LASONIL 220 mg Tabletki Powlekane

Treść ulotki

1. Lasonil antinfiammatorio e antireumatico 220 mg film-coated tablets
   1. What is Lasonil anti-inflammatory and antirheumatic and what is it used for
   2. What you need to know before taking Lasonil anti-inflammatory and antirheumatic
   3. How to take Lasonil anti-inflammatory and antirheumatic
   4. Possible side effects
   5. How to store Lasonil anti-inflammatory and antirheumatic
   6. Contents of the pack and other information
2. Lasonil anti-inflammatory and antirheumatic 660 mg modified-release tablets
   1. What is Lasonil anti-inflammatory and antirheumatic and what is it used for
   2. What you need to know before taking Lasonil anti-inflammatory and antirheumatic
   3. How to take Lasonil anti-inflammatory and antirheumatic
   4. Possible side effects
   5. How to store Lasonil anti-inflammatory and antirheumatic
   6. Contents of the pack and other information

Lasonil antinfiammatorio e antireumatico 220 mg film-coated tablets

Naproxen sodium

Read this leaflet carefully before taking this medicine as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 3 days in case of a cold, or after 7 days if you are taking the medicine for symptomatic treatment of pain.

Contents of this leaflet:

• 1. What Lasonil antinfiammatorio e antireumatico is and what it is used for
• 2. What you need to know before you take Lasonil antinfiammatorio e antireumatico
• 3. How to take Lasonil antinfiammatorio e antireumatico
• 4. Possible side effects
• 5. How to store Lasonil antinfiammatorio e antireumatico
• 6. Contents of the pack and other information

1. What is Lasonil anti-inflammatory and antirheumatic and what is it used 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 headache, back pain, joint and muscle pain, toothache and colds. 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 a cold, or after 7 days if you are taking the medicine for the symptomatic treatment of pain.

2. What you need to know before taking Lasonil anti-inflammatory and antirheumatic

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
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 assess kidney function,
called “creatinine clearance”, gives values lower than 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 the production

of urine);
If you suffer from gastric or duodenal ulcer;
If you have an ongoing 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 previously experienced gastrointestinal bleeding or perforation following treatment
with certain medicines or have suffered from recurrent gastrointestinal bleeding/ulceration (two or more
distinct episodes of demonstrated ulceration or bleeding).

Warnings and precautions
Consult your doctor or pharmacist before taking Lasonil anti-inflammatory and antirheumatic.
Do not use the product for pains of the gastrointestinal tract.
Avoid using Lasonil anti-inflammatory and antirheumatic in conjunction with other NSAIDs, including
selective COX-2 inhibitors.
After administration of painkillers, antipyretics, non-steroidal anti-inflammatory drugs, it is possible to
worsen asthma.
To minimize side effects, take the lowest effective dose for the shortest possible duration
of treatment necessary to control the symptoms (see the paragraphs below on gastrointestinal and
cardiovascular risks).
If the pain persists or if redness/swelling of the painful area occurs, 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 liver failure(reduced liver function) and 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 previously experienced gastrointestinal side effects 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 failurebecause, in association with treatment with NSAIDs, fluid retention, hypertension and edema (swelling) and a modest increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) have been found;
• if you suffer from coagulation disordersor are taking anticoagulants (medicines that delay 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 allergic-like 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 skin of the face 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
Severe 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 antirheumatic.
If you notice any of the symptoms related to these severe skin reactions, described in paragraph
4, stop treatment with Lasonil anti-inflammatory and antirheumatic and contact
your doctor immediately.

Elderly
Elderly patients are more likely to experience adverse reactions to NSAIDs, especially bleeding and
gastrointestinal perforations, which can be fatal (see “How to take Lasonil
anti-inflammatory and antirheumatic”).

Gastrointestinal bleeding, ulceration and perforation
During treatment with all NSAIDs, at any time, with or without warning symptoms or
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 antirheumatic”). Because the risk is greater 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 who are taking concomitant medicines that could
increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin re-
uptake 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, especially the elderly, should report any
unusual gastrointestinal symptoms (especially gastrointestinal bleeding), particularly in the early
stages of treatment.
If gastrointestinal bleeding or ulceration occurs while you are taking Lasonil
anti-inflammatory and antirheumatic, 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 aggravated
(see “Possible side effects”).

