FLUIMUCIL MUCOL*10EFF TAB 600MG

ALGOPIRINA 300mg + 200mg tablets
acetylsalicylic acid and paracetamol
Equivalent medicinal product

What it is and what it is used for
ALGOPIRINA contains the active ingredients acetylsalicylic acid and paracetamol.
Acetylsalicylic acid and paracetamol belong to a group of medicines called analgesics and antipyretics. Both have a rapid antipyretic and pain-relieving (analgesic) action, combined with an anti-inflammatory action.
ALGOPIRINA is indicated for the treatment of flu and cold symptoms; for the symptomatic treatment of headaches, nerve inflammation (neuralgia), toothaches, menstrual pain and joint pain.
Consult your doctor if you do not feel better or if you feel worse after 5-7 consecutive days of treatment. Take ALGOPIRINA on a full stomach.

What you need to know before taking this medicine
Do not take ALGOPIRINA
- If you are allergic (hypersensitive) to paracetamol, acetylsalicylic acid and/or related substances, or to any of the other ingredients of this medicine listed in section 6.
- If you have a history of gastrointestinal bleeding or tears due to previous treatments, or a history of frequent gastrointestinal bleeding/tears (ulcer) (two or more distinct episodes of confirmed ulceration or bleeding).
- If you have a confirmed tendency to develop bleeding, stomach diseases (e.g., gastroduodenal ulcer), asthma, reduced kidney function; abnormally low levels of phosphate in the blood (hypophosphatemia).
- If you suffer from severe heart failure.
- If you suffer from a condition known as glucose-6-phosphate dehydrogenase deficiency (an enzyme whose genetically determined absence causes a disease characterized by reduced red blood cell survival), or if you suffer from a condition called hemolytic anemia (a pathological state characterized by low hemoglobin concentration in the blood).
- If you suffer from severe liver problems.
- During the third trimester of pregnancy at doses higher than 100 mg/day.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALGOPIRINA
- If you are already taking any other non-steroidal anti-inflammatory drug (NSAID);
- If you are an elderly patient and/or have suffered from gastrointestinal bleeding, especially if complicated by tears (see "Do not take ALGOPIRINA"), if you are using acetylsalicylic acid or other medicines that can cause gastrointestinal damage. The risk of gastrointestinal bleeding or perforation is higher with high doses of NSAIDs. Your doctor will therefore advise you to start treatment with the lowest available dose and to also use stomach protective drugs (misoprostol or proton pump inhibitors) concurrently (see below and "Other medicines and ALGOPIRINA"). For these patients with a history of damage to the gastrointestinal tract, and especially for the elderly, it is advisable to keep your doctor constantly informed about any unusual gastrointestinal symptoms, especially during the initial stages of treatment;
- If you are taking oral corticosteroids, or medicines to reduce blood clot formation (anticoagulants) such as warfarin, or antidepressants (selective serotonin reuptake inhibitors) or agents that reduce platelet aggregation in the blood (antiplatelet agents) such as acetylsalicylic acid. Caution is advised before using ALGOPIRINA because these medicines could increase the risk of developing bleeding/tears in the stomach or intestines (see "Other medicines and ALGOPIRINA");
- If you suffer from gastrointestinal diseases, such as ulcerative colitis or Crohn's disease. Your doctor will advise you on the most suitable therapy as the concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) can amplify these pathological conditions (see section 4);
- If you suffer from a condition known as glucose-6-phosphate dehydrogenase deficiency, from gastric or intestinal disorders, or from impaired kidney function, or if you are pregnant;
- If you suffer from high blood pressure, and/or impaired heart function. Concomitant use of NSAIDs can cause water retention and swelling due to an accumulation of fluids in the intracellular spaces (edema);
- In case of infections caused by viruses, such as flu or chickenpox. Consult your doctor before administering the product to children;
- In children under 12 years of age. The product should only be administered under medical prescription;
- If you suffer from kidney or liver problems;
- If you are already using a medicine containing the same active ingredient paracetamol; in fact, if paracetamol is taken in high doses, serious adverse reactions can occur. Your doctor will tell you whether or not you can take other medicines while taking ALGOPIRINA (see "Other medicines and ALGOPIRINA").

