Non-Drowsy Sudafed Decongestant Tablets

  • Name:

    Non-Drowsy Sudafed Decongestant Tablets

  • 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 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

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
  • Change to section 6 - date of revision

Updated on 19 July 2018 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

Free text change information supplied by the pharmaceutical company

This variation is being submitted to implement the PRAC recommendations following the outcome of the ibuprofen / pseudoephedrine PSUSA (PSUSA/00001711/201707). These recommendations include updating Sections 4.4 and 4.8 of the Summary of Product Characteristics and to update Section 2 and 4 of the Package Leaflet accordingly

Updated on 5 June 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 5 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

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

  • 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 plus incorporating paracetamol updates.

Updated on 23 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 24 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: 240 mg pseudoephedrine”

Added text “Children under 12 years

This medicine is contraindicated in children under the age of 12 years [See Section 4.3]”

 

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

 

Added text “mild to moderate” 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.

 

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 Tablets” with “this medicine” six times

Added text “(MAOIs)” “or hypertensive crisis” “cardiovascular disease including” “and in those who are taking beta blockers (see section 4.5) “This medicine are contraindicated in individuals who have diabetes mellitus, phaeochromocytoma, hyperthyroidisum, closed angle glaucoma, or severe renal impairment” “Not to be used in Children under the age of 12 years”

Removed text “product” “acute ischemic heart disease, thyrotoxicosis, glaucoma or urinary retention” “Do not exceed the stated dose”

Replaced “drugs” with “decongestants”

 

 

Section 4.4 removed text “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 Tablets 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 Tablets” with “this medicine” twice

 

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

 

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

 

            The physician of pharmacist should check that sympatomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations).” “Insomnia, nervousness”

 

Added text “Use with caution in occlusive vascular disease”

 

Section 4.5 Replaced “Non-Drowsy SUDAFED Decongestant Tablets” with “this medicine” three times

 

Added text “or with” “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).”

 

antihypertensive”

 

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)”

 

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 “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” in “Pregnancy”

 

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 benefit 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”

“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 Tablets” with “this medicine” twice

 

 

Section 4.7 Replaced “Non known” with “This medicine has no or negligible influence on the ability to drive and use machines”

 

Section 4.8 Replaced “Serious adverse effects associated with the use of pseudoephedrine are extremely rare.  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 Tablets” 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 23 March 2016 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 12 August 2011 PIL

Reasons for updating

  • Change to packaging

Updated on 12 July 2011 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

4.4       Special Warnings and Special Precautions for Use

 
            Has been amended from-

The physician of pharmacist should check that sympatomimetic containing preparations are not simultaneously administered by several routes i.e. orally and topically (nasal, aural and eye preparations).

to:

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

Updated on 1 July 2011 SmPC

Reasons for updating

  • 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 6.4 - Special Precautions for Storage

"Do not store above 25oC.  Store in the original container"

has been changed to:

"Do not store above 25oC.  Store in the original container to protect from light"

Updated on 27 January 2011 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3:

Addition of:

'Non-Drowsy SUDAFED Decongestant Tablets are contra-indicated in individuals at risk of developing respiratory failure.'

Updated on 2 November 2010 PIL

Reasons for updating

  • Change of contraindications

Updated on 2 November 2010 SmPC

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes to sections 4.3, 4.4 & 4.5 to include standard sympathomimetic warnings.

Updated on 29 October 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to further information section
  • Change due to user-testing of patient information

Updated on 4 January 2010 PIL

Reasons for updating

  • Change of manufacturer

Updated on 27 May 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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

Section 1

Name changed to "Non-Drowsy Sudafed Decongestant 60mg Film-Coated Tablets"

Section 2

Changed to "Each film-coated tablets containsn Pseudoephidrine Hydrochloride 60mg"

"Excipients - Contains lactose monhydrate" added.

"For a full list of excipients , see section 6.1" statement amended.

Section 6.5

Statement "Not all pack sizes may be marketed" added.

Section 10

Changed to "April 2009"

Updated on 22 May 2009 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 25 August 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 24 February 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only