LASONIL ANTI-INFLAMMATORY*12 TABLETS 220MG

Lasonil anti-inflammatory and anti-rheumatic 220 mg film-coated tablets
Naproxen sodium

What it is and what it is used for
Lasonil anti-inflammatory and anti-rheumatic is a medicine belonging to the category of non-steroidal anti-inflammatory/anti-rheumatic drugs, known as NSAIDs.
This medicine is used for the symptomatic treatment of headaches, backaches, joint and muscle pain, toothaches, and cold-related illnesses. It is also indicated for menstrual pain and minor pain in arthritis and osteoarthritis.

Consult your doctor if you do not feel better or if you feel worse after 3 days in case of cold-related illness, or after 7 days if you are taking the medicine for symptomatic pain treatment.

What you need to know before taking the medicine
Do not take Lasonil anti-inflammatory and anti-rheumatic
• If you are allergic to naproxen or any of the other ingredients of this medicine (listed in paragraph 6);
• If you have a history of asthma, urticaria (itching and small skin spots) or allergic reactions following the intake of acetylsalicylic acid or other painkillers, antipyretics, non-steroidal anti-inflammatory drugs;
• If you suffer from severe kidney failure (the laboratory test to evaluate kidney function, called creatinine clearance, gives values below 20 ml/min);
• If you suffer from severe heart failure;
• If you suffer from liver cirrhosis or a severe form of hepatitis (liver inflammation);
• If you are undergoing intensive therapy with diuretics (medicines that increase urine production);
• If you suffer from gastric or duodenal ulcers;
• If you are currently bleeding or are at risk of bleeding;
• If you are undergoing treatment with anticoagulants (medicines that delay blood clotting), as this medicine enhances their action;
• If you are pregnant or breastfeeding (see Pregnancy, breastfeeding and fertility);
• If you are under 16 years of age;
• If you have had gastrointestinal bleeding or perforation in the past following treatment with certain medicines or have suffered from recurrent gastrointestinal bleeding/ulcer (two or more distinct episodes of proven ulceration or bleeding).

Warnings and precautions
Consult your doctor or pharmacist before taking Lasonil anti-inflammatory and anti-rheumatic.

Do not use the product for gastrointestinal pain.
Avoid using Lasonil anti-inflammatory and anti-rheumatic in conjunction with other NSAIDs, including selective COX-2 inhibitors.
After administration of painkillers, antipyretics, non-steroidal anti-inflammatory drugs, asthma may worsen.

To minimise side effects, take the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see the paragraphs below on gastrointestinal and cardiovascular risks).

If the pain persists or if the painful area is red/swollen, or if new symptoms appear compared to those for which you took the medicine, consult your doctor.

Take the medicine only after consulting your doctor:
- if you suffer from hepatic insufficiency (reduced liver function) and if you are undergoing intensive therapy with diuretics (medicines that increase urine production);
- if you are undergoing concomitant treatment with other medicines that may increase the risk of ulceration or bleeding, such as antidepressants, other painkillers, or steroid medicines (e.g. cortisone);
- if you have had gastrointestinal side effects in the past caused by taking painkillers, antipyretics, NSAIDs;
- if you have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease);
- if you suffer from hypertension (high blood pressure) and/or heart failure since, in association with NSAID treatment, fluid retention, hypertension and oedema (swelling) and a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) have been observed;
- if you suffer from coagulation disorders or if you are undergoing therapy with anticoagulants (medicines that delay blood clotting); in this case, you must be carefully monitored by your doctor, as naproxen inhibits platelet aggregation and can prolong bleeding time.

Allergic or similar allergic reactions
Painkillers, antipyretics, non-steroidal anti-inflammatory drugs can cause allergic reactions, potentially fatal. These reactions can occur in subjects with a history of angioedema (swelling of the facial skin and mucous membranes), altered bronchial reactivity (asthma), rhinitis (runny nose), nasal polyposis (small growths in the nasal cavities), allergic diseases, chronic respiratory diseases or allergy to acetylsalicylic acid. This can also happen in patients who experience allergic reactions (skin reactions, urticaria) to naproxen or other NSAIDs.

