ASPIRINAACT*10CPR EFF800+480MG

Aspirinaact 800 mg/480 mg effervescent tablets with Vitamin C
Acetylsalicylic acid and ascorbic acid

What it is and what it is used for
Aspirinaact contains:
   • acetylsalicylic acid, which relieves pain and reduces fever;
   • ascorbic acid, also known as vitamin C.
Aspirinaact is used:
   • for the symptomatic treatment of mild to moderate pain, such as headache, toothache, and menstrual pain;
   • in common cold or flu symptoms for the symptomatic treatment of pain and fever;
   • Vitamin C (ascorbic acid) supports the body's defence system, promoting the action of white blood cells.

Aspirinaact is used in adults and adolescents over 16 years of age.

What you need to know before taking the medicine
Do not take Aspirinaact:
• if you are allergic
   - to acetylsalicylic acid, ascorbic acid, or any of the other ingredients of this medicine (listed in section 6);
   - to other non-steroidal anti-inflammatory drugs (NSAIDs), which are medicines used to treat pain, fever, or inflammation.
• if you have too many mast cells (pre-existing mastocytosis). The use of acetylsalicylic acid can induce severe hypersensitivity reactions (including circulatory shock with redness, low blood pressure, rapid heart rate, and vomiting);
• if you have a history of asthma caused by the use of acetylsalicylic acid or a similar medicine (in particular NSAIDs);
• in the third trimester of pregnancy (if you are more than 24 weeks pregnant);
• if you suffer from gastric or intestinal ulcers;
• if you have bleeding or a risk of bleeding (bleeding condition);
• if you have severely reduced liver or kidney function;
• if you have severely reduced and uncontrolled heart function;
• if you are taking methotrexate therapy in doses of 15 mg/week or more;
• if you are taking blood thinners and anti-clotting medicines (oral anticoagulants) and have a history of gastric or intestinal ulcers;
• if you have kidney stones, a condition where stones form, or a history of kidney stones (nephrolithiasis);
• if you have urinary excretion with high amounts of calcium oxalate crystals (hyperoxaluria);
• if you have a condition that leads to increased iron accumulation in the body (iron overload-hemochromatosis).

Warnings and precautions
Talk to your doctor or pharmacist before taking Aspirinaact
• if you are using other medicines containing acetylsalicylic acid, to avoid the risk of overdose.
• if headaches occur while taking high doses of analgesics for a long period. Do not increase the dose; instead, ask your doctor or pharmacist for advice.
• if you are using analgesics regularly, especially different analgesics in combination. This use could lead to persistent kidney damage, with a risk of reduced kidney function.
• if you have a history of gastric or intestinal ulcer or bleeding, or stomach inflammation (gastritis).
• if you are also taking medicines that thin the blood and prevent clotting (anticoagulants).
• Stop taking Aspirinaact immediately and contact your doctor if gastric or intestinal bleeding or ulcers occur. Signs are blood from the mouth, blood in the stools, and black discoloration of the stools.
• if you have reduced kidney function, or heart or circulatory problems, such as in cases of renal vascular disease, heart failure, recent major surgery, or severe bleeding. Taking acetylsalicylic acid can further reduce kidney function, leading to acute kidney failure. Do not take Aspirinaact if you have severely reduced kidney function or uncontrolled heart function.
• if you have reduced liver function.
Do not take Aspirinaact if you have severely reduced liver function.
• if you have heavy menstrual flow (the volume and duration of menstruation may be increased).
• if you are going to undergo surgery.
Acetylsalicylic acid increases the risk of bleeding; even at low doses or if taken several days beforehand. Inform your doctor, surgeon, anaesthetist, or dentist if you are going to undergo any surgery, even minor (e.g. tooth extraction).
• Acetylsalicylic acid reduces uric acid excretion. This can lead to gout if you already tend to have limited uric acid excretion.
• if you have Glucose-6-phosphate dehydrogenase (G6PD) deficiency: a hereditary disease affecting red blood cells. Acetylsalicylic acid must be administered under medical supervision.
• if you have increased urinary oxalate excretion (hyperoxaluria), a tendency to form calcium oxalate kidney stones, or recurrent kidney stones.
• if you have iron overload or iron utilisation disorders (Mediterranean anaemia, hemochromatosis, sideroblastic anaemia).
• if you have asthma.
Do not take this medicine if the third point of paragraph 2 Do not take Aspirinaact applies to you.
Acetylsalicylic acid can cause bronchial muscle cramps and asthma attacks or other hypersensitivity reactions. Risk factors include:
   - history of asthma
   - hay fever
   - nasal polyps, long-term (chronic) airway disease
   - allergic reactions, such as skin reactions (e.g. itching, hives).
• The use of this medicine is not recommended during breastfeeding.

