LASONIL ANTIINFLAMM 220 MG FILM-COATED TABLETS 24 TABLETS

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


What is it and what is it for?
Lasonil anti-inflammatory and antirheumatic is a medicine that belongs to the category of non-steroidal anti-inflammatory/antirheumatic drugs, so-called NSAIDs.
This medicine is used for the symptomatic treatment of headaches, backaches, joint and muscle pain, toothaches, and colds. It is also indicated for menstrual cramps and minor pain in arthritis and osteoarthritis.

Contact your doctor if you do not feel better or if you feel worse after 3 days if you have a cold, or after 7 days if you are taking the medicine for the symptomatic treatment of pain.


What you need to know before taking the medicine
Do not take Lasonil anti-inflammatory and antirheumatic:
• If you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• If you have suffered in the past from asthma, urticaria (itching and small spots on the skin) or allergic-type 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 ​​lower than 20 ml/min);
• If you suffer from severe heart failure;
• If you suffer from cirrhosis of the liver or a severe form of hepatitis (inflammation of the liver);
• If you are undergoing intensive therapy with diuretics (medicines that increase urine production);
• If you suffer from gastric or duodenal ulcer;
• If you are currently bleeding or are at risk of bleeding;
• If you are being treated with anticoagulants (medicines that slow 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/ulceration (two or more distinct episodes of proven ulceration or bleeding).


Warnings and precautions
Talk to your doctor or pharmacist before taking Lasonil anti-inflammatory and antirheumatic medicine.

Do not use the product for gastrointestinal pain.
Avoid using the anti-inflammatory and antirheumatic drug Lasonil in conjunction with other NSAIDs, including selective COX-2 inhibitors.
After administration of painkillers, antipyretics, and nonsteroidal anti-inflammatory drugs, worsening of asthma is possible.

To minimise side effects, take the lowest effective dose for the shortest duration necessary to control symptoms (see sections below on gastrointestinal and cardiovascular risks).

If the pain or redness/swelling of the painful area persists, or if new symptoms appear other than those for which you took the medicine, consult your doctor.

Take the medicine only after consulting your doctor:
- if you suffer from liver failure (reduced liver function) and if you are undergoing intensive therapy with diuretics (medicines that increase urine production);
- if you are taking 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 previously experienced side effects affecting the gastrointestinal tract 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 fluid retention, hypertension and edema (swelling) and a modest increase in the risk of arterial thrombotic events (for example myocardial infarction or stroke) have been reported in association with treatment with NSAIDs;
- if you suffer from bleeding disorders or are taking anticoagulants (medicines that slow blood clotting); in this case, you must be carefully monitored by your doctor, as naproxen inhibits platelet aggregation and may prolong bleeding time.

Allergic or allergy-like reactions
Painkillers, antipyretics, and nonsteroidal anti-inflammatory drugs can cause potentially fatal allergic reactions. These reactions may occur in individuals with a history of angioedema (swelling of the facial skin and mucous membranes), altered bronchial reactivity (asthma), rhinitis (runny nose), nasal polyps (small growths in the nasal passages), allergic diseases, chronic respiratory diseases, or an allergy to aspirin. This may also occur in patients who experience allergic reactions (skin reactions, hives) 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 the anti-inflammatory and antirheumatic drug Lasonil.
If you notice any of the symptoms of these serious skin reactions, described in section 4, stop treatment with Lasonil anti-inflammatory and antirheumatic medicine and contact your doctor immediately.

Elderly people
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 antirheumatic").

Gastrointestinal bleeding, ulceration and perforation
Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous history of serious GI events.
The risk of gastrointestinal bleeding, ulceration, or perforation is higher in the elderly and in patients with a history of ulcers, especially if complicated by haemorrhage or perforation (see "Do not take Lasonil anti-inflammatory and antirheumatic"). 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 antirheumatic").
Caution is also necessary in patients taking concomitant medications which 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 antirheumatic").
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 antirheumatic drug, discontinue 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 aggravated (see "Possible side effects").

Cardiovascular and cerebrovascular effects
Medicines such as the anti-inflammatory and antirheumatic drug Lasonil may be associated with a modestly 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 relief and 3 days for colds).
If you have heart problems or a history of stroke, or if you think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss your treatment with your doctor or pharmacist.
Painkillers, antipyretics, and nonsteroidal anti-inflammatory drugs can cause fluid retention which, rarely, especially in elderly patients, can precipitate congestive heart failure.
Naproxen may 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 the section "Other medicines and Lasonil anti-inflammatory and antirheumatic" ).

Signs of an allergic reaction to naproxen have been reported, including breathing problems, swelling of the face and neck (angioedema), and chest pain. Stop taking Lasonil anti-inflammatory and antirheumatic medicine immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Effects on the liver
Serious liver reactions, including jaundice (yellowing of the skin and whites of the eyes) and hepatitis (sometimes fatal), 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 antirheumatic").


