NEONISIDINE TABLETS 12 TABLETS

Name
NEO NISIDINA tablets
Acetylsalicylic acid + paracetamol + caffeine


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

NEO NISIDINA is used to treat headaches, nerve inflammation (neuralgia), toothache, menstrual pain, joint pain, fever, and colds.

Talk to 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 group of salicylates or non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have previously developed symptoms such as asthma, swelling of the face, tongue and pharynx (angioedema) and hives following the use of non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have lesions in the stomach or upper part of the intestine (gastric or duodenal ulcer);
- if you have a predisposition to bleeding (haemorrhages), for example if you suffer from blood clotting disorders (haemophilia);
- 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 influenza, as it can cause serious complications (see section "Children and adolescents");
- if you suffer from asthma;
- if you suffer from serious problems with kidney, liver or heart function;
- 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 a deficiency of the enzyme glucose-6-phosphate dehydrogenase;
- if you suffer from a blood disorder characterised by a low number of red blood cells (severe haemolytic anaemia).


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 his or her direct supervision. If pain or fever persists or worsens, if new symptoms appear, or if redness or swelling is present, consult your doctor immediately as these may be signs of a worsening of your existing condition.

During treatment with NEO NISIDINA, inform your doctor immediately if:
- if you suffer from allergic colds and nasal polyps;
- if you have chronic or recurring stomach or intestinal problems or if you have had ulcers, bleeding or perforation in the stomach or intestine in the past;
- if you suspect you are allergic to other similar medicines (antipyretic analgesics or non-steroidal anti-inflammatory drugs (NSAIDs));
- if you regularly drink alcoholic beverages;
- if you suffer from liver problems (mild or moderate liver failure, impaired liver function for example due to chronic alcohol abuse, hepatitis, Gilbert's syndrome);
- if you have kidney problems (impaired kidney function and mild or moderate kidney failure);
- if you are taking medicines to thin the blood (oral anticoagulants, antiplatelet drugs, systemic heparin, thrombolytics, or other drugs) (see the section "Other medicines and NEO NISIDINA");
- if you need to undergo surgery or an invasive diagnostic test, because blood clotting problems may occur;
- if you are in the first or second trimester of pregnancy;
- if you are elderly and over 70 years of age, especially if you are taking other medicines at the same time;
- if you have serious illnesses, including severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality of the blood and fluids) has been reported in patients with these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include severe breathing difficulties with rapid, deep breathing, drowsiness, nausea, and vomiting.

Avoid prolonged or frequent use of the medicine without first consulting your doctor and do not take other products containing paracetamol at the same time, as taking high doses of paracetamol can cause serious side effects. The risk of serious side effects is also increased when NEO NISIDINA is taken with other medicines used to relieve pain (analgesics) or reduce fever (antipyretics), so avoid using these medicines at the same time.

Abruptly stopping painkillers after prolonged misuse 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 restart them without consulting your doctor.

Incorrect use of the medicine (in doses or for a duration greater than those indicated) can cause serious damage, particularly to the liver, kidneys (analgesic nephropathy) or blood, which could put the patient's life at risk.
Acetylsalicylic acid can decrease uric acid elimination and cause a gout attack in susceptible individuals, and it can also mask the symptoms of an infection.

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

Children and adolescents
This medicine is contraindicated in children and adolescents under 16 years of age, but if a viral infection, such as influenza or chickenpox, is suspected, NEO NISIDINA must not be taken by adolescents aged between 16 and 18 years (see the section "Do not use NEO NISIDINA"). In this case, there is a risk of a rare, 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.

The following may occur:
- stomach upset, nausea, vomiting, lesions of the stomach and intestines (gastroduodenal ulcers) and inflammation of the stomach (erosive gastritis) which can lead to even severe bleeding.
These effects occur mainly following 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 (angioedema), skin reactions.

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

Uncommon (may affect up to 1 in 100 people):
- sensation of a racing heart (palpitations);
- vomiting, diarrhea.

Rare (may affect up to 1 in 1,000 people):
- agitation, tremor;
- dizziness caused by ear problems;
- alteration of the heartbeat (tachycardia);
- inflammation of the esophagus (esophagitis);
- hyperhidrosis (increased sweating);
- feeling of tiredness and fatigue;
- alteration of liver function and increase of some enzymes (transaminases);
- lesions in the stomach or intestine (gastrointestinal ulcer) and bleeding.

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

Not known (the frequency of which cannot be established from established data):
- increased risk of bleeding such as nosebleeds (epistaxis) and gum bleeding (gingivorrhagia) due to the antiplatelet effect of acetylsalicylic acid, which may last for several days after stopping 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);
- even serious skin reactions (erythema multiforme, Stevens-Johnson syndrome and epidermal necrolysis);
- iron deficiency anemia, due to bleeding in the digestive tract, especially following prolonged use of acetylsalicylic acid;
- a serious condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see section 2).

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

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

Reporting of side effects
If you experience 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.