ACTION AND MECHANISM - Combination of an [ANALGESIC] [ANTIPYRETIC], a [HISTAMINERGIC (H-1) ANTAGONIST] and a [NASO/PHARYNGEAL DECONGESTANT]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of prostaglandin synthesis at a central level. Pseudoephedrine is an alpha-1 adrenergic agonist, which causes vasoconstriction, reducing nasal congestion. Finally, chlorphenamine antagonizes H1 and cholinergic receptors, eliminating catarrhal 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 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 to discontinue its administration if the adverse reactions are not tolerable. PATIENT ADVICE - 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 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.- The doctor or pharmacist should be notified of any illness the patient suffers from or any medication they are taking.- 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.CONTRAINDICATIONS- Hypersensitivity to any component of the medication, including cases of [PARACETAMOL ALLERGY].- [LIVER DISEASE], such as [LIVER FAILURE] or [HEPATITIS]. Paracetamol may lead to hepatotoxicity.- [PORPHYRIA]. H1 antihistamines are not considered safe in these patients.- Severe heart disease or uncontrolled diabetes mellitus. There is a risk of severe decompensation. - Patients being treated with MAOI-type antidepressants in the 14 days prior to starting therapy with pseudoephedrine (See Interactions). DOPING Pseudoephedrine is a prohibited substance during competition when its concentration in urine exceeds 150 micrograms/ml. It is considered a specific substance and, therefore, a violation of the rule in which this substance is involved may result in a reduction of the sanction provided that the athlete can demonstrate that the use of the specific substance in question was not intended to increase their athletic performance. EFFECTS ON DRIVING This medicine may substantially affect the ability to drive and/or operate machinery. Patients should avoid operating dangerous machinery, including automobiles, 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 medicine have not been evaluated in pregnant women, 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 fever, moderate pain, headache and nasal congestion. INTERACTIONS - Ethyl alcohol. Ethyl alcohol may enhance the sedative effects of this medicine. Furthermore, the consumption of alcoholic beverages together with paracetamol may cause liver damage. 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 may be enhanced by the 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.- Antihypertensives (beta-blockers, diuretics, guanethidine, methyldopa). Pseudoephedrine may antagonize the antihypertensive effects and even lead to hypertensive crises, so it is recommended to monitor blood pressure. Propranolol may inhibit the metabolism of paracetamol, leading to toxic effects.- Activated charcoal. It may adsorb paracetamol, decreasing its absorption and pharmacological effects.- Chloramphenicol. The toxicity of paracetamol may be potentiated, probably by inhibiting its metabolism.- Digoxin. The risk of cardiac arrhythmias associated with pseudoephedrine may be increased.- Nerve stimulants (amphetamines, cocaine, xanthines). Nerve stimulation may be potentiated, leading to intense excitability.- Thyroid hormones. The effects of both drugs may be potentiated, with the risk of high blood pressure and coronary insufficiency.- MAOI. MAOIs may potentiate the effects of pseudoephedrine by inhibiting norepinephrine metabolism, increasing the risk of hypertensive crises and other cardiac phenomena. It is recommended that patients treated with MAOIs within the previous 14 days avoid administration of this medicine.- 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.- Levodopa. The administration of levodopa with sympathomimetics increases the risk of cardiac arrhythmias, so a reduction in the dose of the adrenergic agonist may be necessary.- Nitrates. Pseudoephedrine may antagonize the antianginal effects of nitrates, so it is recommended to avoid the combination.