REACTINE 6CPR 5MG+120MG RP

REACTINE 5 MG + 120 MG COMPRESENT TO PROLUNGED RELATED

active ingredients

A tablet contains: • active ingredient: - cetirizine dichloride 5 mg; - pseudoefedrine hydrochloride 120 mg; • excipient with known effects: lactose. For the full list of excipients, see paragraph 6.1.

Excellent

Excipients of the first layer Hypromellose, microcrystalline cellulose, colloidal silica anidra, magnesium stearate. 2nd layer excipients Lactose, microcrystalline cellulose, crosscaramellose sodium, anidra colloidal silica, magnesium stearate. Exciting coating Opadry Y-1-7000 white (methocel E5, premium (ipromellose) (E 464), titanium dioxide (E 171), macrogol 400).

Therapeutic indications

REACTINE is indicated in the short-term symptomatic treatment of seasonal allergic rhinitis and/or perennials with nasal congestion and hypersecretion, nasal and/or eye itching, sneezing and tearing.

Contraindications

REACTINE is contraindicated in the following cases: • hypersensitivity to active ingredients, to any of the excipients listed in paragraph 6.1, to hydroxyzine or piperazin derivatives; • severe kidney failure (patients with creatinine clearance less than 10 ml/min); • severe hypertension; • severe coronary disorders; • patients who are in treatment or have been treated in the previous two weeks with monoaminooxidase inhibitors (see paragraph 4.5); • increased intraocular pressure; • urinary retention; • children under 12 years; • pregnancy and nursing (see paragraph 4.6).

Population

Population Adults and children from 12 years: a tablet 2 times a day, one in the morning and one in the evening, to be taken without chewing during or away from meals. The duration of treatment should not exceed the period of acute symptomatology and should not be protracted over 7 days. Spend the 7 days of therapy, continue treatment with cetirizine alone. Special popularity Senior Patients The dose must be halved in elderly patients. Patients with renal compromise The dose must be halved in patients with kidney failure. Patients with liver impairment The dose must be halved in patients with liver failure. Paediatric population REACTINE is contraindicated in children under 12 years of age (see section 4.3). Method of administration Oral use.The tablets should be taken with a little water and should not be divided, chewed or crushed.

Conservation

No special storage precautions.

Warnings

REACTINE is intended for short-term treatment only.Reactine must be used under medical supervision in diabetic patients and in subjects with thyroid problems, prostatic hypertrophy, liver failure or reduced kidney function, as well as in elderly subjects.This medicine must be used under medical supervision in patients with pre-existing cardiovascular problems, including those with coronary heart disease, hypertension, tachycardia and arrhythmia.Caution should also be exercised in subjects treated with sympathomimetics (decongestants, appetite suppressants, psychostimulants such as amphetamines), tricyclic antidepressants and digitalis.Cases of abuse have been observed with pseudoephedrine as well as with other central stimulants.At therapeutic doses of cetirizine, no clinically significant interactions with alcohol have been demonstrated (for a blood alcohol level of 0.5 g/l).However, caution is recommended if alcohol is taken at the same time.Use caution in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia), as cetirizine may increase the risk of urinary retention.Caution is advised in epileptic patients and patients at risk of convulsions.Allergy skin tests are inhibited by antihistamines, therefore a wash-out period (3 days) is necessary before performing them.If symptoms persist or worsen, or if new symptoms occur, discontinue use and consult a physician. Excipient with known effects The medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Interactions

Due to the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, there are no interactions with this antihistamine. In fact, no significant pharmacodynamic interactions or pharmacodynamic interactions have been reported in pharmacopharmapharmaceutical interaction studies carried out, in particular, with pseudophedrine or theophylline (400 mg/die). The activity of sympathomimetic amines such as pseudophedrine contained in this drug has increased from the simultaneous administration of monoaminooxidase inhibitors and βblockers. Due to the long duration of action of monoaminooxidase inhibitors the activity of sympathomimetic amines can be observed even after 15 days from the suspension of administration. Sympathomimetic amines reduce the antihypertensive effects of methyldopa, guanetidine and reserpine. The administration of pseudophedrine to digitized patients increases myocardial ectopic activity. Anti-acids increase the absorption of pseudo-ephedrine while it is reduced by the simultaneous intake of kaolin. The degree of absorption of cetirizine is not reduced by food intake, although the absorption rate is decreased.

Effects

Clinical studies have shown that cetirizine at a dose of 10 mg has minor undesirable effects on the central nervous system, including somnolence, fatigue, dizziness and headache.In some cases, paradoxical CNS stimulation has been reported.The following adverse reactions have been reported by ≥ 1% of adult subjects in randomized, placebo-controlled studies with cetirizine alone: somnolence, nervousness, fatigue, dry mouth, dizziness, headache, nausea, pharyngitis, abdominal pain.Somnolence was mild to moderate in the majority of cases, although statistically more common than with placebo.Additional studies in which objective evidence was obtained have shown that usual daily activities are not impaired at the recommended daily dose in healthy young volunteers.Although cetirizine is a selective H-receptor antagonist₁-peripheral and relatively devoid of anti-linergical activity, cases of dysuria, acumodation disorder and dry mouth have been reported. Anomalous liver function has been reported with the raising of liver enzymes accompanied by high bilirubin. Mainly this is resolved by the interruption of treatment with cetirizine dichloride. The following adverse reactions were reported by ≥ 1% of individuals in randomized trials, controlled by placebo, with a pseudophedrine taken individually: dry mouth, nausea, dizziness, insomnia and nervousness. Clinical studies The safety of the combination of cetirizine and pseudoephedrine from clinical studies is based on data from 3 randomized, double-blind, placebo-controlled studies for the treatment of seasonal allergic rhinitis.Table 1 includes adverse reactions that occurred in patients in whom more than one event was reported, and the incidence was greater than placebo and in 1% or more of patients. Table 1: Adverse reactions reported by > 1% of adult subjects treated with the combination of cetirizine and pseudoephedrine in 3 randomized, placebo-controlled clinical studies.