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

The most commonly observed adverse events involve the stomach and intestines. Peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur.
After administration of Lasonil anti-inflammatory and antirheumatic drug, the following have been reported: nausea, vomiting, diarrhea, flatulence (gas in the intestine), constipation (constipation), dyspepsia (indigestion), abdominal pain, melena (passage of black, tarry stools), hematemesis (vomiting blood or "coffee-ground" material), ulcerative stomatitis (inflammation of the mucosa of the mouth), exacerbation of colitis (inflammation of the lower part of the intestine) and Crohn's disease (chronic inflammatory bowel disease).
Gastritis has been observed less frequently.
Edema (swelling), hypertension (high blood pressure), and heart failure have been reported in association with NSAID treatment.
Bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (two serious, potentially fatal skin diseases) have occurred very rarely.
Medicines such as the anti-inflammatory and antirheumatic drug Lasonil may be associated with a modest increased risk of heart attack ("myocardial infarction") or stroke.
Lasonil, an anti-inflammatory and antirheumatic drug, 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 naproxen and naproxen sodium medicines, including those available under prescription, are listed below.
Stop taking Lasonil anti-inflammatory and antirheumatic medicine 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,
- heachache,
- dizziness,
- dyspepsia (indigestion),
- nausea,
- heartburn,
- abdominal pain (stomach ache).

Uncommon side effects (may affect up to 1 in 100 people)
- drowsiness (deep drowsiness),
- insomnia,
- drowsiness,
- vertigo,
- diarrhea,
- constipation,
- vomit,
- skin rash,
- itching,
- hives (itching and small spots on the skin).

Rare side effects (may affect up to 1 in 1,000 people)
- hyperglycemia (increased blood sugar level),
- hypoglycemia (low blood sugar levels),
- tachycardia (rapid heartbeat),
- peptic ulcer with or without hemorrhage or perforation,
- gastrointestinal bleeding,
- hematemesis (vomiting blood or "coffee-ground" material),
- melena (emission of black, tarry stools),
- angioedema (swelling of the facial skin and mucous membranes),
- myalgia (muscle pain),
- muscle weakness,
- impaired renal function,
- glomerulonephritis (a type of inflammation of the kidneys),
- peripheral edema (swelling of the extremities), particularly in patients with high blood pressure or renal insufficiency,
- fever (including chills).

Very rare side effects (may affect up to 1 in 10,000 people)
- anaphylaxis/anaphylactoid reactions (severe allergic or allergy-like reactions), including shock with fatal outcome,
- disorders of haematopoiesis (production of blood cells): leukopenia (lack of white blood cells), thrombocytopenia (lack of platelets), agranulocytosis (lack of blood cells called granulocytes), aplastic anaemia (due to lack of production of red blood cells), eosinophilia (increase in blood cells called eosinophils), haemolytic anaemia (due to destruction of red blood cells),
- psychiatric disorders,
- depression,
- sleep disturbances,
- difficulty concentrating,
- aseptic meningitis (non-infectious inflammation of the meninges),
- cognitive disorders (memory problems),
- convulsions,
- vision problems,
- corneal opacity,
- papillitis (inflammation of the anterior part of the optic nerve),
- retrobulbar optic neuritis (inflammation of the back of the optic nerve),
- papilledema (swelling of the papilla at the back of the eye),
- hearing loss,
- tinnitus (noise or hissing in the ear),
- hearing disorders,
- interstitial nephritis (a type of inflammation of the kidneys),
- papillary necrosis (kidney damage from painkiller abuse),
- nephrotic syndrome (kidney disease characterized by loss of protein in the urine),
- renal failure (reduced kidney function),
- kidney disease,
- hematuria (blood in the urine),
- proteinuria (protein in the urine),
- congestive heart failure (inability of the heart to pump blood),
- hypertension (high blood pressure),
- pulmonary edema (fluid in the lungs),
- palpitations (sensation of irregular or rapid heartbeat),
- vasculitis (inflammation of the blood vessels),
- dyspnea (difficulty breathing),
- asthma,
- eosinophilic pneumonia (a type of lung inflammation),
- alveolitis (inflammation of the lung alveoli),
- pancreatitis (inflammation of the pancreas),
- colitis (inflammation of the lower part of the intestine),
- aphthous ulcers (small ulcers in the mouth),
- stomatitis (inflammation of the mucosa of the mouth),
- esophagitis (inflammation of the esophagus),
- intestinal ulcerations,
- crampy abdominal pain,
- hepatitis (inflammation of the liver, including fatal cases),
- jaundice (yellowish coloration 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 certain enzymes is altered),
- erythema multiforme (red rosette-shaped patches on the skin),
- severe bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (two serious, potentially fatal skin diseases),
- erythema nodosum (red nodules under the skin),
- fixed erythema (redness and blisters),
- lichen planus (inflammatory reaction with the formation of small purplish papules),
- pustules,
- skin rashes,
- systemic lupus erythematosus (autoimmune disease manifesting with muscle and joint pain),
- photosensitivity reactions, including porphyria cutanea tarda ("pseudoporphyria") or epidermolysis bullosa,
- ecchymosis (bruises),
- purpura (red spots on the skin),
- sweating,
- closure of the ductus arteriosus (a small tube necessary for fetal blood circulation),
- infertility (in women),
- edema (swelling),
- thirst,
- malaise,
- increased creatinine in the blood,
- alteration of liver function tests,
- increased potassium in the blood.

Side effects with unknown frequency: the frequency cannot be estimated from the available data
- Extensive skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.
- A distinctive allergic skin reaction known as a fixed drug eruption, which usually recurs at the same site or sites with re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, a rash with blisters (hives), and an itching sensation.
- Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you experience 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.