Cardiovascular and cerebrovascular effects
Medicines like Lasonil anti-inflammatory and antirheumatic may be associated with a modest
increased risk of heart attack (“myocardial infarction”) or stroke. The risk is greater with high
doses and prolonged treatments. Do not exceed the recommended dose or duration of treatment (7 days
for symptomatic treatment of pain and 3 days for colds).
If you have heart problems or a history of stroke or if you think you may be at risk for these conditions
(e.g. in case of high blood pressure, diabetes or high cholesterol or smoking) 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 the elderly, 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 section “Other medicines and Lasonil anti-inflammatory and
antirheumatic”).
Signs of an allergic reaction to this medicine,
including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with naproxen. Immediately stop Lasonil anti-inflammatory and antirheumatic and contact
your doctor or emergency health service 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 (in some cases 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”).

Other medicines and Lasonil anti-inflammatory and antirheumatic
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• Other NSAIDs:do not take this medicine in association with medicines containing naproxen, acetylsalicylic acid or other painkillers, antipyretics, anti-inflammatory drugs, due to increased risk of gastrointestinal bleeding.
• Aspirin/acetylsalicylic acidfor preventing blood clot formation.
• Anticoagulants(medicines that delay blood clotting): NSAIDs may increase the effects of anticoagulants such as warfarin (increased prothrombin time and decreased platelet aggregation).
• Cyclosporine(immunosuppressant drug used after organ transplantation): with concomitant use of cyclosporine, the concentration of the latter may be increased, increasing the risk of kidney toxicity (kidney damage).
• Lithium(medicine used in bipolar depression, a disease characterized by alternating depressed and euphoric mood): concomitant intake may increase lithium levels, which can induce nausea, polydipsia (increased thirst), polyuria (increased urine output), tremors and confusion.
• Methotrexate(medicine used in some cancers and rheumatoid arthritis): the use of Lasonil anti-inflammatory and antirheumatic in conjunction with methotrexate (at doses greater than 15 mg/week) may lead to increased concentrations of methotrexate, with increased risk of toxicity of this substance.
• Corticosteroids:concomitant use increases the risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”).
• Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs):concomitant use increases the risk of gastrointestinal bleeding (see “Warnings and precautions”). Naproxen decreases platelet aggregation and prolongs bleeding time. This must be taken into account when determining bleeding time.
• Diuretics, ACE inhibitors and angiotensin II antagonists(medicines used to lower blood pressure): NSAIDs may reduce the effect of diuretics (medicines that increase urine production) and other antihypertensive medicines (against high blood pressure). In some patients with impaired kidney function (e.g. dehydrated patients or elderly patients with impaired kidney function), the concomitant administration of an ACE inhibitor or an angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to a further deterioration of kidney function, up to acute renal failure (rapid reduction of kidney function), generally reversible. These interactions should be considered in patients taking Lasonil anti-inflammatory and antirheumatic in conjunction with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients. If you are taking these medicines, you should be adequately hydrated and monitoring of kidney function should be considered after starting concomitant therapy.

Interference with laboratory tests:naproxen sodium interferes with some urine tests,
such as analyses of 17-ketosteroids and 5-hydroxyindoleacetic acid.

Lasonil anti-inflammatory and antirheumatic with food
The rate of absorption of naproxen may be slowed down by the simultaneous intake of
food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
Do not take Lasonil antinfiammatorio e antireumatico if you are pregnant or if you suspect you
may be pregnant, as it may harm the fetus or cause problems during labour.
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the tendency of
the mother and child to bleed and delay or prolong labour more than expected. From the 20th
week of pregnancy, NSAIDs can cause kidney problems in the fetus, reducing the levels of
amniotic fluid surrounding the baby (oligohydramnios) or causing the narrowing of a blood
vessel (ductus arteriosus) in the baby's heart.
This medicine can pass into breast milk, so do not take Lasonil antinfiammatorio e antireumatico
during breastfeeding.
If you are a woman of childbearing potential, have fertility problems or are to undergo investigations into fertility,
be aware that the use of Lasonil antinfiammatorio e antireumatico may interfere with fertility.
This effect is reversible with discontinuation of treatment.

Driving and operating machinery
Due to the possible occurrence of drowsiness, dizziness, vertigo or insomnia, Lasonil
antinfiammatorio e antireumatico may impair the ability to drive and operate machinery.
Avoid these activities, or others requiring particular attention, in such cases.

Lasonil antinfiammatorio e antireumatico contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
"sodium-free".
Taking the maximum daily dose of 3 tablets results in a maximum intake of
60 mg of sodium (the main component of table salt). This is equivalent to 3%
of the maximum daily intake of sodium recommended with the diet of an adult.

