ACTIFED COMPOUND * SCIR 100ML

ACTIFED COMPOUND * SCIR 100ML

Therapeutic indications

Symptomatic treatment of cough and congestive affections of the upper respiratory tract, in particular on an allergic basis.

Dosage and method of use

Dosage.Adults and children over 12 years old: a dose of 10 ml of syrup 2 - 3 times a day.Do not exceed the recommended dose.Method of administration:Oral use. The package is accompanied by a measuring cup in the shape of a double teaspoon corresponding to the capacities of 2.5 and 5 ml.

Contraindications

The drug is contraindicated: - in case of hypersensitivity to the active ingredients, to other antihistamines or to any of the excipients listed in section 6; - in children under the age of 12; - during pregnancy and breastfeeding; - in patients being treated with monoamine oxidase inhibitors (MAOIs) or in the two weeks following such treatment. There is a risk that the concomitant use of dextromethorphan and pseudoephedrine with MAOIs may cause an increase in blood pressure or a hypertensive crisis (see section 4.5); - in the treatment of lower respiratory tract diseases, including bronchial asthma. Due to its anticholinergic effects, do not use in case of glaucoma, prostatic hypertrophy, bladder neck obstruction, pyloric and duodenal stenosis or other tracts of the gastrointestinal and urogenital tract. It is also contraindicated in patients with pre-existing cardiovascular diseases especially those with coronary heart disease, hypertension, thyroid disease, as well as epilepsy and diabetes. Dextromethorphan, like other central cough suppressants, is contraindicated in patients who present or may develop respiratory failure.

Side effects

Adverse reactions reported during clinical studiesAdverse reactions reported with a frequency ≥1%, identified in randomized placebo-controlled trials, with formulations containing pseudofedrine as a single active substance are presented below: 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 dextromethorphan, pseuoephedrine and triprolidine.Adverse reactions reported during post-marketing experience: Adverse reactions collected during post-marketing experience with dextromethorphan, pseudoephedrine or the combination of pseudoephedrine and triprolidine, or the combination of dextromethorphan and pseudoephedrine are presented in Table 1. Compared to the adverse reactions already observed with the combinations of active substances above, no additional adverse reactions were identified for the combination dextromethorphan, pseudoephedrine and triprolidine. The adverse reactions listed in Table 1 are listed by frequency categories using the following convention: • Very common (≥ 1/10); • Common (≥ 1/100 e

Acttifed Compound can also cause:Nervous system disorders: sleepiness, tremors, headache, dizziness;General disorders and administration site conditions:fatigue;Skin and subcutaneous tissue disorders:rash, photosensitization;Renal and urinary disorders:retention of urine;Respiratory, thoracic and mediastinal disorders:increased bronchial secretions;Gastrointestinal disorders:vomiting, diarrhea;Psychiatric disorders:euphoric mood;Disorders of the blood and lymphatic system:blood changes;Cardiac disorders:arrhythmia (extrasystole), tachycardia;Vascular pathologies: 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/segnalazionireazioni-avverse.

Special warnings

If symptoms persist or worsen or do not improve within 7 days, or if new symptoms, high fever or other side effects appear, patients should stop treatment and consult their doctor. The medicine should not be used for persistent or chronic cough, such as that which occurs in asthma, or when it is accompanied by excessive secretions, unless directed by your doctor. At common therapeutic doses, antihistamines have very variable adverse reactions from subject to subject and from compound to compound. Consider dose modification in the elderly due to their greater sensitivity to antihistamines and pseudoephedrine. Although pseudoephedrine did not produce important effects on the blood pressure of normotensive subjects, Actifed Compound should not be taken by patients on antihypertensive, tricyclic antidepressant, sympathomimetic agents, such as decongestants, anorectics, amphetamine-like agents.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), pseudoephedrine should be discontinued and a physician should be consulted.Ischemic optic neuropathyCases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or decreased visual acuity occurs, for example in the case of scotoma.Skin safety: Severe 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 COMPOSTO should be discontinued and appropriate measures taken if necessary (see section 4.8). Cases of dextromethorphan abuse and dependence have been reported. Special care is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse.Serotonin syndrome: Serotonergic effects, including the development of a life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin reuptake inhibitors (SSRIs), drugs that alter the metabolism of serotonin (including monoamine oxidase inhibitors[monoamine oxidase inhibitors, MAOI]) and CYP2D6 inhibitors. Serotonin syndrome can include changes in mental status, autonomic instability, neuromuscular abnormalities, and / or gastrointestinal symptoms. If a serotonin syndrome is suspected, treatment with ACTIFED COMPOUND should be discontinued. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population metabolize CYP2D6 slowly. Exaggerated and / or prolonged effects of dextromethorphan may occur in poor metabolisers and patients with concomitant use of CYP2D6 inhibitors. Therefore, caution should be exercised in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5). Consult your doctor or pharmacist: if you are a poor metaboliser of CYP2D6 or are taking other medicines. Actifed Compound should not be used by patients with severe liver disease or with decreased kidney function. Keep this medicine out of the reach and sight of children. Due to the triprolidine content: • careful evaluation is required in patients with respiratory conditions such as emphysema or chronic bronchitis, before using this medicine; ACTIFED COMPOUND may cause drowsiness (see sections 4.7 and 4.8); • the sedative effects of central nervous system depressants, including alcohol, sedatives and tranquilizers, may be enhanced. Therefore, the use of alcoholic beverages should be avoided while taking Actifed Compound and the pharmacological interaction between substances with central nervous system depressant action and ACTIFED COMPOSTO must be evaluated (see section 4.5).Excipients with known effects:ACTIFED COMPOUND contains: •sorbitol: patients with rare hereditary problems of fructose intolerance should not take this medicine; •sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency, should not take this medicine; •ponceau 4R: can cause allergic reactions; •methyl para-hydroxybenzoate: can cause allergic reactions (even delayed); For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive doping tests in relation to the alcohol concentration limits indicated by some sports federations.

