NeoOptalidon 200mg + 125mg + 25mg 8 coated tablets

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Symptomatic treatment of acute painful states (headache; toothache; neuralgia; menstrual pain) and feverish states.

CONTRAINDICATIONS

• Hypersensitivity to the active ingredients or other substances closely related from a chemical point of view and/or to any of the excipients listed in paragraph 6.1; • hemopathies such as granulocytopenia and intermittent porphyrias; • patients with manifest insufficiency of glucose-6-phosphate dehydrogenase; • patients suffering from severe hemolytic anemia; • severe hepatocellular and renal failure; • due to the presence of caffeine, the product should not be administered to children under 12 years of age; • pregnancy and breastfeeding (see section 4.6). • allergies to peanuts or soy.

WARNINGS AND PRECAUTIONS FOR USE

The use of the product is not recommended if the patient is being treated with anti-inflammatories. High or prolonged doses of the product can cause high-risk liver disease and even serious alterations to the kidney and blood. Administer with caution in subjects with renal or hepatic impairment or hematopoietic dysfunction. During treatment with paracetamol, before taking any other medicine, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. If fever, angina, skin or mucous membrane changes appear during treatment, suspend therapy and consult your doctor. Invite the patient to contact the doctor before combining any other drug (see section 4.5). In rare cases of allergic reactions, administration of the product should be suspended. Particular caution is necessary in patients with asthma, chronic rhinitis or chronic urticaria. Isolated cases of asthma attacks and anaphylactic shock have been reported associated with the intake of drugs containing propylphenazone and paracetamol in susceptible individuals. Caution is advised if acetaminophen is administered concurrently with flucloxacillin due to the increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition, and other sources of glutathione deficiency (e.g., chronic alcoholism), as well as in those using maximum daily doses of acetaminophen. Close monitoring, including measurement of urinary 5-oxoproline, is recommended. Important information about some excipients NEO-OPTALIDON contains • sucrose: patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine; • hydrogenated peanut oil: do not use if you are allergic to peanuts or soy.

INTERACTIONS

The product may interact with alcohol, some hypoglycemics (acetohexamide, chlorpropamide, tolbutamide), anticoagulants (warfarin), phenytoin. During therapy with oral anticoagulants it is advisable to reduce the doses. Drugs that slow gastric emptying (e.g. propantheline) can reduce the speed of absorption of paracetamol, delaying its therapeutic effect; on the contrary, drugs that increase the speed of gastric emptying (e.g. metoclopramide, domperidone) lead to an increase in the speed of absorption. Concomitant administration of chloramphenicol can induce a prolongation of the half-life of paracetamol, with the risk of increasing its toxicity. Use with extreme caution and under strict control during chronic treatment with drugs that can cause the induction of hepatic monooxygenases or in case of exposure to substances that can have such an effect (for example rifampicin, cimetidine, antiepileptics such as glutetimide, phenobarbital, carbamazepine). The administration of paracetamol can interfere with the determination of uric acid (using the phosphotungstic acid method) and with that of blood sugar (using the glucose-oxidase-peroxidase method). Concomitant use of paracetamol and AZT (zidovudine) increases the tendency to a reduction in leukocyte counts (neutropenia). NEO-OPTALIDON, therefore, must not be taken in association with AZT (zidovudine) except on medical prescription. The simultaneous administration of NSAIDs or opioids determines a mutual strengthening of the analgesic effect. Paracetamol increases the AUC of ethinyl estradiol by 22%. Paracetamol may reduce the plasma concentration of lamotrigine. Caution should be exercised when paracetamol is used concomitantly with flucloxacillin as concomitant use has been associated with high anion gap metabolic acidosis, especially in patients with risk factors (see section 4.4).

SIDE EFFECTS

The following side effects have been observed: Alterations of the skin and subcutaneous tissue Allergic skin rashes. Erythema multiforme, very rarely Stevens Johnson syndrome and epidermal necrolysis have been reported rarely with the use of paracetamol. Hypersensitivity reactions such as angioedema, pruritus, erythema, urticaria, dyspnoea, asthma, laryngeal edema, anaphylactic shock have been reported. Alterations of the blood and lymphatic system Thrombocytopenia, leukopenia, anemia, agranulocytosis. Alterations of the hepatobiliary system Alterations in liver function and hepatitis. Renal and urinary tract alterations Acute renal failure, interstitial nephritis, hematuria, anuria. Alterations of the auditory and vestibular system Dizziness. Alterations of the gastrointestinal system Gastrointestinal disorders. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.