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Actifed* TABLETS are indicated for the symptomatic relief of nasal congestion and rhinitis associated with upper respiratory tract disorders1

 

 

For adults (including the elderly) and children aged 12 years and over:

 

1 tablet every 4-6 hours as required1

 
Actifed 2

Actifed* is also available as liquid formulations indicated for the relief of symptoms associated with upper respiratory tract disorders.2,3,4

 

 

Actifed* DM COUGH LINCTUS for relief of nasal congestion, rhinitis and cough2

Actifed* SYRUP for relief of nasal congestion and rhinitis3

Actifed* EXPECTORANT for relief of nasal congestion, rhinitis and productive cough4

 

ACTIFED ABRIDGED PRESCRIBING INFORMATION: Please refer to full Summary of Product Characteristics (SPC) before prescribing. TRADE NAME: ACTIFED. ACTIVE INGREDIENT: Actifed DM Cough Linctus: Each 5ml contains Dextromethorphan Hydrobromide 10mg, Pseudoephedrine Hydrochloride 30mg and Triprolidine Hydrochloride 1.25mg; Actifed Syrup: Each 5ml contains Pseudoephedrine Hydrochloride 30mg and Triprolidine Hydrochloride 1.25mg; Actifed Expectorant: Each 5ml contains Triprolidine Hydrochloride 1.25mg, Pseudoephedrine Hydrochloride 30mg and Guaiphenesin 100mg; Actifed Tablets: Each tablet contains Pseudoephedrine Hydrochloride 60mg; Triprolidine Hydrochloride 2.5mg. PHARMACEUTICAL FORM: Oral Solution and Tablets. INDICATIONS: Symptomatic relief of upper respiratory tract disorders which are benefited by a combination of: Actifed DM Linctus: a nasal decongestant, an anti-histamine and an antitussive; Actifed Syrup: a nasal decongestant, and an anti-histamine; Actifed Expectorant: a nasal decongestant, an anti-histamine and an expectorant; Actifed Tablets: a nasal decongestant, and an anti-histamine. DOSAGE: please refer to full SPC. Actifed DM Cough Linctus, Actifed Syrup and Actifed Expectorant are authorised for use without the need of a medical prescription in Adults and Children over 12 years. In Children between 2-11 years of age, these products are authorised for use only against a medical prescription as recommended by your doctor. CONTRAINDICATIONS: Previous intolerance to any of the active substances; use of MAOI’s in the preceding two weeks; severe hypertension or heart disease; concomitant use of pseudoephedrine can cause a rise in blood pressure. PRECAUTIONS: May cause drowsiness; avoid the concomitant use of alcohol or other centrally active sedatives; use with caution in patients with liver impairment or moderate to severe renal impairment. INTERACTIONS: Sympathomimetics; MAOI’s. ADVERSE EVENTS: Central nervous system depression or excitation with drowsiness being reported most frequently; sleep disturbance and rarely hallucinations have also been reported; skin rashes, tachycardia, dryness of mouth, nose and throat and urinary retention have occasionally been reported especially in men with prostatic enlargement. PREGNANCY AND LACTATION: Administration should only be considered if the expected benefits to the mother outweigh the potential risks to foetus or child. PRESENTATION: DM Cough Linctus, Expectorant, Syrup: Amber glass bottle x 100ml; Tablets : Pack x 24 tablets. Marketing Authorisation Holder: Glaxo Wellcome UK Limited, Marketing Authorisation Number: MA 167/00101-7Legal category: POM – Actifed Tablets, POM – Actifed DM Cough Linctus, Actifed Syrup, Actifed Expectorant in Children between 2-11 years, OTC – Actifed DM Cough Linctus, Actifed Syrup, Actifed Expectorant in Adults and Children over 12 years. For further information and full prescribing information contact GlaxoSmithKline (Malta) Ltd: Tel. 21238131. Date of preparation: January 2015

 

In order to ensure that this product information reflects the most up-to-date clinical and post-marketing surveillance data, please always refer to the latest Summary of Product Characteristics (SPC) which is available from GlaxoSmithKline (Malta) Ltd (Tel: +356 21238131)

  

REPORTING ADVERSE EVENTS (AEs):

If you become aware of any AEs, medication errors and/or use during pregnancy in association with GSK products, please report the event promptly to: GSK (Malta) Limited, 1, De la Cruz Avenue, Qormi QRM 2458, Malta (Tel: +356 21238131)

Alternatively, any suspected AEs and medication errors can also be reported via the national Adverse Drug Reactions (ADRs) reporting system:

Report forms can be downloaded from www.medicinesauthority.gov.mt/adrportal and posted to the Malta Medicines Authority, Post-licensing Directorate, 203, Level 3, Rue D’Argens, Gżira GŻR 1368, MALTA, or sent by email to postlicensing.medicinesauthority@gov.mt

 

References: 1. Actifed Tablets SPC (Apr 14); 2. Actifed DM Linctus (Jan15); 3. Actifed Syrup SPC (Mar 15); 4. Actifed Expectorant SPC (Jan 15)

Job No: MLT_GIB/PDH/0001/16

Date of preparation: January 2016

 

 

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