NEONISIDINA*12TABLETS

NEO NISIDINA tablets
Acetylsalicylic acid + paracetamol + caffeine

What it is and what it is used for
NEO NISIDINA is an oral medicine that relieves pain (analgesic) and reduces fever (antipyretic), containing three active ingredients: acetylsalicylic acid, paracetamol, and caffeine.

NEO NISIDINA is used for the treatment of headaches, nerve inflammation (neuralgia), toothache, menstrual pain, joint pain, feverish states, and common colds.

Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment.

What you need to know before taking the medicine
Do not take NEO NISIDINA
- if you are allergic to acetylsalicylic acid, paracetamol, caffeine, or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to medicines belonging to the salicylate group or non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have previously developed symptoms such as asthma, swelling of the face, tongue, and throat (angioedema) and hives after taking non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have lesions in your stomach or the first part of your intestine (gastric or duodenal ulcer);
- if you have a predisposition to bleeding (hemorrhages), for example, if you suffer from blood clotting disorders (hemophilia);
- if you are in the third trimester of pregnancy;
- if you are under 16 years of age;
- if you are between 16 and 18 years old and have chickenpox or the flu virus, as it can cause serious complications (see section "Children and adolescents");
- if you suffer from asthma;
- if you suffer from severe kidney, liver, or heart problems;
- if you are taking methotrexate (at doses of 15 mg/week or more) (see section "Other medicines and NEO NISIDINA");
- if you suffer from a disease caused by glucose-6-phosphate dehydrogenase deficiency;
- if you suffer from a blood disorder characterized by a low number of red blood cells (severe hemolytic anemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking NEO NISIDINA.

Avoid using this medicine for more than 3 days without first consulting your doctor and without their direct supervision. If pain or fever persist or worsen, if new symptoms appear, or if there is redness or swelling, consult your doctor immediately as these could be signs of an worsening of the existing condition.

Take this medicine with caution and only on your doctor's advice in the following cases:
- if you suffer from allergic rhinitis and nasal polyps;
- if you have chronic or recurrent stomach or intestinal problems or if you have previously suffered from ulcers, bleeding, or perforation in the stomach or intestine;
- if you suspect you are allergic to other similar medicines (analgesic antipyretics or non-steroidal anti-inflammatory drugs (NSAIDs));
- if you regularly consume alcoholic beverages;
- if you suffer from liver problems (mild or moderate liver failure, altered liver function, e.g., due to chronic alcohol abuse, hepatitis, Gilbert's syndrome);
- if you have kidney problems (altered kidney function and mild or moderate kidney failure);
- if you are taking blood thinners (oral anticoagulants, antiplatelet agents, systemic heparin, thrombolytics, or other drugs) (see section "Other medicines and NEO NISIDINA");
- if you are scheduled for surgery or an invasive diagnostic examination, as blood clotting problems could occur;
- if you are in the first or second trimester of pregnancy;
- if you are elderly and over 70 years old, especially if you are taking other medicines simultaneously.

Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take other paracetamol-containing products simultaneously, as serious side effects can occur if paracetamol is taken in high doses. The risk of serious side effects is also increased when NEO NISIDINA is taken together with other medicines used to relieve pain (analgesics) or lower fever (antipyretics), therefore avoid the concomitant use of these medicines.

Abrupt discontinuation of analgesics after a prolonged period of incorrect use at high doses can cause headaches, fatigue, nervousness, and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not resume taking them without consulting your doctor.

Incorrect use of the medicine (for doses or durations higher than indicated) can cause serious damage, particularly to the liver, kidneys (analgesic nephropathy), or blood, which could be life-threatening for the patient.
Acetylsalicylic acid can decrease uric acid elimination and cause a gout attack in susceptible individuals, and can also mask the symptoms of an infection.

Taking this medicine may alter the results of some laboratory tests, such as the measurement of uric acid (uricemia) or sugar (glycemia) levels in the blood.

Children and adolescents
This medicine is contraindicated in children and adolescents under 16 years of age, but in cases of suspected viral infection, such as the flu or chickenpox, NEO NISIDINA should not be taken even by adolescents aged between 16 and 18 years (see section "Do not use NEO NISIDINA"). In this case, there is a risk of a rare and life-threatening disease characterized by vomiting, headache, loss of consciousness, liver failure, and central nervous system problems (Reye's syndrome), which requires immediate medical attention.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may experience:
- stomach upset, nausea, vomiting, stomach and intestinal lesions (gastroduodenal ulcers) and inflammation of the stomach (erosive gastritis) which can lead to severe bleeding. These effects occur mainly after the use of high doses but can also occur at low doses;
- severe allergic reactions with symptoms such as low blood pressure (hypotension), breathing problems (dyspnea, bronchoconstriction), anaphylactic shock, swelling of the face, lips and throat (angioneurotic edema), skin reactions;

Furthermore, after using NEO NISIDINA, you may experience the following side effects:
Common (may affect up to 1 in 10 people):
- nervousness;
- dizziness;
- abdominal pain, indigestion (dyspepsia), nausea.

Uncommon (may affect up to 1 in 100 people):
- feeling of rapid heartbeat (palpitations);
- vomiting, diarrhea.

Rare (may affect up to 1 in 1000 people):
- agitation, tremor;
- dizziness caused by ear problems;
- altered heart rate (tachycardia);
- inflammation of the esophagus (esophagitis);
- hyperhidrosis (increased sweating);
- feeling of tiredness and fatigue;
- altered liver function and increased levels of certain enzymes (transaminases);
- stomach or intestinal lesions (gastrointestinal ulcer) and bleeding.

Very rare (may affect up to 1 in 10,000 people):
- reduction of blood glucose levels (hypoglycemia);
- severe lesions of the stomach or intestinal mucosa (gastrointestinal perforation); severe skin diseases (including erythema multiforme);
- impaired kidney function;
- decrease in the number of platelets, white blood cells, or all blood components, including red blood cells (hematocrit alterations, thrombocytopenia, leukopenia, agranulocytosis, pancytopenia);
- allergic reactions such as erythema, urticaria, nausea, Quincke's edema, swelling, difficulty breathing (dyspnea) and anaphylactic shock;
- difficulty breathing caused by bronchoconstriction in people allergic to non-steroidal anti-inflammatory drugs (NSAIDs).

Not known (frequency cannot be estimated from the available data):
- increased risk of bleeding such as nosebleeds (epistaxis) and gum bleeding (gingivorrhagia) due to the antiplatelet effect of acetylsalicylic acid which can last for several days after discontinuation of treatment; headache, drowsiness, confusion;
- vision disorders;
- hearing problems, sound or noise perceived by the patient but not generated by the external environment (tinnitus);
- prolongation of pregnancy and labor;
- kidney problems (acute renal failure, interstitial nephritis, hematuria, anuria);
- severe skin reactions (erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis);
- iron deficiency anemia, due to bleeding in the digestive tract, especially after prolonged use of acetylsalicylic acid;

In cases of overdose, due to the presence of paracetamol, hepatic cytolysis can occur, which can progress to massive and irreversible necrosis.

The presence of caffeine, a central nervous system stimulant, can cause agitation, insomnia, tremor, dyspeptic symptoms and tachycardia.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.