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McNeil Healthcare (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316

Summary of Product Characteristics last updated on medicines.ie: 1/23/2018
SPC ACTIFED 30 mg/1.25 mg per 5 ml Syrup

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ACTIFED 30 mg/1.25 mg per 5 ml Syrup

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ACTIFED Syrup contains 1.25 mg Triprolidine hydrochloride and 30 mg Pseudoephedrine hydrochloride in each 5 ml.

Excipients: Also includes the following substances in each 5 ml:


3.5 g

Methyl Hydroxybenzoate (E218)

5.0 mg

Sunset Yellow (E110)

0.005 mg

For a full list of excipients, see section 6.1

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A clear, golden yellow syrup.

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4.1 Therapeutic indications

ACTIFED Syrup contains a decongestant and antihistamine and is indicated for the management of upper respiratory tract conditions such as the common cold, hay fever, allergic and vasomotor rhinitis and aerotitis (otitis barotrauma).

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4.2 Posology and method of administration


Adults and children 12 years and over:

10 ml every 4-6 hours, up to four times a day.

Children 6 - 12 years:

5 ml every 4-6 hours, up to three times a day.

Maximum daily dose: 15ml syrup.

A pharmacist or other healthcare professional should be consulted before use in children aged 6 to 12 years.

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

Use for more than 5 consecutive days is not recommended .

Children under 6 years:

This medicine is contraindicated in children under 6 years. [See section 4.3]

The Elderly:

There have been no specific studies of ACTIFED Syrup in the elderly. Experience has indicated that normal adult dosage is appropriate.

Hepatic Dysfunction:

Caution should be exercised when administering Actifed Syrup to patients with severe hepatic impairment.

Renal Dysfunction:

Caution should be exercised when administering Actifed Syrup to patients with mild to moderate renal impairment

Method of Administration

For oral use

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4.3 Contraindications

ACTIFED Syrup is contra-indicated in individuals with known hypersensitivity to pseudoephedrine, triprolidine or to any of the excipients listed in section 6.1.

ACTIFED Syrup is contra-indicated in patients with cardiovascular disease including hypertension, and in those who are taking beta-blockers.

ACTIFED Syrup is contra-indicated in individuals who have diabetes mellitus, phaeochromocytoma, hyperthyroidism, closed angle glaucoma, or severe renal impairment.

ACTIFED 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 cause a rise in blood pressure or hypertensive crisis.

This medicine is contra-indicated in individuals at risk of developing respiratory failure.

ACTIFED Syrup is contra-indicated in patients who are currently taking other sympathomimetic decongestants.

ACTIFED Syrup is contra-indicated for use in children under 6 years of age.

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4.4 Special warnings and precautions for use

ACTIFED Syrup may cause drowsiness This product should not be used to sedate a child.

If any of the following occur, this product should be stopped:

• Hallucinations

• Restlessness

• Sleep disturbances

There have been no specific studies of ACTIFED Syrup in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of mild to moderate renal impairment or severe hepatic impairment.

Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, ACTIFED Syrup should be used with caution in patients taking antihypertensive agents and tricyclic antidepressants or other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants. The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

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).

Patients with the following conditions should be advised to consult a physician before using Actifed Syrup: difficulty in urination due to enlargement of the prostate; or susceptibility to angle closure.

Patients with the following conditions should not use ACTIFED Syrup unless directed by a physician: acute or chronic bronchial asthma chronic bronchitis or emphysema.

Patients with thyroid disease who are receiving thyroid hormones should not take pseudoephedrine unless directed by a physician.

There have been reports of ischemic colitis with pseudoephedrine. Pseudoephedrine should be discontinued immediately and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischemic colitis develop

There have been rare cases of posterior reversible encephalopathy (PRES) / reversible cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs, including pseudoephedrine. Symptoms reported include sudden onset of severe headache, nausea, vomiting, and visual disturbances. Pseudoephedrine should be discontinued, and medical advice sought immediately if signs or symptoms of PRES/RCVS develop.

Triprolidine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives, and tranquilizers. While taking ACTIFED Syrup, patients should be advised to avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants.

This product may act as a cerebral stimulant in children and occasionally adults giving rise to insomnia, nervousness, hyperpyrexia, tremors and epileptiform convulsions. Care should be taken when used in epileptic patients.

Use with caution in occlusive vascular disease.

Pseudoephedrine may induce positive results in certain anti-doping tests

Each 5 ml dose of this medicine contains 3.5 g of sucrose. This should be taken in to account in patients with diabetes mellitus.

