ACTION AND MECHANISM - Combination of an analgesic/antipyretic, an H1 receptor antagonist, and a nasal/pharyngeal decongestant. Paracetamol exerts analgesic and antipyretic effects, probably due to the inhibition of prostaglandin synthesis in the central nervous system. Phenylephrine, an alpha-1 adrenergic agonist, causes vasoconstriction, reducing nasal congestion. Finally, chlorphenamine antagonizes H1 and cholinergic receptors, relieving cold symptoms such as sneezing, watery eyes, and runny nose. SPECIAL WARNINGS - In patients treated with anticoagulants, it is recommended to follow short treatments with low doses, monitoring coagulation parameters. - Hematological counts are recommended in patients treated with high doses or for prolonged periods of time. - It is advisable to monitor transaminase levels in patients undergoing prolonged treatment or at risk of hepatotoxicity. - In case of overdose, the specific antidote for paracetamol is N-acetylcysteine. SENIORS Elderly patients may be more susceptible to the adverse effects of this medication, so it is recommended to use it with caution, and to discontinue its administration if adverse reactions are not tolerable. PATIENT ADVICE - It is advisable to drink plenty of water during treatment, avoiding the intake of alcoholic beverages as much as possible. - It is recommended not to exceed the recommended daily doses and to avoid treatments longer than ten days without a doctors prescription. - If symptoms continue or worsen after five days, it is recommended to consult a doctor. - The doctor or pharmacist should be notified of any illness the patient has or any medication they are taking. - It can cause drowsiness, so caution is advised when driving, and it should not be combined with drugs or other sedatives such as alcohol. CONTRAINDICATIONS - Hypersensitivity to any component of the medication, including cases of [PARACETAMOL ALLERGY]. - [LIVER DISEASE], such as severe liver failure or [HEPATITIS]. Paracetamol can cause hepatotoxicity. - Severe kidney failure. - [PORPHYRIA]. H1 antihistamines are not considered safe in these patients. - Severe heart disease or uncontrolled diabetes mellitus. There is a risk of severe decompensation. - [HIGH BLOOD PRESSURE]. - [HYPERTHYROIDISM] - [TACHYCARDIA] - Patients undergoing treatment with MAOI-type antidepressants in the 14 days prior to starting phenylephrine therapy (See Interactions). EFFECTS ON DRIVING This medication may substantially impair the ability to drive and/or operate machinery. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that the medication does not adversely affect them. PREGNANCY Some active ingredients in this product can cross the placental barrier. The safety and efficacy of this medication in pregnant women have not been evaluated; therefore, its use is not recommended unless there are no safer therapeutic alternatives and the benefits outweigh the potential risks. INDICATIONS - [COMMON COLD]. Symptomatic treatment of catarrhal processes and [FLU] that present with fever, moderate pain, headache, tearing, nasal congestion and rhinorrhea. INTERACTIONS - Ethyl alcohol. Ethyl alcohol may enhance the sedative effects of this medicine. In addition, consuming alcoholic beverages with paracetamol may cause liver damage. It is recommended to avoid alcohol consumption during treatment. In chronic alcoholics, no more than 2 g/24 hours of paracetamol should be administered. - Alpha blockers (ergotamines for migraines, oxytocin). Their simultaneous use is not recommended because it may increase vasoconstrictive effects. Alpha blockers used for hypertension or benign prostatic hyperplasia, because they do not block beta receptors, may cause an increased risk of hypotension and tachycardia. - Inhaled anesthetics (halothane). May increase the risk of arrhythmias. - Oral anticoagulants. In very rare cases, usually with high doses, the anticoagulant effects could be potentiated by paracetamols inhibition of hepatic synthesis of clotting factors. It is recommended to administer the lowest dose, for the shortest possible duration of treatment, and to monitor the INR. - Anticholinergics (antiparkinsonian drugs, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine may potentiate anticholinergic effects, so this combination should be avoided. - Oral contraceptives. They could increase the plasma clearance of paracetamol, decreasing its effects. - Tricyclic antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, maprotiline). Their simultaneous use may potentiate the pressor effects of phenylephrine. - Antihypertensives (beta-blockers, diuretics, guanethidine, methyldopa). Phenylephrine may antagonize the antihypertensive effects and even lead to hypertensive crises; therefore, monitoring of blood pressure is recommended. Propranolol may inhibit the metabolism