

Replaced “Non-Drowsy SUDAFED Decongestant Syrup” with “this medicine” three times

Added text “mild to” removed text “to several”

Added text “Duration of use:

Patients should be advised not to use this product for more than 5 days and to seek medical advice if symptoms persist.

Parents or carers of children aged 6-12 years of age should seek medical attention if the child’s condition deteriorates during treatment.

 

Do not exceed the stated dose.

 

Keep out of the sight and reach of children

 

Method of Administration:

For oral use

 

Section 4.3 Replaced “Non-Drowsy SUDAFED Decongestant Syrup” with “this medicine” five times

Added text “cardiovascular disease including” “and in those who are taking beta blockers (see section 4.5)” and removed text “severe” “or coronary artery disease”

Added text “MAOIs” “or hypertensive crisis” “This medicine is contraindicated in individuals who have diabetes mellitus, phaeochromocytoma, hyperthyroidism, closed angle glaucoma or severe renal impairment.

 

This medicine is contraindicated in individuals who are currently taking other sympathomimetic  decongestants

Replaced “Non-Drowsy SUDAFED Decongestant Syrup is contraindicated in children under 6 years” with “Not to be used in children under the age of 6 years

 

 

Section 4.4 removed text “tablets” “antihypertensive agents” “decongestants”

Added text “The physician or pharmacist should check that sympathomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations)

Removed text “The effects of a single dose of Non-Drowsy SUDAFED Decongestant Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment”

Added text “If any of the following occur, This medicine should be stopped:

 

• Hallucinations

• Restlessness

• Sleep disturbances

 

Replaced “Non-Drowsy SUDAFED Decongestant Syrup” with “this medicine” twice

Replaced “hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and” with “urinary retention due to

 

Removed text “severe” “to severe” added “mild to”

Added text “Use with caution inocclusive vascular disease” “This product may act as a cerebral stimulant giving rise to hyperpyrexia, tremor and epileptiform convulsions

 

Section 4.5 Replaced “Non-Drowsy SUDAFED Decongestant Syrup” with “this medicine

 

Added text “or with other” “Pseudoephedrine exerts its vasoconstricting properties by stimulating α-adrenergic receptors and displacing noradrenaline from neuronal storage sites. Since MAOIs impede the metabolism of sympathomimetic amines and increase the store of releasable noradrenaline in adrenergic nerve endings, MAOIs may potentiate the pressor effect of pseudoephedrine.

 

MAOIs and/or RIMAs: This medicine should not be given to patients treated with MAOIs or within 14 days of stopping treatment as there is an increased risk of hypertensive crisis.

 

Moclobemide: risk of hypertensive crisis

 

The antibiotic furazolidone is a monoamine oxidase inhibitor. Therefore it should not be taken with this medicine (see Section 4.3)

 

Anytihypertensive” “bethanidine” “reserpine

 

Oxytocin: risk of hypertension

 

Cardiac glycosides: increased risk of dysrhythmias

 

Ergot alkaloids (ergotamine & methysergide): increased risk of ergotism

 

Anticholinergic drugs: enhances effects of anticholinergic drugs (such as TCAs)

such as chloroform, cyclopropane, halothane, enflurane or isoflurane

 

Removed text “decongestants” “or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines” “Use with caution in diabetic patients as the product may cause an increase in blood sugar level”

 

Replaced text “Tablets” with “Syrup”, “partially reverse” with “antagonise”, “alpha” with “adrenergic neurone blockers”, “adrenergic blocking agents” with “blockers” 

 

Section 4.6 added text “Fertility” to title. Replaced “P” with “p” and “L” with “l” in “Pregnancy and Lactation”

 

Added text “Pregnancy”

There are no adequate and well-controlled clinical studies in pregnant women.

 

This product should not be used during pregnancy unless the potential benefits of treatment to the mother outweighs the possible risks to the developing foetus

Although pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus

 

Fertility

Breast-feeding

 

This medicine should not be used during lactation unless the potential benefit of treatment to the mother outweighs the possible risks to the nursing infant.

Pseudoephedrine distributes into and is concentrated in breast milk

 

Removed text “Although pseudoephedrine has been in widespread use for many years without apparent ill consequence, there are no specific data on its use during pregnancy.  Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing foetus”

“Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects”

“Systemic administration of pseudoephedrine in rats, up to 7 times the human daily dosage in females and 35 times the human daily dosage in males, did not impair fertility nor alter foetal morphological development and survival”

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 protein plasma 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.

