MOMENDOL - PACKAGE LEAFLET - LEAFLETS

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Momendol - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Naproxen

MOMENDOL 220 mg film-coated tablets

Momendol package inserts are available for pack sizes:

MOMENDOL 220 mg film-coated tablets
MOMENDOL 220 mg granules for oral solution
MOMENDOL 5% gel
MOMENDOL 10% gel

Indications Why is Momendol used? What is it for?

Momendol belongs to the class of non-steroidal analgesics-anti-inflammatory-antirheumatics, ie medicines that fight pain, inflammation, fever and are useful in the symptomatic treatment of rheumatic diseases.

Momendol is used for the short-term symptomatic treatment of mild to moderate pain such as muscle and joint pain (eg, back pain, stiff neck), headache, toothache and menstrual pain.

Momendol can also be used for the treatment of fever.

Contraindications When Momendol should not be used

Do not take MOMENDOL

If you are allergic (hypersensitive) to the active substance or to any of the excipients or to other closely related substances from a chemical point of view.
If you have allergic manifestations, such as asthma, hives, rhinitis, nasal polyps, angioedema, and allergic reactions induced by acetylsalicylic acid, analgesics, anti-inflammatory and / or antirheumatic drugs.
If you have had a history of gastrointestinal bleeding or perforation, recurrent peptic ulcer in its active phase or related to previous episodes, inflammatory bowel diseases (ulcerative colitis, Crohn's disease), severe hepatic insufficiency, severe heart failure, severe renal insufficiency (clearance creatinine intensive therapy with diuretics, in subjects with ongoing bleeding and at risk of bleeding during anticoagulant therapy (See "Taking MOMENDOL with other medicines" and "Take special care with MOMENDOL".
In pregnancy, starting from the third trimester, and during lactation (See "Pregnancy and breastfeeding").
The product cannot be administered under the age of 12, while under the age of 16 it must be administered only after consulting your doctor.

Precautions for use What you need to know before taking Momendol

Take special care with MOMENDOL

Since there is a close correlation between dosage and the occurrence of severe gastrointestinal side effects. Therefore the lowest effective dosage should always be used.
Medicines such as MOMENDOL may be associated with a modest increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatments. Do not exceed the recommended dose or duration of treatment [7 days for pain and 3 days for fever treatment]
When MOMENDOL is used in hypertensive patients and / or in patients with reduced heart and / or kidney function. Diuresis and renal function should be well monitored during treatment with MOMENDOL, particularly in the elderly, in patients with heart failure or chronic renal failure and in patients treated with diuretics, following major surgery involving a large loss of blood.
If you have heart problems, have a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke) you should discuss your treatment with your doctor or pharmacist.
When MOMENDOL is used in patients with severe heart failure, worsening of the condition may occur.
When MOMENDOL is used in patients with a history of gastrointestinal diseases or hepatic insufficiency and in patients with current or previous allergic manifestations, as in these subjects the product can cause bronchospasm, asthma, or other allergic phenomena, particular caution is advised.
MOMENDOL should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
If visual disturbances occur, treatment with MOMENDOL should be discontinued.
Since naproxen like any other anti-inflammatory drug can mask the concomitant symptoms of infectious diseases.
Since in isolated cases an exacerbation of inflammation on an infectious basis has been reported in temporal connection with the use of anti-inflammatory drugs.
When used in elderly patients, who generally have some degree of impaired renal, hepatic and cardiac functions, since this group of patients is more exposed to the risk of developing side effects related to the use of anti-inflammatory drugs. Prolonged use. of anti-inflammatory drugs in the elderly is not recommended.
Since naproxen inhibits platelet aggregation and may prolong bleeding time. Patients with bleeding disorders or on medication that interfere with clotting should be carefully monitored while taking MOMENDOL.
When MOMENDOL is used by regular users of high doses of alcohol there is a high risk of stomach bleeding.
The use of the product should be avoided in cases of pain of gastrointestinal origin. It is in fact known that bleeding in the stomach or intestines can occur in patients taking anti-inflammatory drugs.
As the product belongs to a class of drugs (NSAIDs, anti-inflammatory drugs) which may cause fertility problems in women. This effect is reversible upon discontinuation of treatment.
In asthmatic patients, the product is generally contraindicated.
When MOMENDOL is used in combination with other medicines that require caution, see "Taking MOMENDOL with other medicines".

Interactions What medications or foods can change the effect of Momendol

Administration of naproxen with other anti-inflammatory drugs or corticosteroids is not recommended as it increases the risk of gastro-duodenal ulcers and bleeding.

