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MULTI-ACTION ACTIFED is a brand name for Triprolidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the symptomatic relief of upper respiratory tract disorders which are benefited by a combination of a nasal decongestant and histamine H1-receptor antagonist, for example: Allergic Rhinitis Vasomotor Rhinitis The Common Cold and Influenza
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults and children over 12 years One tablet every 4-6 hours up to 4 times a day. Not more than 4 doses should be given in any 24 hours. Use in the Elderly No specific studies have been carried out in the elderly, but triprolidine and pseudoephedrine have been widely used in older people.
Hepatic Dysfunction Caution should be exercised when administering Multi-Action ACTIFED Tablets to patients with hepatic impairment. Renal Dysfunction Caution should be exercised when administering Multi-Action ACTIFED Tablets to patients with moderate renal impairment.
Method of Administration For oral use.
Placebo-controlled studies with sufficient adverse event data are 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 according to the following convention:
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.
4) Psychomotor hyperactivity Very common Common Common Common Common Rare Rare Rare Not Known Not Known Not Known Not Known Vision blurred CommonEye Disorders Ischaemic optic neuropathy Not Known Cardiac Disorders Palpitations Dysrhythmias Myocardial infarction / myocardial ischaemia Tachycardia Rare Not Known Not Known Not Known Vascular Disorders Hypotension Hypertension Rare Not Known Respiratory, Thoracic and Mediastinal Disorders Increased viscosity of bronchial secretion Dry throat Epistaxis Nasal dryness Common Not known Not known Not known Gastrointestinal Disorders Dry mouth Gastrointestinal disorder Nausea Abdominal discomfort Ischaemic colitis Vomiting Common Common Common Not Known Not Known Not Known Hepatobiliary Disorders Liver Disorder Rare Skin and Subcutaneous Tissue Disorders Angioedema Pruritus Rash Severe skin reactions, including acute generalised exanthematous pustulosis (AGEP) Urticaria Not known Not known Not known Not known Not known Renal and Urinary Disorders Urinary Retention (in men whom prostatic enlargement could have been an important predisposing factor) Dysuria Common Not known General Disorders and Administration Site Conditions Fatigue Not known Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important.
Multi-Action ACTIFED Tablets may cause drowsiness. This product should not be used to sedate a child. Triprolidine may enhance the sedative effects of central nervous system depressants including alcohol, sedatives and tranquilisers.
While taking Multi-Action ACTIFED Tablets, patients should be advised to avoid alcoholic beverages and consult a healthcare professional prior to taking with central nervous system depressants. Use with caution in prostatic hypertrophy, urinary retention or susceptibility to angle closure.
Patients with thyroid disease who are receiving thyroid hormones are advised to consult a physician before using this product. Use with caution in occlusive vascular disease. If any of the following occur, this product should be stopped.
Hallucinations Restlessness Sleep disturbances Severe Skin Reactions:
Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with pseudoephedrine-containing products. This acute pustular eruption may occur within the first 2 days of treatment, with fever, and numerous, small, mostly non-follicular pustules arising on a widespread oedematous erythema and mainly localized on the skin folds, trunk, and upper extremities.
Patients should be carefully monitored. If signs and symptoms such as pyrexia, erythema, or many small pustules are observed, administration of this medicine should be discontinued, and appropriate measures taken if needed.
Ischaemic colitis:
Some cases of ischaemic colitis have been reported with pseudoephedrine. Pseudoephedrine should be discontinued, and medical advice sought if sudden abdominal pain, rectal bleeding or other symptoms of ischaemic colitis develop.
Ischaemic optic neuropathy:
1. Multi-Action ACTIFED is contraindicated in patients who are taking or have taken monoamine oxidase inhibitors within the preceding 14 days. 5). 5). Cardiovascular disease Severe hypertension or uncontrolled hypertension Diabetes mellitus Phaeochromocytoma Hyperthyroidism Closed angle glaucoma Severe acute or chronic kidney disease/renal failure
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Cases of ischaemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity such as scotoma occurs. 8). 3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances.
Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment. Patients with the following conditions should not use Multi-Action Actifed Tablets unless directed by a physician: acute or chronic asthma, chronic bronchitis or emphysema.
There have been no specific studies of Multi-Action ACTIFED Tablets in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of hepatic or moderate to severe renal impairment. This medicinal product contains lactose monohydrate.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.