ACTION AND MECHANISM

Combination of analgesics and antipyretics. - Propyphenazone: Analgesic and antipyretic. Pyrazolone derivative, inhibitor of prostaglandin synthesis. - Paracetamol: Analgesic and antipyretic, p-aminophenol derivative, inhibitor of prostaglandin synthesis. It has demonstrated weak anti-inflammatory properties in some non-rheumatic disorders. In other circumstances, anti-inflammatory action is not expected. - Caffeine: Psychostimulant, increases analgesic action.

SPECIAL WARNINGS

- Monitoring: When used continuously for prolonged periods, periodic blood tests should be performed. - Treatment should be discontinued immediately if any signs or symptoms suggestive of anaphylaxis/anaphylactic shock appear. Patients should be informed of this before starting treatment. - Given the risks associated with treatment with pyrazolones, the benefit-risk balance should be carefully assessed compared to other therapeutic alternatives. - In patients with pre-existing hematopoietic problems (e.g., cytotoxic therapy), pyrazolones should only be administered under clinical supervision.

SENIORS

No specific geriatric problems are anticipated in this age group. Accepted use.

PATIENT ADVICE

- If you are pregnant or think you may be pregnant, consult your doctor or pharmacist before taking any medication.- If pain persists for more than 10 days (5 days for children) or fever for more than 3 days, or worsens or other symptoms appear, the clinical situation should be reassessed.- Do not take this medicine if you have previously experienced an allergic reaction to it.- Warn the patient to immediately contact their doctor if they experience labored breathing, asthma, rhinitis, edema, hypotension, skin rashes or swelling of the mouth, nose or throat, lesions on the oral or genital mucosa.- Warn your doctor about the medications you are taking, especially if you are taking oral anticoagulants.C

CONTRAINDICATIONS

- Allergy to any of the components, [PYRAZOLINE ALLERGY] and/or [NSAID ALLERGY].- History of [AGRANULOCYTOSIS] due to medications and aplastic anemia: increases the risk of agranulocytosis, due to altered cell production.- [LIVER DISEASE] (with or without liver failure), viral [HEPATITIS]: increases the risk of hepatotoxicity.- [GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY]: increases the risk of hemolysis.- [PORPHYRIA]: its hepatic metabolism can enhance the synthesis of certain enzymes such as ALA synthetase, which can lead to an increase in porphyrins, causing exacerbation of the disease.

PREGNANCY

Propyphenazone crosses the placenta. Adequate and well-controlled studies have not been conducted in humans; however, no teratogenic effects have been reported with the use of propyphenazone in pregnant women. This medication is only recommended if safer therapeutic alternatives are lacking.

INDICATIONS

- Processes that present with mild or moderate [PAIN]: Migraines, toothaches, dysmenorrhea, etc. - [FEVER].

INTERACTIONS

- Oral anticoagulants (acenocoumarol, warfarin): studies have been conducted with other drugs with a pyrazolone structure (phenylbutazone, feprazone) in which a possible potentiation of the anticoagulant effect has been recorded, with a risk of bleeding, due to displacement of its binding to plasma proteins.- Ethyl alcohol: potentiation of the toxicity of paracetamol, due to the possible induction of hepatic production of hepatotoxic products derived from paracetamol.- Anticonvulsants (phenytoin, phenobarbital, methylphenobarbital, primidone): decreased bioavailability of paracetamol as well as potentiation of hepatotoxicity in overdose, due to the induction of hepatic metabolism. - Busulfan: since paracetamol can decrease available glutathione, busulfan clearance may be reduced and its organic levels may increase. It is recommended to minimize or avoid the administration of paracetamol before (< 72 hours) or during treatment with busulfan.- Estrogens: decreased plasma levels of paracetamol, with possible inhibition of its effect, due to possible induction of its metabolism.- Exenatide: the absorption of paracetamol could be decreased by exenatide, as it slows down gastric emptying. This interaction can be avoided if the analgesic is administered 1 hour before exenatide.- Isoniazid: decreased clearance of paracetamol, with possible potentiation of its action and/or toxicity, due to inhibition of its hepatic metabolism.- Lamotrigine: decreased area under the curve (20%) and half-life (15%) of lamotrigine, with possible inhibition of its effect, due to possible induction of its hepatic metabolism.- Propranolol: increased plasma levels of paracetamol, due to possible inhibition of its hepatic metabolism.- Rifampicin: increased clearance of paracetamol due to possible induction of its hepatic metabolism. In addition, there is clinical data on interactions with other mechanisms:- Anticholinergics (glycopyrronium, propantheline): decreased absorption of paracetamol, with possible inhibition of its effect, due to decreased gastric emptying rate. - Ion exchange resins (cholestyramine): decreased absorption of paracetamol, with possible inhibition of its effect, due to the fixation of paracetamol in the intestine.

