NEO NISIDINA Tablet

Зміст інструкції

1. NEO NISIDINA tablets
   1. What is NEO NISIDINA and what is it used for
   2. What you need to know before taking NEO NISIDINA
   3. How to take NEO NISIDINA
   4. Possible side effects
   5. How to store NEO NISIDINA
   6. Contents of the pack and other information
2. NEO NISIDINA effervescent tablets with vitamin C
   1. What is NEO NISIDINA and what is it used for
   2. What you need to know before taking NEO NISIDINA
   3. How to take NEO NISIDINA
   4. Possible side effects
   5. How to store NEO NISIDINA
   6. Contents of the pack and other information

NEO NISIDINA tablets

Acetylsalicylic acid + paracetamol + caffeine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

• 1. What NEO NISIDINA is and what it is used for
• 2. What you need to know before you take NEO NISIDINA
• 3. How to take NEO NISIDINA
• 4. Possible side effects
• 5. How to store NEO NISIDINA
• 6. Contents of the pack and other information

1. What is NEO NISIDINA and what is it used for

NEO NISIDINA is a medicine for oral use 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 headache, nerve inflammation (neuralgia), toothache,
menstrual pain, joint pain, febrile states and colds.
See a doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking NEO NISIDINA

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 that belong to the group of salicylates or non-steroidal anti-inflammatory drugs (NSAIDs);
• if in the past you have developed symptoms such as asthma, swelling of the face, tongue and throat (angioedema) and urticaria following the intake of 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 (haemorrhage), for example if you suffer from blood coagulation disorders (haemophilia);
• if you are in the third trimester of pregnancy;
• if you are less than 16 years of age;
• if you are between 16 and 18 years of age and are affected by the chickenpox or influenza virus, because it can cause serious complications (see section “Children and adolescents”);
• if you suffer from asthma;
• if you suffer from severe problems with the function of the kidneys, liver or heart;
• 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 glucose-6-phosphate dehydrogenase enzyme;
• if you suffer from a blood disease characterized by a low number of red blood cells (severe haemolytic anaemia).

Warnings and precautions
Consult 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 the pain or fever persists or worsens, if new symptoms appear, or if redness or swelling is present, consult your doctor immediately as these could be signs of a worsening of the underlying condition.

• During treatment with NEO NISIDINA, immediately inform your doctor if:
• if you suffer from allergic rhinitis and nasal polyps;
• if you have chronic or recurrent problems with your stomach or intestines or if you have previously suffered from ulcers, bleeding or perforation of the stomach or intestine;
• if you suspect you are allergic to other similar medicines (analgesics, antipyretics or non-steroidal anti-inflammatory drugs (NSAIDs));
• if you regularly consume alcoholic beverages;
• if you suffer from liver problems (mild or moderate hepatic insufficiency, altered liver function for example due to chronic alcohol abuse, hepatitis, Gilbert's syndrome);
• if you have kidney problems (impaired renal 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 section “Other medicines and NEO NISIDINA”);
• if you are going to undergo surgery or an invasive diagnostic examination, as problems with blood coagulation 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 suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). Patients in these situations have reported a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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 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 to lower fever (antipyretics), so avoid the simultaneous use of these medicines.
The sudden cessation of taking analgesics after a prolonged period of incorrect use at high doses can cause headache, fatigue, nervousness and withdrawal symptoms that resolve within a few days. Until then, avoid taking other painkillers and do not start taking them again without consulting your doctor.
Incorrect use of the medicine (at doses or for durations longer than those indicated) can cause serious damage, particularly to the liver, kidneys (analgesic nephropathy) or blood, which could endanger the patient's life.
Acetylsalicylic acid can decrease the elimination of uric acid and cause a gout attack in susceptible people, and it can also mask the symptoms of an infection.
Taking this medicine can alter the results of some laboratory tests such as the measurement 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 you suspect an infection caused by a virus, such as influenza or chickenpox, NEO NISIDINA should not be taken even in adolescents between the ages of 16 and 18 (see 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 problems with the central nervous system (Reye's syndrome), which requires immediate medical attention.

