ACTIFED 60/2.5 Milligram Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Available from:
McNeil Healthcare (Ireland) Ltd
ATC code:
R01BA02
INN (International Name):
PSEUDOEPHEDRINE HYDROCHLORIDE, TRIPROLIDINE HYDROCHLORIDE
Dosage:
60/2.5 Milligram
Pharmaceutical form:
Tablets
Prescription type:
Product not subject to medical prescription
Therapeutic area:
Sympathomimetics
Authorization status:
Authorised
Authorization number:
PA0823/006/003
Authorization date:
1993-04-01

60 mg/2.5 mg Tablets

®

Pseudoephedrine hydrochloride

Triprolidine hydrochloride

turn over

360092B

17-0128

ACTIFED

Read all of this leaflet carefully before you start using this

medicine because it contains important information for

you.

Always use this medicine exactly as described in this leaflet or as your

doctor or pharmacist have told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side-effects, talk to your doctor or pharmacist. This includes

any possible side-effects not listed in this leaflet. See section 4.

You must talk to a doctor if you do not feel better or if you feel worse

after 5 days.

What is in this leaflet

What Actifed Tablets is and what it is used for

What you need to know before you use Actifed Tablets

How to use Actifed Tablets

Possible side-effects

How to store Actifed Tablets

Contents of the pack and other information

1 What Actifed Tablets is and what

it is used for

Actifed Tablets is a medicine which is used to relieve the symptoms of

colds, flu and allergies including sneezing, runny nose, watery eyes, nasal

congestion and blocked sinuses. The tablets contain pseudoephedrine

hydrochloride, which is a decongestant that relieves nasal and sinus

congestion and triprolidine hydrochloride which is an antihistamine that

helps stop sneezing, runny nose and watery eyes.

This medicine is for use in adults and children aged 12 years and over.

2 What you need to know before

you use Actifed Tablets

This medicine is suitable for most adults and children aged 12 years and

over but a few people should not use it. If you are in any doubt, talk to

your doctor or pharmacist.

Do not use this medicine…

If you have ever had a bad reaction (allergic reaction) to

any of the ingredients (listed in section 6).

If you have diabetes.

If you have an overactive thyroid gland.

If you have glaucoma (increased pressure in the eye).

If you have prostate problems (difficulty with passing water or

needing to pass water often).

If you have a phaeochromocytoma (rare tumour that affects

your heart rate and blood pressure).

If you have high blood pressure or heart disease.

If you have lung disease or breathing difficulties.

If you are taking beta blockers (used to treat high blood pressure).

If you are taking, or have taken in the last two weeks, drugs for

depression known as Monoamine Oxidase Inhibitors (MAOIs)

or Reversible Inhibitors of Monoamine Oxidase (RIMAs).

If you are taking any other cough and cold medicines.

If any of these apply to you, get advice from a doctor or

pharmacist without using Actifed Tablets.

Warnings and precautions

Talk to your doctor or pharmacist...

If you have kidney or severe liver problems.

If you are susceptible to glaucoma (increased pressure in

the eye).

If you have blocked arteries or veins (occlusive vascular disease).

If you are being treated for a thyroid disorder.

If you have prostate problems (difficulty with passing water or

needing to pass water often).

If you have alcohol dependence.

If you have epilepsy.

If you experience the following, stop taking the

product immediately and contact your doctor:

Sudden stomach pain

Passing blood in your stools or bleeding from your back passage

Sudden severe headaches

Feeling sick

Being sick

Confusion

Fits

Visual disturbances

Children

Do not use to sedate a child.

Other medicines and Actifed Tablets

Tell your doctor or pharmacist if you are taking any other

medicines, including:

Sedatives (drugs used to treat anxiety and tension).

Antihypertensives (drugs used to treat high blood pressure

such as guanethidine, reserpine, methyldopa, adrenergic neurone

blockers, debrisoquine, bretylium and betanidine).

Stimulants or appetite suppressants and drugs used to treat

congestion and asthma (sympathomimetic drugs).

Tricyclic antidepressants (used to treat mood disorders).

