ACTIFED 60 mg / 2.5 mg Tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 04/11/19

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Summary of Product Characteristics last updated on medicines.ie: 4/11/2019

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (bottle) Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets Active Ingredients Loperamide Hydrochloride
1 - 0 of 65 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 4 November 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 4 November 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 6 March 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 6 March 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 19 July 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

This variation is being submitted to implement the PRAC recommendations following the outcome of the ibuprofen / pseudoephedrine PSUSA (PSUSA/00001711/201707). These recommendations include updating Sections 4.4 and 4.8 of the Summary of Product Characteristics and to update Section 2 and 4 of the Package Leaflet accordingly

Updated on 19 July 2018 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

This variation is being submitted to implement the PRAC recommendations following the outcome of the ibuprofen / pseudoephedrine PSUSA (PSUSA/00001711/201707). These recommendations include updating Sections 4.4 and 4.8 of the Summary of Product Characteristics and to update Section 2 and 4 of the Package Leaflet accordingly

Updated on 18 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 30 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 24 May 2018

Updated on 21 May 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 May 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 25 January 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 January 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 24 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

PSE V3 CCDS update plus incorporating PSE/Triprolidine PRAC updates.

Updated on 24 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 8 September 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changed from:

 

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

 

to

 

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

Updated on 15 April 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2

 

Heading  ‘Posology’ added.

 

‘Oral’ deleted from dosage sentence for adults and children

 

Added:

 

Method of Administration

For oral use

 

Section 4.3

 

Added ‘or hypertensive crisis to end of sentence ‘The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure or hypertensive crisis.

 

 

Section 4.4

 

Deleted:

 

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.

 

Patients with prostatic hypertrophy may have increased difficulty with micturition.

 

Added:

 

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 this Actifed Syrup, patients should be advised to avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants.

 

 

This medicinal product contains lactose monohydrate

 

Section 4.5

 

Added:

 

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.

 

 

Deleted:

 

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

 

Following text changed:

 

From:

 

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.

 

To:

 

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.

 

Added:

 

Triprolidine may enhance the sedative effects of central nervous system depressants, including alcohol, sedatives and tranquilizers.

 

 

Section 4.6

 

‘Fertility’ added to title.

 

Following text changed:

 

From:

 

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

 

To:

 

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 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. 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.

 

 

Section 4.8

 

Following text changed:

 

From:

 

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 could have been an important predisposing factor.

 

To:

 

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.

 

Section 4.9

 

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.

 

Change to:

 

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.

 

 

Section 5.1

 

Added:

Pharmacotherapeutic group: Sympathomimetics, pseudoephedrine, combinations

ATC code: R01BA52

 

Section 6.6

 

Changed from:

 

6.6        Instructions for use and handling

 

No special requirements

 

 

To:

 

6.6        Special precautions for disposal and handling

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

 

Updated on 1 April 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to drug interactions
  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 29 April 2013 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 2 November 2010 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
  • Change to section 4.3 - Contraindications

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes to sections 4.3, 4.4 & 4.5 to include standard sympathomimetic warnings.

Updated on 2 November 2010 PIL

Reasons for updating

  • Change of contraindications

Updated on 29 October 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to drug interactions
  • Change to further information section
  • Change due to user-testing of patient information

Updated on 12 August 2010 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 22 May 2009 PIL

Reasons for updating

  • Change to storage instructions
  • Change of trade or active ingredient name

Updated on 24 March 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

 Renewal changes to PIL:

Inclusion of API and strength in product name.
Inclusion of excipients in the composition section
Inclusion of breakbar descripion in tablet
Inclusion of E numbers in excipient list       
Inclusion of "not all pack sizes are marketed" in container closure system
Revision of renewal date 

Updated on 25 August 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 11 March 2008 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

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.

Updated on 28 February 2006 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 18 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only