Aspirinetta - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Unwanted Effects Shelf Life and Storage Other Information

Active ingredients: Acetylsalicylic acid

Aspirinetta 100 mg tablets

Why is Aspirinetta used? What is it for?

Aspirinetta is an antipyretic (antipyretic: reduces fever), anti-inflammatory and analgesic (painkiller: reduces pain).

Aspirinetta is used to treat:

  • rheumatic disease (acute febrile inflammatory disease affecting joints, heart, skin and nervous system);
  • Kawasaki syndrome (disease that occurs in children with fever, swollen lymph nodes in the neck, inflammation of the arteries).

Contraindications When Aspirinetta should not be used

Do not take Aspirinetta 100 mg tablets

  • if you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6);
  • if you are allergic to other analgesics (painkillers) / antipyretics (feverfew) / non-steroidal anti-inflammatory drugs (NSAIDs);
  • if you suffer from gastroduodenal ulcer (ulcer of the stomach or the first part of the intestine);
  • if you suffer from bleeding diathesis (bleeding tendency);
  • if you suffer from severe heart (heart) or hepatic (liver) or renal (kidney) failure;
  • if you suffer from glucose-6-phosphate dehydrogenase deficiency (G6PD, an enzyme whose absence, genetically determined, leads to a disease characterized by reduced survival of red blood cells, called favism);
  • if you are being treated concomitantly with methotrexate (at doses of 15 mg / week or more) or with warfarin (see "Other medicines and Aspirinetta 100 mg tablets");
  • if you suffer from asthma or if you have suffered in the past from asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs;
  • if you suffer from hypophosphataemia (lack of phosphates in the blood);
  • if you are in the last trimester of pregnancy or if you are breastfeeding (see "Pregnancy, breastfeeding and fertility");
  • if you have viral infections (due to viruses), such as chicken pox or the flu, due to the risk of Reye's syndrome (a disease that causes damage to the brain and liver, affecting children and adolescents).

Precautions for use What you need to know before taking Aspirinetta

Talk to your doctor or pharmacist before taking Aspirinetta 100 mg tablets.

Only take this medicine on a full stomach.

Before administering any medicine you must take all necessary precautions to prevent unwanted reactions:

  • rule out the existence of previous allergic reactions to this or other medicines;
  • rule out the existence of other contraindications or conditions that may expose you to risk of potentially serious side effects. If in doubt, consult your doctor or pharmacist.
  • do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time.

Tell your doctor if:

  • you must undergo surgery (even a small one, such as the extraction of a tooth), since pre-operative use can hinder intraoperative haemostasis (stopping bleeding during surgery);
  • must perform a search for occult blood, as acetylsalicylic acid can cause gastrointestinal bleeding;
  • have problems with blood clotting or are taking anticoagulant medicines;
  • suffer from kidney, heart or liver disease;
  • suffer from a disease called gout (inflammation of the joints which causes pain and swelling).

Taking acetylsalicylic acid and other NSAIDs can hide the symptoms of gout and delay diagnosis.

Interactions Which drugs or foods can modify the effect of Aspirinetta

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Aspirinetta 100 mg tablets with these medicines (see "Do not take Aspirinetta 100 mg tablets"):

  • Methotrexate (used in some cancers and rheumatoid arthritis) (doses greater than or equal to 15 mg / week);
  • Warfarin (anticoagulant) can increase the risk of bleeding.

The effect of the treatment may also be changed if acetylsalicylic acid is taken concomitantly with anti-rejection medicines (eg cyclosporine or tacrolimus, used to prevent organ transplant reactions).

Only take Aspirinetta 100 mg tablets together with these medicines under strict medical supervision:

  • Selective serotonin re-uptake inhibitors (SSRIs) (used against depression): can increase the risk of gastrointestinal bleeding;
  • ACE inhibitors (used against high blood pressure); - Acetazolamide (used in some types of edema (swelling);
  • Valproic acid (used in epilepsy);
  • Other NSAIDs (excluding those for local use);
  • Antacids (used against digestive disorders);
  • Antiplatelet agents (used for the prevention and treatment of blood clots in the arteries);
  • Thrombolytics (used to dissolve blood clots) or anticoagulants (used to slow or inhibit the blood clotting process) taken by mouth or by injection;
  • Antidiabetics (for example insulin and oral hypoglycaemics) (used to stimulate the production of insulin by the pancreas): they can induce hypoglycemia (low blood sugar);
  • Digoxin (used in heart failure);
  • Diuretics (used to increase the amount of urine produced): can increase the risk of kidney toxicity;
  • Phenytoin (used in epilepsy);
  • Corticosteroids (corticosteroids, excluding those for local use and those used in replacement therapy in the insufficiency of the adrenal gland): they can increase the risk of gastrointestinal lesions;
  • Metoclopramide (used against vomiting);
  • Methotrexate (doses below 15 mg / week);
  • Uricosurics eg probenecid, benzbromarone (used to increase the elimination of uric acid);
  • Zafirlukast (used against asthma): may increase the risk of kidney toxicity.

