NEONISIDINA C*10EFF TAB VIT-C

NEO NISIDINA effervescent tablets with vitamin C
Acetylsalicylic acid + paracetamol + ascorbic acid (vitamin C)

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 vitamin C (ascorbic acid).

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

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, ascorbic acid 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 urticaria after taking non-steroidal anti-inflammatory drugs (NSAIDs);
- if you have lesions in the stomach or the first part of the intestine (gastric or duodenal ulcer);
- if you have a predisposition to bleeding, for example if you suffer from blood clotting disorders (hemophilia);
- if you are in your third trimester of pregnancy;
- if you are under 16 years of age;
- if you are between 16 and 18 years of age and suffer from chickenpox or flu virus, as it may cause serious complications (see the 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 the 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 disease characterized by a low number of red blood cells (severe hemolytic anemia).

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

Avoid using this medicine for more than 3 days without consulting your doctor first and without their direct supervision. If the pain or fever persists or worsens, if new symptoms appear, or if there is redness or swelling, consult your doctor immediately as these could be signs of a worsening of the ongoing 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 and intestinal problems or if you have a history of ulcer, 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 habitually consume alcoholic beverages;
- if you suffer from liver problems (mild or moderate hepatic insufficiency, impaired liver function due to chronic alcohol abuse, hepatitis, Gilbert's syndrome);
- if you have kidney problems (impaired kidney function and mild or moderate renal insufficiency);
- if you are taking medicines to thin the blood (oral anticoagulants, antiplatelet agents, systemic heparin, thrombolytics, or other drugs) (see the section "Other medicines and NEO NISIDINA");
- if you are to undergo surgery or an invasive diagnostic examination, as blood clotting problems may occur;
- if you are in your first or second trimester of pregnancy;
- if you are elderly and over 70 years old, especially if you are taking other medicines at the same time.

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 may 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 to lower fever (antipyretics), so avoid concomitant use of these medicines.
The use of analgesics (painkillers), especially in high doses, can cause headaches that should not be treated with higher doses of the drug.

Suddenly stopping 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 them without consulting your doctor.

Incorrect use of the medicine (for doses or 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 the elimination of uric acid 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 levels (uricemia) or sugar (glycemia) in the blood.

Children and adolescents
This medicine is contraindicated in children and adolescents under 16 years of age, but in cases where a viral infection, such as flu or chickenpox, is suspected, NEO NISIDINA should not be taken even in adolescents aged between 16 and 18 years (see the section "Do not take 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.

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

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

Uncommon (may affect up to 1 in 100 people):
- vomiting;
- diarrhea.

Rare (may affect up to 1 in 1,000 people):
- psychotic disorders;
- dizziness caused by ear problems;
- flatulence;
- hyperhidrosis (increased sweating);
- feeling tired and fatigued;
- impaired liver function and increased levels of some enzymes (transaminases);
- stomach or intestinal lesions (gastrointestinal ulcer) and bleeding.

Very rare (may affect up to 1 in 10,000 people):
- reduced 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 constriction of the bronchi (bronchospasm) 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);
- prolonged pregnancy and labor;
- kidney problems (acute renal failure, interstitial nephritis, hematuria, anuria);
- even 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.

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