Children and adolescents
Reye's syndrome, a very rare and potentially fatal disease associated with neurological and liver damage, has been observed in children suffering from virus-induced diseases (especially influenza and chickenpox), when acetylsalicylic acid is used. Consequently:
• acetylsalicylic acid should be administered to children and adolescents in these conditions only after medical advice and when other measures have proven ineffective.
• if signs of dizziness or fainting, abnormal behaviour or vomiting occur, stop treatment and inform your doctor immediately.

The use of salicylates should be avoided for 6 weeks after vaccination against the chickenpox virus.

This medicine is not indicated for children and adolescents under 16 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Aspirinaact and inform your doctor immediately or go to the nearest hospital if you notice any of the following symptoms:
• swelling of the face, tongue and windpipe that causes great difficulty breathing, and which is a sign of a severe allergic reaction (angioedema)
• stomach pain, black stools, haematemesis (vomiting blood), vomit the colour of coffee grounds, which are signs of gastric or intestinal bleeding

Side effects can occur with the following frequencies:

Common: may affect up to 1 in 10 people
• gastric or intestinal disorders, such as heartburn, diarrhoea, nausea, vomiting, indigestion

Uncommon: may affect up to 1 in 100 people
• stomach, intestinal and abdominal pain
• hives, rash, itching

Rare: may affect up to 1 in 1,000 people
• inflammation and gastric and intestinal ulcer (inflammations and ulcers of the oesophagus, stomach or intestine). These reactions may or may not be associated with bleeding, and may occur with any dose of acetylsalicylic acid in patients with or without warning symptoms or a previous history of serious gastrointestinal events.
• hypersensitivity reactions such as asthma symptoms, runny nose and blocked nose

Very rare: may affect up to 1 in 10,000 people
• occult or overt bleeding of the stomach or intestine (blood in vomit, black stools, etc.) leading to iron deficiency anaemia. The risk of bleeding is dose-related
• stomach and intestinal perforations
• reduced uric acid excretion, which can cause gout in patients with limited uric acid excretion

Not known: frequency cannot be estimated from the available data
• increases in liver enzyme levels called transaminases, reduced liver function
• liver injury, mainly to liver cells
• reduced red blood cell count (anaemia) as a result of bleeding
• drop and destruction of red blood cells in patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency
• drop in platelet count
• low blood sugar (hypoglycaemia)
• skin reactions
• hypersensitivity reactions, severe allergic reactions (anaphylactic reactions)
Hypersensitivity reactions can affect the skin, airways, circulatory system, stomach and intestine, particularly in patients with asthma. Symptoms include:
- swelling of tissues caused by excess fluid
- drop in blood pressure
- shortness of breath, dyspnoea
- cardiac or respiratory distress
- potentially fatal allergic shock reaction
- rash, hives, itching, severe allergic reaction including swelling of the face or throat
- asthma symptoms, inflammation inside the nose causing sneezing, runny nose and blocked nose
• bleeding with prolonged bleeding time, such as epistaxis (nosebleeds), bleeding gums, red spots under the skin, bleeding of the genitourinary organs The risk of bleeding persists for 4-8 days after stopping treatment with Aspirinaact. It can cause an increased risk of bleeding in case of surgery. Bleeding inside the skull, stomach or intestine can also occur. Bleeding inside the skull can be fatal, especially if the medicine is administered to the elderly.
• severe bleeding, cerebral haemorrhage, especially in patients with uncontrolled hypertension and/or who use medicines to inhibit blood clotting (anticoagulants) In isolated cases, these effects could be potentially fatal.
• fluid in the lungs (non-cardiogenic pulmonary oedema) with chronic use and in the context of a hypersensitivity reaction due to acetylsalicylic acid.
• reduced kidney function, up to rapid loss of kidney function, gallstones due to ascorbic acid.
• diarrhoea with high doses of ascorbic acid.
• headache, dizziness, feeling of hearing loss, tinnitus (constant perception of a sound in the ears), which are signs of overdose
• Reye's Syndrome (disorder of consciousness or abnormal behaviour, or vomiting) (see paragraph 2. What you need to know before taking Aspirinaact)
• Intestinal diaphragm disease (narrowing of the intestine) (mainly in long-term treatments).

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.