LACTATION

- It is excreted in breast milk. The possible consequences for the infant are unknown. It is recommended to discontinue breastfeeding or avoid administration of this medication.

CHILDREN

- Not recommended for use in children.

RULES FOR CORRECT ADMINISTRATION

Take with half a glass of water.

POSOLOGY

- Adults: 1-2 tablets/8 hours. - Children over 12 years: 1 tablet/8 hours.

PRECAUTIONS

- [ASTHMA] chronic: due to the possible appearance of bronchospasm reactions.- History of multiple drug allergies (especially to salicylates): may cause respiratory depression due to cross-allergy to salicylates.- Situations of circulatory collapse (hypertension, myocardial infarction): may be aggravated by hypotension and tachycardia.- [LIVER FAILURE]: since it is mainly metabolized in the liver, the dose should be adjusted to the gradient of functional disability of the same.- [RENAL FAILURE]: its elimination may be reduced, which may increase renal adverse effects.- [PEPTIC ULCER] or recent [GASTROINTESTINAL HEMORRHAGE]: may be exacerbated due to the gastrointestinal toxicity of the pyrazolone derivative. Increases the risk of gastrointestinal bleeding.- [CHRONIC ALCOHOLISM]: Chronic consumption of alcoholic beverages (more than 3-4 drinks/day) may potentiate the liver toxicity of paracetamol. Chronic alcoholics should avoid prolonged treatment or excessive doses of paracetamol (no more than 2 g/day should be administered). An increased incidence of hepatotoxicity and gastrointestinal bleeding has been observed in patients treated with fixed doses of paracetamol plus aspirin. - [ANEMIA]: Due to the possible appearance of blood disorders such as thrombocytopenia, leukopenia, agranulocytosis, hemolytic anemia, etc., caution is recommended in patients with anemia, avoiding prolonged treatment. In these patients, there is a risk that cyanosis will not manifest despite elevated methemoglobin levels.

ADVERSE REACTIONS

- Occasionally (1-9%): allergic reactions such as [EXANTHEMATOUS RASHES], [URTICARIA], [ALLERGIC CONTACT DERMATITIS]. Exceptionally (<<1%): [AGRANULOCYTOSIS], [APLASTIC ANAEMIA], [LEUKOPENIA], [THROMBOPENIA], [ANAPHYLAXIS], [DYSPNEA], [JAUNDICE], [ELEVATED TRANSAMINASES], [HEPATOTOXICITY] (associated with cases of overdose, either by ingesting 1 toxic dose or several excessive doses). May cause [NEPHROPATHY] which in turn may develop into renal failure, sterile [PYURIA] (cloudy urine), renal adverse effects (with high doses). Treatment should be discontinued immediately if the patient experiences any episode of fever or mouth ulcer.

COMPOSITION

CAFFEINE: 50 MILLIGRAMS
PARACETAMOL: 250 MILLIGRAMS
PROPIFENAZONE: 150 MILLIGRAMS