NEONISIDINA 12CPR

NEO-COMPRESENT NISIDINE

active ingredients

1 tablet contains: active ingredients: acetylsalicylic acid 250 mg, paracetamol 200 mg, caffeine 25 mg. For excipients see sez. 6.1

Excellent

Corn starch, lactose, stearic acid.

Therapeutic indications

Syntomatic treatment of headaches, nerves, toothache, menstrual pain, joint pain, fever states and cooling syndromes.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Paracetamol-based products are contraindicated in patients with manifest insufficiency of glucose-6-phosphate dehydrogenase and those with severe haemolytic anemia. Severe hepatocellular failure. Neo-Nisidine should not be used in case of gastric ulcer or active duodenal ulcer, in patients with a tendency established to hemorrhages (e.g. hemophilia) or who present hypersensitivity to salicylates or paracetamol or other product components. Asthmatic patients. Dose > 100 mg/die of acetylical acid during the third trimester of pregnancy. The use of this medicine is contraindicated in children and children under the age of sixteen. For the risk of Reye syndrome, Neo-Nisidine should not be used in children and adolescents affected by chickenpox or flu. For caffeine, do not administer children and children under the age of 16.

Population

Adults: 1 to 4 tablets per day. Intake by mouth must take place on a full stomach. Do not exceed the recommended doses, especially older patients should comply with the above minimum dosages.

Conservation

None.

Warnings

This medicinal product should not be used in children and children under the age of sixteen (see contraindications); subjects over 70 years of age, especially in the presence of concomitant therapies, must use this medicine only after consulting a doctor. After three days of use at the maximum dose or after 5-7 days of continuous use without results, consult your doctor. If pain or fever persists or worsens, if new symptoms occur or if there are redness or swelling, you should consult a doctor because these may be signs of an aggravation of the disease in place. Carefully administer in subjects with kidney or liver failure. During treatment with paracetamol before taking any other medication check that does not contain the same active ingredient, since if the paracetamol is taken in high doses severe adverse reactions may occur. Also, before associating any other medication contact your doctor. See also the voice “Interactions”. It should also be consulted by patients with glucose-6-phosphate-dehydrogenase deficiency, chronic or recurrent gastric or intestinal disorders, or impaired kidney function, asthma, allergic rhinitis and nasal polyps, hypersensitivity to non-steroidal anti-inflammatory drugs, liver dysfunction (e.g. chronic alcohol abuse, hepatitis), Gilbert syndrome, pregnant women. High or prolonged doses of the product may result in high-risk hepatopathy and alterations to the kidney and blood. In case of viral affections, such as flu or chickenpox, consult the doctor before administering the product to the boys; if prolonged vomiting and deep drowsiness occur during treatment, stop administration. The use of the product is not recommended if the patient is in treatment with other anti-inflammatory drugs. In rare cases of allergic reaction the administration must be suspended. Medication containing lactose therefore is not suitable for individuals with lactase deficiency, galactosemia or glucose/galactose disease syndrome. Keep the medicine out of reach and view of children.

Interactions

The drug can interact with anticoagulants, uricosurics, hypoglycemic sulfaniluree. Pre-operative use can prevent intraoperative hemostasis. Acetylsalicylic acid, one of the components of Neo-Nisidine, can enhance the effect of anticoagulants (e.g. derivatives of cumarin and heparine). It can also increase the risk of gastrointestinal side effects, when administered simultaneously to non-steroidal anti-inflammatory drugs (NSAID) or corticosteroids. The effect of hypoglycemic agents and the toxicity of metotrexate may be increased by the concomitant administration of acetylsalicylic acid. Neo-Nisidine can decrease the natriuretic effect of spironolactone and inhibit the effect of uric agents (e.g. probenecid, sulfinpirazone). Patients in treatment with rifampin, cimetidine, or with antiepileptic drugs such as glutethymmide, phenobarbital, carbamazepine should use paracetamol with extreme caution and only under strict medical control. Paracetaminol administration may interfere with the determination of uricemia (by the method of phosphotungstic acid) and glycemia (by the method of glucose-oxidase-peroxidase). Drugs that slow gastric emptying, such as propane, reduce the absorption rate of the paracetamol and delay the onset of the effect. Drugs instead of accelerating gastric emptying, such as metoclopramide, lead to an increase in absorption rate. The association of paracetamol with chloramphenicol can prolong the half-life of chloramphenicol, increasing the risk of toxicity. It was not possible to assess the clinical relevance of the interactions between paracetamol and warfarin and with the derivatives of cumarin. Therefore, prolonged use of paracetamol in patients treated with oral anticoagulants is recommended only under medical control. Concurrent use of paracetamol and AZT (zidovudine) enhances the risk of neutropenia induced by the latter. Lost, you should take Neo-Nisidine with AZT only under medical supervision. Caffeine can antangonize the sedative effect of different drugs (e.g. barbituric, antihistamine). It can also increase the effect of tachycardia caused by other medicines (e.g. sympathomimetics, thyroxin). Oral contraceptives, cimetidine and disulfiram slow the metabolism of caffeine in the liver, barbiturates and smoke increase it. Caffeine reduces the excretion of theophylline. Concurrent administration of analgesics does not increase the risk of addiction. The administration of chinolonic antibiotics can delay the elimination of caffeine.

