ACTION AND MECHANISM - Combination of an [ANALGESIC] [ANTIPYRETIC] and a [HISTAMINERGIC ANTAGONIST (H-1)]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of prostaglandin synthesis at the central level. Brompheniramine acts as a histaminergic and muscarinic antagonist, eliminating cold symptoms such as sneezing, whining, or rhinorrhea.SPECIAL WARNINGS- In patients treated with anticoagulants, it is recommended to follow short courses of treatment with low doses, monitoring coagulation parameters.- It is recommended to perform hematological 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 people are more susceptible to adverse reactions from brompheniramine, such as dizziness, sedation, and hypotension. It is recommended to use with caution, and to discontinue administration if adverse reactions are not tolerable. PATIENT ADVICE - It is advisable to drink plenty of water during treatment, avoiding alcoholic beverages if possible. - 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. - 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 medication: [ALLERGY TO PARACETAMOL], to caffeine or [ALLERGY TO XANTHINES], to brompheniramine or to any of the excipients. - Concomitant administration or in the previous 14 days of monoamine oxidase inhibitors (MAOIs) (see Interactions).- Asthmatic patients who have previously experienced severe bronchopulmonary adverse effects induced by antihistamines.- Focal lesions of the CNS.- [LIVER DISEASE], such as [LIVER FAILURE] or [HEPATITIS]. Paracetamol may lead to hepatotoxicity.- [PORPHYRIA]. H1 antihistamines are not considered safe in patients with porphyria. EFFECTS ON DRIVING This medicine may substantially affect the ability to drive and/or operate machinery. Patients should avoid operating dangerous machinery, including cars, until they are reasonably certain that the pharmacological treatment does not adversely affect them. PREGNANCY Some active ingredients of 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 relief of catarrhal processes and [FLU] that present with fever, mild to moderate pain and nasal discharge. INTERACTIONS - Ethyl alcohol. The consumption of alcoholic beverages together with paracetamol could cause liver damage. In addition, the sedative effects of brompheniramine 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. - 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). Brompheniramine 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.- 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.- 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 brompheniramine with a sedative drug may enhance the hypnotic action.- Zidovudine. Paracetamol may increase the elimination of zidovudine, decreasing its effects. BREASTFEEDING Some of the active ingredients in this medicine are excreted in milk, so it is recommended to stop breastfeeding or avoid the use of this medicine in pregnant women. CHILDREN The safety and efficacy of the sachets in children under 12 years of age have not been evaluated, so their use is not recommended. Children treated with brompheniramine may experience paradoxical excitation, characterized by agitation, insomnia, tremors, euphoria, nervousness, delirium, palpitations and even seizures. RULES FOR CORRECT ADMINISTRATION The tablets should be taken with a little water. The sachets should be dissolved in half a glass of water, shaking until completely dissolved, and then swallowed. Taking this medicine with food and drink does not affect its effectiveness. DOSAGE DOSAGE: - Adults, oral: 2 tablets/8 h or 1 sachet/6-8 h. Maximum dose: 6 tablets/24 h or 4 sachets/24 h. - Children 12 years or older, oral: 1 tablet/8 h or 1 sachet/6-8 hours. Maximum dose: 6 tablets/24 h or 3 sachets/24 h.- Children under 12 years: contraindicated. If symptoms worsen or persist for more than 5 days of treatment, the clinical situation should be assessed. Discontinuation of treatment: once symptoms have disappeared. PRECAUTIONS- [KIDNEY FAILURE]. Accumulation of the active ingredients may occur. Adverse renal reactions to paracetamol are more common in these patients.