3. How to take Lasonil anti-inflammatory and antirheumatic

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:

• Symptomatic treatment of pain: 1 tablet every 8-12 hours, for no more than 7 days
• Cold-related illnesses: 1 tablet every 8-12 hours, for no more than 3 days

You may benefit more by starting with 2 tablets followed by 1 tablet every 12
hours, as needed. The maximum daily dose is 3 tablets.
Take the medicine on a full stomach.
Swallow the film-coated tablet whole, with a glass of water.
Caution: do not exceed the doses and duration of treatment indicated without your doctor's advice.
Undesirable effects can be reduced by using the minimum effective dose, for the shortest possible duration of treatment to control symptoms (see “Warnings and precautions”).

Use in children and adolescents
Safety and efficacy in children under 16 years of age have not yet been established (see
“What you need to know before taking Lasonil anti-inflammatory and antirheumatic”).

Use in the elderly
Use the minimum effective dosage.

Use in patients with renal, hepatic or cardiac insufficiency
If you suffer from renal and/or cardiac insufficiency (reduced kidney function and/or weak heart) and/or severe
hepatic insufficiency (severe reduction of liver function), a
reduction in dosage may be necessary.

If you take more Lasonil anti-inflammatory and antirheumatic than you should
Signs of overdose may include dizziness, drowsiness, heartburn,
pain in the epigastrium, digestive disorders, nausea and vomiting, transient alterations of
liver function, hypoprothrombinemia (decrease in prothrombin in the blood), renal
dysfunction, metabolic acidosis (increase of acids in body fluids), apnea (cessation of breathing) and
disorientation. In some patients, convulsions have been reported, but it is not clear whether these
were related to naproxen overdose.
Some cases of acute renal failure (rapid reduction of kidney function) have been described
reversible.
In case of overdose, therapy is symptomatic (to relieve symptoms) and supportive.
In case of accidental ingestion/taking of an excessive dose of Lasonil anti-inflammatory and
antirheumatic, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed adverse events affect the stomach and intestines. Peptic ulcers, perforation or
gastrointestinal bleeding, sometimes fatal, particularly in the elderly, can occur.
Following administration of Lasonil anti-inflammatory and antirheumatic, the following have been reported:
nausea, vomiting, diarrhea, flatulence (gas in the intestines), constipation, dyspepsia (indigestion),
abdominal pain, melena (passing of black, tarry stools), hematemesis (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).
Gastritis has been observed less frequently.
In association with treatment with NSAIDs, edema (swelling), hypertension (high blood pressure) and
heart failure have been reported.
Very rarely, blistering reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (two
serious skin diseases that can be potentially fatal) have manifested.
Medicines like Lasonil anti-inflammatory and antirheumatic may be associated with a modest increase in the
risk of heart attack (“myocardial infarction”) or stroke.
Lasonil anti-inflammatory and antirheumatic causes a modest and transient increase, dose-dependent,
in bleeding time. However, these values often do not exceed the upper limit of the reference range.
Adverse effects observed with medicines based on naproxen and naproxen sodium, including those subject
to medical prescription, are reported below.
Stop taking Lasonil anti-inflammatory and antirheumatic and contact your doctor immediately if you
notice the appearance of any of the following side effects:

Common side effects(may affect up to 1 in 10 people)

• dizziness,
• headache,
• lightheadedness,
• dyspepsia (indigestion),
• nausea,
• heartburn,
• abdominal pain (stomach ache).

Uncommon side effects(may affect up to 1 in 100 people)

• somnolence (deep sleepiness),
• insomnia,
• drowsiness,
• vertigo,
• diarrhea,
• constipation,
• vomiting,
• skin rash,
• itching,
• urticaria (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 (decreased blood sugar level),
• tachycardia (fast heartbeat),
• peptic ulcer with or without bleeding or perforation,
• gastrointestinal bleeding,
• hematemesis (vomiting blood or coffee-ground material),
• melena (passing of black, tarry stools),
• angioedema (swelling of the skin of the face and mucous membranes),
• myalgia (muscle pain),
• muscle weakness,
• impaired kidney function,
• glomerulonephritis (a type of kidney inflammation),
• peripheral edema (swelling of the extremities), especially 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 allergic-like reactions), including shock with
  fatal outcome,
• blood disorders: leukopenia (deficiency of white blood cells), thrombocytopenia (deficiency of
  platelets), agranulocytosis (lack of blood cells called granulocytes), aplastic anemia (due to failure
  to produce red blood cells), eosinophilia (increased blood cells called eosinophils), hemolytic anemia
  (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 papilla in the back of the eye),
• hearing loss,
• tinnitus (noise or ringing in the ear),
• hearing disorders,
• interstitial nephritis (a type of kidney inflammation),
• papillary necrosis (kidney damage from abuse of painkillers),
• nephrotic syndrome (kidney disease characterized by protein loss in the urine),
• renal insufficiency (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 (feeling of irregular or fast heartbeat),
• vasculitis (inflammation of 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 last part of the intestine),
• aphthous ulcers (small ulcers in the mouth),
• stomatitis (inflammation of the oral mucosa),
• esophagitis (inflammation of the esophagus),
• intestinal ulcerations,
• cramping abdominal pains,
• hepatitis (inflammation of the liver, 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-shaped spots on the skin),
• severe blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (two
  serious skin diseases that can be potentially fatal),
• erythema nodosum (red nodules under the skin),
• fixed erythema (redness and blisters),
• lichen planus (inflammatory reaction with the formation of small purple papules),
• pustules,
• skin eruptions,
• systemic lupus erythematosus (autoimmune disease that manifests with muscle and joint pain),
• photosensitivity reactions, including porphyria cutanea tarda (“pseudoporphyria”) or bullous
  epidermolysis,
• ecchymosis (bruises),
• purpura (red spots on the skin),
• sweating,
• closure of the ductus arteriosus (tubule 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: frequency cannot be estimated on the basis of
available data

