ASPIRIN C*40 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 (painkiller: 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 and toothaches, neuralgia, menstrual pain, rheumatic pain and muscle pain.
Vitamin C (ascorbic acid) participates in the body's defence system.
The product is intended 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 tablets with Vitamin C
- if you are allergic to acetylsalicylic acid, ascorbic acid, other analgesics (painkillers)/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 haemorrhagic 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 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 tablets with Vitamin C);
- if you have a history of asthma induced by the administration of salicylates or similar substances, especially non-steroidal anti-inflammatory drugs (NSAIDs);
- if you are in the last trimester of pregnancy or 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 or urinary tract stones);
- if you suffer from hyperoxaluria (increased urinary excretion of calcium oxalate);
- hemochromatosis (a disorder of iron metabolism that leads to progressive iron accumulation 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 should take all 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 can cause allergic reactions [including asthma attacks, rhinitis (runny nose), angioedema (swelling of the skin and mucous membranes), or urticaria (small skin patches accompanied by itching)].
The risk is greater in individuals who have previously had an allergic reaction after using this type of medicine (see Do not take Aspirin 400 mg effervescent tablets with Vitamin C) 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 need 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 undergo a stool 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 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 ulcer or gastrointestinal bleeding (see Do not take Aspirin 400 mg effervescent tablets with Vitamin C) or who use high amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
• if you have blood clotting disorders 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 have a predisposition to calcium-oxalate nephrolithiasis (kidney stones) or recurrent nephrolithiasis.
It is also advisable to consult your doctor if the above 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 tablets with Vitamin C);
• if you are over 70 years old, 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 individuals.
If you are over 70 years old, 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 everyone gets them.
The most frequently observed side effects affect the gastrointestinal system.
These disturbances 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,
- anaemia due to gastrointestinal haemorrhage,
- reduction in platelets (thrombocytopenia) in extremely rare cases.Haemorrhagic/iron deficiency anaemia (due to iron deficiency) may occur following haemorrhage (due, for example, to occult microhaemorrhages) with associated changes in laboratory parameters and clinical signs and symptoms such as asthenia (fatigue), 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, potentially fatal disease affecting the brain and liver, which 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 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,
- gingivorrhagia (bleeding gums),
- vomiting,
- diarrhoea,
- nausea,
- cramping abdominal pain (associated with allergic reactions).
Rarely, the following may occur:
- gastrointestinal inflammation,
- gastrointestinal erosion,
- gastrointestinal ulceration,
- haematemesis (vomiting blood or coffee-ground material),
- melaena (black, tarry stools),
- oesophagitis (inflammation of the oesophagus)
Very rarely, the following may occur:
- haemorrhagic gastrointestinal ulcer and/or gastrointestinal perforation with associated clinical signs and symptoms and changes in laboratory parameters.
Frequency unknown (especially in long-term treatment):
- Intestinal diaphragm disease.

Effects on the liver
- rarely: hepatotoxicity (usually mild and asymptomatic hepatocellular injury) manifesting as an increase in transaminases.

Effects on the skin
- rash,
- oedema (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 haemorrhages (of the urinary and genital system).

Effects on the body as a whole
- procedural bleeding (immediately before, during, and immediately after surgery),
- haematomas (collections of blood outside the blood vessels).

Effects on the immune system
- rarely: anaphylactic shock (severe, potentially fatal allergic reaction) with associated 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 aggression) to disorientation, confusion or delirium, even to seizures or loss of consciousness. The variability of the clinical picture should be kept in mind: even vomiting may be absent or replaced by diarrhoea.
If these symptoms occur in the days immediately following a flu-like (or similar flu or chickenpox or other viral infection) episode during which acetylsalicylic acid or other medicines containing salicylates were administered, the doctor's attention should 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, talk to 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.