Therefore, unless otherwise prescribed, do not take Aspirinetta 100 mg tablets concomitantly with the above preparations. Do not give any other medicines by mouth within 1 to 2 hours of using this medicine.

Aspirinetta 100 mg tablets with alcohol

The sum of the effects of alcohol and acetylsalicylic acid causes an increased risk of gastrointestinal bleeding.

Warnings It is important to know that:

Allergic reactions

Acetylsalicylic acid and other NSAIDs can cause allergic reactions (including asthma attacks, rhinitis (a feeling of stuffy and runny nose), angioedema (swelling of the skin on the face and mucous membranes) or hives (small spots on the skin and itch)).

The risk is greater in subjects who have already experienced an allergic reaction in the past after the use of this type of medicines (see "Do not take Aspirinetta 100 mg tablets") and in subjects who have allergic reactions to other substances (for example skin reactions , itching, hives).

In people with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria, reactions may be more frequent and severe.

Elderly (especially over the age of 75)

If you are an elderly person you have an increased risk of serious side effects.

Pregnancy, breastfeeding and fertility

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 this medicine.

Pregnancy

Do not take Aspirinetta 100 mg tablets in the last trimester of pregnancy.

In the first and second trimester of pregnancy, take this medicine only after consulting your doctor and evaluating with him the risk / benefit ratio in your case.

Feeding time

Do not take Aspirinetta 100 mg tablets while breastfeeding.

Fertility

If you are a woman with fertility problems or are undergoing fertility investigations, please note that the use of acetylsalicylic acid, as well as any prostaglandin synthesis and cyclooxygenase inhibitor medicine, may interfere with fertility.

Driving and using machines

Due to the possible onset of dizziness, Aspirinetta may impair the ability to drive or use machines. Aspirinetta 100 mg tablets contains sodium This medicine contains sodium. Take this into account if you are on a low sodium diet.

Dosage and method of use How to use Aspirinetta: Dosage

Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Use in children and adolescents

Aspirinetta tablets should preferably be dissolved directly in water, or chewed and then swallowed with plenty of liquid.

Due to the small size and the pleasant fruit taste, the 100 mg Aspirinetta tablets can be dissolved in the mouth, even by the smallest patients.

Take this medicine preferably after main meals, or in any case on a full stomach.

The recommended dose is:

1-3 years old children: 1 tablet 1-2 times a day.

Children 3-5 years old: 1 tablet 3 times a day.

Children aged 5-11: 2 tablets 3 times a day.

11-15 year olds: 3 tablets 3 times a day.

Do not exceed the recommended dose.

Kawasaki syndrome

Treatment should start with a dose of 80-100mg / kg of body weight per day, in 4 single doses, and be continued until the 14th day of illness. This treatment should be followed by a daily dose of 3-5 mg / kg body weight for 6-8 weeks. After this period, if there is evidence of coronary lesions (in the blood vessels of the heart), continue indefinitely.

Always use the lowest effective dosage and only increase it if it is not enough to relieve symptoms.

Overdose What to do if you have taken too much aspirinette

In case of accidental ingestion of an overdose of Aspirinetta 100 mg tablets, notify your doctor immediately or go to the nearest hospital.

Salicylate toxicity (a dose greater than 100 mg / kg / day for 2 consecutive days can induce toxicity) may be the consequence of a "chronic overdose or acute overdose, potentially life-threatening and which also includes "accidental ingestion in children.

  • Chronic poisoning: Chronic salicylate poisoning can be insidious since the signs and symptoms are nonspecific. Mild chronic salicylate poisoning, or salicylism, usually occurs only after repeated use of large doses. Symptoms there are dizziness, vertigo, tinnitus (a ringing or hissing in the ear), deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus can occur at blood concentrations between 150 and 300 micrograms / ml, while more serious adverse events occur at concentrations above 300 micrograms / ml.
  • Acute intoxication: the main characteristic of acute intoxication is a serious alteration of the acid-base balance, which can vary with age and the severity of the intoxication; in the child, the most common presentation is metabolic acidosis (accumulation of acids in the body). It is not possible to estimate the severity of the poisoning from the concentration in the blood alone; the absorption of acetylsalicylic acid may be delayed due to reduced gastric emptying, the formation of concrements in the stomach, or as a consequence of the ingestion of gastro-resistant preparations. The management of an "acetylsalicylic acid intoxication is determined by the" entity, stage and clinical symptoms of the latter ", and must be implemented according to conventional poisoning management techniques. The main measures to be adopted are the" acceleration of " elimination of the substance and in the restoration of the electrolytic (salts) and acid-base balance.