Other medicines and NEO NISIDINA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
For each of the components of NEO NISIDINA, the medicines that can modify its effect are indicated.
Pay particular attention if you are taking the following medicines, because acetylsalicylic acidcan increase their effects and the risk of toxicity:

• other medicines used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids) and alcohol, because they increase the risk of side effects on the stomach and intestines (e.g. gastrointestinal bleeding);
• medicines used for some heart diseases (cardiac glycosides, such as digoxin, digitoxin);
• lithium, a medicine used for mental problems;
• medicines to thin the blood (antiplatelet agents, thrombolytics, anticoagulants), antidepressant medicines (selective serotonin reuptake inhibitors (SSRIs)) and medicines for gout (uricosurics), because they can increase the risk of bleeding;
• methotrexate, a medicine used for rheumatoid arthritis and to treat some cancers;
• medicines that lower blood sugar levels (hypoglycaemic agents);
• valproic acid, a medicine used for epilepsy. Acetylsalicylic acid can also decrease the effect of the following medicines:
• medicines used to lower blood pressure (antihypertensives) and diuretics, including spironolactone;
• medicines that promote the elimination of uric acid (e.g. probenecid, sulfinpyrazone).

Metamizole (a substance used to reduce pain and fever) can decrease the effect of acetylsalicylic acid on platelet aggregation (blood cells that attach and form a blood clot), if taken at the same time. Therefore, this combination should be used with caution in patients taking aspirin at low doses for cardioprotection.
Pay attention if you are taking the following medicines, because they can modify the activity of the

paracetamol:

• probenecid, used for gout, and salicylamide, a pain reliever, which delay the elimination of paracetamol and increase its toxicity;
• medicines used to thin the blood (oral anticoagulants), because they increase the risk of bleeding when paracetamol is administered simultaneously for 7 days or more;
• cholestyramine, used to reduce cholesterol levels in the blood, propantheline, used for stomach cramps, or other medicines that slow down gastric emptying, because they can reduce the absorption of paracetamol;
• medicines that, instead, accelerate gastric emptying, such as metoclopramide, used to inhibit the vomiting reflex, because they lead to an increase in the rate of absorption;
• medicines that cause enzyme induction, for example some hypnotic and antiepileptic medicines (glutethimide, phenobarbital, phenytoin, carbamazepine), cimetidine, a medicine for heartburn, and rifampicin, an antibiotic, because they can cause serious liver damage. The same can occur in case of alcohol abuse;
• chloramphenicol, an antibiotic, because paracetamol can increase its toxicity;
• zidovudine (AZT), used for the treatment of AIDS, because the concomitant use with paracetamol enhances the risk of reduction of white blood cells (neutropenia) induced by the latter. Therefore, NEO NISIDINA should be taken together with AZT only under medical supervision.
• -flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis with high anion gap) that needs urgent treatment (see paragraph 2).

In addition, pay attention if you are taking the following medicines:

• medicines for epilepsy (barbiturates) and for allergies (antihistamines), because caffeine can reduce their sedative activity;
• medicines that cause an acceleration of the heartbeat (tachycardia) (e.g. sympathomimetics, thyroxine), because caffeine increases their activity;
• oral contraceptives, cimetidine, used for heartburn, and disulfiram, used to treat alcoholism, because they slow down the metabolism of caffeine in the liver;
• medicines for epilepsy (barbiturates) and cigarette smoking, because they increase the metabolism of caffeine in the liver;
• theophylline, used for asthma, because caffeine reduces its elimination from the body;
• quinolone antibiotics, because they can delay the elimination of caffeine.

NEO NISIDINA with alcohol
Avoid taking alcohol together with this medicine because it can increase the risk of bleeding in the stomach and intestines, and liver damage.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, this medicine is considered safe only for use in obstetrics limited to 100 mg of acetylsalicylic acid per day. Use of higher doses may negatively affect pregnancy or the development of the child.
If necessary, in the first two months of pregnancy, NEO NISIDINA can be used only after consulting your doctor and with the lowest possible dose. It is advisable to use the lowest possible dose that reduces pain and/or fever and to take it for the shortest possible time. Contact your doctor if the pain and/or fever does not decrease or if you need to take the medicine more often.
During the first and second trimester of pregnancy, the medicine should not be administered unless in strictly necessary cases.
Do not take this medicine during the third trimester of pregnancy, as acetylsalicylic acid can cause serious problems for the child and mother, even during and after delivery (See section “Do not take NEO NISIDINA”).
Avoid prolonged intake of caffeine, as it can induce spontaneous abortion or premature birth of the child.
Avoid taking this medicine if you are breastfeeding, as the components of the medicine pass into breast milk and could cause problems for the child.
Stop using this medicine if you have fertility problems or are undergoing fertility investigations.

Driving and operating machinery
There is no data available regarding the effects of the medicine on the ability to drive vehicles or operate machinery.

