ACTION AND MECHANISM- Combination of a [NASO/PHARYNGEAL DECONGESTANT] with a [HISTAMINERGIC (H-1) ANTAGONIST], from the piperazine group.SPECIAL WARNINGS- It is recommended to periodically monitor blood pressure in hypertensive patients and blood glucose in diabetic patients.- It is advisable to separate the intake of MAOI and pseudoephedrine by at least 14 days.PATIENT ADVICE- It is recommended not to exceed the recommended daily dose.- In very rare cases it may cause drowsiness, so it is recommended to be cautious when driving, and not to combine it with drugs or other sedative substances such as alcohol.- Treatment should be discontinued and a doctor consulted if symptoms persist for more than five days, if they worsen or if high fever, dizziness, insomnia or nervousness appear.- The doctor or pharmacist should be notified if the patient has diabetes, heart disease, hypertension or glaucoma, as well as if they are under treatment with any other drug.- It is recommended to discontinue treatment at least 24 hours before surgery and 72 hours before performing skin allergy tests.CONTRAINDICATIONS- Hypersensitivity to any component of the medication.- [PORPHYRIA]. H1 antihistamines are not considered safe in these patients.- Severe heart disease or uncontrolled diabetes mellitus.- Patients being treated with MAOI antidepressants in the 14 days prior to starting therapy with pseudoephedrine (See Interactions).- [KIDNEY FAILURE]DOPINGPseudoephedrine is a prohibited substance during competition. It is prohibited when its administration results in a urinary concentration greater than 150 mcg/ml. The detection in an in-competition sample of any amount of pseudoephedrine in combination with a diuretic or masking agent will be considered an Adverse Analytical Finding, unless the athlete has obtained an approved Therapeutic Use Exemption (TUE) for ephedrine in addition to that granted for the diuretic or masking agent. It is considered a "Specified Substance," and therefore a rule violation involving this substance may result in a reduced sanction provided the athlete can demonstrate that the use of the specific substance in question was not intended to enhance performance. ADVANCED AGE The elderly are more susceptible to the side effects of these medications, so caution is recommended. EFFECTS ON DRIVING This medication may impair, in particularly predisposed patients, the ability to drive and/or operate machinery. Patients should avoid operating hazardous machinery, including automobiles, until they are reasonably certain that drug treatment does not adversely affect them.PREGNANCY Adequate and well-controlled clinical trials in humans have not been conducted, so the use of this medicine is only accepted in the absence of safer therapeutic alternatives, and provided that the benefits outweigh the possible risks.INDICATIONS- Symptomatic treatment of symptoms associated with [SEASONAL ALLERGIC RHINITIS] or [PERENNIAL ALLERGIC RHINITIS], such as nasal congestion, sneezing, rhinorrhea, eye and nose itching.INTERACTIONS- Acenocoumarol. Cetirizine may enhance the anticoagulant effects of acenocoumarol.- Inhalational anesthetics. May increase the risk of serious ventricular arrhythmias, so it is recommended to discontinue treatment at least 24 hours before surgery.- Tricyclic antidepressants. Tricyclic antidepressants may potentiate the vasopressor effects of sympathomimetic amines, leading to hypertensive crises. Their combination is recommended to be avoided.- Antihypertensives (beta-blockers, diuretics, guanethidine, methyldopa). Pseudoephedrine may antagonize their effects. Administration with beta-blockers has led to hypertensive crises due to beta-blockade. Regular monitoring of blood pressure is recommended.- Digoxin. The risk of cardiac arrhythmias associated with pseudoephedrine may be increased.- Nervous stimulants (amphetamines, cocaine, xanthines). Nervous stimulation may be potentiated, leading to intense excitability.- Thyroid hormones. The cardiac effects of pseudoephedrine may be potentiated, with a risk of high blood pressure and coronary insufficiency.- MAOI. MAOIs may potentiate the effects of pseudoephedrine by inhibiting norepinephrine metabolism, increasing the risk of hypertensive crises and other cardiac events. It is recommended that this drug be avoided in patients treated with MAOIs in the previous 14 days.- Levodopa. Increases the risk of cardiac arrhythmias.- Nitrates. Pseudoephedrine may antagonize the antianginal effects of nitrates, so it is recommended to avoid the combination.- Reserpine. Reserpine may reduce the effects of indirect sympathomimetics such as pseudoephedrine, due to the depletion of noradrenergic vesicles.- Sympathomimetics. There may be an increase in side effects, both of nervous and cardiovascular origin. BREASTFEEDING Some of the active ingredients of this medicine are excreted in milk, so it is recommended to stop breastfeeding or avoid administering this medicine. CHILDREN The safety and efficacy of the pills of this medicine in children under 12 years of age, nor of the syrup in children under one year of age, have not been evaluated, so its use is not recommended. RULES FOR CORRECT ADMINISTRATION This medicine should be administered in the morning and at night, before going to bed. The tablets should be swallowed whole, without chewing or breaking them, with the aid of a glass of water.DOSAGE- Adults: 1 tablet/12 hours.- Children:* Children 12 years and older: 1 tablet/12 hours.* Children under 12 years: Safety and efficacy have not been evaluated.Duration of treatment: Treatment may be extended for 2 weeks in the case of seasonal allergic rhinitis and 3 weeks in perennial allergic rhinitis.DOSAGE IN RENAL FAILURE- CrCl < 60 ml/min: 1 tablet/24 hours.PRECAUTIONS- [RENAL FAILURE], [LIVER FAILURE]. Active ingredients may accumulate, with a risk of adverse reactions.- Patients with [DIABETES], [GLAUCOMA], [CORONARY FAILURE], [ISCHEMIC HEART DISEASE], [HEART ARRHYTHMIA], [ARTERIAL HYPERTENSION], [HYPERTHYROIDISM], [PHEOCHROMOCYTOMA] or [PROSTATIC HYPERPLASIA]. Pseudoephedrine may aggravate these conditions. In cases of serious or decompensated disease, the use of this medicine may be contraindicated (See Contraindications).- [EPILEPSY]. Some antihistamines may induce seizures.PRECAUTIONS RELATING TO EXCIPIENTS- This medicine contains lactose. Patients with hereditary [LACTOSE INTOLERANCE] or galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.- This medicine contains fructose. Patients with [FRUCTOSE INTOLERANCE] should not take this medicine. ADVERSE REACTIONS The adverse effects of this medicine are, in general, rare at the recommended doses, although they may increase in intensity and severity at higher doses. The most frequent alterations are:- Digestive. [NAUSEA], [VOMITING], [DYSPEPSIA] and [DRY MOUTH].- Neurological/psychological. Cases of [DROWSY], [NERVOUSNESS], [EXCITABILITY], [INSOMNIA], [DIZZINESS] or [VERTIGO] may appear.- Cardiovascular. [CARDIAC ARRHYTHMIA], with [TACHYCARDIA] and [PALPITATIONS]. [ARTERIAL HYPERTENSION] and reflex [BRADYCARDIA] may also occur.- Genitourinary. [URINARY RETENTION].- Allergic/dermatological. [HYPERSENSITIVITY REACTIONS], with [URTICARIA] and [SKIN RASHES]. OVERDOSE Symptoms: An overdose of this medicine may lead to the appearance of neurological symptoms (drowsiness, nervousness, restlessness, hallucinations, respiratory depression) and/or cardiovascular symptoms (tachycardia, bradycardia, high blood pressure, palpitations, reflex hypotension). Treatment: It is recommended to carry out the usual elimination measures, with forced emesis and gastric lavage. If absorption of active ingredients has already occurred, it is recommended to keep the patient under surveillance and start symptomatic treatment.