Classification for Systems and Organs	Cetirizine 5 mg/Pseudoefedrine 120 mg	Placebo
	Multi-dose
Preferred Term	(N =840)	(N = 831)
	% (frequency)	% (frequency)
Systemic pathologies and conditions for administration
Austria	2,0 (Common)	0,7 (Not common)
Gastrointestinal diseases
Dry mouth	3,3 (Common)	0,4 (Not common)
Diseases of the nervous system
Heads	1.1 (Common)	0.1 (Not common)
Insomnia	3,8 (Common)	0.5 (Not common)
Sleep	2.5 (Common)	0.2 (Not common)

Adverse reactions to 1% or more in children aged between 6 months and 12 years, including in placebo controlled clinical studies are: diarrhea, drowsiness, rhinitis, fatigue. Side effects, observed and reported during treatment with REACTINE are reported according to the classification for systems and organs according to MedDRA. The frequencies are defined as follows: • Very common (≥ 1/10); • Common (≥ 1/100, Table 2. Adverse reactions identified during the post-marketing experience with cetirizine, pseudo-ephedrine or the combination of cetirizine and pseudo-ephedrine by frequency category estimated by spontaneous signals* SOC   Frequency Action against Emolinfopoietic system pathologies: Very rare trombocytopenia Immune system disorders: Rare Hypersensitivity (including anaphylactic shock) Disorders of metabolism and nutrition: Notable increased appetite Psychiatric disorders: Town nervousness Not common anxiety Not common agitation Rare hallucinations Rare psychotic disorder Rare aggression Rare state of confusion Rare depression Rare insomnia Very rare tick Notable euphoric behaviour Very rare visual hallucination Notable suicidal behavior Diseases of the nervous system: Town chief Town headache Town drowsiness Not common restlessness Not common the week Rare convulsion Very rare dysgeusia Very rare syncope Very rare tremor Very rare dystonia Very rare dyskinesia Very rare feeling of nervousness Very rare feeling of unease Notable amnesia Notable memory impairment Eye pathologies: Very rare accommodation disorder Very rare blurred vision Very rare oculogyric crisis Very rare swelling of the eyes Notable mydriasis Notable eye pain Notable compromise of vision Notable photophobia Ear and labyrinth pathologies: Notable vertigo Heart disease: Not common palpitations Rare arithmia Rare tachycardia Vascular diseases: Rare pallor Rare hypertension Very rare circular collapse Very rare hypotension Respiratory diseases, , thoracic and mediastinic: Very rare cough Not common dispnea Gastrointestinal diseases:   Town dry mouth Town nausea Not common diarrhea Rare vomiting Very rare ischemic colitis; Abdominal Fastidium Hepatobiliary diseases: Rare abnormal liver function (increased transaminasis, increased alkaline phosphates, increased GT range, increased blood bilirubin) Pathologies of skin and subcutaneous tissue: Not common itching Not common skin rash Rare dry skin Rare hyperhydrides Rare hives Very rare eruption from drugs Very rare angioedema Very rare reaction of the skin Very rare generalized acute exantematic pustolosis Renal and urinary disorders: Very rare enures Very rare disaster Notable urinary retention Systemic pathologies and conditions for administration: Town weakness Not common astenia Not common malaise Rare edema Diagnostic examinations:   Rare weight gain Pathologies of the reproductive apparatus and of the breast: Notable erectile dysfunction * Patient exposure was estimated by the calculation of sales data from IMS MIDAS 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-re action-adverse.

Overdosing

Synonyms In case of overdose you can observe: tachycardia, arrhythmia, hypertension, depressive or stimulating effects on S.N.C. (sedation, apnea, collapse, insomnia, hallucinations, tremors, seizures). These effects can be fatal. Symptoms observed after overdose of cetirizine are mainly associated with SNC load effects or effects that may suggest an anti-linergical effect. The adverse events reported after taking at least 5 times the dose of 10 mg of cetirizine are: confusion, diarrhea, dizziness, fatigue, headache, malaise, midriasis, itching, restlessness, sedation, drowsiness, astonishment, tachycardia, tremor and urinary retention. In case of overdose of pseudoephedrine, nausea, vomiting, midriasis, anxiety, agitation, palpitations and reflex bradycardia can occur. Other possible effects are dysrithmia, hypertensive crisis, intracerebral hemorrhage, myocardial infarction, psychosis, radbomiolisis, hypocaliemia, and ischemic infarction of the intestine. In the case of overdose in children, drowsiness was reported. Keep away from the reach of children. In case of overdosing, request your doctor’s help or contact an anti-veleni center immediately. Treatment The treatment, which should take place preferably in the hospital environment, must be symptomatic. A gastric lavender is recommended. No known antidotes. It is important to avoid using sympathomimetics. Hypertension can be controlled with α-blockers, possible tachycardia with β-blockers, convulsions with diazepam iv. There is no specific antidote for cetirizine. If an overdose occurs, symptomatic or support treatment is recommended. Following recent ingestion, gastric lavender is recommended. Cetirizine is not effectively eliminated with dialysis.

REACTINE is contraindicated in pregnancy and nursing. Pregnancy For cetirizine there are very few clinical data on pregnancies exposed to treatment. Animal studies show no direct or indirect harmful effects on pregnancy, embryo/fetal development, birth or post-natal development. Food Both cetirizine and pseudoephedrine are excrete with breast milk for which REACTINE should not be taken during breastfeeding. Cetirizine is excreted in breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the sampling time after administration.

Source: Farmadati