ACETYLSALICYLIC ACID LFM*20TABS500

ACETYLSALICYLIC ACID L.F.M. 500 mg tablets
Acetylsalicylic acid

What it is and what it is used for
ACETYLSALICYLIC ACID L.F.M. is an analgesic (pain reliever: reduces pain), anti-inflammatory and antipyretic (fever reducer: reduces fever).
ACETYLSALICYLIC ACID L.F.M. is used for the symptomatic treatment of febrile conditions and flu and cold syndromes, and for the symptomatic treatment of headaches, toothaches, neuralgia, menstrual pain, rheumatic pain, and muscle pain.
The product is for adult patients only.

Consult your doctor if you do not feel better or if your symptoms worsen after 3-5 days.

What you need to know before taking the medicine
Do not take ACETYLSALICYLIC ACID L.F.M.
- if you are allergic to acetylsalicylic 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 section 6);
- if you suffer from gastroduodenal ulcers (stomach ulcers or ulcers in the first part of the intestine);
- if you suffer from hemorrhagic diathesis (tendency to bleed);
- if you suffer from severe kidney (reduced kidney function) or 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 per week or more), or warfarin (see section Other medicines and ACETYLSALICYLIC ACID L.F.M.);
- if you have previously suffered from asthma induced by the administration of salicylates or similar substances, particularly non-steroidal anti-inflammatory drugs (NSAIDs);
- if you are in the last trimester of pregnancy or are breastfeeding (see Pregnancy, breastfeeding and fertility);
- if you are under 16 years of age (see Children and adolescents).

Warnings and precautions
Talk to your doctor or pharmacist before taking ACETYLSALICYLIC ACID L.F.M.
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 spots on the skin accompanied by itching)].
The risk is greater in individuals who have previously experienced an allergic reaction after using this type of medicine and in individuals who experience allergic reactions (e.g., skin reactions, itching, urticaria) to other substances.
In individuals with asthma and/or rhinitis (with or without nasal polyposis) 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 perform an occult blood test, as acetylsalicylic acid can cause gastrointestinal bleeding.

In the following cases, your doctor will prescribe this medicine only after a careful evaluation of the risk/benefit ratio:
- if you have a greater 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 greater risk of gastrointestinal lesions, as acetylsalicylic acid and other NSAIDs can cause serious gastrointestinal side effects (bleeding, ulcers, perforation); for this reason, these medicines should not be used in individuals who suffer or have suffered in the past from gastrointestinal ulcers or gastrointestinal bleeding (see Do not take ACETYLSALICYLIC ACID L.F.M.) or who consume high amounts of alcohol or higher doses of acetylsalicylic acid (dose-related effect);
- if you have blood clotting defects or if you are undergoing treatment with anticoagulant medicines (used to slow down or inhibit the blood clotting 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.
It is also advisable to consult your doctor if the disorders listed above have occurred in the past.

- if you are taking medicines not recommended or that require special precautions or dosage adjustment (see Other medicines and ACETYLSALICYLIC ACID L.F.M.);
- 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).

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.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequently observed side effects concern the gastrointestinal system.
These disorders can be partially relieved 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
- prolonged bleeding time,
- anemia due to gastrointestinal bleeding,
- reduction of platelets (thrombocytopenia) in extremely rare cases.
Following hemorrhage, acute and chronic post-hemorrhagic/iron deficiency anemia (due to, for example, occult microhemorrhages) may occur, with related 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 brain and liver disease, potentially fatal, which affects almost exclusively children.
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
- asthmatic syndrome,
- rhinitis (runny nose)
- nasal congestion (stuffy 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 (stomach acid),
- gastrointestinal pain,
- gingival bleeding (bleeding gums),
- vomiting,
- diarrhea,
- nausea,
- crampy abdominal pain (associated with allergic reactions).
Rarely, the following may occur:
- gastrointestinal inflammation,
- gastrointestinal erosion,
- gastrointestinal ulceration,
- hematemesis (vomiting blood or coffee-ground material),
- melena (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.

Effects on the liver
- rarely: hepatotoxicity (hepatocellular injury, generally mild and asymptomatic) which manifests as 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
- altered kidney function (in the presence of altered blood circulation in the kidneys),
- urogenital bleeding (of the urinary and genital system).

Effects on the body as a whole
- peri-operative hemorrhages (just before, during and immediately after surgery),
- hematomas (collections of blood outside blood vessels).

Effects on the immune system
- rarely: anaphylactic shock (severe allergic reaction, potentially fatal) with related changes in laboratory parameters and clinical manifestations.

Other possible side effects:
- delayed labor.

(*) 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 an influenza episode (or flu-like illness or chickenpox or another viral infection) during which acetylsalicylic acid or other salicylate-containing medicines 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.