In a limited study, three mothers nursing healthy infants were given an antihistamine-decongestant preparation containing 60 mg of pseudoephedrine and 2.5 mg of triprolidine. Milk concentrations of pseudoephedrine were higher than plasma levels in all three patients, with peak milk concentrations occurring at 1.0–1.5 hours. The investigators calculated that 1000 ml of milk produced during 24 hours would contain approximately 0.5%–0.7% of the maternal dose. However, following a single-blind, crossover study of a single dose of pseudoephedrine 60 mg vs. placebo conducted in 8 lactating mothers, and assuming maternal intake of 60 mg pseudoephedrine hydrochloride four times daily, the estimated infant dose of pseudoephedrine based on AUC and an estimated milk production rate of 150 ml/kg/day was 4.3% (95% CI, 3.2, 5.4%; range 2.2 to 6.7%) of the weight-adjusted maternal dose.

 

“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 – 0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours”

 

Replaced “Non-Drowsy SUDAFED Decongestant Syrup” with “this medicine

 

 

Section 4.7 Replaced “Non-Drowsy SUDAFED Decongestant Syrup” with “this medicine

 

Section 4.8 Replaced “Serious adverse effects associated with the use of pseudoephedrine are rare. 

 

Cardiovascular system effects include increased heart rate, tachycardia, palpitations.

 

Symptoms of central nervous system excitation may occur, including sleep disturbances and rarely hallucinations have been reported.

 

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.”

With

The safety of pseudoephedrine from clinical trial data is based on 6 randomised, placebo-controlled single dose clinical trials and 6 randomised, placebo-controlled multiple dose trials for the treatment of nasal congestion with allergic rhinitis or common cold or prevention of sinus symptoms/infection after a natural cold.

 

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with pseudoephedrine are listed below by System Organ Class (SOC). The frequencies are defined according to the following convention:

Very common ³1/10

Common ³1/100 and < 1/10

Uncommon ³1/1,000 and <1/100

Rare ³1/10,000 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, when available, or 2) when incidence cannot be estimated, frequency category is listed as ‘Not known’.

System Organ Class (SOC)

Frequency

Adverse dru g reaction (Preferred Term)

Immune system disorders

Not known

Hypersensitivity – cross sensitivity may occur with other sympathomimetics

Psychiatric Disorders

Common

Insomnia

Nervousness

Rare

Hallucination

Not known

Agitation

Anxiety

Delusion

Euphoric mood

Irritability

Restlessness

Sleep disorder

Nervous System Disorders

Very common

Headache

Common

Dizziness

Not known

Psychomotor hyperactivity

Cardiac Disorders

Not known

Arrhythmia

Palpitations

Tachycardia

Vascular Disorders

Not known

Hypertension

Gastrointestinal Disorders

Common

Dry mouth

Nausea

Not known

Vomiting

Skin and Subcutaneous Tissue Disorders

Not known

Rash (with or without irritation)

Renal and urinary Disorders

Not known

Dysuria

Urinary retention (in male patients in whom prostatic enlargement could have been an important predisposing factor)

General Disorders and administration site conditions

Not known

Feeling jittery


 

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

 

Section 4.9 Replaced “As with other sympathomimetic agents, symptoms and signs of overdosage include irritability, restlessness, tremor, convulsions, palpitations, hypertension and difficulty in micturition” With “Overdosage may result in:

Metabolism and nutrition disorders: hyperglycaemia, hypokalaemia

Psychiatric disorders: CNS stimulation, insomnia; irritability, restlessness, anxiety, agitation; confusion, delirium, hallucinations, psychoses

Nervous system disorders: convulsions, tremor, intracranial haemorrhage including intracerebral haemorrhage, drowsiness in children

Eye disorders: mydriasis

Cardiac disorders: palpitations, tachycardia, reflex bradycardia, supraventricular and ventricular arrhythmias, dysrhythmias, myocardial infarction

Vascular disorders: hypertension, hypertensive crisis

Gastrointestinal disorders: nausea, vomiting, ischaemic bowel infarction

Musculoskeletal and connective tissue disorders: rhabdomyolysis

Renal and urinary disorders: acute renal failure, difficulty in micturition

 

Section 5.3 Replaced “Non-Drowsy SUDAFED Decongestant Syrup” with “this medicine

Added text “There is insufficient information available to determine whether pseudoephedrine has mutagenic or carcinogenic potential.

