Name
Aspirin 400 mg effervescent tablets 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 (antifebrile: reduces fever).
Aspirin is used for the symptomatic treatment of feverish states and flu and cold syndromes and for the symptomatic treatment of headaches and toothaches, neuralgia, menstrual pain, rheumatic and muscular pain.
Vitamin C (ascorbic acid) participates in the body's defense system.
The product is intended for use by adult patients only.
Contact your doctor if you notice no improvement or if you notice worsening of symptoms after 3-5 days.


What you need to know before taking the medicine
Do not take Aspirin 400 mg effervescent tablets with Vitamin C
- if you are allergic to acetylsalicylic acid, ascorbic acid, other analgesics (painkillers)/antipyretics (fever relievers)/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 (ulcer in the stomach or the first part of the intestine);
- if you suffer from haemorrhagic diathesis (tendency to bleed);
- if you suffer from severe renal (reduced kidney function) or hepatic (liver) or cardiac (heart) insufficiency;
- 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 tablets with Vitamin C");
- 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 (NSAIDs);
- if you are in the last trimester of pregnancy or if you are breast-feeding (see "Pregnancy, breast-feeding and fertility");
- if you are under 16 years of age (see "Children and adolescents");
- if you suffer or have suffered from nephrolithiasis (stones in the urinary tract or kidney);
- if you suffer from hyperoxaluria (increased urinary excretion of calcium oxalate);
- hemochromatosis (alteration of iron metabolism which leads to the progressive accumulation of iron in the body).


Warnings and precautions
Talk to your doctor or pharmacist before taking Aspirin 400 mg effervescent tablets with Vitamin C.

Take the medicine only on a full stomach.
Before administering any medicine you must take all necessary 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 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.

Allergic reactions
Acetylsalicylic acid and other NSAIDs may 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 higher 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 tablets with Vitamin C") and in subjects who have allergic reactions (e.g. skin reactions, itching, hives) 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.

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

In the following cases, your doctor will prescribe this medicine only after a careful risk/benefit assessment:
• 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 an increased risk of gastrointestinal lesions, since acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcer, perforation); for this reason these medicines must 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 tablets with Vitamin C") or who consume large quantities of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood clotting problems or if you are undergoing treatment with anticoagulant 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 level of uric acid in the blood);
• if you have a predisposition to calcium-oxal 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 any medicines that are not recommended or that require special precautions or dosage adjustment (see "Other medicines and Aspirin 400 mg effervescent tablets 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, breast-feeding and fertility");
• if you are on a low-sodium diet.

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

Elderly people
The risk of serious side effects is higher in older people.
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 involve the gastrointestinal system.
These symptoms 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,
- anemia due to gastrointestinal bleeding,
- reduction of platelets (thrombocytopenia) in extremely rare cases. Following haemorrhage, haemorrhagic/iron deficiency anaemia (due, for example, to occult microhaemorrhages) may occur with related alterations 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
- heachache,
- dizziness.
Rarely, the following may occur:
- Reye's syndrome (*), an acute, potentially fatal disease of the brain and liver that affects almost exclusively children.
Rarely to very rarely, the following may occur:
- cerebral haemorrhage, 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 life-threatening.

Effects on the ear
- tinnitus (ringing/buzzing/ringing/ringing 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 disorders,
- heartburn (pyrosis),
- gastrointestinal pain,
- gingivorrhagia (bleeding gums),
- vomit,
- 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 (emission of black, tarry stools),
- esophagitis (inflammation of the esophagus)
Very rarely, the following may occur:
- haemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with related clinical signs and symptoms and alterations in laboratory parameters.
Frequency not known (especially in long-term treatment):
- Disease of the intestinal diaphragms.

Effects on the liver
- rarely: hepatotoxicity (generally mild and asymptomatic hepatocellular damage) manifested by an increase in transaminases.

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

Effects on the kidneys and urinary tract
- alteration of renal function (in the presence of conditions of altered blood circulation in the kidneys) and acute kidney injury,
- urogenital bleeding (of the urinary and genital tract).

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 allergic reaction, potentially fatal) with related alterations in laboratory parameters and clinical manifestations.

(*) Reye's Syndrome (RS)
SdR initially manifests itself with vomiting (persistent or recurrent) and with other signs of encephalic suffering of varying degrees: 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 must be taken into account: vomiting may also be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following an episode of influenza (or flu-like illness or chickenpox or another viral infection) during which acetylsalicylic acid or other medicinal products containing salicylates have been administered, the doctor's attention must immediately be drawn 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.