Active ingredients: Naproxen
NAPROXENE SODIUM DOC Generici 550 mg coated tablets
Why is Naproxen sodium used - Generic drug? What is it for?
This medicine contains the active substance naproxen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs ("NSAIDs") used to reduce pain caused by inflammation.
NAPROXENE SODICO DOC Generici is indicated for the reduction of medium to moderate pain caused by inflammation of the bones and muscles, in particular for the treatment of:
- an autoimmune disease affecting the joints called rheumatoid arthritis, including juvenile arthritis;
- inflammatory joint diseases (degenerative arthrosis, ankylosing spondylitis, gout);
- acute pains of muscles and bones (tears, sprains, trauma, lumbosacral and cervical pain, tenosynovitis and fibrositis;
- menstrual pain (dysmenorrhea);
- inflammations that occur after trauma or after surgical operations (post-traumatic and post-operative).
Contraindications When Naproxen sodium should not be used - Generic drug
Do not take Naproxene Sodium
- if you are allergic to naproxen, similar substances or any of the other ingredients of this medicine;
- if you are allergic to acetylsalicylic acid, to other medicines used to reduce pain (analgesics), to other non-steroidal anti-inflammatory drugs (NSAIDs) or antirheumatic drugs; or if you experience allergic reactions following the use of these medicines, such as asthma, skin irritation (urticaria), inflammation of the nose (rhinitis), a nose disorder characterized by the presence of nodules (nasal polyposis), swelling of the tissues due to fluid accumulation (angioedema);
- if you have ever had stomach or bowel bleeding or perforation following use of this medicine;
- if you have or have ever had bleeding, perforation or injury (ulcer) of the stomach or intestines;
- if you suffer from chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
- if you have a severe heart (severe heart failure), liver (severe liver failure) or kidney (severe kidney failure) problem;
- if you suffer from swelling due to fluid accumulation (angioedema);
- if you are taking medicines used to help pass urine (diuretics);
- if you have ongoing blood loss (bleeding), or are at risk for this condition and are taking medicines used to thin the blood (anticoagulants);
- if you suffer from asthma;
- if you are in the last 3 months of pregnancy or if you are breast-feeding.
Naproxene Sodium Generici should not be used in children and adolescents under 18 years of age.
Precautions for use What you need to know before taking Naproxen sodium - Generic drug
Talk to your doctor or pharmacist before taking Naproxene Sodium.
Take this medicine at the lowest doses and for short periods of time to reduce the appearance of side effects.
Tell your doctor before taking this medicine in the following cases:
- if you are taking other non-steroidal anti-inflammatory medicines (NSAIDs);
- if you have or have suffered from allergic reactions, as this medicine could cause asthma, breathing difficulties (bronchospasm) or other allergic manifestations;
- if you have or have suffered from stomach or bowel problems (ulcer, gastrointestinal bleeding or perforation, chronic inflammatory bowel disease such as ulcerative colitis, Crohn's disease);
- if you are elderly, as it increases the possibility of injury or bleeding in the stomach or intestines. In this case, your doctor may decide to reduce your daily dose;
- if you are taking medicines that can cause stomach or bowel problems or medicines used to prevent blood clots in the vessels (anticoagulants)
- if you have heart problems (heart failure), high blood pressure (hypertension), problems with blood flow to the legs (peripheral arterial disease) or brain (cerebrovascular disease, stroke) or you think you may be at risk for these conditions (e.g. if you have high blood pressure, high cholesterol levels, diabetes or if you smoke). Tell your doctor before using Naproxene Sodium as it may increase the risk of heart attack or stroke;
- if you suffer from blood clotting disorders, as this medicine may increase the risk of bleeding;
- if you suffer from kidney problems;
- if you suffer from liver problems;
- if you are using an intrauterine contraceptive tool, as its effectiveness may decrease;
- if you are due to have a urinalysis, as the use of this medicine may interfere with the test results; your doctor will inform you if you need to stop using this medicine 48 hours before having the urinalysis.
Stop taking this medicine and contact your doctor immediately in the following cases:
- if you develop symptoms of an allergic reaction (See section 4 Possible Side Effects).
- if you get any unusual symptoms of your stomach or intestines, especially bleeding (haemorrhages) or lesions (ulcers) of your stomach or intestines;
- if you have a skin disorder characterized by irritation, injury or blistering;
- if you have vision problems.
