Saridon 20 Tablets

Saridon (20 Tablets)

ACTION AND MECHANISM
Association of analgesics and antipyretics.
- Propiphenazone: Analgesic and antipyretic. Pyrazolonic derivative, inhibitor of prostaglandin synthesis.
- Paracetamol: Analgesic and antipyretic, derived from p-aminophenol, inhibitor of prostaglandin synthesis. It has shown weak anti-inflammatory properties in some non-rheumatic disorders. In other circumstances, anti-inflammatory action is not to be expected.
- Caffeine: Psychostimulant, increases the analgesic action.

INDICATIONS
- Processes with mild or moderate [PAIN]: migraines, toothaches, dysmenorrhea, etc.
- [FEVER].

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

RULES FOR CORRECT ADMINISTRATION
Take with half a glass of water.

CONTRAINDICATIONS
- Allergy to any of the components, [ALLERGY TO PYRAZOLONES] and / or [ALLERGY TO NSAIDs].
- History of [AGRANULOCYTOSIS] due to medications and aplastic anemia: the risk of agranulocytosis increases, due to alteration of cell production.
- [HEPATOPATIA] (with or without liver failure), viral [HEPATITIS]: increases the risk of hepatotoxicity. - [GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIT]: increases the risk of hemolysis. - [PORFIRIA]: its hepatic metabolism can enhance the synthesis of certain enzymes such as ALA synthetase, which can lead to an increase in porphyrins, which causes the exacerbation of the disease.

PRECAUTIONS
- Chronic [ASTHMA]: due to the possible appearance of bronchospasm reactions. - History of multiple allergies to drugs (especially salicylates): can cause respiratory depression due to cross allergy to salicylates. - Situations of circulatory collapse (hypertension, myocardial infarction): it can be aggravated by hypotension and tachycardia. - [HEPATIC INSUFFICIENCY]: given that it is mainly metabolized in the liver, the dose must be adjusted to the gradient of functional disability of the same. - [KIDNEY INSUFFICIENCY]: its elimination may be diminished, which may increase adverse kidney effects. - Recent [PEPTIC ULCER] or [GASTROINTESTINAL HEMORRHAGE]: may be exacerbated due to 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) can enhance the hepatic toxicity of paracetamol. Chronic alcoholics should avoid prolonged treatments or excessive doses of paracetamol (no more than 2 g / day should be administered). Increased incidence of hepatotoxicity and gastrointestinal bleeding has been observed in patients treated with fixed doses of paracetamol plus acetylsalicylic acid.
- [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 treatments. In these patients, there is a risk that cyanosis will not develop despite high levels of methemoglobin.

ADVICE TO THE PATIENT

- Si está usted embarazada o cree que pudiera estarlo, consulte a su médico o farmacéutico antes de tomar medicamentos.
- Si el dolor se mantiene durante más de 10 días (5 días para los niños) o la fiebre durante más de 3 días, o empeora o aparecen otros síntomas, se debe reevaluar la situación clínica.
- No tome este medicamento si ha experimentado con anterioridad una reacción alérgica al mismo.
- Advertir al paciente para que se ponga inmediatamente en contacto con su médico si experimenta respiración forzada, asma, rinitis, edema, hipotensión, erupciones cutáneas o inflamación en boca, nariz o garganta, lesiones en mucosa oral o genital.
- Advierta a su médico de los medicamentos que está tomando, especialmente si toma anticoagulantes orales.

ADVERTENCIAS ESPECIALES

- Monitoring: When used uninterruptedly and for a long time, periodic blood tests should be carried out.
- Treatment will be interrupted immediately if any sign or symptom suggestive of anaphylaxis / anaphylactic shock appears. Patients should be informed about this before starting treatment.
- Given the risks associated with treatment with pyrazolones, the benefit-risk balance of the treatment should be carefully assessed in comparison with other therapeutic alternatives.
- In patients with pre-existing hematopoiesis problems (eg cytostatic treatment) it will only be administered under clinical surveillance.

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

PREGNANCY
Propiphenazone crosses the placenta. Adequate and well-controlled studies have not been performed in humans, however teratogenic effects have not been recorded with the use of propiphenazone in pregnant women. The use of this medicine is only accepted in the absence of safer therapeutic alternatives.

LACTATION
- It is excreted with breast milk. The possible consequences for the infant are unknown. It is recommended to stop breastfeeding or avoid the administration of this medicine.

CHILDREN
- Use not recommended in children.

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

ADVERSE REACTIONS
- Occasionally (1-9%): allergic reactions such as [EXANTEMATIC ERUPTIONS], [URTICARIA], [[ALLERGIC CONTACT DERMATITIS]. Exceptionally (<< 1%): [AGRANULOCITOSIS], [APLASICA ANEMIA], [LEUCOPENIA], [THROMBOCYTOPENIA], [ANAPHYLAXIA], [DYSNEA], [JAUNDICE], [TRANSAMINASE INCREASE], [HEPATOTOXICITY] (associated with cases of overdose, either from the intake of 1 toxic dose or several takes of excessive doses).
It can cause [NEFROPATIA] which in turn can evolve to a picture of renal failure, sterile [PIURIA] (cloudy urine), renal adverse effects (with high doses).
Treatment should be stopped immediately in the event that the patient experiences an episode of fever or mouth ulcer.

Saridon Leaflet 20 Tablets