Skin reactions
Serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with Lasonil anti-inflammatory and anti-rheumatic.
If you notice any of the symptoms related to these severe skin reactions, described in paragraph 4, discontinue treatment with Lasonil anti-inflammatory and anti-rheumatic and contact your doctor immediately.

Elderly
Elderly patients are more likely to experience adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see How to take Lasonil anti-inflammatory and anti-rheumatic).
Gastrointestinal bleeding, ulceration and perforation
During treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which can be fatal.
The risk of gastrointestinal bleeding, ulceration or perforation is higher in the elderly and in patients with a history of ulcer, especially if complicated by bleeding or perforation (see Do not take Lasonil anti-inflammatory and anti-rheumatic). Since the risk increases with increasing doses of NSAIDs, these patients should start treatment with the lowest available dose (see How to take Lasonil anti-inflammatory and anti-rheumatic).
Caution is also required in patients concurrently taking medicines that could increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin reuptake inhibitors (medicines used against depression) or antiplatelet agents such as acetylsalicylic acid (see Other medicines and Lasonil anti-inflammatory and anti-rheumatic).
In all these cases, the concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the initial stages of treatment.
If gastrointestinal bleeding or ulceration occurs while taking Lasonil anti-inflammatory and anti-rheumatic, stop treatment immediately.
NSAIDs should be administered with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), as these conditions may be exacerbated (see Possible side effects).

Cardiovascular and cerebrovascular effects
Medicines such as Lasonil anti-inflammatory and anti-rheumatic may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment (7 days for symptomatic pain treatment and 3 days for cold-related illnesses).
If you have heart problems or a history of stroke or if you think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes, high cholesterol or smoke), you should discuss your therapy with your doctor or pharmacist.
Painkillers, antipyretics, non-steroidal anti-inflammatory drugs can cause fluid retention which rarely, especially in elderly patients, can precipitate congestive heart failure.
Naproxen can reduce the antiplatelet effect of acetylsalicylic acid. Patients should consult their doctor if they are being treated with acetylsalicylic acid and intend to use naproxen/naproxen sodium (see section Other medicines and Lasonil anti-inflammatory and anti-rheumatic).

Effects on the liver
Severe liver reactions, including jaundice (yellowing of the skin and whites of the eyes) and hepatitis (in some fatal cases) have been reported with the use of naproxen or other NSAIDs. Cross-reactivity has also been reported.

Children and adolescents
This medicine should not be taken by children and adolescents under 16 years of age (see Do not take Lasonil anti-inflammatory and anti-rheumatic).

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

The most commonly observed adverse events concern the stomach and intestines. Peptic ulcers, gastrointestinal perforation or bleeding may occur, sometimes fatal, particularly in the elderly.
After administration of Lasonil anti-inflammatory and anti-rheumatic, the following have been reported: nausea, vomiting, diarrhoea, flatulence (gas in the intestine), constipation, dyspepsia (indigestion), abdominal pain, melaena (passage of black, tarry stools), haematemesis (vomiting blood or coffee ground material), ulcerative stomatitis (inflammation of the oral mucosa), exacerbation of colitis (inflammation of the last part of the intestine) and Crohn's disease (chronic inflammatory bowel disease).
Less frequently, gastritis has been observed.
In association with NSAID treatment, oedema (swelling), hypertension (high blood pressure) and heart failure have been reported.
Very rarely, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (two severe, potentially fatal skin diseases) have occurred.
Medicines such as Lasonil anti-inflammatory and anti-rheumatic may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke.
Lasonil anti-inflammatory and anti-rheumatic causes a modest and transient dose-dependent increase in bleeding time. However, these values often do not exceed the upper limit of the reference range.

Side effects observed with medicines based on naproxen and naproxen sodium, including those subject to medical prescription, are listed below.
Stop taking Lasonil anti-inflammatory and anti-rheumatic and contact your doctor immediately if you notice any of the following side effects:

Common side effects (may affect up to 1 in 10 people)
- dizziness;
- headache;
- light-headedness;
- dyspepsia (indigestion);
- nausea;
- heartburn;
- abdominal pain (stomach ache).

Uncommon side effects (may affect up to 1 in 100 people)
- stupor (deep drowsiness);
- insomnia;
- sleepiness;
- vertigo;
- diarrhoea;
- constipation;
- vomiting;
- skin rash;
- itching;
- urticaria (itching and small skin spots).

