ACTIFED * 12CPR 2,5MG + 60MG
Decongestant of the nasal mucosa, especially in case of colds.
Dosage and method of use
Dosage ACTIFED syrup A measuring cup is attached to the package with level marks corresponding to the capacities of 5 and 10 ml. Adults and children over 12 years old: a 10 ml dose of syrup 2 - 3 times a day. ACTIFED tablets Adults and children over 12 years: one tablet 2 - 3 times a day. Do not exceed the recommended dose. Method of administration Oral use
• hypersensitivity to the active substances, to other antihistamines or to any of the excipients listed in section 6.1; • children under the age of 12; • Pregnancy and breastfeeding; • in patients being 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 may cause 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.
Adverse reactions reported with a frequency ≥1 are presented below%, identified in randomized placebo-controlled trials, with formulations containing pseudofedrine as a single active ingredient: dry mouth, nausea, dizziness, insomnia and nervousness. There are no placebo-controlled clinical trials with sufficient adverse reaction data for the combination of the active substances pseuoephedrine and triprolidine. Adverse reactions identified during post-marketing experience with pseudoephedrine, triprolidine or the combination are presented in Table 1 according to frequency categories using the following convention: • very common (≥ 1/10); • common (≥ 1/100 e
| Psychiatric disorders |
| Very rare || Anxiety, euphoric mood, hallucination, restlessness, visual hallucination. |
| Nervous system disorders |
| Very Rare || Headache, paraesthesia, psychomotor hyperactivity (in the pediatric population), somnolence, tremor. |
| Not known || Cerebrovascular accident *, posterior reversible encephalopathy (PRES), reversible cerebral vasoconstriction syndrome (RCVS) (see section 4.4) |
| Cardiac pathologies |
| Very Rare || Arrhythmia, extrasystoles, palpitations, tachycardia |
| Not known || Myocardial infarction / Myocardial ischaemia * |
| General disorders and administration site conditions |
| Very Rare || Asthenia. |
| Disorders of the immune system |
| Very rare || Hypersensitivity |
| Respiratory, thoracic and mediastinal disorders |
| Very rare || Epistaxis |
| Gastrointestinal disorders |
| Very rare || Vomiting, abdominal discomfort. |
| Not known || Ischemic colitis (see section 4.4) * |
| Skin and subcutaneous tissue disorders |
| Very rare || Itching, rash, urticaria, angioedema. Acute generalized exanthematous pustulosis (AGEP) (see section 4.4), angioedema. |
| Renal and urinary disorders |
| Very rare || Dysuria, urinary retention. |
| Diagnostic tests |
| Very rare || Blood pressure increased. |
* adverse reactions collected during post-marketing experience with pseudoephedrine ACTIFED can also cause dizziness, photosensitivity reaction, diarrhea, hyperviscosity of bronchial secretions, very rarely blood disorders and especially in the elderly, hypotension. Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.