While using this medicine, pay attention to the following conditions:
- this medicine may hide the symptoms of some infections;
- in the event of persistence of pain or fever, redness or swelling of the painful area, or the onset of new symptoms, ask your doctor for advice;
- Prolonged use of this medicine may cause visual disturbances. If you have been taking this medicine for a long time, periodic eye checks are advised;
- limit your alcohol consumption, because alcohol increases the risk of side effects.
Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.
Interactions Which drugs or foods can modify the effect of Naproxen sodium - Generic drug
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following medicines, tell your doctor as they may interact with Naproxene Sodium:
- acetylsalicylic acid or other NSAIDs;
- hydantoin medicines, used to treat epilepsy, barbiturates, used as sedatives, or sulfonamides, used to treat infections caused by bacteria;
- propanolol and other beta blockers, medicines used to treat some heart disorders, as their effect may diminish;
- lithium, used to treat depression and similar ailments;
- probenecid, a medicine used to help eliminate uric acid in the urine;
- methotrexate, a chemotherapeutic agent, because its toxicity can increase;
- corticosteroids, medicines used to treat inflammatory states; because they increase the risk of the toxic effects of Naproxene Sodium on the stomach and intestines;
- anticoagulants (e.g. warfarin, dicumarol) or antiplatelet drugs, medicines used to prevent blood clots from forming in blood vessels, or selective serotonin reuptake inhibitors, medicines used in the treatment of depression, as they may increase the risk of stomach or stomach bleeding. "intestine;
- ACE inhibitors, angiotensin II antagonists or diuretics (eg furosemide), medicines used to control blood pressure or heart problems, because NAPROXENE SODICO DOC Generici can reduce their effects. it is necessary to take water and check the functionality of the kidneys;
- cyclcosporin and tacrolimus, medicines used to treat diseases of the immune system;
- sulfonylureas, medicines used to treat diabetes;
- digoxin, a medicine used to treat some heart problems;
- quinolone antibiotics, medicines used to treat infections caused by bacteria.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take NAPROXEN SODIUM DOC Generici during the last 3 months of pregnancy, as it can cause problems during pregnancy and for your baby. Take NAPROXENE SODICO DOC Generici during the first 6 months of pregnancy only in cases of absolute necessity and under the direct supervision of your doctor.
Feeding time
If you are breast-feeding do not take this medicine as naproxen passes into breast milk.
Fertility
Naproxene Sodium Generici can cause fertility problems in women. Therefore, if you plan to become pregnant, you should inform your doctor as this medicine may reduce fertility.
Driving and using machines
This medicine does not affect the ability to drive or use machines. However, if you notice lightheadedness, sleepiness, dizziness or depression, avoid driving or using machines.
Dose, Method and Time of Administration How to use Naproxen sodium - Generic drug: Posology
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
The recommended starting dose is 550 mg (1 tablet). Thereafter, therapy can be continued by taking 550 mg (1 tablet) every 12 hours or 275 mg every 6 - 8 hours, according to the doctor's advice.
How to take Naproxene Sodium
The tablet should be swallowed whole with a glass of water.
People who have stomach problems are advised to take the tablet with a meal.
Use in the elderly
If you are an elderly person, your doctor will determine if the dose needs to be reduced.
If you forget to take Naproxene Sodium
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Overdose What to do if you have taken too much Naproxen sodium - Generic drug
Numbness, sleepiness, heartburn, difficulty digesting (dyspepsia), nausea, vomiting, diarrhea or convulsions may occur after taking too much of this medicine.
If you accidentally take too much of this medicine, notify your doctor immediately or go to the nearest hospital emergency department.
Side Effects What are the side effects of Naproxen sodium - Generic drug
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Common (which may affect up to 1 in 10 people):
- feeling of thirst;
- increased perception of heartbeat (palpitations).