- Sedatives (opioid analgesics, barbiturates, benzodiazepines, antipsychotics). The sedative effects may be potentiated.- Sympathomimetics. There may be an increase in side effects, both of nervous and cardiovascular origin.- 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 12 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 water. The capsules should be swallowed whole with a glass of water. Administration of this medicine should be started at the first appearance of symptoms. As these disappear, this medication should be discontinued. DOSAGEDOSAGE:- Adults, oral: 1 capsule/6-8 hours or 1 sachet/6-8 hours (Vincigrip) or 1 sachet/8 hours (Vincigrip Forte). The maximum daily dose is 8 sachets/24 hours or 8 capsules/24 hours (Vincigrip) or 6 sachets/24 hours (Vincigrip Forte).- Children, oral:* Children 12 years and older: 1 capsule/6-8 hours or 1 sachet/6-8 hours (Vincigrip) or 1 sachet/8 hours (Vincigrip Forte). The maximum daily dose is 8 sachets/24 hours or 8 capsules/24 hours (Vincigrip) or 6 sachets/24 hours (Vincigrip Forte).* Children under 12 years: The safety and efficacy of this medicine have not been evaluated. PRECAUTIONS- [KIDNEY FAILURE]. Accumulation of the active ingredients may occur. In these patients, adverse renal reactions to paracetamol are more common.- Patients with [DIABETES], [GLAUCOMA], [HEART DISEASE] ([CORONARY FAILURE], [ISCHAEMIC HEART DISEASE]), [ARTERIAL HYPERTENSION], [HEART ARRHYTHMIA], [HYPERTHYROIDISM], [PHEOCHROMOCYTOMA], [PROSTATIC HYPERPLASIA], [URINARY BLADDER OBSTRUCTION], [MYASTHENIA GRAVIS], stenosing [PEPTIC ULCER] or [INTESTINAL OBSTRUCTION]. Both pseudoephedrine and chlorphenamine may aggravate symptoms. In severe cases, it may be advisable to avoid administration.- [ASTHMA], [PULMONARY EMPHYSEMA] or [CHRONIC OBSTRUCTIVE PULMONARY DISEASE]. Chlorphenamine may worsen these processes 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.- [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 are significantly increased.ADVERSE REACTIONSThe adverse reactions described are:- Digestive. Anticholinergic phenomena such as [DRY MOUTH] and [CONSTIPATION] may occur. More rarely, the appearance of [ANOREXIA].- Hepatic. Occasionally, [LIVER PATHY] may occur with or without [JAUNDICE].- Neurological/psychological. Occasionally, [DROWSINESS], mental [CONFUSION] and [EUPHORIA] may appear. The appearance of [EXCITABILITY] phenomena, with [NERVOUSNESS] and [INSOMNIA] is very rare, being especially frequent in children and the elderly.- Cardiovascular. [ARTERIAL HYPERTENSION], [TACHYCARDIA].- Genitourinary. [URINARY RETENTION].- Allergic/dermatological. Rarely [HYPERSENSITIVITY REACTIONS], with [DERMATITIS], [EXANTHEMATOUS ERUPTIONS], [PHOTOSENSITIVITY REACTIONS] and [EXCESSIVE SWEATING].- Ophthalmological. [MYDRIASIS], [BLURRED VISION], [OCULAR HYPERTENSION].- Blood. [ANEMIA], [HEMOLYTIC ANEMIA], [LEUKOPENIA] with [NEUTROPENIA] or [GRANULOCYTOPENIA], and [THROMBOPENIA].- Metabolic. Rarely [HYPOGLYCEMIA]. OVERDOSE Symptoms: An overdose with paracetamol-containing products is a very serious and potentially fatal poisoning. Symptoms may not appear immediately, and may even 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 chlorphenamine overdose (deep sedation, anticholinergic symptoms) and pseudoephedrine overdose (excitability, seizures, tachycardia, high blood pressure) may also appear. Treatment: In case of overdose, seek medical attention immediately, as paracetamol poisoning can be fatal even if symptoms are asymptomatic. 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 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 are below 200 µg/ml. In addition to administering the antidote, symptomatic treatment should be initiated, keeping the patient under clinical surveillance. In the event of hepatotoxicity, it is advisable to perform a liver function test and repeat the test at 24-hour intervals. COMPOSITION CHLORPHENAMINE: 4 MILLIGRAMS - MALEATOPARACETAMOL: 500 MILLIGRAMS PSEUDOEPHEDRINE: 24.54 MILLIGRAMS - HYDROCHLORIDE