NEO NISIDINA contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with lactose intolerance, contact them before taking this medicine.

3. How to take NEO NISIDINA

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablets with a full stomach.
Do not take this medicine for more than 3 consecutive days without consulting your doctor.

Adults:
The recommended doseis from 1 to 4 tablets per day. Do not exceed the indicated doses.
Consult your doctor if the disorder occurs again or if you notice any change in its characteristics.

Use in elderly people
If you are elderly, you should take this medicine with the lowest possible dosage.

If you use more NEO NISIDINA than you should
In case of accidental ingestion/intake of an excessive dose of NEO NISIDINA, immediately inform your doctor or go to the nearest hospital.
Overdosage has very serious consequences and can even lead to death. Immediately inform your doctor if you notice any symptoms of overdose.
Ingestion of excessive doses of paracetamol can cause signs of liver toxicity (hepatic dysfunction) after 24-48 hours, which can worsen to coma (hepatic coma), even with a fatal outcome, and kidney damage.
The symptoms of paracetamol intoxicationmanifest in several stages. In the first stage (first day) the signs are nausea, vomiting, sweating, drowsiness and a general feeling of
malessere. After a temporary subjective improvement, in the second stage (the third or fourth day) a considerable increase in transaminase values, yellowish discoloration of the skin and whites of the eyes (jaundice), blood coagulation disorders, reduction in blood sugar levels (hypoglycemia) with severe liver damage that could lead to coma (hepatic coma) tend to appear.
The symptoms of acetylsalicylic acid intoxicationfrom moderate to acute are: hyperventilation, ringing in the ears (tinnitus), nausea, vomiting, altered vision and hearing, dizziness and confused states. In case of severe poisoning, delirium, tremors, convulsions, breathing problems (dyspnea), sweating, bleeding, dehydration, alteration of pH and mineral salt levels in the blood, increased body temperature (hyperthermia) and coma can be observed.
The first symptoms of a caffeine overdoseare normally tremor and agitation. These are followed by nausea, vomiting, increased heart rate (tachycardia) and confusion. Symptoms caused by severe intoxication can be delirium, seizures, altered heartbeat (supraventricular and ventricular tachycardia), reduced calcium levels (hypocalcemia) and increased sugar levels (hyperglycemia) in the blood.

If you forget to use NEO NISIDINA
Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following can occur:

• stomach disorders, nausea, vomiting, lesions to the stomach and intestine (gastroduodenal ulcers) and inflammation of the stomach (erosive gastritis) which may lead to even 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 pharynx (angioedema), skin reactions;

In addition, after using 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):

• feeling of a racing heartbeat (palpitations);
• vomiting, diarrhea.

Rare(may affect up to 1 in 1000 people):

• agitation, tremor;
• dizziness caused by ear problems;
• irregular heartbeat (tachycardia);
• inflammation of the esophagus (esophagitis);
• hyperhidrosis (increased sweating);
• feeling tired and fatigued;
• impaired liver function and increased levels of certain enzymes (transaminases);
• lesions to the stomach or intestine (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 mucous membrane of the stomach or intestine (gastrointestinal perforation); severe skin diseases (including erythema multiforme);
• kidney function disorders;
• decrease in the number of platelets, white blood cells, or all blood components, including red blood cells (changes in hematocrit, thrombocytopenia, leukopenia, agranulocytosis, pancytopenia);
• allergic reactions such as, for example, erythema, urticaria, nausea, angioedema, swelling, difficulty breathing (dyspnea) and anaphylactic shock;
• difficulty breathing caused by a constriction of the bronchi (bronchospasm) in people allergic to non-steroidal anti-inflammatory drugs (NSAIDs).

Not known(frequency cannot be estimated from 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 stopping treatment; headache, drowsiness, confusion;
• visual disturbances;
• hearing problems, sound or noise perceived by the patient but not generated by the external environment (tinnitus);
• prolongation of pregnancy and labour;
• kidney problems (acute renal failure, interstitial nephritis, hematuria, anuria);
• skin reactions, even severe (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;
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2).

In cases of overdose, due to the presence of paracetamol, it can cause liver cytolysis, which can
evolve into 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, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store NEO NISIDINA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
Store at a temperature not exceeding 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NEO NISIDINA contains

• The active ingredients are acetylsalicylic acid, paracetamol and caffeine. Each tablet contains 250 mg of acetylsalicylic acid, 200 mg of paracetamol and 25 mg caffeine.
• The other ingredients are: corn starch, lactose, stearic acid.