Rare (may affect up to 1 in 1,000 people):
- allergic reaction (anaphylactic reaction). Some of the symptoms of an allergic reaction can be: sudden drop in blood pressure, fast or slow heart beat, unusual tiredness, anxiety, agitation, dizziness, fainting, difficulty breathing or swallowing, itching (especially on the soles of the feet or palms), irritation and redness of the skin with or without swelling (especially in the hands, feet, genitals, face, eyes, lips or ears), blue-purplish discoloration of the skin (cyanosis), profuse sweating, nausea, vomiting, pain in the abdomen, diarrhea, fever;
- inflammation of the intestines (colitis), inflammation and injury of the mouth (ulcerative stomatitis), inflammation of the pancreas (pancreatitis);
- hair loss (alopecia), inflammation of the skin exposed to light (photosensitivity dermatitis), skin lesions (Lyell's syndrome or toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome), red, swollen lumps under the skin (erythema nodosum);
- abnormal liver function tests, yellowing of the skin (jaundice);
- mood disorder (depression), difficulty concentrating, feeling unwell, inflammation of the brain (aseptic meningitis), cognitive disorders;
- changes in the number of white blood cells in the blood (agranulocytosis, leukopenia, granulocytopenia, eosinophilia), reduction in the number of platelets (thrombocytopenia), reduction in the number of all blood cells (aplastic anemia), destruction of red blood cells (haemolytic anemia); - severe heart problem (congestive heart failure), inflammation of the blood vessels (vasculitis), increased heart rate (tachycardia); - inflammation of the lungs with accumulation of eosinophils (eosinophilic pneumonia), contraction of the bronchial muscles (bronchospasm), inflammation of the pulmonary alveoli (alveolitis), swelling of the throat (edema of the larynx), asthma, difficulty in breathing (dyspnoea); - increase in blood glucose (hyperglycaemia), decrease in blood glucose (hypoglycaemia).
Very rare (may affect up to 1 in 10,000 people):
- skin reactions characterized by irritation and blistering (bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis);
- inflammation of the liver (severe hepatitis).
Frequency not known (frequency cannot be estimated from the available data):
- nausea, vomiting, diarrhea, gassing (flatulence), digestive disturbances (dyspepsia), constipation (constipation, constipation), heartburn (heartburn), abdominal pain, headache (headache), dizziness (vertigo) ), inflammation of the mouth (stomatitis), pain in the stomach (epigastric pain);
- blood loss with vomiting (haematemesis), passing of dark stools (melaena), stomach or bowel ulcers, perforation or bleeding, kidney and liver toxicity (nephrotoxicity, hepatoxicity), allergic reactions (hypersensitivity reactions);
- worsening of inflammation of the intestine (colitis and Crohn's disease);
- stomach inflammation (gastritis).
- increased blood pressure (hypertension), heart problems (heart failure);
- swelling due to fluid accumulation in the body (edema); heart attack, stroke;
- skin irritation (rash, hives), bruising (bruising), sweating, breaking of the capillaries under the skin (purpura), itching;
- swelling due to fluid accumulation (angioedema);
- dark discoloration of the skin (skin necrosis), increased sensitivity of the skin to light (photosensitivity, including pseudoporphyria or epidermolysis bullosa);
- inflammation of the kidneys (glomerular nephritis, interstitial nephritis), loss of protein in the urine (nephrotic syndrome), blood in the urine (haematuria), kidney damage (papillary necrosis), accumulation of fluid in different parts of the body (water retention ), excess potassium in the blood (hyperkalaemia), kidney problems (kidney failure);
- light-headedness, sleep disturbances (insomnia or sleepiness), seizures, difficulty concentrating, confusion and lightheadedness;
- muscle pain (myalgia), muscle weakness;
- visual disturbances (visual disturbances), hearing disturbances, impaired hearing, ringing in the ear (tinnitus), swelling of the feet and legs (middle peripheral edema).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Store in the original package to protect from heat and moisture.
Do not throw any medicines 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 NAPROXENE SODICO DOC Generici contains
The active ingredient is naproxen sodium. Each tablet contains 550 mg of naproxen sodium (equivalent to 500 mg of naproxen).
The other ingredients are: stearic acid, magnesium stearate, hydroxypropylcellulose type LF, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, indigo dye.
Description of the appearance of Naproxene Sodium Generici and contents of the pack
The package contains 30 tablets in blisters.
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.
01.0 NAME OF THE MEDICINAL PRODUCT
NAPROXENE SODICO DOC GENERICI 550 MG COATED TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
active ingredient: naproxen sodium 550 mg (equivalent to naproxen 500 mg).