• Extensive skin 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 in the same
  site or sites upon re-exposure to the medicine and may appear as round or oval patches with redness
  and skin swelling, skin rash with blisters (urticaria), feeling of itching.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can
also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/
segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Lasonil anti-inflammatory and antirheumatic

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the packaging.
The expiry date refers to the last day of that month. The expiry date refers to the
product in intact packaging, correctly stored.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lasonil anti-inflammatory and antirheumatic contains

• The active ingredient is sodium naproxen. One film-coated tablet contains 220 mg of sodium naproxen (equivalent to 200 mg of naproxen).
• The other ingredients are: microcrystalline cellulose, povidone K 30, talc, magnesium stearate; film coating: Opadry Blue YS 1-4215.

Description of the appearance of Lasonil anti-inflammatory and antirheumatic and pack contents
Lasonil anti-inflammatory and antirheumatic is presented in the form of film-coated tablets.
The pack contains 10, 12, 20 or 24 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bayer S.p.A. Viale Certosa 130, 20156 Milan

Manufacturer
Bayer Bitterfeld GmbH - Greppin – Germany

Lasonil anti-inflammatory and antirheumatic 660 mg modified-release tablets

Naproxen sodium

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4 [for RR-12 tablet packs]

Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any of the side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days [for SOP - 4 and 8 tablet packs]

Contents of this leaflet:

• 1. What Lasonil anti-inflammatory and antirheumatic is and what it is used for
• 2. What you need to know before you take Lasonil anti-inflammatory and antirheumatic
• 3. How to take Lasonil anti-inflammatory and antirheumatic
• 4. Possible side effects
• 5. How to store Lasonil anti-inflammatory and antirheumatic
• 6. Contents of the pack and other information

1. What is Lasonil anti-inflammatory and antirheumatic and what is it used for

Lasonil anti-inflammatory and antirheumatic contains the active ingredient naproxen which belongs to a
group of medicines called non-steroidal anti-inflammatory/antirheumatic drugs (NSAIDs).
This medicine is used for the symptomatic treatment of back pain, joint and
muscle pain, toothache, minor pain in arthritis and osteoarthritis.
Consult your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 7 days.
[for the SOP package – 4 and 8 tablets]

2. What you need to know before taking Lasonil anti-inflammatory and antirheumatic

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 paragraph 6);
If you are under 16 years of age (see How to take Lasonil anti-inflammatory and
antirheumatic);
If you have previously suffered from altered bronchial reactivity (asthma), itching and small spots on the
skin (urticaria) or allergic-type reactions following the intake of drugs used for the
treatment of pain, fever and inflammation (acetylsalicylic acid or other painkillers,
antipyretics, non-steroidal anti-inflammatory drugs);
If you have severe kidney problems (severe renal insufficiency) (the laboratory test to assess
kidney function, called “creatinine clearance” has values lower than 20 ml/min);
If you have severe heart problems (severe heart failure);
If you have severe liver problems (liver cirrhosis) or a severe form of liver inflammation
(hepatitis);
If you are taking medicines that increase urine production (intensive therapy with
diuretics);
If you have problems with the stomach (gastric ulcer) or the intestine (duodenal ulcer);
If you have ongoing bleeding (hemorrhage) or are at risk of bleeding;
If you are taking medicines that delay blood clotting (anticoagulants) as
this medicine enhances their action;
If you are pregnant or if you are breastfeeding (see “Pregnancy, breastfeeding and
fertility”);
If you have previously experienced gastrointestinal bleeding or perforation following treatment
with certain medicines or have suffered from recurrent gastrointestinal bleeding/ulceration (two or more
distinct episodes of demonstrated ulceration or bleeding) (see “Warnings and
precautions”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lasonil anti-inflammatory and antirheumatic.
Do not use this medicine for stomach and intestinal pain (gastrointestinal tract).
Lasonil anti-inflammatory and antirheumatic 660 mg modified-release tablets are not
interchangeable with Lasonil anti-inflammatory and antirheumatic 220 mg film-coated tablets, as
these formulations have different therapeutic indications and different dosage and method of
administration.
The use of Lasonil anti-inflammatory and antirheumatic in conjunction with other anti-inflammatory drugs (NSAIDs),
including selective COX-2 inhibitors should be avoided.
After administration of painkillers, antipyretics, non-steroidal anti-inflammatory drugs, asthma may worsen.
To minimize side effects, take the lowest effective dose for the shortest possible duration
of treatment necessary to control symptoms (see the sections below on gastrointestinal and
cardiovascular risks).