Due to the complex pathophysiological effects associated with salicylate poisoning, the signs and symptoms / results of biochemical and instrumental investigations may include:

  • Signs and symptoms of mild / moderate overdose: tachypnea (rapid breathing), hyperventilation (breathing too deep), respiratory alkalosis (altered acid-base balance due to changes in breathing), sweating, nausea, vomiting, headache, dizziness.
  • Signs and symptoms of moderate / severe overdose: respiratory alkalosis with compensatory metabolic acidosis (alteration of the acid-base balance due to altered breathing and accumulation of acids in the body), fever, hyperventilation (breathing too deep), pulmonary edema ( water in the lungs), respiratory failure, asphyxia, arrhythmias (changes in the heartbeat), hypotension (low blood pressure), cardiac arrest (cessation of heartbeat), dehydration, oliguria (decreased urine) up to renal failure (impaired function kidney), ketosis (acetone), hyperglycaemia (increased blood sugar level), severe hypoglycaemia (severe decrease in blood sugar level), tinnitus (a ringing or wheezing in the ear), deafness, gastrointestinal bleeding, ulcer gastric disorder, coagulopathy (impaired blood clotting), encephalopathy (pain in the brain) and depression of the nervous system central with variable manifestations from lethargy (profound sleepiness) and confusion to coma and convulsions, cerebral edema (swelling of the brain tissue), liver damage.
  • At high dosages, iron deficiency anemia may also appear (only after prolonged treatment), taste alterations and skin rashes (acneiform, erythematous, scarlet-like, eczematoid, desquamative, bullous, purpuric), itching.
  • Other signs and symptoms: conjunctivitis, anorexia (loss of appetite), decreased visual acuity (ability to clearly distinguish objects), drowsiness.
  • Rarely, they can occur: aplastic anemia (lack of red blood cell production), agranulocytosis (lack of blood cells called granulocytes), disseminated intravascular coagulation (disseminated presence of numerous blood clots), pancytopenia (lack of all types of blood cells) , leukopenia (shortage of white blood cells), thrombocytopenia (shortage of platelets), eosinopenia (lack of blood cells called eosinophils), purpura (reddish patches on the skin), eosinophilia (increased eosinophils) associated with drug-induced hepatotoxicity, toxicity kidney (allergic tubulointerstitial nephritis), hematuria (blood in the urine).

Acute allergic reactions following the intake of acetylsalicylic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine. In case of emergency and in the absence of contraindications (such as for example: conditions of reduction / absence of protective reflexes in the airways or of reduced consciousness or of subjects at risk of gastrointestinal bleeding or perforation or in case of simultaneous intake of corrosives) groped to favor the elimination of acetylsalicylic acid taken orally by administering activated charcoal or performing a gastric lavage.

Fluid and electrolyte management and forced alkaline diuresis may be required.

Acetylsalicylic acid is dialyzable (can be eliminated by blood dialysis).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Aspirinetta

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

The most frequently observed side effects are related to the gastrointestinal tract. Their frequency increases significantly in subjects at risk of gastrointestinal disorders. These disorders can be partially alleviated by taking the medicine on a full stomach. Most side effects are dependent on both the dose and duration of treatment. Undesirable effects seen with acetylsalicylic acid are generally common to other NSAIDs.

Effects on the blood

  • prolongation of bleeding time,
  • gastrointestinal bleeding anemia,
  • reduction of platelets (thrombocytopenia) in extremely rare cases.

Following haemorrhage, acute and chronic post-haemorrhagic / iron deficiency anemia (due to iron deficiency) (due, for example, to occult micro-haemorrhages) may occur with the relative alterations of laboratory parameters and the relative clinical signs and symptoms such as asthenia (fatigue ), paleness and hypoperfusion (reduced blood flow to the tissues).

Effects on the nervous system

  • headache,
  • dizziness.

Rarely, it can occur: Reye's syndrome (*), an acute, potentially fatal disease affecting the brain and liver that almost exclusively affects children.

Rarely to very rarely can occur:

  • cerebral haemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and / or on anticoagulants (medicines used to slow or inhibit the blood clotting process), which, in isolated cases, can be life-threatening.

Effects on the ear and the labyrinth

  • tinnitus (ringing / rustling / ringing / ringing in the ear).

Effects on the respiratory system

  • asthmatic syndrome;
  • rhinitis (runny nose);
  • nasal congestion (feeling of stuffy nose and stuffy nose), (associated with allergic reactions);
  • epistaxis (nosebleed).

Effects on the heart

  • cardiorespiratory distress (severe and sudden respiratory failure) (associated with allergic reactions).

Effects on the eye

  • conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal system

  • gastrointestinal bleeding (occult),
  • gastric disorders,
  • heartburn (heartburn),
  • gastrointestinal pain,
  • gingivorrhagia (bleeding from the gums),
  • He retched,
  • diarrhea,
  • nausea,
  • crampy abdominal pain (associated with allergic reactions).

Rarely they can occur:

  • gastrointestinal inflammation,
  • gastrointestinal erosion,
  • gastrointestinal ulceration,
  • haematemesis (vomiting of blood or similar "coffee grounds" material),
  • melena (black stools, picee),
  • esophagitis (inflammation of the esophagus).

Very rarely it can occur:

  • haemorrhagic gastrointestinal ulcer and / or gastrointestinal perforation with related clinical signs and symptoms and alterations in laboratory parameters.

