ASPIRIN*ORAL GRANULES 10 SACHETS 500MG

Aspirin 400 mg effervescent granules with Vitamin C
Acetylsalicylic acid + ascorbic acid

What it is and what it is used for
Aspirin is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (fever reducer: reduces fever).
Aspirin is used for the symptomatic treatment of feverish states, flu and cold syndromes, and for the symptomatic treatment of headaches, toothaches, neuralgia, menstrual pain, rheumatic pain, and muscle pain.
Vitamin C (ascorbic acid) participates in the body's defense system.
The use of this product is reserved for adult patients only.
Consult your doctor if you do not notice improvements or if your symptoms worsen after 3-5 days.

What you need to know before taking the medicine
Do not take Aspirin 400 mg effervescent granules with Vitamin C
- if you are allergic to acetylsalicylic acid, ascorbic acid), other analgesics (pain relievers), antipyretics (fever reducers)/non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in paragraph 6);
- if you suffer from gastroduodenal ulcer (ulcer in the stomach or 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, or heart 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 Aspirin 400 mg effervescent granules with Vitamin C);
- 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 if you are breastfeeding (see Pregnancy, breastfeeding and fertility);
- if you are under 16 years of age (see Children and adolescents);
- if you suffer or have suffered from nephrolithiasis (kidney stones in the urinary tract or kidney);
- if you suffer from hyperoxaluria (increased urinary excretion of calcium oxalate);
- hemochromatosis (iron metabolism disorder that leads to progressive accumulation of iron in the body).

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirin 400 mg effervescent granules with Vitamin C.

Take the medicine only on a full stomach.
Before administering any medicine, you must take all useful precautions to prevent unwanted reactions:
• exclude the existence of previous allergic reactions to this or other medicines;
• exclude the existence of other contraindications or conditions that may expose you to the risk of potentially serious adverse effects. In case of doubt, consult your doctor or pharmacist;

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 spots on the skin accompanied by itching)].
The risk is greater in subjects who have already had an allergic reaction in the past after using this type of medicine (see Do not take Aspirin 400 mg effervescent granules with Vitamin C) and in subjects who have allergic reactions (e.g. skin reactions, itching, urticaria) to other substances.
In subjects 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 must undergo surgery (even minor surgery such as tooth extraction), as the pre-operative use of this medicine can make it more difficult to stop bleeding during surgery (intraoperative hemostasis);
- you need to have a test for occult blood, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe this medicine only after a careful evaluation of the risk/benefit ratio:
• if you have a higher 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 serious gastrointestinal side effects (bleeding, ulcer, perforation); for this reason, these medicines should not be used in subjects who suffer or have suffered in the past from gastrointestinal ulcers or gastrointestinal bleeding (see Do not take Aspirin 400 mg effervescent granules with Vitamin C) or who consume high amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood clotting defects or if you are undergoing treatment with anticoagulants (medicines used to slow down or inhibit the blood clotting 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);
• if you have a predisposition to calcium-oxalate nephrolithiasis (kidney stones) or recurrent nephrolithiasis.

It is advisable to consult your doctor even if the above-mentioned disorders have occurred in the past.
• if you are taking medicines that are not recommended or that require special precautions or dosage adjustments (see Other medicines and Aspirin 400 mg effervescent granules with Vitamin C);
• if you are over 70 years of age, especially if you are taking 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 bleeding anemia,
- reduction of platelets (thrombocytopenia) in extremely rare cases.
Following hemorrhage, hemorrhagic/iron deficiency anemia (due to iron deficiency) (due, for example, to occult microhemorrhages) may occur with related changes in laboratory parameters and related clinical signs and symptoms such as asthenia (tiredness), pallor and hypoperfusion (reduced blood supply to tissues).

Effects on the nervous system
- headache,
- dizziness.
Rarely, Reye's syndrome (*) may occur, an acute, potentially fatal disease affecting the brain and liver, which affects almost exclusively children.
From 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 clotting 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
- Acetylsalicylic acid-exacerbated respiratory disease
- asthmatic syndrome
- rhinitis (runny nose)
- nasal congestion (stuffy 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,
- cramp-like 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 (emission of 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.
Frequency not known (especially in long-term treatment):
- Intestinal diaphragm disease.

Effects on the liver
- rarely: hepatotoxicity (usually mild and asymptomatic hepatocellular damage) manifesting 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 renal function (in the presence of conditions of altered blood circulation in the kidneys) and acute kidney injury,
- urogenital hemorrhages (of the urinary and genital systems).

Effects on the organism as a whole
- procedural 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, potentially fatal allergic reaction) 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 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: even vomiting may be absent or replaced by diarrhea.
If these symptoms appear in the days immediately following a flu-like episode (or similar to flu 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.

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