Pay particular attention with Lasonil anti-inflammatory and antirheumatic:

• if you suffer from reduced liver function (hepatic impairment);
• if you are taking other medicines, such as other painkillers or anti-inflammatory medicines (e.g. cortisone), or are taking high doses of medicines that increase urine production (diuretics);
• if you have previously experienced side effects caused by taking painkillers (analgesics), antipyretics (antipuretics), anti-inflammatory drugs;
• if you have a history of gastrointestinal disease (ulcerative colitis, Crohn's disease);
• if you suffer from high blood pressure (hypertension) and/or severe heart problems (heart failure) because, in association with treatment with NSAIDs, fluid retention, hypertension and swelling (edema) and a modest increase in the risk of thrombosis (e.g. myocardial infarction or stroke) have been found;
• if you suffer from blood clotting disorders; in this case you must be carefully monitored by your doctor, as naproxen inhibits platelet aggregation and may prolong bleeding time.

Allergic or allergic-like (anaphylactic/anaphylactoid) reactions
Painkillers (analgesics), antipyretics (antipuretics), non-steroidal anti-inflammatory drugs can cause
allergic reactions, potentially fatal, even in subjects who have previously taken this type of
drug and have not had allergic reactions. These reactions can occur in subjects with
a history of swelling of the skin of the face and mucous membranes (angioedema), altered bronchial reactivity
(asthma), runny nose (rhinitis), small growths in the nasal cavity (nasal polyps), allergic diseases,
chronic respiratory diseases or allergy to acetylsalicylic acid. This can happen
even in patients who experience allergic reactions (skin reactions, urticaria) to naproxen or
other NSAIDs.
Allergic reactions, such as anaphylaxis, can be fatal.

Skin reactions
Severe 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 antirheumatic. If you notice any of the symptoms relating to
these severe skin reactions, described in paragraph 4, stop treatment with Lasonil
anti-inflammatory and antirheumatic and consult your doctor immediately.

Elderly
Elderly patients are more likely to experience adverse reactions to NSAIDs, especially bleeding and
perforations of the stomach and intestines (gastrointestinal perforations), which can be fatal
(see “How to take Lasonil anti-inflammatory and antirheumatic”).

Gastrointestinal bleeding, ulceration and perforation
During treatment with all NSAIDs, at any time, with or without warning symptoms or
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 with increased doses of
NSAIDs 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 antirheumatic”). These patients
should start treatment with the lowest available dose (see “How to take Lasonil
anti-inflammatory and antirheumatic”).
Caution is also advised in patients taking medicines that can
increase the risk of ulceration or bleeding, such as corticosteroids taken orally,
medicines used against depression (selective serotonin re-uptake inhibitors) or drugs that
prevent platelet aggregation (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, especially the elderly, should report any
unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the early
stages of treatment.
If gastrointestinal bleeding or ulceration occurs while you are taking Lasonil
anti-inflammatory and antirheumatic, 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 aggravated
(see “Possible side effects”).

Cardiovascular and cerebrovascular effects
Medicines such as Lasonil anti-inflammatory and antirheumatic may be associated with a modest
increased risk of thrombosis (myocardial infarction or stroke). The risk is higher with high doses and
prolonged treatments.
If you have heart problems or a history of stroke or if you think you may be at risk for these conditions
(e.g. in case of high blood pressure, diabetes or high cholesterol or smoking) 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 the elderly, 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
antirheumatic”).
Signs of an allergic reaction to this medicine,
including breathing problems, swelling of the face and neck (angioedema) and chest pain, have been reported with naproxen. Stop Lasonil anti-inflammatory and antirheumatic immediately and contact
your doctor or emergency medical service immediately if you notice any of these signs.

