Non-Drowsy SUDAFED Decongestant 30mg/5ml Syrup

PSE V3 CCDS update

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”

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

 

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.

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.

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

Correct SPC loaded as error noticed on current version.

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

Change from "Plastic" to "HDPE"

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.