Description of the appearance of NEO NISIDINA and contents of the pack
Neo Nisidina is available in tablet form.
Pack of 1, 2, 4, 8, 10 or 12 tablets

Marketing Authorisation Holder
Pharm@idea S.r.l – Via del Commercio, 5 – 25039 Travagliato (Brescia)

Manufacturer
Istituto De Angeli S.r.l. – Loc. Prulli n. 103/c – 50066 Reggello (FI)

NEO NISIDINA effervescent tablets with vitamin C

Acetylsalicylic acid + paracetamol + ascorbic acid (vitamin C)

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days of treatment.

Contents of this leaflet:

• 1. What NEO NISIDINA is and what it is used for
• 2. What you need to know before you take NEO NISIDINA
• 3. How to take NEO NISIDINA
• 4. Possible side effects
• 5. How to store NEO NISIDINA
• 6. Contents of the pack and other information

2. What is NEO NISIDINA and what is it used for

NEO NISIDINA is a medicine for oral use that relieves pain (analgesic) and reduces fever (antipyretic) which contains three active ingredients: acetylsalicylic acid, paracetamol and vitamin C (ascorbic acid).
NEO NISIDINA is used for the treatment of symptoms of influenza and colds, headache, nerve inflammation (neuralgia), toothache, menstrual pains, joint pains.
See a doctor if you do not feel better or if you feel worse after 3 days of treatment.

2. What you need to know before taking NEO NISIDINA

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 that belong 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 throat (angioedema) and urticaria following the intake of 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 (haemorrhage), for example if you suffer from blood coagulation 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 are affected by the chickenpox or influenza virus, because it can cause serious complications (see section “Children and adolescents”);
• if you suffer from asthma;
• if you suffer from severe 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 glucose-6-phosphate dehydrogenase enzyme;
• if you suffer from a blood disease characterized by a low number of red blood cells (severe haemolytic anaemia).

Warnings and precautions
Consult 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 the pain or fever persists or worsens, if new symptoms appear, or if redness or
swelling is present, consult your doctor immediately, as these could be signs of a worsening of the
underlying condition.
During treatment with NEO NISIDINA, immediately inform your doctor if:

• if you suffer from allergic rhinitis and nasal polyps;
• if you have chronic or recurrent problems with your stomach and intestines or if you have previously suffered from ulcers, bleeding or perforation of the stomach or intestine;
• if you suspect you are allergic to other similar medicines (analgesics, antipyretics or non-steroidal anti-inflammatory drugs (NSAIDs));
• if you regularly consume alcoholic beverages;
• if you suffer from liver problems (mild or moderate hepatic insufficiency, altered liver function, for example due to chronic alcohol abuse, hepatitis, Gilbert's syndrome);
• if you have kidney problems (impaired renal 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 section “Other medicines and NEO NISIDINA”);
• if you are to undergo surgery or an invasive diagnostic examination, as coagulation 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 also taking other medicines at the same time.
• If you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). Patients in these situations have reported a serious condition called metabolic acidosis (an abnormality of the blood and fluids) when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken in association with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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 if paracetamol is taken in high doses, serious side effects can occur. The risk of serious side effects is increased even when NEO NISIDINA is taken together with other medicines used to relieve pain (analgesics) or to lower fever (antipyretics), therefore avoid the simultaneous use of these medicines. The use of analgesics (pain relievers), especially at high doses, can cause headache that should not be treated with higher doses of the drug.

The sudden interruption of taking analgesics after a prolonged period of incorrect use at
high doses can cause headache, fatigue, nervousness and withdrawal symptoms that
resolve within a few days. Until then, avoid taking other pain relievers and do not
restart taking them without consulting your doctor.
Incorrect use of the medicine (at doses or for longer durations than indicated) can cause
serious damage, particularly to the liver, kidneys (analgesic nephropathy) or blood, which
could endanger the patient's life.
Acetylsalicylic acid can decrease the elimination of uric acid and cause a gout attack in
susceptible people, and it can also mask the symptoms of an infection.
Taking this medicine can 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 if
an infection caused by a virus, such as influenza or chickenpox, is suspected, NEO NISIDINA
should not be taken even in adolescents between the ages of 16 and 18 (see 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
problems with the central nervous system (Reye's syndrome), which requires immediate
medical intervention.