Effects on the liver

  • infrequently: hepatotoxicity (usually mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases.

Effects on the skin

  • rash,
  • edema (swelling),
  • urticaria,
  • itch,
  • erythema (redness),
  • angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract

  • impaired kidney function (in the presence of conditions of impaired blood circulation in the kidneys),
  • urogenital bleeding (of the urinary and genital tract).

Effects on the organism as a whole

  • peri-operative bleeding (immediately before, during and immediately after surgery),
  • hematomas (collections of blood outside the blood vessels).

Effects on the immune system

  • rarely: anaphylactic shock (severe allergic reaction, life-threatening) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (SdR) The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of varying degrees: from listlessness, drowsiness or personality changes (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness. The variability of the clinical picture should be kept in mind: vomiting may also be absent or be replaced by diarrhea.

If these symptoms arise in the days immediately following a flu (or flu-like or chickenpox or "other viral infection) episode during which acetylsalicylic acid or other salicylate-containing medicinal products have been administered, medical attention should be directed immediately. to the possibility of an SDR.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not store above 25 ° C.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Deadline "> Other information

What Aspirinetta 100 mg tablets contains

  • The active ingredient is acetylsalicylic acid. One tablet contains 100 mg of acetylsalicylic acid.
  • The other ingredients are: cellulose powder, corn starch, sodium saccharin, raspberry flavor.

What Aspirinetta 100 mg tablets look like and contents of the pack

The contents of the pack are 24 or 30 tablets of 100 mg.

Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Aspirinetta is available in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT - 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION - 03.0 PHARMACEUTICAL FORM - 04.0 CLINICAL PARTICULARS - 04.1 Therapeutic indications - 04.2 Posology and method of administration - 04.3 Contraindications - 04.4 Special warnings and appropriate precautions for use - 04.5 Interactions with other medicinal products and other forms of interaction - 04.6 Pregnancy and lactation - 04.7 Effects on the ability to drive and use machines - 04.8 Undesirable effects - 04.9 Overdose - 05.0 PHARMACOLOGICAL PROPERTIES - 05.1 "Pharmacodynamic properties - 05.2 Pharmacokinetic properties" - 05.3 Preclinical safety data - 06.0 PHARMACEUTICAL PARTICULARS - 06.1 Excipients - 06.2 Incompatibility "- 06.3 Shelf life" - 06.4 Special precautions for storage - 06.5 Nature of the primary packaging and contents of the package - 06.6 Instructions for use and handling - 07.0 AUTHORIZATION HOLDER ALL "PLACING ON THE MARKET - 08.0 MARKETING AUTHORIZATION NUMBER - 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION - 10.0 DATE OF REVISION OF THE TEXT - 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY - 12.0 INSTRUCTIONS FOR RADIOPHONES ON EXTEMPORARY PREPARATION AND QUALITY CONTROL -

01.0 NAME OF THE MEDICINAL PRODUCT -

ASPIRINETTA 100 MG TABLETS

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -

One tablet contains:

active principle:

acetylsalicylic acid 100 mg.

For the full list of excipients see section 6.1.

03.0 PHARMACEUTICAL FORM -

Tablets.

04.0 CLINICAL INFORMATION -

04.1 Therapeutic indications -

Rheumatic disease.

Kawasaki syndrome.

04.2 Posology and method of administration -

The ASPIRINETTA tablets should preferably be dissolved directly in water, or chewed and then swallowed with plenty of liquid.

1-3 years old children: 1 tablet 1-2 times a day.

3-5 year old children: 1 tablet 3 times a day.

Children aged 5-11: 2 tablets 3 times a day.

11-15 year olds: 3 tablets 3 times a day.

Do not exceed the recommended dose.

Due to their small size and pleasant fruit flavor, the 100 mg ASPIRINETTA tablets can be dissolved in the mouth, even by the smallest patients.

Kawasaki syndrome

Treatment should start with a dose of 80-100mg / kg body weight per day, in 4 single doses and be continued until the 14th day of illness.

This treatment should be followed by a daily dose of 3-5 mg / kg body weight for 6-8 weeks.

After this period, if there is evidence of coronary lesions, continue indefinitely.

Always use the lowest effective dosage and only increase it if it is not sufficient to relieve symptoms.

Those most at risk of serious side effects, who can use the drug only if prescribed by a doctor, must strictly follow its instructions (see section 4.4).

Take the medicine preferably after main meals or, in any case, on a full stomach.

04.3 Contraindications -

Aspirinetta is contraindicated in case of:

- hypersensitivity to the active substance (acetylsalicylic acid) or to other closely related substances from a chemical point of view and / or to any of the excipients

- hypersensitivity to other analgesics (pain relievers) / antipyretics (antipyretics) / non-steroidal anti-inflammatory drugs (NSAIDs)

- gastroduodenal ulcer

- hemorrhagic diathesis;

- severe heart or liver or kidney failure;

- glucose-6-phosphate dehydrogenase deficiency (G6PD / favism);

- concomitant treatment with methotrexate (at doses of 15 mg / week or more) or with warfarin (see section 4.5);

- history of asthma induced by the administration of salicylates or substances with similar activity, in particular non-steroidal anti-inflammatory drugs;

- hypophosphatemia;

- third trimester of pregnancy and lactation (see section 4.6).