Moclobemide (used to treat mood disorders).

Cardiac glycosides (drugs used to control heart rhythms or

contractions such as digoxin).

Ergot alkaloids (drugs used to treat migraine such as ergotamine

and methysergide).

Oxytocin (drugs used to help contractions during childbirth).

Anticholinergic drugs (drugs used to treat cramps or spasms

such as atropine).

Hypnotics (sleeping tablets including barbiturates).

Opioid analgesics (drugs used to relieve pain e.g. codeine,

tramadol, morphine).

Antipsychotics (drugs used to treat mood disorders).

If you are not sure about any of the medicines you are taking,

show the bottle or pack to your pharmacist.

If any of these bullet points apply to you now or in the past, talk to

a doctor or pharmacist.

Pregnancy and breast-feeding

If you are pregnant, or breast-feeding, think you may be pregnant

or are planning to have a baby, ask your doctor or pharmacist for

advice before using this medicine.

Driving and using machines

This medicine may cause dizziness, drowsiness, reduce alertness

and impair hearing. If affected, do not drive or operate machinery.

Avoid alcoholic drink.

Anti-doping tests

This medicine contains pseudoephedrine hydrochloride, which may

produce positive results in anti-doping tests.

Actifed Tablets contain lactose monohydrate

If you have been told by your doctor that you have an intolerance

to some sugars, contact your doctor before taking this medicine.

3 How to use Actifed Tablets

Check the tables that follow to see how much medicine to take.

For oral use only.

Do not use more than the stated dose shown in the table.

Do not use to sedate a child.

Children under 12 years

This medicine should not be given to children under 12 years old

Adults and children aged 12 years and over

Age

Dose

Adults and children

One tablet every 4-6 hours,

aged 12 years and over

up to 4 times a day.

Leave at least 4 hours between doses.

Do not give more than 4 doses in 24 hours.

If symptoms persist or worsen talk to your doctor or pharmacist

If you use more Actifed Tablets than

you should

If anyone has too much contact a doctor or your nearest Accident and

Emergency Department immediately taking this leaflet and pack with you.

If you forget to use Actifed Tablets

If you forget to take a dose, take the next dose when needed

provided that the last dose was taken at least 4 hours ago.

Do not take a double dose.

4 Possible side-effects

Like all medicines, Actifed Tablets can have side-effects, although not

everybody gets them.

If you experience any of the following, stop taking

this medicine and seek immediate medical help:

Swelling of the face, lips, mouth, tongue or throat which may cause

difficulty in swallowing or breathing.

Feeling unusually tired, unexpected bruising or bleeding and getting more

infections (such as colds) than normal.

Allergic reactions including skin rashes such as hives (which may be

severe and include blistering or peeling of the skin) and itching.

Hallucinations, paranoid delusions or fits.

If you experience any of the following, stop using

this medicine and talk to your doctor:

Restlessness or sleep disturbances.

A fast or irregular heartbeat or an increased awareness of the

heartbeat (palpitations).

Trouble passing water (especially in men with prostate problems).

Other effects which may occur include:

Very common (may affect more than 1 in 10 people)

Headache

Common (may affect up to 1 in 10 people)

Difficulty sleeping, nervousness, dizziness or feeling jittery

Drowsiness

Blurred vision

Thickened mucus, dry mouth, nausea or an upset stomach

Rare (may affect up to 1 in 1000 people)

Confusion or depression

Tremor, shakiness or slurred speech

Low blood pressure

Other effects which may occur but it is not known

how often:

Severe headache, feeling sick, being sick, confusion, fits, visual disturbances

Stroke

Agitation, anxiety, irritability or feelings of extreme happiness

Tingling or numbness of the hands or feet (pins and needles)

High blood pressure

Nose bleeds, dry nose or dry throat

Vomiting or stomach discomfort

Pain when passing water

Feeling tired

Very high fever

Reporting of side-effects

If you get any side-effects, talk to your doctor, pharmacist or nurse.

