ACTION AND MECHANISM

- Combination of an analgesic/antipyretic, an H1 antihistamine, and an antitussive. Paracetamol exerts analgesic and antipyretic effects, probably due to the inhibition of prostaglandin synthesis in the central nervous system. Chlorphenamine acts as a histamine and muscarinic antagonist, relieving cold symptoms such as sneezing, watery eyes, and runny nose. Finally, dextromethorphan suppresses 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 follow short treatments with low doses, monitoring coagulation parameters.

- The combination of products containing dextromethorphan and antidepressants should be avoided, allowing at least 14 days of rest between the administration of both drugs.

- 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.

PATIENT ADVICE

- It is advisable to drink plenty of water during treatment, avoiding the intake of alcoholic beverages as much as possible.

- Any changes in the patient's behavior or mood should be reported to the doctor.

- It is recommended not to exceed the recommended daily doses and to avoid treatments longer 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 informed 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.

This medication may negatively affect your ability to drive. Avoid driving until you are sure the medication does not significantly affect you.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medicine, including cases of [PARACETAMOL ALLERGY] or [OPIOID ALLERGY].

- [LIVER DISEASE], such as [LIVER FAILURE] or [HEPATITIS]. Paracetamol can cause hepatotoxicity.

- [PORPHYRIA]. H1 antihistamines are not considered safe in patients with porphyria.

- Patients undergoing treatment with MAOI or SSRI antidepressants (See Interactions).

ADVANCED AGE

Elderly patients may be more susceptible to the anticholinergic adverse effects (dizziness, sedation, confusion, hypotension, dry mouth) of this medication, so it is recommended to use it with caution, and to discontinue its administration if adverse reactions are not tolerable.

EFFECTS ON DRIVING

- It does not have significant effects on driving ability. However, drowsiness may occur in some patients with this treatment, so caution is advised when driving.

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

- Symptomatic treatment of [COMMON COLD] and [FLU] accompanied by fever, moderate pain, headache, unproductive cough, runny nose, and sneezing.

INTERACTIONS

- Ethyl alcohol. Consuming alcoholic beverages with paracetamol may cause liver damage. Furthermore, it may potentiate the sedative effects of chlorphenamine. It is recommended to avoid alcohol consumption 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 reported when combined with certain antiarrhythmics.

- Oral anticoagulants. In very rare cases, usually with high doses, the anticoagulant effects could be potentiated by paracetamol's 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.

- Antidepressants (MAOIs, SSRIs). Concomitant administration of dextromethorphan products with MAOIs or SSRIs may result in serious, even fatal, adverse reactions. It is recommended to avoid this combination and not to administer dextromethorphan until at least 14 days have passed since the end of treatment with the antidepressant.

- Activated charcoal. It can adsorb paracetamol, decreasing its absorption and pharmacological effects.

- Chloramphenicol. It could potentiate the toxicity of paracetamol, probably by inhibiting its metabolism.

- Coxibs. Coxibs may increase plasma concentrations of dextromethorphan.

- Expectorants and mucolytics. Cough suppression by dextromethorphan could 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, 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.

- Propranolol. Propranolol may inhibit the metabolism of paracetamol, leading to toxic effects.

- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The combined administration of chlorphenamine with a sedative drug could potentiate the hypnotic effect.

- Zidovudine. Paracetamol could increase the elimination of zidovudine, decreasing its effects.

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.

CHILDREN

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

GUIDELINES FOR PROPER ADMINISTRATION

Dissolve in half a glass of water, then ingest.

Administration with food: Taking this medicine with other food or drinks does not affect its effectiveness. Do not take with grapefruit or orange juice or alcoholic beverages.

POSOLOGY

- Children:

* Children between 6 and 11 years: 1 sachet/6-8 hours.

* Children under 6 years of age: The safety and efficacy of this medicine have not been evaluated.

The four daily doses should not be exceeded.

PRECAUTIONS

- [RENAL INSUFFICIENCY]. Accumulation of the active ingredients may occur. Renal adverse reactions to paracetamol are more frequent in these patients.

- Patients suffering from [GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [HYPERTENSION], [CARDIAC ARRHYTHMIA], [MYASTHENIA GRAVIS], stenosing [PEPTIC ULCER] or [INTESTINAL OBSTRUCTION]. Chlorphenamine could worsen these conditions due to its anticholinergic effects.

- Persistent or chronic cough, such as that associated with asthma, emphysema, or chronic obstructive pulmonary disease (COPD). Chlorphenamine and dextromethorphan may worsen these conditions due to increased viscosity of secretions and inhibition of cough. 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.

- 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.

- Dependence. Although very rare, cases of dependence on products containing dextromethorphan have been reported. Extreme caution is advised, and patients, especially children, should be closely monitored for signs of abuse.

- The simultaneous use of more than one medication containing paracetamol can lead to poisoning, so this medication should not be used with any other product containing paracetamol.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains sunset yellow FCF as an excipient. It may cause allergic-type reactions, including asthma, especially in patients with salicylate allergy.

ADVERSE REACTIONS

- Digestive. Anticholinergic effects such as nausea, vomiting, dry mouth, diarrhea, and constipation may occur. Anorexia is less common.

- Hepatic. Occasionally, [HEPATOPATHY] may occur with or without [JAUNDICE].

- Cardiovascular. [HYPOTENSION] in the elderly and [TACHYCARDIA].

- Neurological/psychological. The most common adverse reaction is drowsiness. Paradoxical reactions of excitability, with nervousness and insomnia, may also occur, and are especially frequent in children and the elderly.

- Genitourinary. [URINARY RETENTION].

- Allergic/dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [URTICARIA], [SKIN RASHES], [HYPERHIDROSIS] and [PHOTOSENSITIVITY REACTIONS].

- Ophthalmological. [MYDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION].

- Sanguine. [ANEMIA], [HEMOLYTIC ANEMIA], [LEUCOPENIA] with [NEUTROPENIA] or [GRANULOCYTOPENIA], and [THROMBOCYTOPENIA].

- Metabolic. Rarely [HYPOGLYCEMIA].

ADVERSE REACTIONS RELATED TO EXCIPIENTS

This medicine contains sulfur dioxide. It may rarely cause severe hypersensitivity reactions and bronchospasm.

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 may occur (deep sedation, anticholinergic symptoms). Dextromethorphan overdose does not usually produce serious symptoms, although increased sedation is to be expected.

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 child's 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 µg/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.