ACTION AND MECHANISM - Combination of an [ANALGESIC] [ANTIPYRETIC], a [HISTAMINERGIC ANTAGONIST (H-1)] and a [ANTITUSSIVE]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of prostaglandin synthesis at the central level. For its part, chlorphenamine acts as a histaminergic and muscarinic antagonist, eliminating cold symptoms such as sneezing, whining or rhinorrhea. Finally, dextromethorphan produces depression of the cough center. SPECIAL WARNINGS - It is recommended to monitor the patient for signs of abuse. - In patients treated with anticoagulants, it is recommended to continue short courses of treatment with low doses, monitoring coagulation parameters. - The combination of products with dextromethorphan and antidepressants should be avoided, leaving at least 14 days of rest between the administration of both drugs. - It is recommended to perform blood counts in patients treated with high doses or for prolonged periods of time. - It is advisable to monitor transaminase levels in patients on prolonged treatment or at risk of hepatotoxicity. - In case of overdose, the specific antidote for paracetamol is N-acetylcysteine. ELDERLY Elderly patients may be more susceptible to the adverse effects of this medicine, so it is recommended to use it with caution, and discontinue its administration if the adverse reactions are not PATIENT ADVICE - It is advisable to drink plenty of water during treatment, avoiding alcoholic beverages if possible. - The doctor should be notified of any change in the patient's behavior or mood. - It is recommended not to exceed the recommended daily doses and to avoid treatments lasting more than ten days without a doctor's prescription. - If symptoms continue or worsen after five days, it is recommended to consult a doctor. - The doctor should be notified of any medication the patient is taking, especially in the case of antidepressants. - Patients with glaucoma or urinary retention should notify their doctor before starting treatment. - 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. CONTRAINDICATIONS - Hypersensitivity to any component of the medication, including cases of [PARACETAMOL ALLERGY] or [OPIOID ALLERGY]. - [LIVER DISEASE], such as [LIVER FAILURE] or [HEPATITIS]. Paracetamol may lead to hepatotoxicity.- [PORPHYRIA]. H1 antihistamines are not considered safe in patients with porphyria.- Patients receiving treatment with MAOI or SSRI antidepressants (See Interactions). EFFECTS ON DRIVINGThis medication may substantially affect the ability to drive and/or operate machinery. Patients should avoid operating hazardous machinery, including automobiles, until they are reasonably certain that the drug treatment does not adversely affect them. PREGNANCYSome active ingredients in this specialty are capable of crossing the placental barrier. The safety and efficacy of this medication in pregnant women have not been evaluated, so it is recommended to avoid its administration, unless there are no safer therapeutic alternatives, and provided that the benefits outweigh the possible risks. INDICATIONS- [COMMON COLD]. Symptomatic treatment of catarrhal processes and [FLU] that present with fever, moderate pain, headache, unproductive cough and rhinorrhea. INTERACTIONS- Ethyl alcohol. The consumption of alcoholic beverages together with paracetamol could cause liver damage. In addition, the sedative effects of chlorphenamine could be enhanced. It is recommended to avoid alcohol intake during treatment. In chronic alcoholics, no more than 2 g/24 hours of paracetamol should be administered.- Antiarrhythmics (amiodarone, quinidine). Cases of dextromethorphan toxicity have been described when combined with certain antiarrhythmic drugs.- Oral anticoagulants. In very rare cases, usually with high doses, the anticoagulant effects could be enhanced by inhibition of hepatic synthesis of coagulation factors by paracetamol. It is recommended to administer the minimum dose, with the shortest possible treatment duration, and to monitor the INR.- Anticholinergics (antiparkinsonian drugs, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine may potentiate the anticholinergic effects, so it is recommended to avoid the combination.- Oral contraceptives. They may increase the plasma clearance of paracetamol, decreasing its effects.- Antidepressants (MAOIs, SSRIs). The co-administration of products containing dextromethorphan with MAOIs or SSRIs may lead to serious adverse reactions, even fatal. It is recommended to avoid the combination and not administer dextromethorphan until at least 14 days after treatment with the antidepressant.- Activated charcoal. It may cause adsorption of paracetamol, decreasing its absorption and pharmacological effects.- Chloramphenicol. The toxicity of paracetamol may be potentiated, probably due to inhibition of its metabolism.- Coxibes. Coxibs may increase plasma concentrations of dextromethorphan.- Expectorants and mucolytics. Cough inhibition by dextromethorphan may lead to pulmonary obstruction in cases of increased volume or fluidity of bronchial secretions.- Enzyme inducers. Drugs such as barbiturates, carbamazepine, hydantoin, isoniazid, rifampicin, or sulfinpyrazone may 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 decreased therapeutic effect.- Propranolol. Propranolol may inhibit the metabolism of paracetamol, leading to toxic effects.- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The co-administration of chlorphenamine with a sedative drug may enhance the hypnotic action.- Zidovudine. Paracetamol may increase the elimination of zidovudine, decreasing its effects.LACTATIONSome of the active ingredients of this medicine are excreted in milk, so it is recommended to stop breastfeeding or avoid the use of this medicine in pregnant women.CHILDRENThe safety and efficacy of this medicine in children under 6 years of age have not been evaluated, so its use is not recommended.RULES FOR CORRECT ADMINISTRATIONThe sachets should be dissolved in half a glass of cold water and then ingested. It is advisable to administer the last dose before going to bed. The administration of this medicine should be started at the first symptoms appear. As these disappear, this medication should be discontinued. DOSAGE DOSAGE: - Children, oral:* Children between 6 and 11 years: 1 sachet/6-8 hours.