Naproxen increases the anticoagulant effect of coumarin-type anticoagulants (eg warfarin, dicumarol) because it prolongs the prothrombin time and reduces platelet aggregation.

The combination of naproxen and lithium should be avoided; when necessary, close monitoring of plasma lithium levels and dosage adjustment are advised.

Due to the high plasma protein binding of naproxen, caution is advised in concomitant treatment with hydantoin or sulfonamides.

Particular caution should also be taken in patients receiving cyclosporine, tacrolimus, sulfonylureas, loop diuretics, methotrexate, beta-blockers, ACE inhibitors, probenecid, thiazide diuretics and digoxin.

Naproxen can alter bleeding time (which may be increased up to 4 days after discontinuation of therapy), creatinine clearance (may decrease), blood urea nitrogen and blood creatinine and potassium levels (may increase), liver function test (increased transaminases may occur).

Naproxen can induce false positives in the determination of urinary 17-ketosteroid values and can interfere with urinary determinations of 5-hydroxy-indolacetic acid.

Naproxen therapy should be discontinued at least 72 hours before adrenal cortical function tests are performed.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those obtained without a prescription.

Taking MOMENDOL with food and drink

MOMENDOL should preferably be taken after a meal.

Warnings It is important to know that:

Pregnancy and breastfeeding

Pregnancy

MOMENDOL, like other anti-inflammatory drugs, is contraindicated during the third trimester of pregnancy. During the first five months of pregnancy, MOMENDOL, like other anti-inflammatory drugs, should be taken only if necessary and after consulting your doctor and having evaluated with him the risk / benefit ratio in your case. Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.

Feeding time

Since NSAIDs are excreted in breast milk, their use during lactation should be avoided as a precautionary measure.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

As a rule, the intake of the product does not alter the ability to drive and use other machinery. However, those who carry out an activity that requires vigilance should use caution if, during therapy, they notice drowsiness, dizziness, depression.

Important information about some of the ingredients of MOMENDOL

The product contains lactose: if your doctor has told you that you have an "intolerance to some sugars, contact your doctor before taking this medicine.

Dosage and method of use How to use Momendol: Dosage

Always take MOMENDOL exactly as your doctor has told you. If in doubt, you should consult your doctor or pharmacist. The usual dose is:

Adults and adolescents over 16 years: 1 film-coated tablet every 8-12 hours.

If necessary, a better effect can be obtained by starting, on the first day, with 2 film-coated tablets followed by 1 film-coated tablet after 8-12 hours.

Elderly patients and patients with mild or moderate renal impairment should not exceed 2 film-coated tablets in 24 hours.

Do not use for more than 7 days for pain and more than 3 days for fever.

See your doctor if the fever or pain persists or gets worse.

Swallow the film-coated tablets whole and accompany them with water or other beverage.

If you forget to take MOMENDOL

Do not take a double dose to make up for a forgotten tablet.

Overdose What to do if you have taken too much Momendol

Drowsiness, heartburn, diarrhea, nausea, vomiting, somnolence, increased blood sodium levels, metabolic acidosis, convulsions may occur as signs of overdose.

In case of ingestion of a large amount of product, accidental or voluntary, you should contact your doctor to implement the normal measures required in these cases. Take this leaflet with you.

Stomach emptying and routine supportive measures are recommended. Prompt administration of an adequate amount of activated charcoal (activated charcoal is a medicine; ask your pharmacist if necessary) can reduce the absorption of the medicine.

Side Effects What are the side effects of Momendol

Like all medicines, MOMENDOL can cause side effects, although not everybody gets them.

The most commonly observed undesirable effects are gastrointestinal in nature.

Like other analgesics - anti-inflammatory, non-steroidal antirheumatic drugs (NSAIDs), naproxen can induce the following side effects.

The following scales of values were used: very common (> 1/10); common (> 1/100, 1/1000, 1 / 10,000, <1/1000); very rare (<1 / 10,000); not known (based on available data it is not possible to calculate the frequency).

Gastrointestinal disorders - Common: nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence. Uncommon: diarrhea, constipation. Rare: peptic ulcer, gastrointestinal perforation or bleeding, sometimes fatal, especially in the elderly, haematemesis may occur, ulcerative stomatitis, worsening of colitis and Crohn's disease Very rare: colitis, stomatitis Gastritis has been observed less frequently.

Nervous system disorders - Common: headache, somnolence, dizziness. Very rare meningitis-like symptoms.

Alterations of the auditory and vestibular system - Uncommon: tinnitus, hearing disorders.

Eye disorders - Uncommon: visual disturbances.