Systemic administration of pseudoephedrine, up to 50 times the human daily dosage in rats and up to 35 times the human daily dosage in rabbits, did not produce teratogenic effects.

Systemic administration of pseudoephedrine in rats, up to 7 times the human daily dosage in females and 35 times the human daily dosage in males, did not impair fertility nor alter foetal morphological development and survival.

 

Section 6.6 removed text “of a used medicinal product or waste materials      derived from such medicinal product” “of the product”

 

Section 10 Removed “(Partial)” and replaced date with “16 March 2016”

Updated on 20 December 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to information about driving or using machinery

Updated on 2 April 2012 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3: “listed in Section 6.1” was added at the end of the proposed contraindication regarding excipients

Section 4.7: text changed to read Sudafed Decongestant Syrup has a negligible influence on the ability to drive and use machines

Section 5.1: Addition of the Pharmacotherapeutic Group and the ATC Code

 

Updated on 22 July 2011 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2 (Posology and Method of Administration)
Amended to read:
Oral
Adults and Children over 12 years:  10ml syrup every 4-6 hours, up to four times a day
Children 6-12 years:  5ml syrup every 4-6 hours, up to four times a day.  Maximum dose: 20ml.  Use only when simple measures have failed to provide adequate relief.  Use for more than five consecutive days is not recommended.
Use in the Elderly:  There have been no specific studies of Non-Drowsy SUDAFED Decongestant Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate.
Hepatic Dysfunction:  Caution should be exercived when administering Non-Drowsy SUDAFED Decongestant Syrup to patients with severe hepatic impairment.
Renal Dysfunction:  Caution shoudl be exercised when administering Non-Drowsy SUDAFED Decongestant Syrup to patients with moderate to severe renal impairment.


Section 4.3 (Contraindications)
Added:
Non-Drowsy SUDAFED Decongestant Syrup is contraindicated in children under 6 years


Section 4.4 (Special Warnings and Precautions for Use)

Although pseudoephedrine has virtually no pressor effects in normotensive patients, Non-Drowsy SUDAFED 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 Non-Drowsy SUDAFED Decongestant Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

 

As with other sympathomimetic agents, Non-Drowsy SUDAFED Decongestant Syrup should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.

 

            There have been no specific studies of Non-Drowsy SUDAFED Decongestant Syrup in patients with hepatic and/or renal dysfunction.  Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment.

 

            Patients with rare hereditary problems of fructose intolerance, glucose – galactose malabsorption or sucrase – isomaltase  insuffiency should not take this medicine.

 

            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 aged 6 to 12 years.



Updated on 21 July 2011 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2:

Removal of indication for use in children under 6 years of age.
Addition of maximum daily dose information
Addition of extra warnings:

Use only when simple measures have failed to provide adequate relief.

Use for more than 5 consecutive days is not recommended

Section 4.3

CI in children under 6.


Section 4.4

Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours. 

changed to:

Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours. 

 

Consult a pharmacist or other healthcare professional before use in children under 6 years.
changed to:

Consult a pharmacist or other healthcare professional before use in children under 12 years.

Updated on 21 July 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to dosage and administration

Updated on 23 February 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update to section 4.8 to include cardiovascular system effects in line with the company core data sheet.

Updated on 8 October 2010 PIL

Reasons for updating

  • Change due to user-testing of patient information
  • Change to name of manufacturer

Updated on 26 April 2010 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Correct SPC loaded as error noticed on current version.

Updated on 2 September 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • 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

Renewal Change have been implemented:

Change to mname from elixir to syrup.
Inclusion of excipients above the threshold.
Inclusion of E numbers where appropriate.
Revised renewal date

Updated on 21 August 2009 PIL

Reasons for updating

  • Change of trade or active ingredient name

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 4 July 2008 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 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

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

Updated on 13 October 2006 PIL

Reasons for updating

  • Change of manufacturer

Updated on 3 November 2004 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Updated on 3 November 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 August 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only