- Patients suffering from [CLOSED ANGLE GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [ARTERIAL HYPERTENSION], [CARDIAC ARRHYTHMIA], [MYASTHENIA GRAVIS], stenosing [PEPTIC ULCER] or [INTESTINAL OBSTRUCTION]. Brompheniramine may worsen these conditions due to its anticholinergic effects.- [ASTHMA], [PULMONARY EMPHYSEMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Brompheniramine may worsen these conditions due to its anticholinergic effects. 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. Furthermore, treatment with anticonvulsants may potentiate the hepatotoxicity of paracetamol and decrease its bioavailability, especially in high-dose treatments. - [BLOOD DYSCRASIAS]. Paracetamol may occasionally lead to [ANEMIA], [LEUKOPENIA] or [THROMBOCYTOPENIA]. Extreme caution is recommended, avoiding prolonged treatment, and performing periodic blood counts in these cases.- [ANXIETY] and other conditions such as [HYPERTHYROIDISM] or cardiac arrhythmias, in which the administration of caffeine could worsen symptoms.- 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), and to exercise 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. PRECAUTIONS RELATED TO EXCIPIENTS- This medicine contains sunset yellow S as an excipient. May cause allergic type reactions including [ASTHMA], especially in patients with [SALICYLATE ALLERGY]. ADVERSE REACTIONS The most frequently reported adverse reactions during the period of use of paracetamol, caffeine and brompheniramine are: hepatotoxicity, renal toxicity, blood count disorders, hypoglycemia and allergic dermatitis, CNS stimulation, gastrointestinal and nervous system disorders. The adverse reactions are described below and are considered very common (>10%), common (1-10%), uncommon (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data): - Digestive. Common: [NAUSEA], [VOMITING], [DRY MOUTH] and gastrointestinal discomfort. - Hepatic. Rare: [ELEVATED TRANSAMINASES]. Very rare: [LIVER PATHY] with or without [JAUNDICE].- Neurological/psychological. Very common: [NERVOUSNESS], [INSOMNIA], [AGITATION], [DELIRIUM] moderate. Common: [DROWSY], paradoxical stimulation, [HEADACHE], psychomotor disturbance. Rare: [EXTRAPYRAMIDAL DISORDERS], [SEIZURES], [TREMOR].- Genitourinary. Common: [URINARY RETENTION]. Very rare: [PYURIA] sterile (cloudy urine). - Allergic/dermatological. Very rare: [HYPERSENSITIVITY REACTIONS], ranging from simple [URTICARIA] or [EXANTHEMATOUS ERUPTIONS], to [ANAPHYLAXIS]. Frequency unknown: [PHOTOSENSITIVITY REACTIONS].- Ophthalmological. Common: [BLURRED VISION].- Haematological. Very rare: [ANEMIA], [HAEMOLYTIC ANEMIA], [LEUKOPENIA] with [NEUTROPENIA] or [GRANULOCYTOPENIA], and [THROMBOCYTOPENIA].- Metabolic. Very rare: [HYPOGLYCAEMIA].- Respiratory. Common: increased respiratory secretions ([BRONCHIAL HYPERSECRETION]).- Cardiovascular. Rare: [HYPOTENSION], [CARDIAC ARRHYTHMIA], [PALPITATIONS]. Treatment should be discontinued if dizziness or palpitations occur. - General. Rare: [GENERAL MALAISE].ADVERSE REACTIONS RELATED TO EXCIPIENTS - As it contains sunset yellow (E-110) it can cause [HYPERSENSITIVITY REACTIONS].OVERDOSE Symptoms: An overdose of 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 may 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, diaphoresis, jaundice, abdominal pain, diarrhea, and liver failure. Children also experience drowsiness and gait disturbances. 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 above 20–25 g of paracetamol are potentially fatal. In addition to the symptoms of a paracetamol overdose, symptoms of a brompheniramine overdose (deep sedation, anticholinergic symptoms) may appear. Treatment: In case of overdose, seek medical attention immediately, as paracetamol poisoning can be fatal even if no symptoms appear. In children, early identification of paracetamol overdose is especially important 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. The recommended dose is 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. 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 dextrose volume should be adjusted based on the child's age and weight to avoid vascular congestion. The antidote's efficacy is maximal 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.