Other medicines and NEO NISIDINA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
For each of the components of NEO NISIDINA, the medicines that can modify its
effect are indicated.
Pay particular attention if you are taking the following medicines, because acetylsalicylic acid
can increase their effects and the risk of toxicity:

• other medicines used to relieve pain and inflammation (non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids) and alcohol, because they increase the risk of side effects on the stomach and intestines (e.g. gastrointestinal bleeding);
• medicines used for some heart diseases (cardiac glycosides, such as digoxin, digitoxin);
• lithium, a medicine used for mental problems;
• medicines to thin the blood (antiplatelet agents, thrombolytics, anticoagulants), antidepressant medicines (selective serotonin reuptake inhibitors (SSRIs)) and medicines for gout (uricosurics), because they can increase the risk of bleeding;
• methotrexate, a medicine used for rheumatoid arthritis and to treat some cancers;
• medicines that lower blood sugar levels (hypoglycaemic agents);
• valproic acid, a medicine used for epilepsy.

Acetylsalicylic acid can also decrease the effect of the following medicines:

• medicines used to lower blood pressure (antihypertensives) and diuretics, including spironolactone;
• medicines that promote the elimination of uric acid (e.g. probenecid, sulfinpyrazone).

Metamizole (a substance used to reduce pain and fever) can decrease the effect of acetylsalicylic
acid on platelet aggregation (blood cells that attach and form a blood clot) if taken at the same time. Therefore, this combination should be used with
caution in patients taking aspirin at low doses for cardioprotection.
Be careful if you are taking the following medicines, because they can alter the activity of

paracetamol:

• probenecid, used for gout, and salicylamide, a pain reliever, which delay the elimination of paracetamol and increase its toxicity;
• medicines used to thin the blood (oral anticoagulants), because they increase the risk of bleeding when paracetamol is administered simultaneously for 7 days or more;
• cholestyramine, used to reduce cholesterol levels in the blood, propantheline, used for stomach cramps, or other medicines that slow down gastric emptying, because they can reduce the absorption of paracetamol;
• medicines that, instead, accelerate gastric emptying, such as metoclopramide, used to inhibit the vomiting reflex, because they lead to an increase in the rate of absorption;
• medicines that cause enzyme induction, for example some hypnotic and antiepileptic medicines (glutethimide, phenobarbital, phenytoin, carbamazepine), cimetidine, a medicine for heartburn, and rifampicin, an antibiotic, because they can cause serious liver damage. The same can occur in case of alcohol abuse;
• chloramphenicol, an antibiotic, because paracetamol can increase its toxicity;
• zidovudine (AZT), used for the treatment of AIDS, because the concomitant use with paracetamol increases the risk of reduction of white blood cells (neutropenia) induced by the latter. Therefore, NEO NISIDINA should be taken together with AZT only under medical supervision.
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis with high anion gap) that needs urgent treatment (see section 2).

NEO NISIDINA with alcohol
Avoid taking alcohol together with this medicine because it can increase the risk of
bleeding in the stomach and intestines, and liver damage.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, this medicine is considered safe only for use in obstetrics limited to 100 mg of
acetylsalicylic acid per day. Use of higher doses can negatively affect pregnancy or the development of
the child.
If necessary, in the first two months of pregnancy, NEO NISIDINA can be used only after
consulting your doctor and with the lowest possible dose. It is advisable to use the lowest
possible dose that reduces pain and/or fever and to take it for the shortest possible time. Contact
your doctor if the pain and/or fever does not decrease or if you have to take the medicine more often.
During the first and second trimester of pregnancy, the medicine should not be administered
unless in strictly necessary cases.
Do not take this medicine during the third trimester of pregnancy, as acetylsalicylic
acid can cause serious problems for the child and the mother even during and after
delivery (See section “Do not take NEO NISIDINA”).
Avoid taking this medicine if you are breastfeeding, as the components of the medicine
pass into breast milk and could cause problems for the baby.
Stop using this medicine if you have fertility problems or are undergoing fertility investigations.

Driving and operating machinery
There is no data available regarding the effects of the medicine on the ability to drive vehicles or operate
machinery.

NEO NISIDINA contains lactose and sodium
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with
intolerance to some sugars, contact him before taking this medicine.
This medicine contains approximately 440 mg of sodium per tablet. This should be taken into
account in people with impaired kidney function or who are following a low-sodium diet.

3. How to take NEO NISIDINA

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
Dissolve the effervescent tablet in half a glass of water before taking it. Take the
medicine on a full stomach.
Do not take this medicine for more than 3 consecutive days without consulting your doctor.

