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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: 15/04/2015
SPC Actifed Syrup



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1. NAME OF THE MEDICINAL PRODUCT

ACTIFED 30 mg/1.25 mg per 5 ml Syrup


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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:

Sucrose

Methyl Hydroxybenzoate (E218)

Sunset Yellow (E110)

3.5 g

5.0 mg

0.005 mg

For a full list of excipients, see section 6.1


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3. PHARMACEUTICAL FORM

Syrup.

A clear, golden yellow syrup.


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4. CLINICAL PARTICULARS

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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

Posology

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.

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.

Method of Administration

For oral use


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4.3 Contraindications

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 or hypertensive crisis.

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.


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4.4 Special warnings and precautions for use

ACTIFED Syrup may cause drowsiness

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.

Patients with the following conditions should be advised to consult a physician before using Actifed Syrup: hypertension; coronary heart disease; diabetes; thyroid disease; difficulty in urination due to enlargement of the prostate; a respiratory condition such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma; or glaucoma.

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.

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).

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

Pseudoephedrine exerts its vasoconstricting properties by stimulating adrenergic receptors and displacing norepinephrine from neuronal storage sites. Since MAOIs impede the metabolism of sympathomimetic amines and increase the store of releasable norepinephrine in adrenergic nervous tissue, MAOIs may potentiate the pressor effect of pseudoephedrine. Acute hypertensive crises have been reported in the medical literature with the concomitant use of MAOIs and sympathomimetic amines.

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) 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.


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4.6 Fertility, pregnancy & lactation

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

Fertility

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

Pregnancy

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.

Breast-feeding

Pseudoephedrine distributes into and is concentrated in breast milk. 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.

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 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.


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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)

Frequency

Immune System Disorders

Hypersensitivity

Not Known

Psychiatric Disorders

Insomnia

Nervousness

Anxiety

Euphoric mood

Hallucination

Restlessness

Common 

Common 

Not known

Not Known

Not known

Not known

Nervous System Disorders

Dizziness

Epilepsy

Headache

Paraesthesia

Psychomotor hyperactivity (in the paediatric population)

Somnolence

Tremor

Common 

Not known

Not Known

Not Known

Not Known

Not Known

Not Known

Cardiac Disorders

Arrhythmia

Palpitations

Tachycardia

Not Known

Not Known

Not Known

Respiratory, Thoracic and Mediastinal Disorders

Dry throat

Epistaxis

Nasal dryness

Not Known

Not Known

Not Known

Gastrointestinal Disorders

Dry mouth

Nausea

Abdominal discomfort

Vomiting

Common 

Common 

Not Known

Not Known

Skin and Subcutaneous Tissue Disorders

Pruritus

Rash

Urticaria

Not Known

Not Known

Not Known

Renal and Urinary Disorders

Dysuria

Urinary Retention

Not Known

Not Known

General Disorders and Administration Site Conditions

Feeling Jittery

Fatigue

Hyperpyrexia

Not Known

Not Known

Not known

Investigations

Blood pressure increased

Not Known

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

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

Symptoms

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

Pseudoephedrine

Overdosage may result in nausea, vomiting, sympathomimetic symptoms including central nervous system stimulation, insomnia, tremor, mydriasis, anxiety, agitation, hallucinations, seizures, palpitations, tachycardia, hypertension and reflex bradycardia. Other effects may include dysrhythmias, hypertensive crisis, intracerebral haemorrhage, myocardial infarction, psychoses, rhabdomyolysis, hypokalaemia, and ischemic bowel infarction. Drowsiness has been reported with overdose in children.

Triprolidine

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.

Management

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. PHARMACOLOGICAL PROPERTIES

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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.


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5.3 Preclinical safety data

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.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Sucrose,

Glycerol,

Methyl hydroxybenzoate (E218),

Sodium benzoate (E211),

Quinoline yellow (E104),

Sunset yellow (E110),

Water


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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

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


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7. MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 823/6/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 01April 1978

Date of last renewal: 01 April 2008


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10. DATE OF REVISION OF THE TEXT

March 2015



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