of paracetamol, leading to toxic effects. - Atropine. Blocks reflex bradycardia caused by phenylephrine and increases the pressor response to phenylephrine. - Activated charcoal. It can adsorb paracetamol, decreasing its absorption and pharmacological effects. - Chloramphenicol. The toxicity of chloramphenicol could be potentiated, probably by inhibition of its metabolism. - Digitalis. The risk of cardiac arrhythmias associated with phenylephrine may be increased. - Diuretics that can cause hypokalemia (furosemide). Hypokalemia may be exacerbated, and arterial sensitivity to vasopressors such as phenylephrine may be decreased. - Nervous system stimulants (amphetamines, cocaine, xanthines). Nervous system stimulation could be enhanced, leading to intense excitability. - Thyroid hormones. There could be an potentiation of the effects of both drugs, with a risk of high blood pressure and coronary insufficiency. - MAOIs. MAOIs may potentiate the effects of phenylephrine by inhibiting the metabolism of norepinephrine, increasing the risk of hypertensive crises and other cardiac events. It is recommended to avoid administering this medication to patients treated with MAOIs within the previous 14 days. - Enzyme inducers. Drugs such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin or sulfinpyrazone, could induce the metabolism of paracetamol, decreasing its effects and increasing the risk of hepatotoxicity. - Lamotrigine. Paracetamol may reduce serum concentrations of lamotrigine, resulting in a decrease in its therapeutic effect. - Levodopa. The administration of levodopa together with sympathomimetics increases the risk of cardiac arrhythmias, so a reduction in the dose of the adrenergic agonist may be necessary. - Metoclopramide and domperidone. They increase the absorption of paracetamol in the small intestine, due to the effect of these medications on gastric emptying. - Probenecid. Increases the plasma half-life of paracetamol by decreasing the degradation and urinary excretion of its metabolites. - Ion exchange resins (cholestyramine). Decreased absorption of paracetamol, with possible inhibition of its effect, due to binding of paracetamol in the intestine. - Nitrates. Phenylephrine may antagonize the antianginal effects of nitrates, so this combination should be avoided. - Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The sedative effects could be potentiated. - Sympathomimetics. An increase in side effects, both nervous and cardiovascular, may occur. - Zidovudine. Although a possible potentiation of zidovudine toxicity (neutropenia, hepatotoxicity) has been described in isolated patients, there does not appear to be any kinetic interaction between the two drugs. LACTATION Some of the active ingredients in this medicine are excreted in breast milk, so it is recommended to stop breastfeeding or avoid using this medicine in pregnant women. POSOLOGY - Adults, oral: 1 tablet/6-8 hours. Maximum dose: 6 tablets/24 hours. - Children, oral: * Children 15 years and older: 1 tablet every 6-8 hours. Maximum dose: 6 tablets/24 hours. * Children under 15 years of age: The safety and efficacy of this medicine have not been evaluated. DOSAGE IN HEPATIC INSUFFICIENCY Do not exceed 3 tablets and the minimum interval between doses will be 8 hours DOSAGE IN RENAL INSUFFICIENCY This medication is not indicated for this population due to the dose of paracetamol. PRECAUTIONS - [RENAL INSUFFICIENCY]. Accumulation of the active ingredients may occur. Renal adverse reactions to paracetamol are more frequent in these patients. Patients with diabetes, glaucoma, heart disease (coronary insufficiency, ischemic heart disease), high blood pressure, cardiac arrhythmia, hyperthyroidism, pheochromocytoma, benign prostatic hyperplasia or urinary bladder obstruction, myasthenia gravis, stenosing peptic ulcer, or intestinal obstruction. Both phenylephrine and chlorphenamine may worsen symptoms. In severe cases, administration may be avoided. - [ASTHMA], [PULMONARY EMPHYSEMA], or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Chlorphenamine may worsen these conditions due to its anticholinergic effects. Bronchospastic reactions have been reported when paracetamol is administered to asthmatic patients with [SALICYLATE ALLERGY], therefore special caution is advised in these patients. - [EPILEPSY]. Some H1 antihistamines have been associated with the onset of seizures. - [BLOOD DYSCRASIAS]. Paracetamol may occasionally cause [ANEMIA], [LEUKOPENIA], or [THROMBOCYTOPENIA]. Extreme caution is advised, avoiding prolonged treatment, and periodic blood counts should be performed in these cases. - [HEPATIC INSUFFICIENCY], Hepatotoxicity. Paracetamol metabolism may produce hepatotoxic substances. Its use should be avoided in patients with pre-existing liver damage (see Contraindications), and