ASPIRINETTA should not be used in the course of viral infections, such as chicken pox or influenza due to the risk of Reye's syndrome.

04.4 Special warnings and appropriate precautions for use -

Hypersensitivity reactions

Acetylsalicylic acid and other NSAIDs can cause hypersensitivity reactions (including asthma attacks, rhinitis, angioedema or urticaria).

The risk is greater in subjects who have already experienced a hypersensitivity reaction in the past after the use of this type of drug (see section 4.3) and in subjects who have allergic reactions to other substances (eg skin reactions, itching, hives) .

In subjects with asthma and / or rhinitis (with or without nasal polyposis) and / or urticaria, reactions may be more frequent and severe.

In rare cases, the reactions can be very serious and potentially fatal.

In the following cases, the administration of the drug requires careful evaluation of the risk / benefit ratio:

- People at increased risk of hypersensitivity reactions (see above)

- Subjects at increased risk of gastrointestinal lesions

Acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation). For this reason these drugs should not be used by people suffering from gastrointestinal ulcer or gastrointestinal bleeding. It is prudent that they avoid them ". I also use those who in the past have suffered from gastrointestinal ulcer or gastrointestinal bleeding. The risk of gastrointestinal lesions is a dose related effect, as gastrolysis is greater in subjects who use higher doses of acetylsalicylic acid.

Even subjects with a habit of drinking large quantities of alcohol are more exposed to the risk of gastrointestinal lesions (bleeding in particular).

- Subjects with coagulation defects or treated with anticoagulants

In subjects suffering from coagulation defects or treated with anticoagulants, acetylsalicylic acid and other NSAIDs can cause a serious reduction in haemostatic capacity, exposing them to the risk of bleeding.

- Subjects with impaired renal or cardiac or hepatic function

Acetylsalicylic acid and other NSAIDs can cause a critical reduction in renal function and water retention; the risk is greater in subjects treated with diuretics. This can be particularly dangerous for the elderly and for subjects with impaired function. renal or cardiac or hepatic.

- People with asthma

Acetylsalicylic acid and other NSAIDs can cause aggravation of asthma.

- Subjects with hyperuricemia / gout

Acetylsalicylic acid can interfere with the elimination of uric acid: high doses have a uricosuric effect while (very) low doses can reduce its excretion. It should also be considered that acetylsalicylic acid and other NSAIDs can mask the symptoms of gout by delaying their diagnosis. An antagonistic effect with uricosuric drugs is also possible (see section 4.5).

- Combination of drugs not recommended or requiring special precautions or dosage adjustment.

The use of acetylsalicylic acid in combination with some drugs may increase the risk of serious side effects (see section 4.5).

Do not use acetylsalicylic acid together with another NSAID or, in any case, do not use more than one NSAID at a time.

Fertility

The use of acetylsalicylic acid as well as any drug that inhibits the synthesis of prostaglandins and cyclooxygenase could interfere with fertility; female subjects must be informed of this and in particular women who have fertility problems or who are undergoing investigations. on fertility.

Sodium

This medicine contains sodium: it may not be suitable for people who must follow a low sodium diet.

If you have to undergo surgery (even a small one, for example the extraction of a tooth) and in the previous days you have used acetylsalicylic acid or another NSAID, you must inform the surgeon for the possible effects on coagulation .

Since acetylsalicylic acid can cause gastrointestinal bleeding, it must be taken into account in case it is necessary to perform a search for occult blood.

Before administering any medicine, all necessary precautions must be taken to prevent unwanted reactions; particularly important is the exclusion of previous hypersensitivity reactions to this or other medicinal products and the exclusion of other contraindications or conditions that may expose you to risk of potentially serious side effects listed above. If in doubt consult your doctor or pharmacist.

The use of high doses and / or for a long time must be carried out under medical supervision.

04.5 Interactions with other medicinal products and other forms of interaction -

Contraindicated combinations (avoid concomitant use - see section 4.3)

- Methotrexate (doses greater than or equal to 15 mg / week): increased plasma levels and methotrexate toxicity; the risk of toxic effects is greater if renal function is impaired.

- Warfarin: serious increase in the risk of haemorrhage due to the enhancement of the anticoagulant effect.

Combinations not recommended (concomitant use of the two drugs requires a doctor's prescription after careful evaluation of the risk / benefit ratio - see section 4.4)

Antiplatelet agents: increased risk of haemorrhage due to the sum of the antiplatelet effect.

Thrombolytics or Oral or parenteral anticoagulants: increased risk of haemorrhage due to enhancement of the pharmacological effect.

