ACTION AND MECHANISM - Combination of an [ANALGESIC] [ANTIPYRETIC] and a [HISTAMINERGIC ANTAGONIST (H-1)]. Acetylsalicylic acid exerts analgesic and antipyretic effects 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. SPECIAL WARNINGS - Dosage adjustments may be necessary when administering products with acetylsalicylic acid to patients treated with anticoagulants, phenytoin, digoxin or methotrexate among others. 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 tolerable. PATIENT ADVICE - This medicine should be administered after meals. - It is advisable to drink plenty of water during treatment, avoiding alcoholic beverages as much as possible. - It is recommended not to exceed the recommended daily doses and to avoid treatments for more than ten days without a doctor's prescription. - If symptoms continue or worsen after five days, it is recommended to consult a doctor. - Before starting treatment, the doctor should be notified of any illness the patient suffers from or any medication being taken.- It is advisable to consult a doctor if blood appears in stool or vomit, stomach pain, general weakness, dizziness or the perception of sounds such as beeps or whistling.- It 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.- The use of products containing acetylsalicylic acid in children under 16 years of age is not recommended.- It is advisable to stop treatment several days before surgery.CONTRAINDICATIONS- Hypersensitivity to any component of the medication, such as [SALICYLATE ALLERGY] or [NSAID ALLERGY].- [PEPTIC ULCER], [GASTROINTESTINAL HEMORRHAGE]. Gastric mucosal erosion may be increased.- [COAGULATION DISORDERS], such as [HEMOPHILIA], [HYPOPROTHROMBINEMIA] or [VITAMIN K DEFICIENCY]. ASA increases the risk of bleeding due to its antiplatelet effects.- [PORPHYRIA]. H1 antihistamines are not considered safe in patients with porphyria.- Children under 16 years of age with fever, influenza or chickenpox. There is a risk of Reye's syndrome. 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 treatment of the common cold and flu, chills, catarrh that present symptoms such as nasal discharge, eye congestion, general malaise, weakness, headache and muscle aches. INTERACTIONS - Acetazolamide. There is a risk of acetazolamide poisoning, so it is recommended to avoid the combination. - Urinary acidifiers (ascorbic acid, ammonium chloride, methionine) or urinary alkalizers (absorbable antacids). They could decrease or increase, respectively, the elimination of ASA. - Tiludronic acid. ASA could intensely decrease the absorption of tiludronate, so it is recommended to space the administration of these medications at least 2 hours apart. - Valproic acid. Possibility of valproate toxicity. Dosage adjustment may be necessary.- NSAIDs. Increases the risk of peptic ulcers and gastric bleeding.- Ethyl alcohol. There is an increased risk of gastric damage. In addition, alcohol may enhance sedation due to chlorphenamine. It is recommended to avoid alcohol consumption during treatment.- Algeldrate. Ascorbic acid may increase aluminum absorption. It is suggested that the administration of both medications be spaced out.- Antacids. They may delay and decrease the absorption of ASA. Absorbable agents may also increase its elimination.- Antiplatelet agents. Possible potentiation of antiplatelet effects may be increased, so extreme caution is recommended.- Oral anticoagulants. Possible potentiation of anticoagulant effects, with the risk of bleeding. It is recommended to avoid the combination; if not possible, extreme caution should be taken and the INR monitored.- Anticholinergics (antiparkinsonian drugs, tricyclic antidepressants, MAOIs, neuroleptics). Chlorphenamine may enhance anticholinergic effects, so it is recommended to avoid the combination.- Oral contraceptives. Ascorbic acid may promote the accumulation of drugs such as ethinylestradiol.- Antiulcer drugs. Increased gastric pH may increase the absorption of ASA, with the possible risk of poisoning.- Barbiturates. ASA may increase barbiturate concentrations, with the consequent risk of poisoning.- Ciclosporin. NSAIDs may increase cyclosporine-induced nephrotoxicity. Periodic assessment of renal function is recommended, especially in the elderly.- Corticosteroids. There is an increased risk of damage to the gastric mucosa.- Deferoxamine. Iron may accumulate in the tissues, so it may be necessary to reduce vitamin C doses.- Digoxin. ASA may increase digoxin concentrations, increasing the risk of poisoning.- Diuretics. ASA may slightly reduce the effects of diuretics, and acute renal failure may be more common.- Ototoxic drugs. ASA may increase the ototoxicity of drugs such as aminoglycosides, cisplatin, erythromycin, furosemide, or vancomycin, especially at high doses.- Phenytoin. Possible adverse effects of phenytoin due to increased levels. Patient monitoring is recommended.- Griseofulvin. May significantly reduce the absorption of ASA; therefore, it is recommended to avoid the combination.- Heparin. Possible potentiation of anticoagulant effects. It is advisable to assess the risk in each patient and monitor their coagulation parameters.- ACE inhibitors. Possible antagonism of antihypertensive effects. Regular monitoring of blood pressure is recommended.- SSRIs. There is an increased risk of bleeding in general, and gastric bleeding in particular; therefore, it is recommended to avoid the combination.- Lithium. ASA may decrease lithium clearance, increasing the risk of intoxication. Dosage adjustment may be necessary.- Methotrexate. ASA may increase the effects of methotrexate. Extreme caution is recommended due to the risk of severe pancytopenia.- Nitroglycerin. ASA may increase plasma nitroglycerin levels.- Pentazocine. A case of reversible renal toxicity from ASA has been reported with the addition of pentazocine. It is recommended that the patient's renal function be assessed.- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The co-administration of chlorphenamine with a sedative drug may potentiate the hypnotic action.- Uricosurics. ASA antagonizes the effects of probenecid or sulfinpyrazone at low doses.- Verapamil. Possible potentiation of the antiplatelet effects of ASA by verapamil.- Zafirlukast. ASA may increase zafirlukast levels, with a possible risk of toxicity.- Food. Taking ASA after meals may reduce its absorption, but does reduce the risk of gastric irritation.LACTATIONSome 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.CHILDRENThe use of ASA in children under 16 years of age with fever associated with viral infections such as influenza or chickenpox has been associated with the onset of Reye's syndrome, which is potentially fatal. It is therefore recommended to avoid administering products containing acetylsalicylic acid to children under 16 years of age. RULES FOR CORRECT ADMINISTRATION The contents of the sachet should be dissolved in half a glass of water and then taken, preferably with meals (especially if digestive discomfort is noticed). DOSAGE DOSAGE: - Adults, oral: 1 sachet/4-6 hours. - Children, oral:* Children 16 years of age or older: 1 sachet/4-6 hours.* Children under 16 years of age: The safety and efficacy of this medicine have not been evaluated. - Kidney, liver or heart failure: consider a dose reduction. Maximum dose: 7 sachets/24 hours. If pain persists for more than 10 days, fever for more than 3 days, or if symptoms worsen or appear, the clinical situation should be assessed. PRECAUTIONS - [KIDNEY FAILURE], [LIVER FAILURE]. Accumulation of the active ingredients of this medicine may occur.- Patients suffering from [GLAUCOMA], [PROSTATIC HYPERPLASIA] or [URINARY BLADDER OBSTRUCTION], [CARDIAC ARRHYTHMIA], [MYASTHENIA GRAVIS] or [INTESTINAL OBSTRUCTION]. Chlorphenamine may worsen these conditions due to its anticholinergic effects.- Chronic [ASTHMA]. There is an increased risk of hypersensitivity reactions and bronchospasm. Furthermore, in these patients, as well as in those with [PULMONARY EMPHYSEMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE], chlorphenamine may worsen the disease due to its anticholinergic effects.- [DIABETES]. ASA may lead to hypoglycemia at high doses, so it is recommended to monitor blood glucose levels periodically.- [GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY]. ASA may induce the onset of hemolytic anemia.- [HIGH PRESSURE] or [HEART FAILURE] if uncontrolled. ASA may lead to fluid retention, worsening these conditions.- [GOUT]. ASA may compete with urates for elimination, potentially increasing their levels. Caution is recommended in patients with gout.- [SURGERY]. It is recommended to discontinue the administration of anti-flu products containing ASA at least 5-7 days before surgery due to the risk of bleeding during the operation.- [EPILEPSY]. Some H1 antihistamines have been associated with the onset of seizures.- [ANXIETY] and other conditions such as [HYPERTHYROIDISM] or cardiac arrhythmias, in which the administration of caffeine may worsen symptoms.- History of [KIDNEY STONES]. Ascorbic acid may promote the formation of kidney stones.- [HEMOCHROMATOSIS]. Vitamin C may lead to iron poisoning. Avoid prolonged treatment.- History of peptic ulcer. May cause ulcer reactivation. In cases of active ulcer, it is recommended to avoid administration (See Contraindications). 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 REACTIONSThe adverse reactions described are:- Digestive. [GASTRIC HYPERACIDITY] and anticholinergic phenomena such as [NAUSEA], [VOMITING], [DRY MOUTH], [DIARRHOEA] and [CONSTIPATION] may appear. More rarely, the appearance of [ANOREXIA] or [GASTRIC ULCER] or [DUODENAL ULCER] is less common.- Neurological/psychological. [DROWSINESS], [NERVOUSNESS], [INSOMNIA] or [HEADACHE] may occur.- Genitourinary. [URINARY RETENTION].- Allergic/dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [URTICARIA], [EXANTHEMATOUS ERUPTIONS], [ANGIOEDEMA], [DYSPNEA], [BRONCHIAL SPASM] and [PHOTOSENSITIVITY REACTIONS].- Ophthalmological. [MYDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION].- Blood. [ANEMIA], [HEMOLYTIC ANEMIA], especially in patients with glucose-6-phosphate dehydrogenase deficiency, [LEUKOPENIA] and/or [THROMBOPENIA].OVERDOSE Symptoms: The main symptoms associated with an overdose of this medicine are due to acetylsalicylic acid. Nausea and vomiting, diarrhea, abdominal pain, headache, deafness and ringing in the ears, blurred vision, hyperthermia, seizures, hyperventilation with respiratory alkalosis, and metabolic acidosis may occur. In the most severe cases, delirium, respiratory depression, collapse, and coma may occur. In addition to the symptoms of salicylate overdose, symptoms of chlorphenamine overdose (deep sedation, anticholinergic symptoms) may also occur. Treatment: There is no antidote for salicylate poisoning. It is recommended to proceed with the usual elimination measures, including gastric lavage and administration of activated charcoal within 2 hours. Syrup of ipecac may be added within 30 minutes of ingestion. If absorption has already occurred, it is recommended to monitor salicylate levels, acid-base balance, and electrolyte balance. It is recommended to properly hydrate the patient by adding an infusion of 5% dextrose in saline solution. In case of acid-base imbalance, bicarbonate will be administered and mechanical ventilation maintained. Seizures will be treated with diazepam, and possible hypoprothrombinemia with vitamin K. Forced diuresis, with alkalinization of the urine, is very effective in promoting the elimination of ASA. COMPOSITION ACETYLSALICYLIC ACID: 388.8 MILLIGRAMS ASCORBIC ACID: 500 MILLIGRAMS CAFFEINE: 32.4 MILLIGRAMS CHLORPHENAMINE: 2 MILLIGRAMS - MALEATE SUCROSE (EXCIPIENT): 3.72 GRAMS ORANGE YELLOW S (E-110) (EXCIPIENT): 0