Saridon Tablets Paracetamol / Propyphenazone Antipyretic 20 Tablets

Therapeutic indications
Saridon is used in the symptomatic treatment of acute painful states (headache; toothache; neuralgia; menstrual pain) and febrile states.

Dosage and method of use
In adults, administer 1-2 tablets, up to 4 Saridon tablets in 24 hours, with a large sip of water. Do not exceed the recommended doses: in particular elderly patients should follow the minimum dosages indicated above. The oral analgesic preparations must be taken on a full stomach.

Contraindications

Hypersensitivity to the active ingredients, to other closely related substances from a chemical point of view and / or to any of the excipients.

History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

Haemopathies such as granulocytopenia and intermittent porphyrias.

Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and in those suffering from severe haemolytic anemia.

Severe hepatic insufficiency (Child-Pugh> 9).

Severe renal insufficiency

Severe heart failure.

Due to the presence of caffeine, the product should not be given to children under 12 years of age.

Pregnancy and breastfeeding.

Special warnings
Do not administer Saridon for more than 3 consecutive days without consulting your doctor. High or prolonged doses of the product can cause high-risk liver disease and even serious changes in the blood.
Elevation of serum alanine aminotransferase (ALT) may occur during administration of therapeutic doses of paracetamol. Moderate alcohol intake in conjunction with paracetamol intake may increase the risk of liver toxicity.

Administer with caution in subjects with renal or hepatic insufficiency (Child-Pugh <9), Gilbert's syndrome or haematopoietic dysfunction. In general, continued use of paracetamol, especially in combination with other analgesics, can lead to permanent kidney damage and kidney failure (analgesic nephropathy). Particular caution is required in patients with asthma, chronic rhinitis or chronic urticaria. There have been isolated reports of asthma attacks and anaphylactic shock associated with the intake of drugs containing propiphenazone and paracetamol in susceptible individuals. The wrong intake of more than recommended quantities can cause convulsions.

If, during the treatment, fever or angina appears, stop the therapy and consult your doctor. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first
month of treatment. Saridon should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

During therapy with oral anticoagulants it is recommended to reduce the doses. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, as serious adverse reactions can occur if paracetamol is taken in high doses.

The use of Saridon should be closely monitored by a physician in case of hyperthyroidism. Instruct the patient to contact the physician before combining any other medication. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms

Pregnancy and breastfeeding

Pregnancy

Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was believed to increase with dose and duration of therapy.
In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); renal dysfunction, which can progress to renal failure with oligo-hydroamnios. At the end of pregnancy, the mother and the newborn may be subjected to:
the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and antiplatelet effect which can occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor.

The use of Saridon is not recommended in case of presumed pregnancy.

Feeding time

The medicine is contraindicated in breastfeeding.

Expiration and retention
The expiry date refers to the product in intact packaging, correctly stored. Keep this medicine out of the reach and sight of children.

Warning: do not use the medicine after the expiry date indicated on the package.

Composition
Saridon contains, for each tablet:
Active ingredients: paracetamol 250 mg, propiphenazone 150 mg, caffeine 25 mg
Excipients: microgranular cellulose, povidone, corn starch, hypromellose, talc, magnesium stearate, precipitated silica.