extreme caution should be exercised in those with [CHRONIC ALCOHOLISM] or other factors that could trigger hepatotoxicity. Prolonged treatment should be avoided, and doses should not exceed 2 g/24 hours in these patients. Likewise, monitoring of transaminase levels is recommended, and treatment should be discontinued if a significant increase occurs. PRECAUTIONS RELATING TO EXCIPIENTS This medicine contains sodium salts. For the exact sodium content, please refer to the composition. Oral and parenteral dosage forms with sodium amounts exceeding 1 mmol (23 mg)/maximum daily dose should be used with caution in patients on sodium-restricted diets. ADVERSE REACTIONS The adverse reactions described are: - Digestive. Anticholinergic effects such as [DRY MOUTH] and [CONSTIPATION] may occur. [ANOREXIA] is less common. - Hepatic. Occasionally, [HEPATOPATHY] may occur with or without [JAUNDICE]. - Cardiovascular. [ARTERIAL HYPERTENSION], [TAchyCARDIA]. - Neurological/psychological. Occasionally, drowsiness, mental confusion, and euphoria may occur. Excitability, with nervousness and insomnia, is very rare, and is especially common in children and the elderly. - Genitourinary. [URINARY RETENTION]. - Allergic/dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [DERMATITIS], [EXANTHEMATOUS ERUPTIONS], [PHOTOSENSITIVITY REACTIONS] and [EXCESSIVE SWEATING]. - Ophthalmological. [MYDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION]. - Sanguine. [ANEMIA], [HEMOLYTIC ANEMIA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCYTOPENIA], and [THROMBOPENIA]. - Metabolic. Rarely [HYPOGLYCEMIA]. OVERDOSE Symptoms: Overdose with paracetamol-containing products is a very serious and potentially fatal poisoning. Symptoms may not appear immediately and can take up to three days to develop. These symptoms may include confusion, excitability with restlessness, nervousness and irritability, dizziness, nausea and vomiting, loss of appetite, and liver damage. Hepatotoxicity usually manifests after 48-72 hours with nausea, vomiting, anorexia, malaise, diaphoresis, jaundice, abdominal pain, diarrhea, and liver failure. In children, drowsiness and gait abnormalities also appear. In the most severe cases, the patient may die from hepatic necrosis or acute renal failure. The minimum toxic dose of paracetamol is 6 g in adults and 100 mg/kg in children. Doses exceeding 20-25 g of paracetamol are potentially fatal. In addition to the symptoms of paracetamol overdose, symptoms of chlorphenamine overdose (deep sedation, anticholinergic symptoms) and phenylephrine overdose (excitability, seizures, tachycardia, high blood pressure) may appear. Treatment: In case of overdose, seek immediate medical attention, as paracetamol poisoning can be fatal, even if no symptoms appear. Early identification of paracetamol overdose is especially important in children due to the severity of the condition and the availability of treatment. In any case, gastric lavage and aspiration of stomach contents will be performed initially, preferably within four hours of ingestion. Administration of activated charcoal may reduce the amount absorbed. There is a specific antidote for paracetamol poisoning: N-acetylcysteine. It is recommended to administer a dose of 300 mg/kg of N-acetylcysteine, equivalent to 1.5 ml/kg of a 20% aqueous solution with a pH of 6.5, intravenously over a period of 20 hours and 15 minutes, according to the following schedule: - Adults. An initial loading dose of 150 mg/kg (0.75 ml/kg of 20% solution) will be administered by slow intravenous injection over 15 minutes, either directly or diluted in 200 ml of 5% dextrose. A maintenance dose of 50 mg/kg (0.25 ml/kg of 20% solution) in 500 ml of 5% dextrose will then be administered by slow intravenous infusion over 4 hours. Finally, 100 mg/kg (0.50 ml/kg of 20% solution) will be administered in 1000 ml of 5% dextrose by slow intravenous infusion over 20 hours. - Children. The same amounts per unit of weight will be administered as in adults, but the volumes of dextrose should be adjusted based on the childs age and weight in order to avoid vascular congestion. The antidote is most effective if administered within 8 hours of ingestion. Its effectiveness gradually decreases thereafter and is ineffective after 15 hours. The administration of 20% N-acetylcysteine ​​may be discontinued when blood paracetamol levels are below 200 mcg/ml. In addition to administering the antidote, symptomatic treatment will be initiated, keeping the patient under clinical surveillance. In the event of hepatotoxicity, it is advisable to perform a liver function study and repeat the study at 24-hour intervals. COMPOSITION CHLORPHENAMINE: 4 MILLIGRAMS - MALEATO PHENYLEPHRINE: 10 MILLIGRAMS - HYDROCHLORIDE PARACETAMOL: 650 MILLIGRAMS SODIUM SALTS (EXCIPIENT): 460.9 MILLIGRAMS