Neo‑Nisidina 12 tablets

Neo-Nisidina 12 tablets is a fast-acting analgesic and antipyretic , ideal for the symptomatic treatment of pain and feverish states. Thanks to its formulation based on acetylsalicylic acid (250 mg), paracetamol (200 mg) and caffeine (25 mg) per tablet, this over-the-counter medicine offers an effective response against headaches, cephalea, neuralgia, toothache, menstrual pain, joint and muscle pain , as well as being useful in cases of fever and cold syndromes .

The combined presence of acetylsalicylic acid and paracetamol guarantees a synergistic action against pain and fever, while caffeine enhances the analgesic effect, promoting rapid relief. Neo-Nisidina is indicated for adults who need an effective pain reliever for pain of various origins and for those looking for a practical and fast solution to take orally .

The 12 tablets are packaged in a practical way, ideal to always carry with you to intervene promptly in case of sudden pain or fever . Choose Neo-Nisidina 12 tablets for a targeted and reliable treatment of the most common symptoms related to pain and fever.

ACTIVE INGREDIENTS

Active ingredients contained in Neo‑Nisidina 12 tablets - What is the active ingredient in Neo‑Nisidina 12 tablets?

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

EXCIPIENTS

Composition of Neo‑Nisidina 12 tablets - What does Neo‑Nisidina 12 tablets contain?

Corn starch, lactose, stearic acid.

DIRECTIONS

Therapeutic indications Neo‑Nisidina 12 tablets - Why is Neo‑Nisidina 12 tablets used? What is it used for?

Symptomatic treatment of headache, neuralgia, toothache, menstrual pain, joint pain, feverish states and cold syndromes.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Neo‑Nisidina 12 tablets - When should Neo‑Nisidina 12 tablets not be used?

Hypersensitivity to the active substance or to any of the excipients. Paracetamol-based products are contraindicated in patients with manifest glucose-6-phosphate dehydrogenase deficiency and in those with severe haemolytic anaemia. Severe hepatocellular insufficiency. Neo-Nisidina should not be used in cases of active gastric or duodenal ulcer, in patients with a known tendency to haemorrhage (e.g. haemophilia) or who have hypersensitivity to salicylates or to paracetamol or other components of the product. Asthmatic patients. Dose > 100 mg/day of acetylsalicylic acid during the third trimester of pregnancy. The use of this medicinal product is contraindicated in children and adolescents under sixteen years of age. Due to the risk of Reye's syndrome, Neo-Nisidina should not be used in children and adolescents affected by chickenpox or influenza. Due to the presence of caffeine, do not administer to children and adolescents under sixteen years of age.

DOSAGE

Quantity and method of taking Neo‑Nisidina 12 tablets - How to take Neo‑Nisidina 12 tablets?

Adults: 1 to 4 tablets per day. Oral intake should be on a full stomach. Do not exceed the recommended doses, especially elderly patients should stick to the minimum dosages indicated above.

CONSERVATION

Storage Neo‑Nisidina 12 tablets - How to store Neo‑Nisidina 12 tablets?

None.

WARNINGS

Warnings Neo‑Nisidina 12 tablets - It is important to know that Neo‑Nisidina 12 tablets:

This medicinal product should not be used in children and adolescents under the age of sixteen (see contraindications); subjects over 70 years of age, especially in the presence of concomitant therapies, should 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 the pain or fever persist or worsen, if new symptoms appear or if redness or swelling is present, you should consult a doctor because these could be signs of a worsening of the current pathology. Administer with caution in subjects with renal or hepatic insufficiency. During treatment with paracetamol, before taking any other drug, check that it does not contain the same active ingredient, since if paracetamol is taken in high doses, serious adverse reactions may occur. Furthermore, before combining any other drug, contact your doctor. See also the entry "Interactions". In addition, patients with glucose-6-phosphate dehydrogenase deficiency, chronic or recurrent gastric or intestinal disorders, or impaired renal function, asthma, allergic rhinitis and nasal polyps, hypersensitivity to nonsteroidal anti-inflammatory drugs, liver dysfunction (e.g. due to chronic alcohol abuse, hepatitis), Gilbert's syndrome, pregnant women should consult their doctor. High or prolonged doses of the product can cause high-risk liver disease and even serious kidney and blood alterations. In case of viral diseases, such as influenza or chickenpox, consult your doctor before administering the product to children; if prolonged vomiting and profound drowsiness appear during treatment, discontinue administration. It is not recommended to use the product if the patient is being treated with other anti-inflammatory drugs. In rare cases of allergic reactions, administration should be suspended. Medicine containing lactose therefore not suitable for subjects with lactase deficiency, galactosemia or glucose/galactose malabsorption syndrome. Keep the medicine out of the reach and sight of children.

