ACTIFED 30 mg/1.25 mg per 5 ml Syrup

*
Pharmacy Only: Non-prescription

Updated on 02 August 2024

File name

ie-pl-actifed syrup-2544.pdf

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 02 August 2024

File name

ie-spc V18-actifed-syrup-2544.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 24 May 2021

File name

ie-pl-proposed-clean-actifed syrup-2144.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - date of revision

Updated on 24 May 2021

File name

ie-spc V16 actifed syrup 2130.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 23 October 2020

File name

ie-pl-actifed-syrup-Bv2058.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 August 2020

File name

ie-spc V14 actifed syrup 2071.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 13 August 2020

File name

ie-pl-actifed syrup 2071.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 04 November 2019

File name

ie-spc V13 Actifed Syrup 1927.pdf

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 04 November 2019

File name

ie-pl-actifed syrup BV 1927.pdf

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 06 March 2019

File name

ie-pl-actifed syrup clean BV 1829.pdf

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 06 March 2019

File name

ie-spc v12 Actifed Syrup BV 1829.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

File name

ie-spc Actifed Syrup clean BV 1811.pdf

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

File name

ie-spc Actifed Syrup clean BV 1811.pdf

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

File name

ie-pl-actifed syrup clean BV 1811.pdf

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 18 July 2018

File name

ie-spc Actifed Syrup clean BV 1811.pdf

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 21 May 2018

File name

spc_actified_syrup.docx

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Supply through pharmacy only

Updated on 18 May 2018

File name

LN514701-PIL ACTIFED SYRUP 100MLv9_6_v1_FVID451256.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 14 May 2018

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

File name

PIL_8978_63.pdf

Reasons for updating

  • New PIL for new product

Updated on 25 January 2018

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 23 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 23 January 2018

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 15 April 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 - 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
  • Change to section 4.3 - Contraindications

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:

 

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.

 

Following text changed:

 

From:

 

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

 

To:

 

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.

 

Added:

 

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.

 

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.

 

 

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 01 April 2015

Reasons for updating

  • Change to drug interactions
  • Addition of information on reporting a side effect.
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects

Updated on 09 November 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 21 July 2011

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

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2:

Removal of indication for use in children under 6 years of age.
Addition of maximum daily dose information
Addition of extra warnings:

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

Use for more than 5 consecutive days is not recommended

Section 4.3

CI in children under 6.

Section 4.4

Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours.  changed to:

Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours. 

 

Consult a pharmacist or other healthcare professional before use in children under 6 years.
changed to:

Consult a pharmacist or other healthcare professional before use in children under 12  years.

 

changed to:

Updated on 21 July 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to dosage and administration

Updated on 07 October 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change from "Plastic" to "HDPE"

Updated on 25 August 2008

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

Change in MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire to McNeil Healthcare Ireland Limited, Airton Road, Tallaght, Dublin 24.

Updated on 25 August 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 04 July 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 19 May 2008

Reasons for updating

  • Change to marketing authorisation holder

Updated on 31 March 2008

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

Section 7.
 
New MA holder: McNeil Helathcare (Ireland) Ltd. Airton road, Tallaght, Dublin 24, Ireland.

Updated on 11 March 2008

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 18 January 2005

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Supply through pharmacy only

Updated on 17 January 2005

Reasons for updating

  • Change to how the medicine works

Updated on 21 September 2004

Reasons for updating

  • Improved electronic presentation

Legal category:Supply through pharmacy only

Updated on 20 September 2004

Reasons for updating

  • New PIL for new product

Updated on 18 August 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only