Rare side effects (may affect up to 1 in 1,000 people)
- hyperglycaemia (increased blood sugar level);
- hypoglycaemia (decreased blood sugar level);
- tachycardia (accelerated heartbeat);
- peptic ulcer with or without bleeding or perforation;
- gastrointestinal bleeding;
- haematemesis (vomiting blood or coffee ground material);
- melaena (passage of black, tarry stools);
- angioedema (swelling of the facial skin and mucous membranes);
- myalgia (muscle pain);
- muscle weakness;
- impaired kidney function;
- glomerulonephritis (a type of kidney inflammation);
- peripheral oedema (swelling of the extremities), particularly in patients with high blood pressure or kidney failure;
- fever (including chills).

Very rare side effects (may affect up to 1 in 10,000 people)
- anaphylaxis/anaphylactoid reactions (severe allergic or similar allergic reactions), including fatal shock;
- haematopoietic disorders (of blood cell production): leucopenia (deficiency of white blood cells), thrombocytopenia (deficiency of platelets), agranulocytosis (lack of blood cells called granulocytes), aplastic anaemia (due to lack of red blood cell production), eosinophilia (increase in blood cells called eosinophils), haemolytic anaemia (due to destruction of red blood cells);
- psychiatric disorders;
- depression;
- sleep disorders;
- difficulty concentrating;
- aseptic meningitis (non-infectious inflammation of the meninges);
- cognitive disorders (memory problems);
- convulsions;
- visual disturbances;
- corneal opacity;
- papillitis (inflammation of the front part of the optic nerve);
- retrobulbar optic neuritis (inflammation of the back part of the optic nerve);
- papilledema (swelling of the optic disc at the back of the eye);
- hearing loss;
- tinnitus (ringing or whistling in the ear);
- hearing disorders;
- interstitial nephritis (a type of kidney inflammation);
- papillary necrosis (kidney damage from painkiller abuse);
- nephrotic syndrome (kidney disease characterized by protein loss in the urine);
- kidney failure (reduced kidney function);
- kidney disease;
- haematuria (blood in the urine);
- proteinuria (protein in the urine);
- congestive heart failure (inability of the heart to pump blood);
- hypertension (high blood pressure);
- pulmonary oedema (fluid in the lungs);
- palpitations (feeling of irregular or accelerated heartbeat);
- vasculitis (inflammation of blood vessels);
- dyspnoea (difficult breathing);
- asthma;
- eosinophilic pneumonia (a type of lung inflammation);
- alveolitis (inflammation of the lung alveoli);
- pancreatitis (inflammation of the pancreas);
- colitis (inflammation of the last part of the intestine);
- aphthous ulcers (small ulcers in the mouth);
- stomatitis (inflammation of the oral mucosa);
- oesophagitis (inflammation of the oesophagus);
- intestinal ulcerations;
- cramping abdominal pain;
- hepatitis (liver inflammation, including fatal cases);
- jaundice (yellowing of the skin and whites of the eyes);
- alopecia (hair loss, usually reversible);
- photosensitivity (sensitivity to sunlight);
- porphyria (a rare disease in which the activity of particular enzymes is altered);
- erythema multiforme (red cockade-like patches on the skin);
- severe bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (two severe, potentially fatal skin diseases);
- erythema nodosum (red nodules under the skin);
- fixed erythema (redness and blisters);
- lichen planus (inflammatory reaction with formation of small purplish papules);
- pustules;
- skin rashes;
- systemic lupus erythematosus (autoimmune disease manifesting with muscle and joint pain);
- photosensitivity reactions, including pseudoporphyria cutanea tarda or epidermolysis bullosa;
- ecchymosis (bruises);
- purpura (red spots on the skin);
- sweating;
- closure of the ductus arteriosus (small vessel necessary for fetal blood circulation);
- infertility (in women);
- oedema (swelling);
- thirst;
- malaise;
- increased blood creatinine;
- altered liver function tests;
- increased blood potassium.

Side effects with unknown frequency: frequency cannot be estimated from the available data:
- widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also paragraph 2;
- a distinctive allergic skin reaction known as fixed drug eruption, which usually recurs at the same site or sites upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, rash with blisters (urticaria), itching sensation.

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.