NSAIDs (topical use excluded): increased risk of serious side effects.

Methotrexate (doses below 15mg / week): The increased risk of toxic effects (see above) should also be considered for treatment with low dose methotrexate.

Selective Serotonin Re-uptake Inhibitors (SSRIs): increased risk of upper gastrointestinal bleeding due to a possible synergistic effect.

Combinations requiring special precautions or dosage adjustment (concomitant use of the two drugs requires a doctor's prescription after careful assessment of the benefit / risk ratio - see section 4.4)

ACE inhibitors: reduced hypotensive effect; increased risk of impaired renal function.

Valproic Acid: increased effect of valproic acid (risk of toxicity).

Antacids: antacids taken at the same time as other drugs can reduce their absorption; the excretion of acetylsalicylic acid increases in alkalized urine.

Antidiabetics (e.g. insulin and oral hypoglycemic agents): increased hypoglycemic effect; the use of acetylsalicylic acid in subjects treated with antidiabetics must take into account the risk of inducing hypoglycaemia.

Digoxin: increase in the plasma concentration of digoxin due to a decrease in renal elimination.

Diuretics: increased risk of nephrotoxicity of acetylsalicylic acid and other NSAIDs; decreased effect of diuretics.

Acetazolamide: reduced elimination of acetazolamide (risk of toxicity)

Phenytoin: increased effect of phenytoin.

Corticosteroids (excluding those for topical use and those used for the therapy of adrenocortical insufficiency):

a- increased risk of gastrointestinal lesions;

b- due to the increased elimination of salicylates induced by corticosteroids there is a reduction in plasma levels of salicylate. On the other hand, after discontinuation of corticosteroid treatment, an overdose of salicylates may occur.

Metoclopramide: increase in the effect of acetylsalicylic acid by increasing the absorption rate.

Uricosurics (ex: probenecid, benzbromarone): decreased uricosuric effect.

Zafirlukast: increased plasma concentration of zafirlukast.

Immunosuppressive drugs (eg cyclosporine, tacrolimus): risk of nephrotoxicity.

The concomitant use of Aspirinetta, especially in the case of prolonged therapy, can potentiate the effects and secondary manifestations of all non-steroidal antirheumatics.

Therefore, unless otherwise prescribed, ASPIRINETTA should not be administered concomitantly with the aforementioned preparations.

However, it is advisable not to administer other drugs by mouth within one or two hours of using the product.

Experimental data indicate that ibuprofen can inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when drugs are administered concomitantly. However, the limited data and uncertainties relating to their application to the clinical situation do not allow us to draw firm conclusions for continued use of ibuprofen; there appears to be no clinically relevant effect from occasional use of ibuprofen (see section 5.1).

Alcohol

The sum of the effects of alcohol and acetylsalicylic acid causes increased damage to the gastrointestinal mucosa and prolonged bleeding time.

04.6 Pregnancy and breastfeeding -

Pregnancy

Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor. in the early stages of pregnancy.

The absolute risk of cardiac malformations was increased from less than 1% to approximately 1.5%. The risk has been estimated to increase with dose and duration of therapy.

In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal 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 needed. If drugs containing acetylsalicylic acid are used by a woman trying to become pregnant, or during the first and second trimester of pregnancy , the treatment should be as short as possible and the dose as low as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose

the fetus to:

- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);

- renal dysfunction which can progress to renal failure with oligo-hydroamnios;

the mother and the unborn child, at the end of pregnancy, to:

- possible prolongation of bleeding time, and antiplatelet effect which can occur even at very low doses;

- inhibition of uterine contractions resulting in delayed or prolonged labor.

Consequently, acetylsalicylic acid is contraindicated during the third trimester of pregnancy.

Aspirinetta is contraindicated during lactation (see section 4.3).

04.7 Effects on ability to drive and use machines -

Due to the possible onset of dizziness, Aspirinetta may impair the ability to drive and use machines.

04.8 Undesirable effects -

The most frequently observed undesirable effects are related to the gastrointestinal system. This percentage increases significantly in subjects at risk of gastrointestinal disorders.

These disorders can be partially alleviated by taking the medicine on a full stomach. Most of the undesirable effects are dependent on both the dose and the duration of treatment.

The side effects seen with acetylsalicylic acid are generally common to other NSAIDs.

Disorders of the blood and lymphatic system

Prolonged bleeding time, gastrointestinal bleeding anemia, reduced platelets (thrombocytopenia) in extremely rare cases.

After haemorrhage acute and chronic post-haemorrhagic / iron deficiency anemia may occur (due, for example, to occult micro-haemorrhages) with the relative alterations of the laboratory parameters and the relative clinical signs and symptoms such as asthenia, pallor and hypoperfusion.

Nervous system disorders

Headache, dizziness.

Rarely: Reye's syndrome (*)

Rarely to very rarely: cerebral haemorrhage, especially in patients with uncontrolled hypertension and / or on anticoagulant therapy which, in isolated cases, can be life threatening.