Effects on the liver
Severe liver reactions, including jaundice (yellowing of the skin and whites of the eyes)
and a severe form of liver inflammation (hepatitis) (in some cases fatal) have been
reported with the use of naproxen sodium or other NSAIDs.

Other medicines and Lasonil anti-inflammatory and antirheumatic
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

• Painkillers (NSAIDs):do not take this medicine in association with medicines containing naproxen, acetylsalicylic acid or other painkillers, antipyretics (antipuretics), anti-inflammatory drugs, due to increased risk of gastrointestinal bleeding.
• Aspirin/acetylsalicylic acidfor preventing blood clot formation.
• Medicines that delay blood clotting (Anticoagulants): NSAIDs can increase the effects of anticoagulants such as warfarin.
• Medicine used to prevent rejection after organ transplantation (Cyclosporine): with concomitant use of cyclosporine, the concentration of the latter may be increased, increasing the risk of kidney toxicity (kidney damage).
• Medicine used in bipolar disorder, a condition characterized by alternating depressed and euphoric mood (Lithium): concomitant use may increase lithium levels, which can cause nausea, increased thirst (polydipsia), increased urine output (polyuria), tremors and confusion.
• Medicine used to treat some cancers and a rheumatic disease called rheumatoid arthritis (Methotrexate): the use of Lasonil anti-inflammatory and antirheumatic in conjunction with methotrexate may lead to increased concentrations of methotrexate, with increased risk of toxicity of this substance.
• Anti-inflammatory drugs (Corticosteroids): concomitant use increases the risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”).
• Medicines that prevent platelet aggregation (Antiplatelet agents)and medicines used to treat depression (selective serotonin reuptake inhibitorsSSRIs): concomitant use increases the risk of gastrointestinal bleeding (see “Warnings and precautions”). Naproxen decreases platelet aggregation and prolongs bleeding time.
• Medicines that increase urine production (Diuretics), medicines used to lower blood pressure (hypertension) (ACE inhibitors and angiotensin II antagonistsII): NSAIDs can reduce the effect of diuretics and other antihypertensive drugs (for high blood pressure). In some patients with kidney problems (impaired renal function) (e.g. dehydrated patients or elderly patients with impaired renal function), concomitant administration of these medicines may lead to further deterioration of renal function, up to rapid reduction of kidney function (acute renal failure), generally reversible. If you take these medicines you should be adequately hydrated and monitoring of renal function should be considered after starting concomitant therapy. If Lasonil anti-inflammatory and antirheumatic is taken for a short period of time, clinically significant interactions with medicines used for: reducing stomach acid (antacids);

reducing high blood sugar levels (antidiabetics);
treatment of epilepsy (hydantoins);
treatment of a rheumatic disease (gout) (probenecid);
treatment of AIDS (zidovudine).

Interference with laboratory tests: naproxen sodium interferes with some urine tests,
such as analyses of 17-ketosteroids and 5-indoleacetic acid.

Lasonil anti-inflammatory and antirheumatic with food
The rate of absorption of naproxen may be slowed down by the simultaneous intake of
food, while the amount absorbed is not changed.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Lasonil antinfiammatorio e antireumatico if you are pregnant or suspect you may be pregnant, as it may harm the fetus or cause problems during labour.
NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the tendency of the mother and child to bleed and delay or prolong labour more than expected. From the 20th week of pregnancy, NSAIDs can cause kidney problems in the fetus by reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
This medicine can pass into breast milk, so do not take Lasonil antinfiammatorio e antireumatico during breastfeeding.
If you are a woman of childbearing potential, have fertility problems or are undergoing fertility investigations, be aware that the use of Lasonil antinfiammatorio e antireumatico may interfere with fertility.
This effect is reversible with discontinuation of treatment.
This medicine can pass into breast milk, so do not take Lasonil antinfiammatorio e antireumatico during breastfeeding.
If you are a woman of childbearing potential, have fertility problems or are undergoing fertility investigations, be aware that the use of Lasonil antinfiammatorio e antireumatico may interfere with fertility.
This effect is reversible with discontinuation of treatment.

Driving and operating machinery
Due to the possible occurrence of drowsiness, dizziness, vertigo or insomnia, Lasonil antinfiammatorio e antireumatico may impair the ability to drive and operate machinery.
Avoid these activities, or others requiring particular attention, in such cases.

