McNeil Healthcare (Ireland) Ltd

ACTIFED 30 mg/1.25 mg per 5 ml Syrup

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:

For a full list of excipients, see section 6.1

Syrup.

A clear, golden yellow syrup.

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).

Adults and children 12 years and over:

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

Children 6 - 12 years:

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

Maximum daily dose: 15ml syrup.

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:

Not recommended. [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, although it may be advisable to monitor renal and/or hepatic function. If there is serious impairment then caution should be exercised.

ACTIFED Syrup is contra-indicated in individuals with known hypersensitivity to the product or any of its components.

ACTIFED Syrup is contra-indicated in patients with severe hypertension, severe coronary artery disease, thyrotoxicosis, glaucoma or urinary retention.

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 occasionally cause a rise in blood pressure.

The antibacterial agent furazolidone is known to cause a dose-related inhibition of monoamine oxidase. Although there are no reports of hypertensive crises caused by the concurrent administration of ACTIFED Syrup and furazolidone, they should not be taken together.

Use in patients who are currently receiving other sympathomimetic drugs.

Use in patients under 6 years of age.

As this product contains sucrose:

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

ACTIFED Syrup may cause drowsiness and impair performance in tests of auditory vigilance. Patients should be cautioned about engaging in activities requiring mental alertness, until they have established their own response to the drug.

Patients should be advised that concomitant use of alcohol or other central nervous depressants whilst taking ACTIFED Syrup may produce additional impairment in mental awareness in some individuals.

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 severe renal or 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.

The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.

As with other sympathomimetic agents, ACTIFED Syrup should be used with caution in patients with hypertension, heart disease and diabetes.

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.

Children 6 to 12 years: Not more than 3 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 12 years.

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

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

Concomitant use of ACTIFED Syrup with alcohol or other central nervous system depressants may, in some individuals, produce additional impairment in mental alertness.

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

Concomitant use of ACTIFED Syrup with tricyclic antidepressants, other sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) or with monoamine oxidase inhibitors (including furazolidone),which interfere with the catabolism of sympathomimetic amines, may occasionally cause a rise in blood pressure.

The effect of antihypertensive agents which interfere with sympathetic activity may be partially reversed by the pseudoephedrine in ACTIFED Syrup, eg., bretylium, bethanidine, guanethidine, debrisoquine, methyldopa, alpha- and beta-adrenergic blocking agents.

This product should not be used during pregnancy unless considered essential by a physician. Although pseudoephedrine and triprolidine have been in widespread use for many years without apparent ill consequence, there are no specific data on their 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.

Pseudoephedrine and triprolidine are excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that approximately 0.5 to 0.7% of a single dose of pseudoephedrine ingested by a nursing mother will be excreted in the breast milk over 24 hours.

ACTIFED Syrup may cause 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.

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.

Skin rashes, with or without irritation, tachycardia, dryness of mouth, nose and throat, and headache have occasionally been reported.

Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement may have been an important predisposing factor.

Symptoms and signs

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

Treatment

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.

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.

After the administration of 10 ml ACTIFED Syrup in healthy adult volunteers, the peak plasma concentration (C_max) of triprolidine is approximately 5.5 - 6.0 ng/ml, occurring at about 1.5 hours (T_max) after drug administration. The plasma half-life of triprolidine is approximately 3.2 hours. The peak plasma concentration (C_max) of pseudoephedrine is approximately 180 ng/ml, with T_max 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.

Mutagenicity

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

Carcinogenicity

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

Teratogenicity

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.

Fertility

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.

Sucrose,

Glycerol,

Methyl hydroxybenzoate (E218),

Sodium benzoate (E211),

Quinoline yellow (E104),

Sunset yellow (E110),

Water

Not applicable

3 years

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

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.

No special requirements

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/6/2

Date of first authorisation: 01April 1978

Date of last renewal: 01 April 2008

April 2011