Effects

See also section 4.9. Acetylsalicylic acid can cause epigastric disorders, nausea, vomiting, gastroduodenal ulcers and erosive gastritis that can lead to severe gastrointestinal bleeding. These effects are most likely related to high doses although they may also occur at low doses. When using products containing acetylsalicylic acid for prolonged periods, anemia from iron deficiency may occur due to the repeated bleeding in the digestive tract. For the presence of acetylsalicylic acid, otovestibular disorders (ronzii, etc.), dizziness, hemorrhagic phenomena (epistassi, gurgivorragia, etc.), prolongation of pregnancy and labor and reduction of the platelet count. Occasionally, allergic reactions can occur (broncostriction, skin reactions). With the use of paracetamol, skin reactions of various types and severity were reported including rare cases of rashes on an allergic basis and cases of multiform erythema, Stevens-Johnson syndrome and epidermal necrolysis. Angioedema, larynx edema, anaphylactic shock have been reported. The following side effects have also been reported: thrombocytopenia, leucopenia, anemia, agranulocytosis, pancitopenia, alterations of liver and hepatitis function, alterations to the kidney (acute kidney failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions and dizziness. In cases of hyperdosage, due to the presence of paracetamol, hepatic cytolysis can be provoked, which can evolve towards massive and irreversible necrosis. Caffeine is a stimulant of SNC and can cause agitation, insomnia, tremor, dispeptic symptoms and tachycardia. For the presence of caffeine, in case of overdose, a hyperstimulation syndrome with excitement, insomnia, rhinthia, muscle tremor, nausea, vomiting, increased diuresis, tachycardia, extrasistolia, scotoma may occur.

Overdosing

Synonyms: The ingestion of excessive doses of paracetamol can cause after 24-48 hours signs of toxicity identifiable in liver dysfunction due to the necrosis of liver cells up to the liver coma, even with fatal outcome. Regardless of these phenomena, renal injuries due to piping necrosis have also been described. Symptoms of paracetamol intoxication occur in different stages. In the first phase (1° day) signs are nausea, vomiting, sweating, drowsiness and a general feeling of malaise. After a temporary subjective improvement, in the second phase (the third or fourth day) tend to appear a considerable increase in the values of transaminase, jaundice, clotting disorders, hypoglycemia with possible passage to the liver coma. Symptoms of moderate to acute toxicity of acetylsalicylic acid are: hyperventilation, tinnitus, nausea, vomiting, alteration of sight and hearing, dizziness and confusion. In case of severe poisoning, delirium, tremor, seizures, dispnea, sweating, bleeding, dehydration, disorders of acid-basic balance and electrolytic composition of plasma, hyperthermia and coma can be observed. The first symptoms of acute overdose from caffeine are normally tremor and agitation. These are followed by nausea, vomiting, tachycardia and confusion. Symptoms caused by severe intoxication can be delirium, crisis, supraventricular and ventricular tachycardia, hypocalemia and hyperglycemia. Therapy: Treatment should start with normal therapies (e.g. activated carbon, gastric lavender). The treatment of overdose from acetylsalicylic acid consists mainly of measures to increase its elimination through forced alkaline diuresis and to restore acid-basic and electrolytic balance. Infusions of sodium and potassium chloride solutions can be administered. The cytotoxic metabolite of paracetamol can be neutralized if possible in the first 8-12 hours from intoxication by intravenous administration of donor drugs of the SH group, such as acetylcysteine which should be used at the first symptoms of intoxication. It is recommended to carry out serial tests of the plasma concentration of paracetamol and liver function. The plasma concentration of both acetylsalicylic acid and paracetamol can be reduced with dialysis.

Pregnancy: Low doses of acetylsalicylic acid (up to 100 mg/die): Clinical studies indicate that doses of up to 100 mg/die can be considered safe only for obstetric use, requiring specialist monitoring. Doses of 100-500 mg/day acetylsalicylic acid: There are insufficient clinical data related to the use of doses greater than 100 mg/die up to 500 mg/die. Therefore, the recommendations below for doses of 500 mg/die and beyond also apply to this dosage range. Doses of 500 mg/die and more of acetylsalicylic acid: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis, in the early stages of pregnancy. The absolute risk of heart failure had increased from less than 1% to about 1.5%. It has been estimated that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, acetylsalicylic acid should not be administered if not in strictly necessary cases. If acetylsalicylic acid is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose and duration of treatment must be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: possible prolongation of the bleeding time, and anti-aggregating effect that can also take place at very low doses; inhibition of uterine contractions resulting in delay or extension of the labor. Consequently, acetylsalicylic acid at doses > 100 mg/die is contraindicated during the third trimester of pregnancy. Prolonged intake of high amounts of caffeine can induce miscarriage or premature birth. Food: Paracetamol and salicylates are excreted in breast milk. Caffeine is also excreted in breast milk and can affect the status and behavior of the child. If regular treatment with higher doses of acetylsalicylic acid is required during breastfeeding, we should consider weaning.

Source: Farmadati