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ACTIFED COMPOUND * SCIR 100ML

  • JOHNSON & JOHNSON SpA
  • 021102037
Features:


Indicated in case of nasal congestion.


Indicated in case of cold.


Deductible over-the-counter drug.


It can induce sleepiness.


















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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: a 10 ml dose 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 studies 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. No placebo-controlled clinical trials with sufficient adverse reaction data are available for the combination of the active substances dextromethorphan, pseudoephedrine 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 have been identified for the combination dextromethorphan, pseudoephedrine and triprolidine. The adverse reactions listed in Table 1 are listed according to frequency categories using the following convention: • Very common (≥ 1/10); • Common (≥ 1/100 e

Classification For systems and organs Adverse reactions
Frequency
Psychiatric disorders
Not known anxiety, hallucinations, restlessness, irritability, visual hallucination.
Nervous system disorders
Not known paraesthesia, psychomotor hyperactivity, cerebrovascular accident
Cardiac pathologies
Not known Palpitations, myocardial infarction
Respiratory, thoracic and mediastinal disorders
Not known Epistaxis
Gastrointestinal disorders
Not known Abdominal discomfort, abdominal pain, ischemic colitis
Skin and subcutaneous tissue disorders
Not known pruritus, urticaria, angioedema, acute generalized exanthematous pustulosis.
Renal and urinary disorders
Not known Dysuria
Disorders of the immune system
Not known Hypersensitivity to drugs, hypersensitivity.
Diagnostic tests
Not known Blood pressure increased
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: urine retention, 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 http://www.agenziafarmaco.gov.it/content/comesegnalare-una-sospetta-reazione-avversa.

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 increased sensitivity to antihistamines and pseudoephedrine. Although pseudoephedrine did not produce important effects on blood pressure in 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 pseudoephedrine-containing medicines. 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. 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 COMPOUND should be discontinued and appropriate measures taken if necessary (see section 4.8). Cases of dextromethorphan abuse 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. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population metabolizes 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 positivity to 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).

Expiration and retention

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

Interactions with other drugs

Central Nervous System Depressors (alcohol, sedatives, tranquilizers) 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. Monoamine oxidase inhibitors (MAOIs) Dextromethorphan should not be used in patients concomitantly using monoamine oxidase inhibitors (MAOIs) or within 14 days after the end of MAOI treatment, because there is a risk of an increase in blood pressure or hypertensive crisis (see section 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 noradrenaline 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 several 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, must be taken at the same time.

Overdose

In case of overdose, marked depressive or stimulating effects on the CNS, somnolence, 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.

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

021102037
12 Items