While using ALGOPIRINA, always keep in mind that:
- Undesirable effects can be minimized by using the drug at the lowest effective dose and for the shortest duration of treatment capable of controlling symptoms;
- Elderly patients are more likely to develop undesirable effects to NSAIDs, especially gastrointestinal bleeding and perforations, which can be fatal (See section 3);
- At any time, with or without warning symptoms or a previous history of serious gastrointestinal events, during treatment with all NSAIDs, gastrointestinal bleeding, injury and perforation, which can be life-threatening, have been reported. When such events occur, immediately stop treatment and inform your doctor or go to the nearest hospital;
- You should not use ALGOPIRINA for prolonged treatments;
- You should consult your doctor if, after a continuous treatment period of 5-7 days, you do not show appreciable improvements in your condition;
- High or prolonged doses of the product can cause high-risk liver diseases and serious kidney and blood alterations;
- In case of infections caused by viruses, such as flu or chickenpox, if prolonged vomiting or deep drowsiness appear during treatment, stop treatment and contact your doctor;
- Use before an operation can interfere with any attempts to block bleeding (hemostasis) during an operation;
- In case of an allergic reaction, stop taking ALGOPIRINA;
- Very rarely, cases of serious skin reactions, some of which fatal, have been reported, such as severe widespread skin irritation with skin peeling (exfoliative dermatitis), severe skin reaction with skin peeling and swelling, skin, mouth, eye, genital blisters (Stevens-Johnson Syndrome), and severe and widespread skin rash with fever (toxic epidermal necrolysis) (see section 4). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Stop treatment when you notice the first appearance of a skin rash, skin lesion, or any other sign of allergy and contact your doctor.

Children
In children under 12 years of age, the product should only be administered under medical prescription.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.

If you experience any of the following serious side effects, stop treatment with ALGOPIRINA and inform your doctor immediately:
- peptic ulcers, gastrointestinal perforation or hemorrhage, sometimes fatal, particularly in the elderly (see "Warnings and precautions");
- allergic reactions such as severe and sudden swelling of the skin or mucous membranes, for example swelling of the hands, feet and ankles, swelling around the eyes, face, lips, tongue and/or throat (angioedema), severe allergic reaction with sudden onset (anaphylactic shock).
Gastrointestinal side effects are the most commonly reported with the use of ALGOPIRINA.

Other side effects that may occur with ALGOPIRINA are:
- nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, black stools (melena), stomach bleeding through vomiting (hematemesis), inflammation with oral cavity lesion, worsening of gastrointestinal system diseases such as colitis and Crohn's disease (see "Warnings and precautions");
- gastritis (less frequently);
- gastrointestinal disturbances, dizziness, allergic skin rashes;
- reduction in the number of all blood cells (thrombocytopenia, leukopenia, anemia, agranulocytosis), severe liver problems (altered liver function and hepatitis), severe kidney problems (acute renal failure, interstitial nephritis, hematuria, anuria).
Due to the presence of acetylsalicylic acid, the following may occur:
- ear disorders (such as tinnitus, etc.), bleeding episodes (epistaxis, gingival bleeding, etc.), delayed delivery (see Pregnancy and breastfeeding) and reduction in the number of platelets in the blood.
Due to the presence of paracetamol, the following may occur:
- severe skin reactions, some of which fatal, such as severe skin inflammation (erythema multiforme), severe widespread skin irritation with skin peeling (exfoliative dermatitis), severe skin reaction with skin peeling and swelling, skin, mouth, eye, genital blisters (Stevens-Johnson Syndrome), and severe and widespread skin rash with fever (toxic epidermal necrolysis).

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.