Pregnancy and breastfeeding

Actifed Compound is contraindicated during pregnancy and lactation (see section 4.3).

Expiry and retention

Store at a temperature not exceeding 25 ° C and protected from light.

Interactions with other drugs

Central Nervous System Depressors (opioid analgesics, some antidepressants, anti-H1- antihistamines, barbiturates, benzodiazepines, clonidine and related products, hypnotic drugs, neuroleptics, anxiolytics other than benzodiazepines):The effects of antihistaminesand dextromethorphanare 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,in order to avoid serious adverse reactions. Monoamine oxidase inhibitors (MAOIs): Dextromethorphan should not be used in patients concomitantly using monoamine oxidase inhibitors (MAOIs) or within 14 days of ending treatment with MAOIs, because there is a risk of increased blood pressure and / or hypertensive crisis (see paragraph 4.3). Pseudoephedrine exerts its vasoconstrictive action by stimulating adrenergic receptors and displacing noradrenaline from neuronal vesicles. Since monoamine oxidase inhibitors hinder the metabolism of sympathomimetic amines and increase the amount of releasable norepinephrine in the adrenergic nervous system, MAOIs may potentiate the effect of pseudoephedrine on blood pressure. Episodes of acute hypertensive crisis have been reported in the medical literature following the concomitant use of MAOIs and sympathomimetic amines.Interactions with CYP₄₅₀- CYP2D6 inhibitors: Dextromethorphan is metabolised by the cytochrome P isoenzyme CYP2D6₄₅₀and has an extensive first pass metabolism. Concomitant use of potent inhibitors of the CYP2D6 enzyme can increase the concentrations of dextromethorphan in the body to levels many times higher than normal. This increases the patient's risk of the toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea and respiratory depression) and of developing serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan are increased up to 20-fold, resulting in increased adverse effects on the central nervous system of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dose of dextromethorphan may need to be reduced. Antihistamines may 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 the Compound Acttifed. 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 the Compound Acttifed, which therefore, also in this case, does not must be taken at the same time.

Overdose

In case of overdose, marked depressive or stimulating effects on the CNS, drowsiness, lethargy, respiratory depression, hypertension, irritability, convulsions are generally observed. In children the dominant action is the exciting one with marked tremors, insomnia, hyperactivity and convulsions.Symptoms and signs: Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, somnolence, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc interval prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability. In case of massive overdose, the following symptoms can be observed: coma, respiratory depression, convulsions. In case of massive overdose, the following symptoms can be observed: coma, respiratory depression, convulsions.Management: - Activated charcoal can be given to asymptomatic patients who have ingested overdoses of dextromethorphan within the previous hour. - For patients who have ingested dextromethorphan and are sedated or comatose, naloxone in the usual doses for the treatment of opioid overdose may be considered. Benzodiazepines for seizures and benzodiazepines and external cooling measures for serotonin syndrome hyperthermia may be used.

Active principles

100 ml of syrup contain: • Active principles : Triprolidine hydrochloride 0.025 g; Pseudoephedrine hydrochloride 0.600 g; Dextromethorphan hydrobromide 0.200 g. • Excipients with known effects : sorbitol, sucrose, ponceau 4R (E124), methyl para-hydroxybenzoate, ethanol. For the full list of excipients see section 6.1

Excipients

Sorbitol (70%) not crystallizable; Sucrose; Sodium benzoate; Methyl para-hydroxybenzoate; Ponceau 4R (E124); Ethanol; Blackberry flavor; Menthol; Vanillin; Purified water.