ACTIFED COMPOUND*SCIR 100ML

ACTIFED COMPOUND*SCIR 100ML

Therapeutic indications

Symptomatic treatment of coughs and congestive diseases 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 includes a measuring cup in the shape of a double teaspoon with 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 paragraph 6; - in children under 12 years of age; - 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, obstruction of the bladder neck, pyloric and duodenal stenosis or other tracts of the gastrointestinal and urogenital system. It is also contraindicated in patients with pre-existing cardiovascular diseases, particularly 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 have or may develop respiratory failure.

Side effects

Adverse reactions reported during clinical trialsThe following are adverse reactions reported with a frequency ≥1%, identified in randomized placebo-controlled studies, with formulations containing pseudophedrine as the single active ingredient: dry mouth, nausea, dizziness, insomnia and nervousness. There are no placebo-controlled clinical studies with sufficient data regarding adverse reactions for the combination of the active substances dextromethorphan, pseudoephedrine and triprolidine.Adverse reactions reported during post-marketing experience: Table 1 shows the adverse reactions collected during the post-marketing experience with dextromethorphan, pseudoephedrine or the combination of pseudoephedrine and triprolidine, or the combination of dextromethorphan and pseudoephedrine. Compared to the adverse reactions already observed with the above combinations of active substances, no additional adverse reactions were identified for the combination dextromethorphan, pseudoephedrine and triprolidine. Adverse reactions reported in Table 1 are listed under frequency categories using the following convention: • Very common (≥ 1/10); • Common (≥ 1/100 e

Actifed Compound can also cause:Nervous system disorders: drowsiness, tremors, headache, dizziness;General disorders and administration site conditions:fatigue;Skin and subcutaneous tissue disorders:skin rash, photosensitization;Renal and urinary disorders:urine retention;Respiratory, thoracic and mediastinal disorders:increased bronchial secretions;Gastrointestinal disorders:vomiting, diarrhea;Psychiatric disorders:euphoric mood;Pathologies of the blood and lymphatic system:blood changes;Cardiac disorders:arrhythmia (extrasystole), tachycardia;Vascular pathologies: hypotension.Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. 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 present adverse reactions that vary greatly from subject to subject and from compound to compound. Evaluate the possibility of a dose modification in the elderly due to their greater sensitivity towards 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 treated with antihypertensives, tricyclic antidepressants, sympathomimetic agents, such as decongestants, anorectics, amphetamine-like agents.Ischemic colitis: Some 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 medical advice should be sought.Ischemic optic neuropathy: Cases of ischemic optic neuropathy have been reported with pseudoephedrine. Pseudoephedrine should be discontinued if sudden loss of vision or reduction in visual acuity occurs, for example in the case of a scotoma.Skin safety: Severe skin reactions such as acute generalized exanthematous pustulosis (AGEP) may occur with products containing pseudoephedrine. This acute pustular eruption 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 should be carefully monitored. If signs and symptoms such as pyrexia, erythema or numerous small pustules are observed, the administration of ACTIFED COMPOUND must be stopped and appropriate measures must be taken if necessary (see section 4.8). Cases of abuse and dependence of dextromethorphan have been reported. Particular caution 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 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 may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If 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. Approximately 10% of the population slowly metabolizes CYP2D6. Exaggerated and/or prolonged effects of dextromethorphan may occur in poor metabolizers and patients with concomitant use of CYP2D6 inhibitors. Caution is therefore necessary 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 metabolizer of CYP2D6 or are taking other medicines. Actifed Compound should not be used by patients with severe liver disease or decreased kidney function. Keep the medicine out of the reach and sight of children. Due to the triprolidine content: • careful evaluation is required in patients experiencing 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 increased. Therefore, while taking Actifed Compound, the use of alcoholic beverages must be avoided and the pharmacological interaction between substances with depressant action on the central nervous system and ACTIFED COMPOUND must be evaluated (see section 4.5).Excipients with known effects:ACTIFED COMPOUND contains: •sorbitol: patients suffering from rare hereditary problems of fructose intolerance should not take this medicine; •sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine; •ponceau 4R: may cause allergic reactions; •methyl parahydroxybenzoate: may cause allergic reactions (even delayed); For those who carry out sporting activities, the use of medicines containing ethyl alcohol can lead to positive anti-doping tests in relation to the blood alcohol concentration limits indicated by some sports federations.

Pregnancy and breastfeeding

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

Expiration and conservation

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

Interactions with other drugs

Central Nervous System depressants (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 an anticholinergic action or a depressive 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 vasoconstrictor action by stimulating adrenergic receptors and displacing norepinephrine from neuronal vesicles. Since monoamine oxidase inhibitors impair 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 crises 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 extensive first pass metabolism. Concomitant use of strong inhibitors of the CYP2D6 enzyme can increase dextromethorphan concentrations in the body to levels many times higher than the normal value. This increases the patient's risk for toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea, and respiratory depression) and for the development of serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine and terbinafine. When used concurrently with quinidine, plasma concentrations of dextromethorphan are increased up to 20-fold, resulting in increased adverse CNS effects 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 shorten 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, therefore it should not be taken at the same time as Actifed Compound. 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 Compound, which therefore, also in this case, does not must be taken at the same time.

Overdose

In case of overdose, marked depressant or stimulant effects on the CNS, drowsiness, lethargy, respiratory depression, hypertension, irritability, convulsions are generally observed. In children the dominant action is the exciting one with accentuated tremors, insomnia, hyperactivity and convulsions.Symptoms and signs: Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, 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 may be observed: coma, respiratory depression, convulsions. In case of massive overdose, the following symptoms may be observed: coma, respiratory depression, convulsions.Management: - Activated charcoal can be administered 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 doses usual for the treatment of opioid overdose, may be considered. Benzodiazepines may be used for seizures and benzodiazepines and external cooling measures for serotonin syndrome hyperthermia.

Active principles

100 ml of syrup contains: • 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 parahydroxybenzoate, ethanol. For the complete list of excipients see section 6.1

Excipients

Sorbitol (70%) non-crystallizable; Sucrose; Sodium benzoate; Methyl parahydroxybenzoate; Ponceau 4R (E124); Ethanol; Blackberry aroma; Menthol; Vanillin; Purified water.