Actifed Decongestant 12 tablets 2.5mg + 60mg

Actifed Decongestant 12 tablets 2.5mg + 60mg is an over-the-counter decongestant drug based on pseudoephedrine hydrochloride and triprolidine hydrochloride. The pseudoephedrine contained in Actifed is a decongestant of the nasal mucosa ; Triprolidine is an antihistamine that reduces secretions from the nose.

Actifed is a medicine used for the relief of symptoms of nasal congestion, due to colds and seasonal allergies . The combination of antihistamine and nasal decongestant quickly clears stuffy nose and promotes nasal decongestion quickly for over 6 hours.

Posology and method of use of Actifed Decongestant 12 tablets 2.5mg + 60mg

How to take Actifed 12 tablets 2.5mg + 60mg?

Adults and children over 12 years: one tablet of Actifed 2 - 3 times a day.

Active Ingredients and Excipients Actifed Decongestant 12 tablets 2.5mg + 60mg

One tablet of Actifed 2.5mg + 60mg contains:

Active ingredients : triprolidine hydrochloride 2.5 mg; pseudoephedrine hydrochloride 60.0 mg.

Excipients : lactose.

Contraindications Actifed Decongestant 12 tablets 2.5mg + 60mg

Actifed Decongestant 12 tablets 2.5mg + 60mg is contraindicated in the case of:

• Hypersensitivity to the active substances, to other antihistamines or to any of the excipients
• Children under the age of 12
• Pregnancy and breastfeeding
• Patients treated with monoamine oxidase inhibitors (MAOIs) or in the two weeks following such treatment, and in the treatment of lower respiratory tract diseases, including bronchial asthma. In such cases, concomitant use of Actifed tablets may lead to an increase in blood pressure or hypertensive crisis
• Glaucoma, prostatic hypertrophy, bladder neck obstruction, pyloric and duodenal stenosis or other tracts of the gastrointestinal and urogenital tracts (due to its anticholinergic effects);
• Cardiovascular diseases, arterial hypertension, hyperthyroidism, epilepsy and diabetes.

Warnings Actifed Decongestant 12 tablets 2.5mg + 60mg

If symptoms do not improve within 7 days or if high fever or other undesirable effects occur, patients should be advised to stop treatment and consult their doctor. Before taking triprolidine, patients with the following respiratory conditions such as emphysema, chronic bronchitis, or acute or chronic bronchial asthma, should be advised to consult a physician. Triprolidine can cause drowsiness and can enhance the sedative effects of substances that depress the central nervous system such as alcohol, sedatives, tranquilizers. Patients should be advised that the use of alcoholic beverages should be avoided during treatment with Actifed tablets and that they should consult their doctor before taking Actifed tablets concomitantly with medicinal products that depress the central nervous system. At common therapeutic doses, antihistamines show highly variable side reactions from subject to subject and from compound to compound. For the dosage in the elderly it is necessary to consider their greater sensitivity towards antihistamines and towards pseudoephedrine. Although pseudoephedrine has not produced significant effects on the blood pressure of normotensive subjects, Actifed tablets should not be taken by patients on antihypertensive therapy, tricyclic antidepressants, sympathomimetic agents, such as decongestants, anorectics, amphetamine-like drugs. Actifed tablets should also not be used by patients with severe kidney or liver disease.

Important information about some of the excipients: Actifed syrup tablets contain:

• Sucrose: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. This medicinal product contains 7 g of sucrose per dose. To be taken into consideration in people with diabetes mellitus; • methyl para-hydroxybenzoate. May cause allergic reactions (possibly delayed);
• Sunset yellow (E110): May cause allergic reactions. Actifed tablets tablets contain:
• Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Side effects Actifed Decongestant 12 tablets 2.5mg + 60mg

Below are the reported and identified adverse reactions of Actifed tablets:

• Psychiatric disorders: Very rare Anxiety, euphoric mood, hallucination, restlessness
• Nervous system disorders: Very Rare Headache, paraesthesia, psychomotor hyperactivity (in the pediatric population), somnolence, tremor
• Cardiac disorders: Very Rare Arrhythmia, extrasystoles, palpitations, tachycardia
• General disorders and administration site conditions: Very Rare Feeling jittery, asthenia
• Immune system disorders: Very rare Hypersensitivity
• Respiratory, thoracic and mediastinal disorders: Very rare Epistaxis
• Gastrointestinal disorders: Very rare Vomiting, abdominal discomfort.
• Skin and subcutaneous tissue disorders: Very rare Pruritus, erythema, urticaria
• Renal and urinary disorders: Very rare Dysuria, urinary retention
• Investigations: Very rare Blood pressure increased

Actifed tablets can also cause dizziness, photosensitivity reaction, diarrhoea, hyperviscosity of bronchial secretions, very rarely blood alterations and especially in the elderly, hypotension.

Overdose Actifed tablets
In case of overdose, marked CNS depressant (due to triprolidine) or stimulant (due to pseudoephedrine) effects are usually observed. Effects of triprolidine: drowsiness, lethargy, respiratory depression, hypertension, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, mouth dryness, urinary retention, low borborygmi) tachycardia, hypotension, nausea, vomiting, agitation, confusional state, hallucinations, psychosis, convulsions, arrhythmias. Patients suffering from prolonged agitation, coma, or seizures may rarely experience rhabdomyolysis and renal failure Effects of pseudoephedrine: Overdose may cause nausea, vomiting, sympathomimetic symptoms including CNS stimulation, insomnia, mydriasis, irritability, convulsions, anxiety, agitation, hallucinations, palpitations, tachycardia, hypertension, reflex bradycardia. Other effects may include arrhythmias, hypertensive crisis, intracerebral haemorrhage, myocardial infarction, psychosis, rhabdomyolysis, hypokalemia, intestinal infarction. In children, the dominant action is the exciting one with accentuated tremors, insomnia, hyperactivity and convulsions, and somnolence has also been reported.

Interactions Actifed tablets and other drugs
Acute hypertensive crises have been reported in the medical literature during concomitant use of monoamine oxidase inhibitors (MAOIs) and sympathomimetic amines. Pseudoephedrine exerts a vasoconstrictive action by stimulating adrenergic receptors and releasing norepinephrine from neuronal sites. Monoamine oxidase inhibitors (MAOIs) may potentiate the pressor effect of pseudoephedrine, as they prevent the metabolism of sympathomimetic amines and increase the releasable amount of norepinephrine in the adrenergic nerve tissue. The effects of antihistamines are made more evident by alcohol, hypnotics, sedatives, tranquilizers, and other substances with an anticholinergic action or a depressant effect on the central nervous system, which therefore should not be taken during therapy. Antihistamines can shorten the duration of action of oral anticoagulants. The use of antihistamines can mask the first signs of ototoxicity of certain antibiotics. Furazolidone causes progressive inhibition of monoamine oxidase, therefore it should not be taken at the same time as Actifed tablets. The effect of antihypertensives that interfere with sympathetic activity (e.g. methyldopa, alpha and beta blockers, debrisoquine, guanethidine, betanidine and bretylium) can be partially canceled by Actifed tablets, which therefore, also in this case, cannot be taken at the same time.

Pregnancy and lactation Actifed Decongestant 12 tablets 2.5mg + 60mg

Can I take Actifed 12 tablets 2.5mg + 60mg when pregnant or breastfeeding?

Actifed tablets are contraindicated during pregnancy and lactation.

Expiration and conservation of Actifed Decongestant 12 tablets 2.5mg + 60mg

How to store Actifed Decongestant tablets 2.5mg + 60mg?

Store Actifed tablets at a temperature not exceeding 25°C, in a dry place.