INTERACTIONS

Interactions Neo‑Nisidina 12 tablets - Which medicines or foods can modify the effect of Neo‑Nisidina 12 tablets?

The drug may interact with anticoagulants, uricosurics, hypoglycemic sulfonylureas. Preoperative use may hinder intraoperative haemostasis. Acetylsalicylic acid, one of the components of Neo-Nisidina, may enhance the effect of anticoagulants (e.g. coumarin and heparin derivatives). It may also increase the risk of gastrointestinal side effects when administered simultaneously with nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. The effect of hypoglycemic agents and the toxicity of methotrexate may be increased by concomitant administration of acetylsalicylic acid. Neo-Nisidina may decrease the natriuretic effect of spironolactone and inhibit the effect of uricosuric agents (e.g. probenecid, sulfinpyrazone). Patients being treated with rifampicin, cimetidine, or with antiepileptic drugs such as glutethimide, phenobarbital, carbamazepine must use paracetamol with extreme caution and only under strict medical supervision. The administration of paracetamol may interfere with the determination of uric acid (by the phosphotungstic acid method) and with that of glycemia (by the glucose-oxidase-peroxidase method). Drugs that slow gastric emptying, such as propantheline, reduce the rate of absorption of paracetamol and delay the onset of its effect. Drugs that accelerate gastric emptying, such as metoclopramide, lead to an increase in the rate of absorption. The association of paracetamol with chloramphenicol may prolong the half-life of chloramphenicol, increasing the risk of toxicity. The clinical relevance of interactions between paracetamol and warfarin and coumarin derivatives could not be assessed. Therefore, prolonged use of paracetamol in patients treated with oral anticoagulants is advisable only under medical supervision. Concomitant use of paracetamol and AZT (zidovudine) increases the risk of neutropenia induced by the latter. Therefore, Neo-Nisidine should be taken together with AZT only under medical supervision. Caffeine can antagonise the sedative effect of various drugs (e.g. barbiturates, antihistamines). It can also increase the tachycardic effect caused by other drugs (e.g. sympathomimetics, thyroxine). Oral contraceptives, cimetidine and disulfiram, slow down the metabolism of caffeine in the liver, barbiturates and smoking increase it. Caffeine reduces the excretion of theophylline. Concomitant administration of analgesics does not increase the risk of developing dependence. Administration of quinolone antibiotics may delay the elimination of caffeine.

SIDE EFFECTS

Like all medicines, Neo‑Nisidina 12 tablets can cause side effects - What are the side effects of Neo‑Nisidina 12 tablets?

See also section 4.9. Acetylsalicylic acid may cause epigastric discomfort, nausea, vomiting, gastroduodenal ulcers and erosive gastritis which may lead to severe gastrointestinal bleeding. These effects are more likely to be related to high doses although they may also occur at low doses. When using products containing acetylsalicylic acid for prolonged periods, iron deficiency anaemia may occur due to recurrence of bleeding in the digestive tract. Otovestibular disorders (tinnitus, etc.), dizziness, haemorrhagic phenomena (epistaxis, gingival bleeding, etc.), prolongation of pregnancy and labour and reduction of platelet count may also occur due to the presence of acetylsalicylic acid. Occasionally, allergic reactions (bronchoconstriction, skin reactions) may occur. Skin reactions of various types and severity have been reported with the use of paracetamol, including rare cases of allergic skin rashes and cases of erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis. Hypersensitivity reactions such as angioedema, laryngeal edema, anaphylactic shock have been reported. The following side effects have also been reported: thrombocytopenia, leukopenia, anemia, agranulocytosis, pancytopenia, alterations in liver function and hepatitis, alterations affecting the kidney (acute renal failure, interstitial nephritis, hematuria, anuria), gastrointestinal reactions and dizziness. In cases of overdose, due to the presence of paracetamol, hepatic cytolysis may occur, which may evolve into massive and irreversible necrosis. Caffeine is a CNS stimulant and may cause agitation, insomnia, tremor, dyspeptic symptoms and tachycardia. Due to the presence of caffeine, in case of overdose, a hyperstimulation syndrome may occur with excitement, insomnia, buzzing, muscle tremors, nausea, vomiting, increased diuresis, tachycardia, extrasystole, scotoma.