If symptoms persist or worsen or if new symptoms appear, patients should discontinue use of the medicine and consult a physician. If symptoms do not improve within 7 days or if a high fever or other side effects appear, patients should be advised to stop treatment and consult their physician. 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 increase the sedative effects of substances that depress the central nervous system such as alcohol, sedatives, tranquilizers. Patients should be advised that alcoholic beverages should be avoided during treatment with ACTIFED and that they should consult their physician before taking ACTIFED concomitantly with central nervous system depressant medications. At common therapeutic doses, antihistamines exhibit highly variable secondary reactions from subject to subject and from compound to compound. For the posology in the elderly it is necessary to consider their greater sensitivity to antihistamines and to pseudoephedrine. Although pseudoephedrine did not produce important effects on blood pressure in normotensive subjects, ACTIFED should not be taken by patients on antihypertensive, tricyclic antidepressant, sympathomimetic agents, such as decongestants, anorexics, amphetamine-like agents. Rare cases of posterior reversible encephalopathy have been reported with sympathomimetic drugs, including pseudoephedrine (posterior reversible encephalopathy, PRES) / reversible cerebral vasoconstriction syndrome (reversible cerebral vasoconstriction syndrome, RCVS). Symptoms reported include sudden onset of severe headache, nausea, vomiting and visual disturbances. If signs or symptoms of PRES / RCVS develop, pseudoephedrine treatment should be discontinued and a physician consulted immediately. Ischemic colitis A few cases of ischemic colitis have been reported with medicinal products containing pseudoephedrine. If sudden abdominal pain, rectal tenesmus, rectal bleeding or other symptoms of ischemic colitis develop (see section 4.8), the use of pseudoephedrine should be discontinued and a physician should be consulted. Skin safety Serious skin reactions such as acute and generalized exanthematous pustulosis (AGEP) can occur with products containing pseudoephedrine. This acute pustular rash can occur within the first 2 days of treatment, with fever and numerous, small, mostly non-follicular pustules resulting from a widespread edematous erythema and located mainly on the skin folds, trunk and upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema, or numerous small pustules are observed, administration of ACTIFED should be discontinued and appropriate measures taken as necessary (see section 4.8). ACTIFED should not be used by patients with severe liver disease or with reduced kidney function unless your doctor deems it necessary. Important information about some of the excipients: ACTIFED syrup contains: • sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine. This medicine contains 7 g of sucrose per dose. To be taken into consideration in people with diabetes mellitus; • methyl para-hydroxybenzoate. It can cause allergic reactions (even delayed); • sunset yellow (E110). It can cause allergic reactions. ACTIFED tablets contains lactose. • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Pregnancy and breastfeeding
ACTIFED is contraindicated during pregnancy and breastfeeding.
Expiration and retention
ACTIFED syrup Keep away from light. ACTIFED tablets Store at a temperature not exceeding 25 ° C, in a dry place.
Interactions with 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 noradrenaline from neuronal sites. Monoamine oxidase inhibitors (MAOIs) may potentiate the pressure effect of pseudoephedrine by preventing the metabolism of sympathomimetic amines and increasing the releasable amount of norepinephrine in the adrenergic nervous tissue. The effects of antihistamines are made more evident by alcohol, hypnotics, sedatives, tranquilizers, and other substances with anticholinergic action or depressant effect on the central nervous system, which therefore should not be taken during therapy. Antihistamines can reduce the duration of action of oral anticoagulants. The use of antihistamines can mask the early signs of ototoxicity of certain antibiotics. Furazolidone causes a progressive inhibition of monoamine oxidase, so it should not be taken at the same time as ACTIFED. 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, which therefore, even in this case, does not go simultaneously hired.
In case of overdose, marked depressive (due to triprolidine) or stimulating (due to pseudoephedrine) effects on the CNS are generally observed Effects of triprolidine: drowsiness, lethargy, respiratory depression, hypertension, hyperthermia, anticholinergic syndrome (mydriasis, flushing, fever, dryness, urinary retention, reduced borborygmas) 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 insufficiency Effects of pseudoephedrine: Overdose may cause nausea, vomiting, sympathomimetic symptoms including CNS stimulation, insomnia, mydriasis, irritability, seizures, anxiety, agitation, hallucinations, palpitations, tachycardia, hypertension, reflex bradycardia. Other effects may include arrhythmias, hypertensive crises, 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. Keep out of reach of children. In case of overdose, seek medical help or contact a poison control center immediately.
ACTIFED tablets One tablet contains: • active ingredients: 2.5 mg triprolidine hydrochloride; pseudoephedrine hydrochloride 60.0 mg; • excipients with known effects: lactose. ACTIFED syrup 100 ml of syrup contain: • active ingredients: triprolidine hydrochloride 0.025 g; pseudoephedrine hydrochloride 0.600 g; • excipients with known effects: sucrose, methyl para hydroxybenzoate, sunset yellow (E110). For the full list of excipients, see section 6.1.
ACTIFED tablets Each tablet contains: lactose; cornstarch; povidone; magnesium stearate. ACTIFED syrup 100 ml of syrup contain: glycerol; sucrose; methyl para-hydroxybenzoate; sodium benzoate; quinoline yellow (E104); sunset yellow (E110); purified water.