Adults:
The recommended doseis from 1 to 4 effervescent tablets per day. Do not exceed the indicated doses.
Consult your doctor if the disorder occurs again or if you notice any change in its
characteristics.

Use in elderly people
If you are elderly, you should take this medicine with the lowest possible dosage.

If you take more NEO NISIDINA than you should
In case of accidental ingestion/intake of an excessive dose of NEO NISIDINA, immediately
inform your doctor or go to the nearest hospital.
Overdosage has very serious consequences and can even lead to death. Immediately inform your
doctor if you notice any symptoms of overdose.
Ingestion of excessive doses of paracetamol can cause, after 24-48 hours, signs of liver toxicity
(hepatic dysfunction) which can worsen to coma (hepatic coma), even with a fatal outcome, and
kidney damage.
The symptoms of paracetamol intoxicationmanifest in several stages. In the first stage (first
day) the signs are nausea, vomiting, sweating, drowsiness and a general feeling of
malessere. After a temporary subjective improvement, in the second stage (the third or fourth
day) a considerable increase in transaminase values, yellowish discoloration of the skin and whites
of the eyes (jaundice), blood coagulation disorders, reduction of blood sugar levels (hypoglycemia)
with severe liver damage that could lead to coma (hepatic coma) tend to appear.
The symptoms of acetylsalicylic acid intoxicationfrom moderate to acute are: hyperventilation,
ringing in the ears (tinnitus), nausea, vomiting, altered vision and hearing, dizziness and states
of confusion. In case of severe poisoning, delirium, tremor, convulsions, respiratory problems
(dyspnea), sweating, bleeding, dehydration, alteration of pH and levels of mineral salts in the blood,
increased body temperature (hyperthermia) and coma can be observed.

If you forget to take NEO NISIDINA
Do not take a double dose to compensate for forgetting the dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following can occur:

• stomach discomfort, nausea, vomiting, lesions to the stomach and intestine (gastroduodenal ulcers) and inflammation of the stomach (erosive gastritis) which can lead to bleeding, even severe. These effects occur especially after 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 pharynx (angioedema), skin reactions.

In addition, 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 1000 people):

• psychotic disorders;
• dizziness caused by problems with the ear;
• flatulence;
• hyperhidrosis (increased sweating);
• feeling of tiredness and fatigue;
• alteration of liver function and increase of certain enzymes (transaminases);
• lesions to the stomach or intestine (gastrointestinal ulcer) and bleeding.

Very rare(may affect up to 1 in 10,000 people):

• reduction of glucose levels in the blood (hypoglycemia);
• severe lesions to the mucosa of the stomach or intestine (gastrointestinal perforation);
• severe 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 of hematocrit, thrombocytopenia, leukopenia, agranulocytosis, pancytopenia);
• allergic reactions such as, for example, erythema, urticaria, nausea, angioedema, swelling, difficulty breathing (dyspnea) and anaphylactic shock;
• difficulty breathing caused by a constriction of the bronchi (bronchospasm) in people allergic to non-steroidal anti-inflammatory drugs (NSAIDs).

Not known(frequency cannot be estimated from 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 stopping treatment;
• headache, drowsiness, confusion;
• visual disturbances;
• problems with hearing, 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);
• skin reactions also severe (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, it can cause liver cytolysis, which can evolve towards massive and irreversible necrosis.
• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who use paracetamol (see paragraph 2).

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

5. How to store NEO NISIDINA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
The preparation is sensitive to humidity. The tube cap contains a desiccant to protect the
tablets from external humidity; therefore, the packaging must be carefully
resealed each time.
Store below 30°C, in the original container.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NEO NISIDINA contains

• The active ingredients are acetylsalicylic acid, paracetamol and ascorbic acid (Vitamin C). Each effervescent tablet contains 300 mg of acetylsalicylic acid, 200 mg of paracetamol and 300 mg of ascorbic acid (Vitamin C).
• The other ingredients are: sodium bicarbonate, citric acid, lactose, lemon flavour, sodium saccharin, polyvinylpyrrolidone, fumaric acid.

Description of the appearance of NEO NISIDINA and contents of the pack
NEO NISIDINA is available in the form of effervescent tablets.
Pack of 10 or 20 effervescent tablets.

Marketing Authorisation Holder
Pharm@idea S.r.l – Via del Commercio, 5 – 25039 Travagliato (Brescia).

Manufacturer
E-Pharma Trento S.p.A. – Frazione Ravina Via Provina, 2 – 38123 Trento (TN).