OVERDOSE

Overdose Neo‑Nisidina 12 tablets - What are the risks of Neo‑Nisidina 12 tablets in case of overdose?

Symptoms : Ingestion of excessive doses of paracetamol can cause, after 24-48 hours, signs of toxicity identifiable in liver dysfunction due to necrosis of liver cells up to hepatic coma, even with fatal outcome. Independently of these phenomena, renal lesions due to necrosis of the tubules have also been described. The symptoms of paracetamol poisoning manifest themselves in different phases. In the first phase (1st day) the 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) a considerable increase in transaminase values, jaundice, coagulation disorders, hypoglycemia tend to appear with possible transition to hepatic coma. The symptoms of moderate to acute toxicity of acetylsalicylic acid are: hyperventilation, tinnitus, nausea, vomiting, alteration of vision and hearing, dizziness and confusional states. In severe poisoning, delirium, tremor, convulsions, dyspnoea, sweating, bleeding, dehydration, disturbances of the acid-base balance and of the electrolyte composition of the plasma, hyperthermia and coma may be observed. The first symptoms of acute caffeine overdose are usually tremor and agitation. These are followed by nausea, vomiting, tachycardia and confusion. Symptoms caused by severe intoxication may be delirium, seizures, supraventricular and ventricular tachycardia, hypokalemia and hyperglycemia. Therapy : Treatment should begin with standard therapies (e.g. activated charcoal, gastric lavage). Treatment of acetylsalicylic acid overdose consists mainly of measures to increase its elimination by forced alkaline diuresis and to restore the acid-base and electrolyte balance. Infusions of sodium bicarbonate and potassium chloride solutions may be administered. The cytotoxic metabolite of paracetamol can be neutralized if possible in the first 8-12 hours after 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 advisable to perform serial tests of plasma concentration of paracetamol and liver function. The plasma concentration of both acetylsalicylic acid and paracetamol can be reduced by dialysis.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Neo-Nisidina 12 tablets.

Pregnancy : Low dose acetylsalicylic acid (up to 100 mg/day): Clinical studies indicate that doses up to 100 mg/day may be considered safe for obstetric use only, requiring specialist monitoring. Doses of 100-500 mg/day acetylsalicylic acid: There are insufficient clinical data on the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above also apply to this dosage range. Doses of 500 mg/day and above acetylsalicylic acid: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformation was increased from less than 1%, up to approximately 1.5%. The risk was estimated to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-foetal 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 first and second trimester of pregnancy, acetylsalicylic acid should not be administered unless clearly necessary. If acetylsalicylic acid is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and neonate, at the end of pregnancy, to: possible prolongation of bleeding time, and antiaggregant effect which may occur even at very low doses; inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, acetylsalicylic acid at doses > 100 mg/day is contraindicated during the third trimester of pregnancy. Prolonged intake of high quantities of caffeine may induce spontaneous abortion or premature birth. Breastfeeding : Paracetamol and salicylates are excreted in breast milk. Caffeine is also excreted in breast milk and may influence the condition and behavior of the child. If, during breastfeeding, regular therapy with higher doses of acetylsalicylic acid is necessary, weaning should be considered.

DRIVING AND USE OF MACHINERY

Taking Neo‑Nisidina 12 tablets before driving or using machines - Does Neo‑Nisidina 12 tablets affect driving or using machines?

The product does not interfere with the ability to drive vehicles or use machinery.