ACTIFED 12CPR 2.5MG+60MG

ACTIFED

active ingredients

ACTIFED tablets A tablet contains: • active ingredients: triprolidine hydrochloride 2,5 mg; 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, yellow sunset (E110), sodium benzoate. For the full list of excipients, see paragraph 6.1.

Excellent

ACTIFED tablets Each tablet contains: lactose; corn starch; povidone; magnesium stearate. ACTIFED syrup 100 ml of syrup contain: glycerol; sucrose; methyl para-hydroxybenzoate; benzoate sodium; yellow chinoline (E104); yellow sunset (E110); purified water.

Therapeutic indications

Decongestant of the nasal mucosa, especially in case of cold.

Contraindications

• hypersensitivity to active ingredients, other antihistamines or any of the excipients listed in paragraph 6.1; • children under the age of 12; • Pregnancy and breastfeeding; • in patients treated with monoaminoxydase inhibitors (IMAO) or in the two weeks following such treatment, and in the treatment of low respiratory diseases, including bronchial asthma. In such cases the concomitant use of ACTIFED can cause increased blood pressure or hypertensive crisis; • glaucoma, prostate hypertrophy, vescic neck obstruction, pyloric and duodenal stenosis or other traits of gastroenteric and urogenital apparatus (due to its anti-linergical effects); • cardiovascular affections, arterial hypertension, hyperthyroidism, epilepsy and diabetes.

Population

Population ACTIFED syrup The packaging is attached to a measuring measuring device with indicated level notches corresponding to the capacity of 5 and 10 ml. Adults and boys over 12 years old: a dose of 10 ml syrup 2 - 3 times a day. ACTIFED tablets Adults and boys over 12 years: a tablet 2 - 3 times a day. Do not exceed the recommended doses. . Method of administration Oral use

Conservation

ACTIFED syrup Keep the light away. ACTIFED tablets Store at a temperature not exceeding 25°C, in a dry place.

Warnings

If symptoms persist or worsen or if new symptoms appear, patients must stop using the medicine and consult a doctor. If symptoms do not improve within 7 days or if there is a high fever or other side effects, patients should be warned to stop treatment and consult the doctor. Before taking triprolidine, patients with the following respiratory conditions such as emphysema, chronic bronchitis or acute or chronic bronchial asthma should be warned to consult a doctor. Triprolidine can cause drowsiness and can increase the sedative effects of substances that depress the central nervous system like alcohol, sedatives, tranquilizers. You should inform patients that you should avoid using alcoholic beverages during treatment with ACTIFED and that you should consult your doctor before taking ACTIFED in conjunction with medicines that depress the central nervous system. At the common therapeutic doses, antihistamines have very variable secondary reactions from subject to subject and compound to compound. For posology in the elderly it is necessary to consider their greater sensitivity to antihistamines and to the pseudophedrine. Although pseudoephedrine has not produced significant effects on the blood pressure of normothetic subjects, ACTIFED should not be taken by patients in antihypertensive therapy, antidepressants, sympathomimetic agents, such as decongestionants, anorexizers, amphetaminosimilies. With sympathomimetic drugs, including pseudoephedrine, rare cases of reversible back encephalopathy were reported (posterior reversible encephalopathy, PRES)/reversible cerebral vasoconstriction syndrome (reversible cerebral vasoconstriction syndrome, RCVS). The reported symptoms include sudden occurrence of severe headaches, nausea, vomiting and visual disorders. If signs or symptoms of PRES/RCVS develop, it is necessary to stop the treatment with pseudo-ephedrine and immediately consult a doctor. Ischemic Colite Some cases of ischemic colitis have been reported with medicines containing pseudophedrine. If sudden abdominal pain develops, rectal tensile, rectal bleeding or other symptoms of ischemic colitis (see paragraph 4.8), the use of pseudophedrine should be interrupted and it is necessary to consult a doctor. Ischemic optics Cases of ischemic optical neuropathy have been reported with the pseudoephedrine. The pseudoephedrine should be interrupted if sudden loss of sight or reduction of visual acuity should occur, for example in case of scotoma. Skin safety Severe skin reactions such as acute and generalized exantematic pustolosis (AGEP) can occur with products containing pseudophedrine. This acute pustolose eruption may occur within the first 2 days of treatment, with fever and numerous, small pustulas, mostly not follicular, resulting from a widespread and localized edematous erythema mainly on the skin folds, on the trunk and on the upper limbs. Patients must be carefully monitored. If signs and symptoms such as pyrexia, erythema, or numerous small pustulas are observed, the administration of ACTIFED must be interrupted and appropriate measures should be taken (see paragraph 4.8). ACTIFED should not be used by patients with severe liver disease or reduced kidney function unless the doctor considers it necessary. Important information about some excipients: ACTIFED syrup contains: • sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains 7 g sucrose per dose. To consider in people with diabetes mellitus; • methyl para-hydroxybenzoate. It can cause allergic reactions (also delayed); • yellow sunset (E110). It can cause allergic reactions; • 10 mg of benzoate sodium per dose (10 ml syrup) • less than 1 mmol (23 mg) of sodium per dose (10 ml syrup), i.e. essentially “without sodium”. ACTIFED tablets contains lactose: • Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine.