* Children under 6 years: The safety and efficacy of this medicine have not been evaluated. The four daily doses should not be exceeded. PRECAUTIONS - [KIDNEY FAILURE]. Accumulation of the active ingredients may occur. In these patients, adverse renal reactions to paracetamol are more common. - Patients suffering from [GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [MYASTHENIA GRAVIS], stenosing [PEPTIC ULCER] or [INTESTINAL OBSTRUCTION]. Chlorphenamine may worsen these conditions due to its anticholinergic effects.- Persistent or chronic cough, such as that associated with [ASTHMA], [PULMONARY EMPHYSEMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Chlorphenamine and dextromethorphan may worsen these conditions due to the increase in the viscosity of secretions and the inhibition of cough. Bronchospastic reactions have been described when administering paracetamol to asthmatic patients with [SALICYLATE ALLERGY], therefore special caution is recommended in these patients.- [EPILEPSY]. Some H1 antihistamines have been associated with the occurrence of seizures.- [BLOOD DYSCRASIAS]. Paracetamol may occasionally lead to [ANEMIA], [LEUKOPENIA] or [THROMBOPENIA]. Extreme caution is recommended, avoiding prolonged treatment, and performing periodic blood counts in these cases.- Hepatotoxicity. The metabolism of paracetamol could give rise to hepatotoxic substances. It is recommended to avoid its use in patients with previous liver damage (See Contraindications), as well as extreme caution in those with [CHRONIC ALCOHOLISM] or other factors that could trigger hepatotoxicity. It is advisable to avoid prolonged treatment and not exceed doses of 2 g/24 hours in these patients. Similarly, it is recommended to monitor transaminase levels, discontinuing treatment if they increase significantly.- Dependence. Although very rare, cases of dependence on products containing dextromethorphan have been reported. Extreme caution is recommended and the patient, especially children, should be monitored for signs of abuse. PRECAUTIONS RELATED TO EXCIPIENTS - This medicine contains sunset yellow S as an excipient. It may cause allergic reactions including [ASTHMA], especially in patients with [SALICYLATE ALLERGY]. ADVERSE REACTIONS The adverse reactions described are: - Digestive. Anticholinergic phenomena such as [NAUSEA], [VOMITING], [DRY MOUTH], [DIARRHOEA] and [CONSTIPATION] may occur. More rarely, the appearance of [ANOREXIA]. - Hepatic. Occasionally, [LIVER PATHY] may occur with or without [JAUNDICE]. - Cardiovascular. [HYPOTENSION] in the elderly and [TACHYCARDIA]. - Neurological/psychological. The most common adverse reaction is the appearance of [DROWSY]. Paradoxical reactions of [EXCITABILITY], with [NERVOUSNESS] and [INSOMNIA] may also occur, being especially frequent in children and the elderly.- Genitourinary. [URINARY RETENTION].- Allergic/dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [URTICARIA], [EXANTHEMATOUS ERUPTIONS], [EXCESSIVE SWEATING] and [PHOTOSENSITIVITY REACTIONS].- Ophthalmological. [MYDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION].- Blood. [ANEMIA], [HEMOLYTIC ANEMIA], [LEUKOPENIA] 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 may take up to three days to appear. These symptoms include confusion, excitability with restlessness, nervousness and irritability, dizziness, nausea and vomiting, loss of appetite, and liver damage. Hepatotoxicity usually manifests within 48–72 hours with nausea, vomiting, anorexia, malaise, sweating, jaundice, abdominal pain, diarrhea, and liver failure. Children also experience drowsiness and changes in gait. In the most severe cases, death may occur due to hepatic necrosis or acute kidney failure. The minimum toxic dose of paracetamol is 6 g in adults and 100 mg/kg in children. Doses greater than 20-25 g of paracetamol are potentially fatal. In addition to the symptoms of a paracetamol overdose, symptoms of a chlorphenamine overdose (deep sedation, anticholinergic symptoms) may also occur. Dextromethorphan overdose does not usually produce severe symptoms, although increased sedation is to be expected. Treatment: In the event of an overdose, seek medical attention immediately, as paracetamol poisoning can be fatal even when symptoms are asymptomatic. Early identification of a paracetamol overdose is especially important in children, due to the severity of the condition and the availability of possible treatment. In any case, gastric lavage and aspiration of the stomach contents should be performed initially, preferably within four hours of ingestion. The administration of activated charcoal can 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 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. A shock dose of 150 mg/kg (0.75 ml/kg of 20% solution) will be administered initially 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 started by slow intravenous infusion over 4 hours. Finally, 100 mg/kg (0.50 ml/kg of 20% solution) in 1000 ml of 5% dextrose will be administered by slow intravenous infusion over 20 hours. - Children. The same amounts per unit of weight should be administered as in adults, but the dextrose volumes should be adjusted based on the child's age and weight to avoid vascular congestion. The antidote's effectiveness is greatest if administered within 8 hours of ingestion. Its effectiveness gradually decreases thereafter and is ineffective after 3 pm. Administration of 20% N-acetylcysteine may be discontinued when blood paracetamol levels fall below 200 µg/ml. In addition to administering the antidote, symptomatic treatment should be initiated, with the patient under clinical surveillance. If hepatotoxicity occurs, it is advisable to perform a liver function test and repeat the test at 24-hour intervals. COMPOSITION CHLORPHENAMINE: 2 MILLIGRAMS - MALEATE EXTROMETHORPHAN: 10.995 MILLIGRAMS - HYDROBROMA PARACETAMOL: 300 MILLIGRAMS SUCROSE (EXCIPIENT): 4.1 GRAMS SODIUM SALTS (EXCIPIENT): 0 YELLOW ORANGE S (E-110) (EXCIPIENT): 0.09 MILLIGRAMS