ASPIRIN RAPID*10CHEWTAB500MG

Aspirina Rapida 500 mg chewable tablets
Acetylsalicylic acid

What it is and what it is used for
Aspirina is an analgesic (painkiller: reduces pain), anti-inflammatory and antipyretic (fever reducer: reduces fever).
Aspirina is used for the symptomatic treatment of feverish conditions and flu and cold syndromes, and for the symptomatic treatment of headache, toothache, neuralgia, menstrual pain, rheumatic pain and muscle pain.
The product is for adult patients only.
Consult your doctor if you do not notice an improvement or if your symptoms worsen after 3-5 days.

What you need to know before taking the medicine
Do not take Aspirina Rapida
- if you are allergic to acetylsalicylic acid, other analgesics (painkillers)/antipyretics (fever reducers)/non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
- if you suffer from gastroduodenal ulcer (stomach ulcer or ulcer in the first part of the intestine);
- if you suffer from hemorrhagic diathesis (tendency to bleeding);
- if you suffer from severe kidney (reduced kidney function), liver (hepatic) or heart (cardiac) failure;
- if you suffer from glucose-6-phosphate dehydrogenase deficiency (an enzyme whose genetically determined absence leads to a disease characterized by reduced red blood cell survival);
- if you are already taking methotrexate (at doses of 15 mg/week or more) or warfarin (see Other medicines and Aspirina Rapida);
- if you have previously suffered from asthma induced by the administration of salicylates or similar substances, in particular non-steroidal anti-inflammatory drugs (NSAIDs);
- if you are in the last trimester of pregnancy or are breastfeeding (see Pregnancy, breastfeeding and fertility);
- if you are under 16 years of age (see Children and adolescents).

Warnings and precautions
Talk to your doctor or pharmacist before taking Aspirina Rapida.

Take the medicine only on a full stomach.
Before administering any medicine, you should take all precautions to prevent unwanted reactions:
• rule out any previous allergic reactions to this or other medicines;
• rule out the existence of other contraindications or conditions that may expose you to the risk of potentially serious undesirable 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.

Allergic reactions
Acetylsalicylic acid and other NSAIDs can cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes) or urticaria (small itchy spots on the skin)].
The risk is greater in individuals who have previously experienced an allergic reaction after using this type of medicine (see Do not take Aspirina Rapida) and in individuals who have allergic reactions (e.g., skin reactions, itching, urticaria) to other substances.
In individuals with asthma and/or rhinitis (with or without nasal polyps) and/or urticaria, reactions may be more frequent and severe.

Tell your doctor if:
- you are to undergo surgery (even minor, such as tooth extraction), as pre-operative use of this medicine may make it more difficult to stop bleeding during surgery (intraoperative hemostasis);
- you need to undergo a fecal occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will only prescribe this medicine after a careful assessment of the risk/benefit ratio:
• if you have an increased risk of allergic reactions, for example if you suffer from asthma and/or rhinitis (with or without nasal polyps) and/or urticaria;
• if you have an increased risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause severe gastrointestinal side effects (bleeding, ulcer, perforation); for this reason, these medicines should not be used in individuals who suffer or have suffered in the past from gastrointestinal ulcers or gastrointestinal bleeding (see Do not take Aspirina Rapida) or who consume large quantities of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or are undergoing treatment with anticoagulant medicines (used to slow down or inhibit the blood coagulation process);
• if you suffer from impaired kidney, heart or liver function;
• if you suffer from asthma;
• if you have hyperuricemia/gout (increased uric acid level in the blood).

It is also advisable to consult your doctor if the above-mentioned disorders have occurred in the past.

• if you are taking medicines not recommended or that require special precautions or dosage adjustment (see Other medicines and Aspirina Rapida);
• if you are over 70 years of age, especially in the presence of concomitant therapies;
• if you are in the first or second trimester of pregnancy (see Pregnancy, breastfeeding and fertility);
• if you are following a low-sodium diet.

Children and adolescents
This medicine should not be taken by children and adolescents under 16 years of age.

Elderly
The risk of serious side effects is greater in elderly subjects.
If you are over 70 years of age, consult your doctor before taking this medicine.

Patients with impaired kidney and liver function
This medicine should be used with caution (see warnings and precautions).

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequently observed side effects affect the gastrointestinal system.
These disorders can be partially alleviated by taking the medicine on a full stomach. Most side effects are dependent on both the dose and the duration of treatment. The side effects observed with acetylsalicylic acid are generally common to other NSAIDs.

The following side effects may occur:
Effects on the blood
- prolonged bleeding time,
- gastrointestinal hemorrhage anemia,
- reduction in platelets (thrombocytopenia) in extremely rare cases. Following hemorrhage, hemorrhagic/iron deficiency anemia (due to iron deficiency) may occur (due, for example, to occult microhemorrhages) with related changes in laboratory parameters and related clinical signs and symptoms such as asthenia (tiredness), pallor and hypoperfusion (reduced blood supply to the tissues).

Effects on the nervous system
- headache,
- dizziness.
Rarely, the following may occur:
- Reye's syndrome (*), an acute disease affecting the brain and liver, potentially fatal, which almost exclusively affects children.
Rarely to very rarely, the following may occur:
- cerebral hemorrhage, especially in patients with uncontrolled hypertension (high blood pressure) and/or on anticoagulant therapy (medicines used to slow down or inhibit the blood coagulation process) which, in isolated cases, can be potentially fatal.

Effects on the ear
- tinnitus (ringing/hissing/clanging/whistling in the ear).

Effects on the respiratory system
- respiratory disease exacerbated by acetylsalicylic acid,
- asthmatic syndrome
- rhinitis (runny nose)
- nasal congestion (blocked nose) (associated with allergic reactions);
- epistaxis (nosebleed).

Effects on the heart
- cardiorespiratory distress (severe and acute respiratory failure) (associated with allergic reactions).

Effects on the eye
- conjunctivitis (associated with allergic reactions).

Effects on the gastrointestinal system
- gastrointestinal bleeding (occult),
- gastric disturbances,
- heartburn,
- gastrointestinal pain,
- gingival bleeding (bleeding gums),
- vomiting,
- diarrhea,
- nausea,
- crampy abdominal pain (associated with allergic reactions).
Rarely, the following may occur:
- gastrointestinal inflammation,
- gastrointestinal erosion,
- gastrointestinal ulceration,
- hematemesis (vomiting blood or coffee-ground material),
- melena (passing black, tarry stools),
- esophagitis (inflammation of the esophagus).
Very rarely, the following may occur:
- hemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with related clinical signs and symptoms and changes in laboratory parameters.
May occur with unknown frequency (especially with long-term treatment):
- intestinal diaphragm disease.

Effects on the liver
- rarely: hepatotoxicity (hepatocellular injury, generally mild and asymptomatic) which manifests as an increase in transaminases.

Effects on the skin
- skin rash,
- edema (swelling),
- urticaria,
- itching,
- erythema (redness),
- angioedema (associated with allergic reactions).

Effects on the kidneys and urinary tract
- impaired kidney function and acute kidney injury (in the presence of altered blood circulation in the kidneys),
- urogenital hemorrhages (of the urinary and genital system).

Effects on the body as a whole
- procedural hemorrhages (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, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
RS initially manifests with vomiting (persistent or recurrent) and other signs of varying degrees of brain distress: from sluggishness, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium, up to convulsions or loss of consciousness. It is important to note the variability of the clinical picture: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following a flu-like episode (or chickenpox or another viral infection) during which acetylsalicylic acid or other medicines containing salicylates have been administered, the doctor's attention must immediately be directed to the possibility of RS.