Lasonil antinfiammatorio e antireumatico contains sodium and lactose
This medicine contains 60 mg of sodium (the main component of table salt) per tablet.
This is equivalent to 3% of the maximum recommended daily intake of sodium with the diet of an adult.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Lasonil anti-inflammatory and antirheumatic

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist. [for RR pack – 12 tablets]
Take this medicine following exactly what is stated in this leaflet or the
instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. [for the
SOP packs – 4 and 8 tablets]
The recommended dose is:

Adults and adolescents over 16 years:1 tablet every 24 hours until symptoms disappear.
The maximum daily dose is 1 tablet (equivalent to 660mg of sodium naproxen).
Do not exceed the daily dose (24 hours) of 660mg of sodium naproxen without medical supervision.
Sodium naproxen should not be taken for more than 7 days unless otherwise indicated by your doctor.
Take the medicine with a glass of water, on a full stomach.
Undesirable effects can be reduced by using the minimum effective dose, for the shortest
possible duration of treatment to control the symptoms (see “Warnings and precautions”).

Use in children and adolescents
Safety and efficacy in children under 16 years of age have not yet been established (see
“What you need to know before taking Lasonil anti-inflammatory and antirheumatic”).

Use in the elderly
Use the minimum effective dosage.

Use in patients with renal, hepatic or cardiac insufficiency
Do not take this medicine if you suffer from severe impairment of renal and/or
hepatic and/or cardiac function (see “Do not take Lasonil anti-inflammatory and antirheumatic”).

If you take more Lasonil anti-inflammatory and antirheumatic than you should
Signs of overdose may include dizziness, drowsiness, heartburn,
pain in the upper abdomen (epigastric pain), indigestion, nausea and vomiting,
transient alterations in liver function, decreased prothrombin in the blood
(hypoprothrombinemia), impaired renal function (renal dysfunction), increased acids in body fluids
(metabolic acidosis), apnea and disorientation. In some patients, convulsions have been reported but it is not clear whether these were related to naproxen overdose.
Some cases of rapid reduction in kidney function (acute renal failure) have been described and are reversible.
In case of overdose, therapy should be instituted to relieve symptoms (symptomatic) and of
support.
In case of accidental ingestion/intake of an excessive dose of Lasonil anti-inflammatory and
antirheumatic, immediately inform your doctor or go to the nearest hospital.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly observed adverse events affect the stomach and intestines. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly
in the elderly, can occur.
Following administration of Lasonil anti-inflammatory and antirheumatic, the following have been reported: nausea,
vomiting, diarrhoea, gas in the intestines (flatulence), constipation, indigestion (dyspepsia
), abdominal pain, emission of black, tarry stools (melena), vomiting of blood or material “like coffee grounds” (hematemesis ), inflammation of the oral mucosa (ulcerative stomatitis ), inflammation
of the last part of the intestine (exacerbation of colitis ) and chronic inflammatory bowel disease
(Crohn's disease ).
Gastritis has been observed less frequently.
In association with treatment with NSAIDs, swelling (edema), high blood pressure (hypertension) and heart problems (heart failure) have been reported.
Very rarely, two serious skin diseases that are potentially fatal (blistering reactions including Stevens Johnson syndrome and toxic epidermal necrolysis) have manifested.
Medicines like Lasonil anti-inflammatory and antirheumatic can be associated with a modest
increased risk of thrombosis (e.g. myocardial infarction or stroke).
Lasonil anti-inflammatory and antirheumatic causes a modest and transient increase, dose-dependent,
in bleeding time. However, these values often do not exceed the upper limit
of the reference range.
Adverse effects observed with medicines based on naproxen and naproxen sodium, including
those subject to medical prescription are reported below.
Stop taking Lasonil anti-inflammatory and antirheumatic and contact your doctor immediately if you notice the appearance of any of the following side effects:

Common(may affect up to 1 in 10 people)

• dizziness,
• headache,
• lightheadedness,
• indigestion (dyspepsia),
• nausea,
• heartburn (pyrosis),
• stomach pain (abdominal pain).

Uncommon(may affect up to 1 in 100 people)

• sopor (deep sleepiness),
• insomnia,
• drowsiness,
• vertigo,
• diarrhoea,
• constipation,
• vomiting,
• skin rash (exanthema, rash),
• itching,
• itching and small spots on the skin (urticaria).

Rare (may affect up to 1 in 1,000 people)

• increased blood sugar level (hyperglycemia),
• decreased blood sugar level (hypoglycemia),
• fast heartbeat (tachycardia),
• peptic ulcer with or without bleeding or perforation,
• gastrointestinal bleeding,
• vomiting of blood or material “like coffee grounds” (hematemesis),
• emission of black, tarry stools (melena),
• angioedema (swelling of the skin of the face and mucous membranes),
• muscle pain (myalgia),
• muscle weakness,
• impaired kidney function,
• inflammation of the kidneys (glomerulonephritis),
• swelling of the extremities, especially in patients with high blood pressure or with kidney failure (peripheral edema),
• fever (pyrexia) (including chills).