The excipients methyl hydroxybenzoate (E218) and Sunset Yellow (E110) may cause allergic reactions (possibly delayed).

As this product contains sucrose:

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

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4.5 Interaction with other medicinal products and other forms of interaction

MAOIs and/or RIMAs: 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 norepinephrine in adrenergic nerve endings, MAOIs may potentiate the pressor effect of pseudoephedrine. This medicine should not be used in 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.

Oxytocin: risk of hypertension.

Cardiac glycosides: increased risk of dysrhythmias.

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

Anticholinergic drugs: The effects of anti-cholinergics e.g., some psychotropic drugs (such as tricyclic antidepressants) and atropine, may be potentiated by this product giving rise to tachycardia, mouth dryness, gastrointestinal disturbances, e.g., colic, urinary retention and headache.

Sympathomimetic agents: Concomitant use of ACTIFED Syrup with tricyclic antidepressants, other sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) may cause a rise in blood pressure.

Antihypertensives: The effect of antihypertensive agents which interfere with sympathetic activity may be partially reversed by the pseudoephedrine in ACTIFED Syrup, eg. bretylium, betanidine, guanethidine, reserpine, debrisoquine, methyldopa, adrenergic neurone blockers and beta-blockers. .

Anaesthetic agents: Concurrent use with halogenated anaesthetic agents such as chloroform, cyclopropane, halothane, enflurane or isoflurane may provoke or worsen ventricular arrhythmias.

CNS depressants: Triprolidine may enhance the sedative effects of alcohol and other central nervous system depressants including barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and antipsychotics.

4.6 Fertility, pregnancy & lactation

There are no adequate and well-controlled studies for pseudoephedrine, triprolidine in pregnant or breast-feeding women.


There is no information on the effects of ACTIFED syrup on human fertility.


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.


Pseudoephedrine distributes into and is concentrated in breast milk.

Triprolidine is excreted in breast milk, it has been estimated that approximately 0.06 to 0.2% of a single 2.5 mg dose of triprolidine ingested by a nursing mother will be excreted in the breast-milk over 24 hours.

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

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4.7 Effects on ability to drive and use machines

ACTIFED Syrup may have a moderate influence on the ability to drive and use machines. ACTIFED Syrup may cause dizziness or drowsiness and impair performance in tests of auditory vigilance. Patients should be cautioned about engaging in activities requiring mental alertness, such as driving a car or operating machinery, until they have established their own response to the drug.

It is recommended that patients are advised not to undertake tasks requiring mental alertness whilst under the influence of alcohol or other CNS depressants. Concomitant administration of ACTIFED Syrup may, in some patients, produce additional impairment.

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4.8 Undesirable effects

Placebo-controlled studies with sufficient adverse event data were not available for the combination of pseudoephedrine and triprolidine.

Adverse drug reactions identified during clinical trials and post-marketing experience with pseudoephedrine, triprolidine or the combination are listed below by System Organ Class (SOC). The frequencies are defined in accordance with current guidance, as:

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'.

ADRs Identified During Post-Marketing Experience with Pseudoephedrine or the Combination of Pseudoephedrine and Triprolidine by Frequency Category Estimated from Clinical Trials or Epidemiology Studies.

System Organ Class (SOC)

Adverse Drug Reaction (Preferred Term)


Blood and Lymphatic System Disorders

Blood disorder


Immune System Disorders

Hypersensitivity – cross sensitivity may occur with other sympathomimetics


Psychiatric Disorders




Confusional state


Sleep disorder




Euphoric mood

Hallucination, visual









Not known

Not known

Not known

Not Known

Not known

Not known

Not known

Nervous System Disorders



Paradoxical dug reaction

Psychomotor hyperactivity


Extrapyramidal disorder





Very common








Not known

Not Known

Eye Disorders

Vision blurred


Cardiac Disorders




Myocardial infarction / Myocardial ischemia

Posterior reversible encephalopathy (PRES) / Reversible cerebral vasoconstriction syndrome (RCUS)

Cerebrovascular accident



Not Known

Not Known

Not Known


Not known

Vascular Disorders




Not known

Respiratory, Thoracic and Mediastinal Disorders

Dry throat


Nasal dryness

Not Known

Not Known

Not Known

Gastrointestinal Disorders

Increased viscosity of bronchial secretions

Dry mouth

Gastrointestinal disorder


Abdominal discomfort






Not Known

Not Known

Hepatobiliary Disorders

Liver disorder


Skin and Subcutaneous Tissue Disorders

Acute generalised exanthematous pustulosis





Not known   

Not known

Not Known

Not Known

Not Known

Renal and Urinary Disorders

Urinary Retention



Not Known

General Disorders and Administration Site Conditions



Not Known

Not known

Adverse events reported by ≥1% of subjects in randomised, placebo-controlled trials with single-ingredients pseudoephedrine

No differences between adult and paediatric safety profiles have been identified.