General disorders and administration site alteration - Uncommon: chills, edema (including peripheral edema).

Immune system disorders - Uncommon: allergic reactions (including face edema and angioedema).

Psychiatric disorders - Uncommon: sleep disturbances, arousal.

Renal and urinary disorders - Uncommon decreased renal function.

Skin and subcutaneous tissue disorders - Uncommon: rash / pruritus. Very rare: photosensitivity, alopecia, vesicular rash including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Vascular disorders - Uncommon: ecchymosis.

Blood and lymphatic system disorders - Very rare: aplastic or haemolytic anemia, thrombocytopenia, granulocytopenia.

Cardiac disorders - Very rare: tachycardia, edema, hypertension and heart failure have been observed concurrently with NSAID treatment.

Alterations of the hepatobiliary system - Very rare: jaundice, hepatitis, impaired liver function.

Investigations - Very rare: increase in blood pressure.

Abnormalities of the respiratory system, chest and mediastinum - Very rare: dyspnoea, asthma.

As with other analgesics - anti-inflammatory, non-steroidal antirheumatic (NSAID), anaphylactic or anaphylactoid-type allergic reactions may occur in patients with or without prior exposure to drugs of the same class.

The characteristic symptoms of an anaphylactic reaction are: severe and sudden hypotension, rapid or slow heart rate, unusual tiredness or weakness, anxiety, agitation, loss of consciousness, difficulty in breathing or swallowing, itching, hives with or without angioedema, redness of the skin, nausea, vomiting, crampy abdominal pain, diarrhea.

Medicines such as MOMENDOL may be associated with a modest increased risk of heart attack ("myocardial infarction") or stroke.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Expiry and Retention

Keep this medicine out of the reach and sight of children.

Do not use MOMENDOL after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

Store in the original package to keep it away from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Other information

What MOMENDOL contains

The active ingredient is naproxen 200 mg (equivalent to naproxen sodium 220 mg).

The other ingredients are: Tablet core: lactose monohydrate, maize starch, microcrystalline cellulose, povidone (K25), sodium carboxymethyl starch, anhydrous colloidal silica, magnesium stearate.

Film-coating: hypromellose, macrogol 400, titanium dioxide (E 171), talc.

Description of what MOMENDOL looks like and contents of the pack

MOMENDOL comes as a white, round and biconvex film-coated tablet.

Each pack contains 12 or 24 film-coated tablets.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

Further information on Momendol can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

MOMENDOL 220

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Naproxen 200 mg (corresponding to naproxen sodium 220 mg).

Excipients: 41.8 mg of lactose per film-coated tablet

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Film-coated tablet.

White, round biconvex.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Short-term symptomatic treatment of mild to moderate pain such as muscle and joint pain, headache, toothache and menstrual pain.

Momendol can also be used in the treatment of fever.

04.2 Posology and method of administration

Adults and adolescents over 16 years: 1 film-coated tablet every 8-12 hours.

If necessary, a better effect can be obtained by starting, on the first day, with 2 film-coated tablets followed by 1 film-coated tablet after 8-12 hours.

Do not exceed 3 film-coated tablets in 24 hours.

Elderly patients and patients with mild or moderate renal impairment should not exceed 2 film-coated tablets in 24 hours. (See 4.3, "Contraindications " and 4.4 "Special warnings and special precautions for "use").

Momendol should preferably be taken after a meal.

Do not use for more than 7 days for pain and more than 3 days for fever.

Patients should be advised to consult a physician if pain and fever persist or worsen.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients or to other closely related substances from a chemical point of view.

Naproxen is contraindicated in patients with allergic manifestations, such as asthma, urticaria, rhinitis, nasal polyps, angioedema, and anaphylactic or anaphylactoid reactions induced by acetylsalicylic acid, analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and / or antirheumatics, due to the possible cross sensitivity.

Naproxen is contraindicated in patients with gastrointestinal bleeding or perforation related to previous treatment with non-steroidal anti-inflammatory drugs, active treatments or history of recurrent peptic haemorrhage / ulcer (two or more distinct episodes of proven ulceration or bleeding), stomach ulcer and duodenum in active phase, inflammatory bowel diseases (ulcerative colitis, Crohn's disease), severe hepatic insufficiency, severe heart failure, severe renal insufficiency (creatinine clearance intensive therapy with diuretics, in subjects with ongoing bleeding and at risk of haemorrhage in course of therapy with anticoagulants.

Third trimester of pregnancy and lactation (See section 4.6).

Contraindicated in children under 12 years.

04.4 Special warnings and appropriate precautions for use

Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see below on gastrointestinal and cardiovascular risks).