This includes any possible side-effects not listed in this leaflet. You can also

report side-effects directly via HPRA Pharmacovigilance, Earlsfort Terrace,

IRL-Dublin 2; Tel: +35316764971; Fax: +35316762517 Website:

www.hpra.ie; Email: medsafety@hpra.ie.

By reporting side-effects, you can help provide more information on the

safety of the medicine.

5 How to store Actifed Tablets

Keep out of the sight and reach of children.

Do not use Actifed tablets after the expiry date which is stated on the

carton label and blister after ‘EXP’. The expiry date refers to the last day

of that month.

Do not store above 25°C.

Store in original container to protect from moisture and light.

Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required.

These measures will help protect the environment.

6 Contents of the pack and other

information

What Actifed Tablets contain

The active ingredients in Actifed Tablets are: Pseudoephedrine

hydrochloride 60 mg and triprolidine hydrochloride 2.5 mg in each tablet.

Other ingredients are: Lactose monohydrate, maize starch, povidone

and magnesium stearate (E572).

What Actifed Tablets looks like and the contents of

the pack

Actifed Tablets are off-white, biconvex, branded and scored tablets, coded

M2A available in packs of 12 tablets.

Marketing Authorisation holder: McNeil Healthcare (Ireland) Ltd.,

Airton Road, Tallaght, Dublin 24, Ireland.

Manufacturer: Janssen Cilag, Domaine de Maigremont,

27100 Val de Reuil, France

This leaflet was revised January 2018.

Actifed is a registered trade mark.

Package leaflet: Information for the user

17-0128

4

Actifed Tablets

PIL

IRE

24/01/2018

Val de Reuil

7 pts

code Laetus 958

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Actifed 60mg/2.5mg Tablets.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 60 mg Pseudoephedrine hydrochloride and 2.5 mg Triprolidine hydrochloride.

Excipients: contains 127.5 mg lactose monohydrate per tablet.

For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablet.

White, round biconvex tablet with bisecting score and M2A engraved on one side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

ACTIFED Tablets are indicated for the symptomatic relief of upper respiratory tract disorders which are benefited by a

combination of a nasal decongestant and H

-receptor antagonist, for example allergic rhinitis, vasomoter rhinitis and the

common cold.

4.2 Posology and method of administration

Posology

Adults and children 12 years and over:

One tablet to be taken every 4-6 hours, up to four times a day.

Children under 12 years:

This medicine is contraindicated in children under the age of 12 years (see section 4.3).

The Elderly:

There have been no specific studies of ACTIFED Tablets in the elderly. Experience has indicated that normal adult

dosage is appropriate.

Hepatic Dysfunction:

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

Renal Dysfunction:

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

Method of Administration

For oral use.

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4.3 Contraindications

ACTIFED Tablets are contra-indicated in individuals with known hypersensitivity to pseudoephedrine, triprolidine or to

any of the excipients listed in section 6.1.

ACTIFED Tablets are contra-indicated in patients with cardiovascular disease including hypertension, and in those who are

taking beta-blockers.

ACTIFED Tablets are contra-indicated in individuals who have diabetes mellitus, phaeochromocytoma, hyperthyroidism,

closed angle glaucoma, or severe renal impairment.

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

ACTIFED Tablets are contra-indicated for use in children under 12 years of age.

4.4 Special warnings and precautions for use

ACTIFED Tablets 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

Caution should be exercised when administering to patients with severe hepatic impairment or mild to moderate renal

impairment.

Although pseudoephedrine has virtually no pressor effects in patients with normal blood pressure, ACTIFED Tablets

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 Tablets:

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

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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 tablets, 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 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.

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the

Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

MAOIs and/or RIMAs: Pseudoephedrine exerts its vasoconstricting properties by stimulating

-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 Tablets 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 Tablets, e.g. 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 and lactation

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

women.

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Fertility

There is no information on the effects of ACTIFED Tablets 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.

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.

4.7 Effects on ability to drive and use machines

ACTIFED Tablets may have a moderate influence on the ability to drive and use machines. ACTIFED Tablets 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 Tablets may, in some patients, produce

additional impairment.