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.

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4.9 Overdose


The effects of acute toxicity from ACTIFED Syrup may include drowsiness, incoordination, weakness, irritability, palpitations, hypertension, convulsions and difficulty with micturition.


Overdose 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: seizures, 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


Overdosage of an H1 receptor antagonist may result in CNS depression, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dry mouth, urinary retention, decreased bowel sounds), tachycardia, hypotension, hypertension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, seizures, or dysrhythmias. Rhabdomyolysis and renal failure may rarely develop in patients with prolonged agitation, coma or seizures.


The treatment of overdosage is likely to be symptomatic and supportive. 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.

Alpha-adrenergic blockade may be required to treat hypertensive crises and beta-adrenergic blockade for the control of supra-ventricular dysrhythmias.

If desired, the elimination of pseudoephedrine can be accelerated by acid diuresis or by dialysis.

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Sympathomimetics, pseudoephedrine, combinations

ATC code: R01BA52

Triprolidine provides symptomatic relief in conditions believed to depend wholly, or partly, upon the triggered release of histamine. Triprolidine is a potent, competitive H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.

Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective upper respiratory decongestant. Pseudoephedrine is less potent than ephedrine in producing both tachycardia and elevation of systolic blood pressure and is less potent in causing stimulation of the central nervous system.

After oral administration of a single dose of 2.5 mg triprolidine to adults the onset of action, as determined by the ability to antagonise histamine-induced weals and flares in the skin, is within 1 to 2 hours. Peak effects occur at about 3 hours, and although activity declines thereafter, significant inhibition of histamine-induced weals and flares still occurs 8 hours after dose. Pseudoephedrine produces its decongestant effect within 30 minutes persisting for at least 4 hours.

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5.2 Pharmacokinetic properties

After the administration of 10 ml ACTIFED Syrup in healthy adult volunteers, the peak plasma concentration (Cmax) of triprolidine is approximately 5.5 - 6.0 ng/ml, occurring at about 1.5 hours (Tmax) after drug administration. The plasma half-life of triprolidine is approximately 3.2 hours. The peak plasma concentration (Cmax) of pseudoephedrine is approximately 180 ng/ml, with Tmax approximately 1.5 hours after drug administration. The plasma half-life is approximately 5.5 hours (urine pH maintained between 5.0 - 7.0). The plasma half-life of pseudoephedrine is markedly decreased by acidification of urine and increased by alkalination.

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.

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5.3 Preclinical safety data


There is insufficient information available to determine whether triprolidine or pseudoephedrine have mutagenic potential.


There is insufficient information available to determine whether triprolidine or pseudoephedrine has carcinogenic potential.


In rats and rabbits systemic administration of triprolidine up to 75 times the human daily dosage did not produce teratogenic effects. 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.


No studies have been conducted in animals to determine whether triprolidine or pseudoephedrine have potential to impair fertility. There is no information on the effect of ACTIFED Syrup on human fertility.

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6.1 List of excipient(s)



Methyl hydroxybenzoate (E218),

Sodium benzoate (E211),

Quinoline yellow (E104),

Sunset yellow (E110),


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6.2 Incompatibilities

Not applicable

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6.3 Shelf life

3 years

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6.4 Special precautions for storage

Do not store above 25°C. Store in the original container. Keep the bottle tightly closed.

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6.5 Nature and contents of container

100 ml amber glass bottles with metal roll on closures or HDPE screw caps. Each cap type containing PVDC-lined wads or polyethylene/expanded polyethylene laminated wad.

100 ml amber glass bottles with a 3 piece plastic, child resistant, tamper evident closure fitted with a PVDC faced wad or polyethylene/expanded polyethylene laminated wad.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements

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McNeil Healthcare (Ireland) Limited

Airton Road


Dublin 24


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PA 823/6/2

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Date of first authorisation: 01April 1978

Date of last renewal: 01 April 2008

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January 2018.

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