Clinical studies and epidemiological data suggest that the use of coxibs and some NSAIDs (especially at high doses and for long-term treatments) may be associated with a modest increased risk of arterial thrombotic events (eg myocardial infarction or stroke) Although some data suggest that the use of naproxen (1000 mg / day) may be associated with a lower risk, some risks cannot be excluded. There are insufficient data regarding the effects of the low dose of naproxen (600 mg / day) to reach precise conclusions on possible thrombotic risks.

There is a close correlation between dosage and the appearance of severe gastrointestinal side effects.

Therefore the lowest effective dosage should always be used.

Caution is required (discuss with your doctor or pharmacist) before starting treatment in patients with a history of hypertension and / or heart failure as fluid retention, hypertension and edema have been reported in association with NSAID treatment.

Diuresis and renal function should be well monitored, particularly in the elderly, in patients with chronic congestive heart failure or chronic renal failure, in patients receiving diuretics, or following major surgery involving hypovolaemia..

In patients with severe heart failure, worsening of the condition may occur.

Particular caution is advised in patients with a history of gastrointestinal diseases or hepatic insufficiency and in patients with current or previous allergic manifestations, as in these subjects the product can cause bronchospasm, asthma, or other allergic phenomena.

If visual disturbances occur, Momendol treatment should be discontinued.

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see 4.8). In the early stages of therapy patients appear to be higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Momendol should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

Naproxen, like any other NSAID, can mask the symptoms of concomitant infectious diseases.

In isolated cases an exacerbation of infectious inflammations (eg the development of necrotizing fasciitis) has been reported in temporal connection with the use of NSAIDs.

Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.

In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal haemorrhage, ulceration or perforation is higher with increased doses of NSAIDs. These patients should initiate treatment with the lowest dose available. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5).

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.

Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).

When gastrointestinal bleeding or ulceration occurs in patients taking Momendol the treatment should be discontinued.

NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8 - undesirable effects).

The use of Momendol should be avoided in conjunction with selective COX-2 inhibitory NSAIDs.

Elderly patients, who generally have some degree of impaired renal, hepatic and cardiac functions, are at increased risk of developing side effects related to the use of NSAIDs, especially gastrointestinal bleeding and perforation which can be fatal.

Prolonged use of NSAIDs in the elderly is not recommended.

Naproxen inhibits platelet aggregation and can prolong bleeding time.

Patients with bleeding disorders or on therapy with medicinal products that interfere with haemostasis should be carefully monitored while taking Momendol.

Caution is advised in habitual consumers of high doses of alcohol, as they are at risk of gastric bleeding.

The use of the product should be avoided in cases of pain of gastrointestinal origin.

This medicine contains lactose: Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

Concerning combinations with other drugs requiring caution, see section 4.5 "Interaction with other Medicines and other forms of interaction".

04.5 Interactions with other medicinal products and other forms of interaction

Combinations not recommended:

Administration of naproxen with other non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids is not recommended as it increases the risk of gastro-duodenal ulcers and bleeding (see section 4.4).

Naproxen may increase the effect of anticoagulants, such as coumarin-type anticoagulants (eg warfarin, dicumarol) because it prolongs the prothrombin time and reduces platelet aggregation, increasing the risk of gastrointestinal bleeding (see section 4.4).

The combination of naproxen and lithium should be avoided; when necessary, close monitoring of plasma lithium levels and dosage adjustment are advised.

Associations to be used with caution:

Due to the high plasma protein binding of naproxen, caution is advised in concomitant treatment with hydantoin or sulfonamides.

Naproxen can induce false positives in the determination of urinary 17-ketosteroid values and can interfere with urinary determinations of 5-hydroxy-indolacetic acid.

Naproxen therapy should be discontinued at least 72 hours before adrenal cortical function tests are performed.

04.6 Pregnancy and breastfeeding

Fertility:

There is some evidence that drugs that inhibit prostaglandin and cyclooxygenase synthesis could cause problems with female fertility through an effect on ovulation. This is reversible if treatment is stopped.

Pregnancy:

Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.

Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk has been believed to increase with dose and duration of therapy. . In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.

During the first and second trimester of pregnancy, naproxen should not be administered except in strictly necessary cases.

If naproxen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can exhibit:

the fetus to:

cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);

renal dysfunction, which can progress to renal failure with oligo-hydroamnios;

the mother and the newborn, at the end of pregnancy, to:

possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;

inhibition of uterine contractions resulting in delayed or prolonged labor

Consequently, naproxen is contraindicated during the third trimester of pregnancy.