Interactions

During the concomitant use of monoaminoxydase inhibitors (IMAO) and sympathomimetic amines, acute hypertensive crises were reported in medical literature. The pseudoephedrine exercises vasoconstrictoral action by stimulating adrenergic receptors and releasing norepinephrine from neuronal sites. Monoaminoxydase inhibitors (IMAO) can enhance the diary effect of pseudoephedrine, as they prevent the metabolism of sympathomimetic amines and increase the releasing 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 depressive effect on the central nervous system, which therefore do not be taken during therapy. Antihistamines can reduce the duration of action of oral anticoagulants. The use of antihistamines can mask the first signs of ototoxicity of certain antibiotics. Furazolidone causes a progressive inhibition of monoaminoxydasis, so it should not be taken simultaneously to ACTIFED. The effect of antihypertensives that interfere with the activity of the sympathetic (e.g. methyldopa, alpha and beta blockers, debrisochina, guanetidine, betanidine and bretilio) can be partially canceled by ACTIFED, which therefore, even in this case, should not be taken simultaneously.

Effects

Below are the reported adverse reactions reported with a frequency ≥1%, identified in randomized studies controlled with placebo, with formulations containing pseudophedrine as a single active ingredient: dry mouth, nausea, dizziness, insomnia and nervousness. Placebo-controlled clinical trials are not available, with sufficient evidence of adverse reaction for the combination of active pseuoefedrin and triprolidine. The adverse reactions identified during the post-marketing experience conpseudoefedrin, triprolidine or combination are shown in Table 1 according to the frequency categories using the following convention: § very common (≥ 1/10); • common (≥ 1/100 and Psychiatric disorders Very rare Anxiety, euphoric mood, hallucination, restlessness, visual hallucination. Diseases of the nervous system Very Rare Cephalea, paresthesia, psychomotor hyperactivity (in the pediatric population), drowsiness, tremor. Notable Reversible posterior encephalopathy (PRES), reversible cerebral vasoconstriction syndrome (RCVS) (see paragraph 4.4) Heart disease Very Rare Aritmia, extrasistoli, palpitations, tachycardia Notable Myocardial infarction* Systemic pathologies and conditions for administration Very Rare Astenia. Immune system pathologies Very rare Hypersensitivity Respiratory, chest and mediastinic pathologies Very rare Epistassi Gastrointestinal diseases Very rare Vomito, abdominal disorder. Notable Hischemic Colite (see paragraph 4.4)* Pathologies of skin and subcutaneous tissue Very rare Prurito, rash, hives, angioedema. generalized acute exantematic pustolosis (AGEP) (see paragraph 4.4), angio. Kidney and urinary pathologies Very rare Disuria, urinary retention. Diagnostic examinations Very rare Increased blood pressure. Pathologies of the eye Notable Ischemic Optical Neuropatia * adverse reactions collected during post-marketing experience with pseudo-phedrine ACTIFED may also cause dizziness, photosensitivity reaction, diarrhea, hyperviscosity of bronchial secretions, very rarely ethical alterations and species in the elderly, hypotension. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

In case of hyperdosage, depressive effects (due to triprolidine) or stimulants (due to pseudoephedrine) are generally observed S.N.C. Effects of triprolidine: drowsiness, lethargy, respiratory depression, hypertension, hyperthermia, anti-linergical syndrome (midriasis, redness, fever, dry mouth, urinary retention, reduced borborigmas) tachycardia, hypotension, nausea, vomiting, agitation, confusion, hallucinations, psychosis, convulsions, arrhythmias. Patients suffering from prolonged agitation, coma, or seizures may rarely manifest rhabdomiolisis and kidney failure Effects of pseudoephedrine: overdose can cause nausea, vomiting, sympathomimetic symptoms including SNC stimulation, insomnia, midriasis, irritability, seizures, anxiety, agitation, hallucinations, palpitations, tachycardia, hypertension, reflex bradycardia. Other effects may include arrhythmias, hypertensive crisis, intracerebral hemorrhage, myocardial infarction, psychosis, rhabdomiolisis, hypocaliemia, intestinal infarction. In children the dominant action is the exciting action with accentuated tremors, insomnia, hyperactivity and seizures, it has also been reported drowsiness. Keep out of reach of children. In case of overdose, ask your doctor for help or contact a poison center immediately.

ACTIFED is contraindicated during pregnancy and nursing.

Source: Farmadati