Ear and labyrinth disorders

Tinnitus (buzzing / rustling / ringing / ringing in the ears).

Respiratory, thoracic and mediastinal disorders

Asthmatic syndrome, rhinitis (profuse rhinorrhea), nasal congestion (associated with hypersensitivity reactions).

Epistaxis.

Cardiac pathologies

Cardiorespiratory distress (associated with hypersensitivity reactions).

Eye disorders

Conjunctivitis (associated with hypersensitivity reactions).

Gastrointestinal disorders

Gastrointestinal (occult) bleeding, gastric upset, heartburn, gastrointestinal pain, gingivorrhagia.

Vomiting, diarrhea, nausea, crampy abdominal pain (associated with hypersensitivity reactions).

Rarely: gastrointestinal inflammation, gastrointestinal erosion, gastrointestinal ulceration, haematemesis (vomiting of blood or "coffee" material), melaena (emission of black faeces, picee), esophagitis.

Very rarely: haemorrhagic gastrointestinal ulcer and / or gastrointestinal perforation with related clinical signs and symptoms and changes in laboratory parameters.

Hepatobiliary disorders

Rarely: hepatotoxicity (usually mild and asymptomatic hepatocellular injury) manifested by an increase in transaminases.

Skin and subcutaneous tissue disorders

Rash, edema, urticaria, erythema, angioedema (associated with hypersensitivity reactions).

Renal and urinary disorders

Altered renal function (in the presence of conditions of impaired renal haemodynamics), urogenital bleeding.

General disorders and administration site conditions

Peri-operative haemorrhages, hematomas.

Disorders of the immune system

Rarely: anaphylactic shock with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (SdR)

The SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of brain pain of various entities: from listlessness, drowsiness or personality changes (irritability or aggression) to disorientation, confusion or delirium up to convulsions or loss of consciousness . The variability of the clinical picture should be kept in mind: vomiting may also be absent or be replaced by diarrhea.

If these symptoms arise in the days immediately following a flu (or flu-like or chickenpox or "other viral infection) episode during which acetylsalicylic acid or other salicylate-containing medicinal products have been administered, medical attention should be directed immediately. to the possibility of an SDR.

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.

04.9 Overdose -

Salicylate toxicity (a dose greater than 100 mg / kg / day for 2 consecutive days can induce toxicity) may be the consequence of a "chronic overdose, or acute overdose, which is potentially life-threatening and also includes accidental ingestion in children.

Chronic salicylate poisoning can be insidious since the signs and symptoms are nonspecific. Chronic mild salicylate poisoning, or salicylism, usually occurs only after repeated use of large doses. Symptoms include dizziness. , dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion. These symptoms can be controlled by reducing the dosage. Tinnitus can occur at plasma concentrations between 150 and 300 mcg / ml, while more serious adverse events occur at concentrations above 300 mcg / ml.

The main characteristic of acute intoxication is a severe alteration of the acid-base balance, which can vary with age and the severity of the intoxication; the most common presentation in children is metabolic acidosis. It is not possible to estimate the severity of poisoning from plasma concentration alone; Absorption of acetylsalicylic acid may be delayed due to reduced gastric emptying, formation of concrements in the stomach, or as a consequence of the ingestion of gastro-resistant preparations. Management of acetylsalicylic acid intoxication is determined by the extent, the stage and clinical symptoms of the latter, and must be implemented according to conventional poisoning management techniques. The main measures to be taken consist in "accelerating" the excretion of the drug and in restoring the electrolyte and acid-base metabolism.

Due to the complex pathophysiological effects associated with salicylate poisoning, the signs and symptoms / results of biochemical and instrumental investigations may include:

Signs and symptoms Results of biochemical and instrumental investigations Therapeutic measures Mild to moderate poisoning Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis Tachypnea, hyperventilation, respiratory alkalosis Alkalemia, alkaluria Fluid and electrolyte management Sweating Nausea, vomiting, headache, dizziness MODERATE TO SEVERE POISONING Gastric lavage, repeated administration of activated charcoal, forced alkaline diuresis, hemodialysis in severe cases Respiratory alkalosis with compensatory metabolic acidosis, Acidemia, aciduria Fluid and electrolyte management Hyperpyrexia Fluid and electrolyte management Respiratory: ranging from hyperventilation and non-cardiogenic pulmonary edema to respiratory arrest and asphyxia Cardiovascular: variable from arrhythmias and hypotension to cardiocirculatory arrest Eg. altered blood pressure, altered ECG Loss of fluids and electrolytes: dehydration, from oliguria to kidney failure Eg. hypokalaemia, hypernatremia, hyponatremia, impaired renal function Fluid and electrolyte management Alterations in glucose metabolism, ketosis Hyperglycaemia, hypoglycaemia (especially in children) Increased ketone levels Tinnitus, deafness Gastrointestinal: gastrointestinal bleeding, gastric ulcer Hematological: coagulopathy, iron deficiency anemia Eg. PT prolongation, hypoprothrombinemia Neurological: toxic encephalopathy and CNS depression with manifestations ranging from lethargy and confusion to coma and convulsions. Cerebral edema. Hepatic: liver damage Increased levels of liver enzymes

At high dosages, the following may also appear:

Changes in taste.

