ASPIRIN*ORAL GRN 10SACH400+240

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 conditions, 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 product is for adult patients only.
Consult your doctor if you do not notice any improvement 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), to other analgesics (painkillers), antipyretics (fever reducers) / non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other ingredients of this medicine (listed in paragraph 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 bleed);
- 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 survival of red blood cells);
- 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 a history of asthma induced by the administration of salicylates or substances with similar activity, particularly 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 or stones in the urinary tract);
- If you suffer from hyperoxaluria (increased urinary excretion of calcium oxalate);
- hemochromatosis (a disorder of iron metabolism that leads to the 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 necessary precautions to prevent adverse 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 previously experienced an allergic reaction 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 polyposis) and/or urticaria, reactions may be more frequent and severe.

Inform your doctor if:
- you are to undergo surgery (even minor surgery 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 perform a fecal occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe this medicine only after a careful assessment 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 polyposis) and/or urticaria;
• if you have a higher 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 ulcer or gastrointestinal bleeding (see Do not take Aspirin 400 mg effervescent granules with Vitamin C) or who use 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 have asthma;
• if you have hyperuricemia/gout (increased uric acid level in the blood);
• if you are predisposed to calcium-oxalate nephrolithiasis (kidney stones) or recurrent nephrolithiasis.

It is also advisable to consult your doctor 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 adjustment (see Other medicines and Aspirin 400 mg effervescent granules with Vitamin C);
• 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 the elderly.
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 tract.
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 blood - prolonged bleeding time,
- anemia from gastrointestinal hemorrhage,
- reduction of platelets (thrombocytopenia) in extremely rare cases.
Hemorrhagic/sideropenic anemia (due to iron deficiency) (due, for example, to occult microhemorrhages) may occur following hemorrhage, with the 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 disease affecting the brain and liver, potentially fatal, 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/tinkling/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 tract
- gastrointestinal bleeding (occult),
- gastric disorders,
- heartburn (stomach acid),
- gastrointestinal pain,
- gingivorrhagia (bleeding gums),
- vomiting,
- diarrhea,
- nausea,
- cramping 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 (generally mild and asymptomatic hepatocellular damage) manifesting with 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
- altered renal function (in the presence of altered blood circulation in the kidneys) and acute kidney injury,
- urogenital hemorrhages (of the urinary and genital tract).

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, 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 cerebral distress: from listlessness, drowsiness or personality changes (irritability or aggressiveness) to disorientation, confusion or delirium, up to convulsions or loss of consciousness. The variability of the clinical picture should be noted: 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 should immediately be directed to the possibility of RS.

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: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.