Non-Drowsy Sudafed Decongestant Tablets

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

PSE V3 CCDS update plus incorporating paracetamol updates.

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)

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”

4.4       Special Warnings and Special Precautions for Use

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).

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.