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

Blood and Lymphatic System

Disorders

Blood disorder

Rare

Immune System Disorders

Hypersensitivity – cross sensitivity may occur

with other sympathomimetics

Rare

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Psychiatric Disorders

Insomnia

Nervousness

Hallucination

Confusional state

Depression

Sleep disorder

Agitation

Anxiety

Delusion

Euphoric mood

Hallucination, visual

Irritability

Restlessness

Common

Common

Rare

Rare

Rare

Rare

Not known

Not known

Not known

Not Known

Not known

Not known

Not known

Nervous System Disorders

Headache

Dizziness

Paradoxical dug reaction

Psychomotor hyperactivity

Somnolence

Extrapyramidal disorder

Seizure

Tremor

Epilepsy

Paraesthesia

Very common

Common

Common

Common

Common

Rare

Rare

Not Known

Not Known

Not Known

Eye Disorders

Vision blurred

Common

Cardiac Disorders

Arrhythmia

Palpitations

Tachycardia

Myocardial infarction / Myocardial ischemia

Posterior reversible encephalopathy (PRES) /

Reversible cerebral vasoconstriction syndrome

(RCUS)

Cerebrovascular accident

Rare

Rare

Not Known

Not Known

Not Known

Not known

Vascular Disorders

Hypotension

Hypertension

Rare

Not known

Respiratory, Thoracic and

Mediastinal Disorders

Dry throat

Epistaxis

Nasal dryness

Not Known

Not Known

Not Known

Gastrointestinal Disorders

Increased viscosity of bronchial secretions

Dry mouth

Gastrointestinal disorder

Nausea

Abdominal discomfort

Vomiting

Common

Common

Common

Common

Not Known

Not Known

Hepatobiliary Disorders

Liver disorder

Rare

Skin and Subcutaneous Tissue

Disorders

Acute generalised exanthematous pustulosis

Angioedema

Pruritus

Rash

Urticaria

Not Known

Not Known

Not Known

Not Known

Not Known

Renal and Urinary Disorders

Urinary Retention

Dysuria

Common

Not Known

General Disorders and

Fatigue

Not Known

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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.

4.9 Overdose

Symptoms

The effects of acute toxicity from ACTIFED Tablets may include drowsiness, lethargy, dizziness, ataxia, weakness,

hypotonicity, respiratory depression, dryness of skin and mucous membranes, tachycardia, hypertension, hyperpyrexia,

hyperactivity, irritability, palpitations, convulsions and difficulty with micturition.

Pseudoephedrine

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

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 up to 3 hours after

ingestion if indicated. Catheterisation of the bladder may be necessary. If desired, the elimination of pseudoephedrine can

be accelerated by acid diuresis or by dialysis.

Administration Site Conditions

Hyperpyrexia

Not Known

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5 PHARMACOLOGICAL PROPERTIES

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 H

-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.

5.2 Pharmacokinetic properties

After the administration of one ACTIFED Tablet in healthy adult volunteers, the peak plasma concentration (C

) of

triprolidine is approximately 5.5 - 6.0 ng/ml, occurring at about 2.0 hours (T

) after drug administration. The plasma

half-life of triprolidine is approximately 3.2 hours. The peak plasma concentration (C

) of pseudoephedrine is

approximately 180 ng/ml, with T

approximately 2 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.

5.3 Preclinical safety data

Mutagenicity

There is insufficient information available to determine whether triprolidine or pseudoephedrine has 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 Tablets on human fertility.

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Maize starch

Povidone (E1201)

Magnesium stearate (E572)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

Store in original container to protect from moisture and light.

6.5 Nature and contents of container

12 tablets in PVC/PVDC Aluminium foil blister packs.

500 tablets in polypropylene containers with polyethylene snap-fitting lids.

Not all pack sizes may be marketed.

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.

7 MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Ltd

Airton Road

Tallaght

Dublin 24

Ireland

8 MARKETING AUTHORISATION NUMBER

PA0823/006/003

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 0

1 April 1978

Date of last renewal: 0

1 April 2008

10 DATE OF REVISION OF THE TEXT

January 2018

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