ACTION AND MECHANISM

- Combination of an [ANALGESIC] [ANTIPYRETIC], a [HISTAMINERGIC (H-1) ANTAGONIST] and a [ANTITUSSIVE]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of central prostaglandin synthesis. 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 association between 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 with 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 discontinue its administration if adverse reactions are not tolerable.

PATIENT ADVICE

- It is advisable to drink plenty of water during treatment, avoiding alcoholic beverages if possible.- The patient's doctor should be notified of any changes in 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 patient should be notified of any medication the patient is taking, especially antidepressants.- Patients with glaucoma or urinary retention should notify their doctor before starting treatment.- It may cause drowsiness, so it is recommended to be cautious when driving, and not to combine it with medications or other sedative substances such as alcohol.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug, 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 DRIVING

This medication may substantially impair 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

Some active ingredients in this specialty are able to cross 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 whenever the benefits outweigh the potential 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. Consuming alcoholic beverages with paracetamol may cause liver damage. Furthermore, the sedative effects of chlorphenamine may be enhanced. It is recommended to avoid alcohol during treatment. In chronic alcoholics, no more than 2 g of paracetamol should be administered per 24 hours. - Antiarrhythmics (amiodarone, quinidine). Cases of dextromethorphan toxicity have been reported when combined with certain antiarrhythmics. - Oral anticoagulants. Very rarely, usually with high doses, the anticoagulant effects may be enhanced by paracetamol inhibiting hepatic synthesis of coagulation factors. It is recommended to administer the lowest dose, with the shortest possible treatment duration, and to monitor the INR. - Anticholinergics (antiparkinsonian drugs, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine may enhance 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 enhanced, probably due to inhibition of its metabolism.- Coxibes. Coxibes 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 potentiate the hypnotic action.- Zidovudine. Paracetamol may increase the elimination of zidovudine, decreasing its effects.

LACTATION

Some of the active ingredients in this medicine are excreted in milk, so it is recommended to stop breastfeeding or avoid using this medicine in pregnant women.

CHILDREN

The safety and efficacy of this medicine have not been evaluated in children under 6 years of age, so its use is not recommended.

RULES FOR CORRECT ADMINISTRATION

The sachets should be dissolved in half a glass of cold water and then swallowed. It is recommended that the last dose be administered before bedtime. This medication should be started as soon as the first symptoms appear. As these symptoms disappear, the medication should be discontinued.

POSOLOGY

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. Do not exceed four daily doses.

PRECAUTIONS

- [KIDNEY FAILURE]. Accumulation of the active ingredients may occur. Adverse renal reactions to paracetamol are more common in these patients.- 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 cause [ANEMIA], [LEUKOPENIA] or [THROMBOPENIA]. Extreme caution is recommended, avoiding prolonged treatment, and periodic blood counts should be performed in these cases.- Hepatotoxicity. The metabolism of paracetamol may 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 to exceed doses of 2 g/24 hours in these patients. Likewise, it is recommended to monitor transaminase levels, discontinuing treatment if they increase significantly. Dependence. Although very rare, cases of dependence on dextromethorphan products have been reported. Extreme caution is recommended, and patients, 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-type 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], [DIARRHEA] and [CONSTIPATION] may appear. 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 SICKNESS]. Paradoxical reactions of [EXCITABILITY], with [NERVOUSNESS] and [INSOMNIA] may also appear, 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 can 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 body weight should be administered as in adults, but the volume of dextrose should be adjusted based on the child's age and weight to avoid vascular congestion. The antidote is most effective if administered within 8 hours of ingestion. Its effectiveness progressively decreases thereafter and is ineffective after 3 hours. Administration of 20% N-acetylcysteine may be discontinued when blood paracetamol levels are below 200 µg/ml. In addition to administering the antidote, symptomatic treatment should be initiated, with the patient under clinical surveillance. If hepatotoxicity occurs, liver function tests should be performed and repeated at 24-hour intervals.

COMPOSITION

CHLORPHENAMINE: 2 MILIGRAMS - MALEATO
DEXTROMETHORPHAN: 10,995 MILLIGRAMS - HYDROBROMIDE
PARACETAMOL: 300 MILLIGRAMS
SUCROSE (EXCIPIENT): 4.1 GRAMS
SODIUM SALTS (EXCIPIENT): 0
ORANGE YELLOW S (E-110) (EXCIPIENT): 0.09 MILLIGRAMS