ACTION AND MECHANISM

- Combination of an [ANALGESIC] [ANTIPYRETIC] and a [HISTAMINERGIC (H-1) ANTAGONIST]. Paracetamol exerts analgesic and antipyretic effects probably due to the inhibition of central prostaglandin synthesis. 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 continue short courses 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 with prolonged treatments or at risk of hepatotoxicity.- In case of overdose, the specific antidote for paracetamol is N-acetylcysteine.

SENIORS

Older adults are more susceptible to adverse reactions from brompheniramine, such as dizziness, sedation, and hypotension. It is recommended to use with caution, and discontinue use if adverse reactions are intolerable.

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 being taken by the doctor.- 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: [PARACETAMOL ALLERGY], to caffeine or [XANTHINE ALLERGY], to brompheniramine or to any of the excipients.- Concomitant administration or administration within 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 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 relief of catarrhal and [FLU] processes that present with fever, mild to moderate pain, and nasal discharge.

INTERACTIONS

- Ethyl alcohol. Consuming alcoholic beverages with paracetamol may cause liver damage. Furthermore, the sedative effects of brompheniramine may be enhanced. It is recommended to avoid alcohol consumption during treatment. In chronic alcoholics, no more than 2 g of paracetamol should be administered per 24 hours. - Oral anticoagulants. Very rarely, usually with high doses, the anticoagulant effects may be enhanced by paracetamol's inhibition of 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). Brompheniramine may enhance 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 enhanced, probably by inhibiting 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.

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 these sachets have not been evaluated in children under 12 years of age, 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, shaken until completely dissolved, and then swallowed. Taking this medicine with food and drink does not affect its effectiveness.

POSOLOGY

DOSAGE:- Adults, oral: 2 tablets/8 hours or 1 sachet/6-8 hours. Maximum dose: 6 tablets/24 hours or 4 sachets/24 hours.- Children 12 years or older, oral: 1 tablet/8 hours or 1 sachet/6-8 hours. Maximum dose: 6 tablets/24 hours or 3 sachets/24 hours.- 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 the 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. On the other hand, treatment with anticonvulsants can potentiate the hepatotoxicity of paracetamol and decrease its bioavailability, especially in high-dose treatments. - [BLOOD DYSCRASIAS]. Paracetamol may occasionally lead to [ANEMIA], [LEUKOPENIA] or [THROMBOPENIA]. Extreme caution is recommended, avoiding prolonged treatments, 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 may produce 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 exceed doses of 2 g/24 hours in these patients. It is also recommended to monitor transaminase levels, discontinuing treatment if they increase significantly.

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains carboxymethyl starch with gluten, which should be taken into account in patients with [CELIAC DISEASE].

Patients with [STARCH ALLERGY] other than celiac disease should not take this medicine.

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 DISEASE] with or without [JAUNDICE].- Neurological/psychological. Very common: [NERVOUSNESS], [INSOMNIA], [AGITATION], [DELIRUS] moderate. Common: [DROWSY], paradoxical stimulation, [HEADACHE], psychomotor disturbance. Rare: [EXTRAPYRAMIDAL SYMPTOMS], [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], [HEMOLYTIC ANEMIA], [LEUKOPENIA] with [NEUTROPENIA] or [GRANULOCYTOPENIA], and [THROMBOPENIA].- 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: [MALANGE].

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 brompheniramine overdose (deep sedation, anticholinergic symptoms) may also occur. Treatment: In the event of an overdose, seek medical attention immediately, as paracetamol poisoning can be fatal even if 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 all cases, gastric lavage and aspiration of the stomach contents should be performed initially, preferably within four hours of ingestion. The 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 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

BROMPHENYRAMINE: 3 MILLIGRAMS - MALEATO
CAFFEINE: 30 MILLIGRAMS
PARACETAMOL: 325 MILLIGRAMS
CARBOXYMETHYL STARCH (EXCIPIENT): 0 - SODIUM (SALT)