ASPIRINAACT DOL INF*12TABLETS 1G

Aspirinaact pain and inflammation 1000 mg film-coated tablets
Acetylsalicylic acid

What it is and what it is used for
Aspirinaact pain and inflammation contains acetylsalicylic acid, which relieves pain and reduces fever. It provides rapid pain relief due to the rapid dissolution and fast absorption of acetylsalicylic acid.

Aspirinaact pain and inflammation is used for the symptomatic treatment of mild to moderate fever and/or pain such as headache, flu syndrome, toothache, muscle pain.

Aspirinaact pain and inflammation is for adults and adolescents aged 16-65 years.

Consult your doctor if you do not notice an improvement or if symptoms worsen after 3 days in case of fever or 3-4 days in case of pain.

What you need to know before taking the medicine
Do not take Aspirinaact pain and inflammation:
If you:
• are allergic to
- acetylsalicylic acid;
- salicylates: a group of medicines to reduce pain or fever to which acetylsalicylic acid belongs;
- any of the other ingredients of this medicine (listed in section 6)
• have previously suffered from asthma or allergic reactions (e.g., hives, angioedema, severe rhinitis, shock) caused by the use of acetylsalicylic acid or similar medicines, particularly those called non-steroidal anti-inflammatory drugs (NSAIDs)
• suffer from stomach or intestinal ulcers
• have bleeding, or are at risk of bleeding
• have severely reduced liver or kidney function
• have severely reduced and uncontrolled heart function
• are taking methotrexate in doses exceeding 20 mg/week
See section 2 Other medicines and Aspirinaact pain and inflammation, first point
• are undergoing treatment with oral anticoagulants (medicines to thin the blood and prevent clot formation)
• are in the last trimester of pregnancy

Warnings and precautions
Consult your doctor or pharmacist before taking Aspirinaact pain and inflammation if: • you are taking other products containing acetylsalicylic acid, to avoid the risk of overdose.
• you have a headache after using Aspirinaact pain and inflammation.
Do not increase the dosage; consult your doctor or pharmacist if the headache occurs while taking a high dose of painkiller for a prolonged period.
• you use painkillers regularly, particularly different painkillers in combination, this can lead to reduced kidney function.
• you have a G6PD (glucose-6-phosphate dehydrogenase) deficiency (a hereditary disease that affects red blood cells), as high doses of acetylsalicylic acid could cause hemolysis (destruction of red blood cells).
• you have a history of gastric or intestinal ulcers or bleeding, or inflammation of the inner walls of the stomach.
Do not take Aspirinaact pain and inflammation if you have a stomach or intestinal ulcer, or bleeding.
Gastric or intestinal bleeding or ulcers/perforations can occur at any time during treatment. The risk increases in the elderly, in patients with low body weight, and in patients using medicines to inhibit blood clotting.
• you have reduced kidney or liver function.
Do not take Aspirinaact pain and inflammation if you have severely reduced liver or kidney function. Regular use of analgesics, especially combinations of analgesics, can lead to persistent kidney damage, with a risk of reduced kidney function.
• you have impaired cardiovascular function (e.g., when the heart does not adequately pump blood through the body, volume depletion, major surgery, blood infection, or major bleeding event).
• suffer from asthma.
Do not take Aspirinaact pain and inflammation if asthma is caused by the use of acetylsalicylic acid or similar medicines.
• you have unusually heavy and prolonged menstruation, or uterine bleeding at irregular intervals.
There is a risk of increased volume and duration of menstruation.
• you are about to undergo surgery.
Acetylsalicylic acid increases the risk of bleeding even if taken several days beforehand. Inform your doctor or dentist if surgery, even minor, is planned.
• gastrointestinal bleeding occurs during treatment (blood coming from the mouth, blood in the stools, black stools). You must stop treatment and call your doctor or emergency medical service immediately.
• suffer from gout.
Acetylsalicylic acid reduces the excretion of uric acid.
• The use of this medicine during breastfeeding is not recommended.

Children and adolescents
Aspirinaact pain and inflammation is not indicated for children and adolescents under 16 years of age.

General advice:
Reye's syndrome is a rare and serious disease associated with damage to the nervous system and liver. It has been observed in children who suffer from viral diseases, such as flu and chickenpox, and who use acetylsalicylic acid. Therefore:
• acetylsalicylic acid should be administered to children suffering from viral diseases only on medical advice
• if dizziness or fainting, abnormal behavior or vomiting occur, stop treatment and inform your doctor immediately

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. Their frequency cannot be defined based on available data.

Possible side effects due to acetylsalicylic acid:
These side effects are all very serious and you may urgently need medical attention or to be hospitalized. Inform your doctor immediately or go to the nearest hospital if you notice any of the following symptoms:
• bleeding, such as:
- epistaxis (nosebleeds), bleeding gums
- reddish or purplish spots on the skin, bruising
- bleeding from the urinary tract and genital organs.

The risk of bleeding persists for 4-8 days after stopping the use of Aspirinaact pain and inflammation. It can cause an increased risk of bleeding in case of surgery. Bleeding inside the skull, stomach or intestines may also occur.
• hypersensitivity reactions, severe allergic reactions that can cause swelling of the face or throat, asthma
• headache, dizziness, feeling of hearing loss, ringing in the ears, which are generally indicative of an overdose
• cerebral hemorrhage
• stomach pain
• gastric or intestinal bleeding.
Symptoms are blood in vomit and black stools. The risk of bleeding is dose-dependent.
• stomach ulcer and perforation
• increased liver enzyme levels, usually reversible after stopping treatment, liver impairment (mainly hepatocellular)
• hives, skin reactions
• Reye's Syndrome (see section 2)
• hemolysis (destruction of red blood cells) in cases of severe G6PD (glucose-6-phosphate dehydrogenase) deficiency
• kidney failure, kidney damage
• intestinal diaphragm disease (especially with long-term treatment)

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.