ASPIRIN C*10 EFF TABS 400+240MG

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 (fever reducer: reduces fever).
Aspirin is used for the symptomatic treatment of feverish conditions, flu-like syndromes, and colds, and for the symptomatic treatment of headaches, toothaches, neuralgia, menstrual pain, and rheumatic and muscular 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 tablets 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 (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, liver or heart failure (reduced function of the kidneys, liver or heart);
– 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 previously suffered 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 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 (stones in the urinary tract or kidney);
– 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 tablets with Vitamin C.
Take the medicine only on a full stomach.
Before administering any medicine, you must take all useful precautions to prevent undesirable 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 reactionsAcetylsalicylic 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 higher in subjects who have already had an allergic reaction after using this type of medicine in the past (see “Do not take Aspirin 400 mg effervescent tablets 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 need to undergo surgery (even minor 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 undergo a fecal occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe the administration of 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 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 tablets with Vitamin C”) or who use high quantities of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood coagulation defects or if you are undergoing treatment with anticoagulants (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);
• 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 a dosage adjustment (see “Other medicines and Aspirin 400 mg effervescent tablets with Vitamin C”);
• if you are over 70 years of age, especially if you are on 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 higher 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
- prolongation of bleeding time;
- anemia from gastrointestinal bleeding;
- reduction of platelets (thrombocytopenia) in extremely rare cases.
Following bleeding, 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 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 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 system
– gastrointestinal bleeding (occult);
– gastric disorders;
– heartburn;
– gastrointestinal pain;
– gingival bleeding (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 of 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 (hepatocellular injury, generally mild and asymptomatic) which manifests 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
– alteration of kidney function (in the presence of conditions of altered blood circulation in the kidneys) and acute kidney injury;
– urogenital hemorrhages (of the urinary and genital system).

Effects on the whole organism
– 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 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 kept in mind: even vomiting may be absent or replaced by diarrhea.
If these symptoms occur in the days immediately following a flu-like episode (or similar-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.