Feeding time:

Since NSAIDs are excreted in breast milk, their use during lactation should be avoided as a precautionary measure.

04.7 Effects on ability to drive and use machines

04.8 Undesirable effects

Like other NSAIDs, naproxen can induce the following side effects.

The most commonly observed undesirable effects are gastrointestinal in nature

Clinical studies and epidemiological data suggest that the use of coxibs and some NSAIDs (especially at high doses and for long-term treatment) may be associated with a modest increased risk of arterial thrombotic events (eg myocardial infarction or stroke) (see Section 4.4).

The following scales of values were used: very common (> 1/10); common (> 1/100, 1/1000, 1 / 10,000,

Alterations of the gastrointestinal system:

Common: nausea, dyspepsia, vomiting, heartburn, gastralgia, flatulence.

Uncommon: diarrhea, constipation.

Rare: peptic ulcer, gastrointestinal perforation or bleeding, sometimes fatal, especially in elderly subjects, haematemesis, ulcerative stomatitis, aggravation of colitis and Crohn's disease may occur (see section 4.4).

Very rare: colitis, stomatitis. Gastritis was observed less frequently.

Alterations of the nervous system: Common: headache, somnolence, dizziness. Very rare: meningitis-like symptoms.

Alterations of the auditory and vestibular apparatus: Uncommon: tinnitus, hearing disturbance.

Eye disorders: Uncommon: visual disturbances.

General disorders and alteration of the administration site: Uncommon: chills, edema (including peripheral edema).

Alterations of the immune system: Uncommon: allergic reactions (including face edema and angioedema).

Psychiatric disorders: Uncommon: sleep disturbances, arousal.

Renal and urinary disorders: Uncommon: impaired renal function.

Alterations of the skin and subcutaneous tissue: Uncommon: rash / itching. Very rare: photosensitivity, alopecia, vesicular rash including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Alterations of the vascular system: Uncommon: bruising.

Changes in the blood and lymphatic system: Very rare: aplastic or haemolytic anemia, thrombocytopenia, granulocytopenia.

Cardiac alterations: Very rare: tachycardia, edema, hypertension and heart failure have been observed concurrently with NSAID treatment.

Alterations of the hepatobiliary system: Very rare: jaundice, hepatitis, hepatic impairment

Diagnostic investigations: Very rare: increase in blood pressure.

Alterations of the respiratory system, chest and mediastinum: Very rare: dyspnoea, asthma.

As with other NSAIDs, allergic reactions of the anaphylactic or anaphylactoid type may occur in patients with or without prior exposure to drugs belonging to this class.

04.9 Overdose

Drowsiness, heartburn, diarrhea, nausea, vomiting, somnolence, increased blood sodium levels, metabolic acidosis, convulsions may occur as signs of overdose.

In case of ingestion / administration of a large amount of product, accidental or voluntary, the doctor must implement the normal measures required in these cases.

Stomach emptying and routine supportive measures are recommended.

Prompt administration of an adequate amount of activated charcoal may reduce the absorption of the medicinal product.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: anti-inflammatory / antirheumatic drugs, non-steroids - Derivatives of propionic acid, ATC code: M01AE02. Naproxen is endowed with an analgesic, anti-inflammatory and antipyretic activity.

The "analgesic activity is" of a non-narcotic type.

Naproxen also inhibits platelet function.

These properties are probably the result of a reduction in prostaglandin synthesis through inhibition of the cyclo-oxygenase enzyme chain.

In addition, naproxen stabilizes lysosomal membranes and has antibradykinin and anti-complement effects.

05.2 Pharmacokinetic properties

In "man, naproxen sodium is absorbed after oral administration and reaches therapeutic blood concentrations after about 1 hour." The "half-life" is approximately 16 hours and steady-state is reached after 4-5 doses. Over 99% of naproxen sodium is reversibly bound to plasma proteins. 95% of the administered dose is excreted in the urine, partly unchanged and partly as 6-o-desmethylnaproxene, in free or conjugated form.

05.3 Preclinical safety data

The toxicological tests on different animal species, for different routes of administration, have shown that the acute toxicity of naproxen is "low.

In chronic toxicity studies, naproxen showed the typical toxicological profile of NSAIDs, such as gastrointestinal toxicity and, at high doses, renal damage.

There was no evidence of teratogenic effects with naproxen and in a two-year study in the rat, there was no indication of carcinogenic potential.

Mutagenicity studies with naproxen yielded negative results.

Due to the inhibition of prostaglandin synthesis, naproxen administered during the last period of pregnancy can cause delayed delivery and foetotoxic effects.