Very rare (may affect up to 1 in 10,000 people)

• severe allergic or allergic-type reactions (anaphylaxis/anaphylactoid reactions), including shock with fatal outcome,
• disorders of blood cell production (hemopoiesis): deficiency of white blood cells (leukopenia), deficiency of platelets (thrombocytopenia), lack of blood cells called granulocytes (agranulocytosis), anemia due to failure to produce red blood cells (aplastic), increase of blood cells called eosinophils (eosinophilia), anemia due to destruction of red blood cells (hemolytic);
• psychiatric disorders,
• depression,
• sleep disorders,
• difficulty concentrating,
• non-infectious inflammation of the meninges (aseptic meningitis),
• memory problems (cognitive disorders),
• convulsions,
• visual disturbances ,
• corneal opacity,
• inflammation of the front part of the optic nerve (papillitis),
• inflammation of the back part of the optic nerve (retrobulbar optic neuritis),
• swelling of the papilla in the back of the eye (papilledema),
• hearing loss,
• noise or ringing in the ear (tinnitus),
• hearing disorders,
• inflammation of the kidneys (interstitial nephritis),
• kidney damage from abuse of painkillers (papillary necrosis),
• kidney disease characterized by loss of protein in the urine (nephrotic syndrome),
• reduced kidney function (renal insufficiency),
• kidney disease (nephropathy),
• blood in the urine (hematuria),
• protein in the urine (proteinuria),
• inability of the heart to pump blood (congestive heart failure),
• high blood pressure (hypertension),
• fluid in the lungs (pulmonary edema),
• feeling of heartbeat (palpitations),
• inflammation of blood vessels (vasculitis),
• difficulty breathing (dyspnea),
• altered bronchial reactivity (asthma),
• inflammation of the lungs (eosinophilic pneumonia),
• inflammation of the lung alveoli (alveolitis),
• inflammation of the pancreas (pancreatitis),
• inflammation of the intestine (colitis),
• small ulcers in the mouth (aphthous ulcers),
• inflammation of the oral mucosa (stomatitis),
• inflammation of the esophagus (esophagitis),
• intestinal ulcerations,
• cramping abdominal pains,
• inflammation of the liver (hepatitis, including fatal cases),
• yellowing of the skin and whites of the eyes (jaundice),
• hair loss (alopecia, usually reversible),
• sensitivity to sunlight (photosensitivity),
• altered activity of certain proteins (porphyria),
• target-like red spots on the skin (erythema multiforme),
• severe blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis,
• red nodules under the skin (erythema nodosum),
• redness and blisters (fixed erythema),
• inflammatory reaction with the formation of small purple papules (lichen planus),
• pustules,
• skin eruptions,
• autoimmune disease manifesting with pain in muscles and joints (systemic lupus erythematosus),
• photosensitivity reactions, including late cutaneous porphyria (“pseudoporphyria”) or bullous epidermolysis,
• bruising (ecchymosis),
• red spots on the skin (purpura),
• sweating,
• closure of the tubule necessary for fetal blood circulation (ductus arteriosus),
• infertility (in women),
• swelling (edema),
• thirst,
• general feeling of being unwell,
• increased creatinine in the blood,
• alteration of liver function tests,
• increased potassium in the blood.

Side effects with frequency not known: frequency cannot be estimated on the basis of
available data

• Extensive skin 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 in 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), feeling of itching
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Lasonil anti-inflammatory and antirheumatic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to the last day of that month. The expiry date refers to the product in
intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lasonil anti-inflammatory and antirheumatic contains

• The active ingredient is sodium naproxen. One tablet contains 660 mg of sodium naproxen (equivalent to 600 mg of naproxen).
• The other ingredients are: povidone, microcrystalline cellulose, talc, magnesium stearate, purified water, hypromellose 2910, lactose monohydrate, anhydrous colloidal silica, titanium dioxide, macrogol 8000, aluminium indigo carmine lake (E132), carnauba wax.

Description of the appearance of Lasonil anti-inflammatory and antirheumatic and pack contents
Lasonil anti-inflammatory and antirheumatic is available in the form of modified-release tablets.
The pack contains 4, 8 or 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bayer S.p.A. Viale Certosa 130, 20156 Milan

Manufacturer
Bayer Bitterfeld GmbH - Greppin – Germany