Skin rashes (acneiform, erythematous, scarlet-like, eczematoid, desquamative, bullous, purpuric), itching.

Others: conjunctivitis, anorexia, reduced visual "acuity", drowsiness.

Rarely: aplastic anemia, agranulocytosis, disseminated intravascular coagulation, pancytopenia, leukopenia, thrombocytopenia, eosinopenia, purpura, eosinophilia associated with drug-induced hepatotoxicity, nephrotoxicity (allergic tubulointerstitial nephritis), hematuria (presence of blood in the urine).

Acute allergic reactions following the intake of acetylsalicylic acid can be treated, if necessary, with the administration of adrenaline, corticosteroids and an antihistamine.

In the event of an overdose, contact a poison control center or the nearest hospital immediately.

Acetylsalicylic acid is dialyzable.

05.0 PHARMACOLOGICAL PROPERTIES -

05.1 "Pharmacodynamic properties -

Pharmacotherapeutic group: analgesics-other analgesics (non-opioids) and antipyretics-acetylsalicylic acid and derivatives.

ATC code: NO2BA01.

Acetylsalicylic acid belongs to the group of acidic non-steroidal anti-inflammatory drugs with analgesic, antipyretic and anti-inflammatory properties.

Its mechanism of action is based on the irreversible inhibition of the cyclo-oxygenase enzyme involved in the synthesis of prostaglandins.

ASPIRINETTA also has anti-inflammatory properties that make it particularly effective in rheumatic forms. In order to facilitate the administration of single doses provided for children and to make the intake of the drug pleasant for young patients, Aspirinetta for children has been created in tablets dosed with 0.1 g of active ingredient, sweetened and corrected to the flavor of fruit. .

Experimental data indicate that ibuprofen may inhibit the effects of low-dose acetylsalicylic acid on platelet aggregation when the drugs are administered concomitantly. In one study, following administration of a single 400 mg dose of ibuprofen, taken 8 hours. before or 30 minutes after the administration of acetylsalicylic acid (81 mg), there was a decrease in the effect of acetylsalicylic acid on thromboxane formation and platelet aggregation. application to the clinical situation does not allow definitive conclusions to be drawn on the continued use of ibuprofen; there appears to be no clinically relevant effect from the occasional use of ibuprofen.

05.2 "Pharmacokinetic properties -

Absorption

After oral administration, acetylsalicylic acid is rapidly and completely absorbed from the gastrointestinal tract. During and after absorption, acetylsalicylic acid is converted to its main metabolite, salicylic acid. Maximum plasma levels are reached after 10-20 minutes for acetylsalicylic acid and after 0.3 - 2 hours for salicylic acid, respectively.

Distribution

Both acetylsalicylic acid and salicylic acid bind extensively to plasma proteins, about 80%, and are rapidly distributed throughout the body. Salicylic acid appears in breast milk and crosses the placenta.

Metabolism

Salicylic acid is eliminated primarily by metabolism in the liver; metabolites include salicyluric acid, salicylic phenolic glucuronide, salicylic acyl glucuronide, gentisic acid and gentisuric acid.

Elimination

The elimination kinetics of salicylic acid are dose-dependent, as metabolism is limited by the capacity of liver enzymes. Therefore, the elimination half-life ranges from 2 - 3 hours after low doses to approximately 15 hours after high doses. Salicylic acid and its metabolites are mainly excreted via the kidney.

05.3 Preclinical safety data -

Chronic toxicity (rat and mini-pig): lesions of the gastric mucosa, alterations of some haematochemical parameters, proteinuria and pathological changes of the liver only at the highest dose (300 mg / kg) used daily for 6 months.

The preclinical data have little clinical relevance in light of the extensive experience acquired with the use in humans of the active substance (s) contained in the medicinal product.

There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).

06.0 PHARMACEUTICAL INFORMATION -

06.1 Excipients -

Tablets

Excipients:

cellulose powder;

cornstarch;

sodium saccharin;

raspberry flavoring.

06.2 Incompatibility "-

Not relevant.

06.3 Period of validity "-

4 years.

06.4 Special precautions for storage -

Store at a temperature not exceeding 25 ° C.

06.5 Nature of the immediate packaging and contents of the package -

Not all pack sizes may be marketed

PVC-PVDC / Aluminum

24 tablets of 0.1 g

30 tablets of 0.1 g

06.6 Instructions for use and handling -

Not relevant.

07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -

Bayer S.p.A. - Viale Certosa 130 - Milan

08.0 MARKETING AUTHORIZATION NUMBER -

AIC 026721035 tablets

AIC 026721100 tablets

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -

24 tablets July 1987 31.05.2010

30 tablets May 1996 31.05.2010

10.0 DATE OF REVISION OF THE TEXT -

SEPTEMBER 2015

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -

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