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of pain of medium and moderate intensity with an inflammatory component, especially if of musculoskeletal origin. Naproxen is indicated for the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis), degenerative arthrosis, ankylosing spondylitis, gout, acute musculoskeletal pain such as tears, sprains, trauma, lumbosacral and cervical pain, tenosynovitis and fibrositis , dysmenorrhea.
Inflammatory manifestations of post-traumatic and post-operative origin.
04.2 Posology and method of administration
Adulti: 550 mg at the beginning; then 275 mg every 6-8 hours, or 550 mg every 12 hours according to the doctor's opinion.
In the treatment of patients Senior citizens the posology must be carefully established by the doctor who will have to evaluate a possible reduction of the dosages indicated above.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).
04.3 Contraindications
Hypersensitivity to the active substance or to other closely related substances from a chemical point of view or to any of the excipients. The drug is also contraindicated in subjects with hypersensitivity to acetylsalicylic acid or other analgesics, antipyretics, non-steroidal anti-inflammatory drugs.
Naproxen must not be administered in patients in whom these substances induce allergic reactions such as asthma, urticaria, rhinitis since severe anaphylactic-like reactions have been observed.
Active peptic ulcer, gastroduodenal ulcer, ulcerative colitis and gastrointestinal inflammation.
History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Severe heart failure.
Third trimester of pregnancy and during lactation (see section 4.6).
The product is not intended for use in children.
04.4 Special warnings and appropriate precautions for use
The use of NAPROXENE SODIUM DOC Generici should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks).
Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious, including those of the anaphylactic type, even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking naproxen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs (see section 4.3).
Naproxen should not be used at the same time as another naproxen sodium drug as they both circulate in the blood in ionized form, as the naproxenate anion.
The antipyretic and anti-inflammatory activity of naproxen can reduce fever and inflammation thereby reducing the diagnostic utility of these symptoms.
Bronchospasm can occur in patients with bronchial asthma or allergic diseases or who have suffered from it.
Gastrointestinal effects
There have been reports of gastrointestinal bleeding in patients receiving naproxen; therefore, in patients with previous gastrointestinal pathology, naproxen should be administered under strict medical supervision.
In the course of therapy with anti-inflammatory drugs it is possible the onset of serious gastrointestinal side effects such as haemorrhage and perforation; the risk of this occurrence seems to increase linearly with the duration of treatment and is probably associated with the use of higher doses of these drugs.
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.
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).
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 bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low dose 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 Naproxene Sodium, 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).
Cardiovascular and cerebrovascular effects
Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment.
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.
Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with naproxen after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Naproxen decreases platelet aggregation and prolongs bleeding time. This effect should be taken into account when determining bleeding times.
Patients suffering from coagulation disorders or who are being treated with drugs that interfere with haemostasis, must be carefully observed if they are given naproxen. heparin or warfarin) (The risk / benefit should be carefully weighed in these cases).
Peripheral edema has been observed in a limited number of patients receiving naproxen, therefore cardiac patients should be considered at high risk when administering the drug.
Use in patients with impaired renal function
Since naproxen is eliminated mostly in the urine (95%) it should be used with great caution in patients with impaired renal function and serum creatinine and / or creatinine clearance should be monitored in these patients. Administration of naproxen is not recommended in patients with a baseline creatinine clearance of less than 20 ml / minute.
Renal function should be carefully monitored before and during treatment with naproxen in patients with impaired renal blood flow, extracellular volume depletion, liver cirrhosis, sodium limitation, congestive heart failure and previous renal disease. Elderly patients in whom limited renal function is to be expected should also be included among these patients. Consideration should be given to reducing the daily dose in these patients to avoid accumulation of naproxen metabolites.
Use in patients with impaired hepatic function
In patients with chronic hepatic insufficiency of alcoholic origin but also in cases of cirrhosis the total plasma concentration of naproxen is reduced while that of free naproxen is increased; the cause of this behavior is not known; therefore it is prudent, in these patients, to use the drug at the lowest effective dose.
Sporadic changes in laboratory tests (eg liver function tests) have been observed in patients taking naproxen; however, no changes in toxicity tests were detected.
Skin effects
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 section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Naproxene Sodium Generici should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Effects on fertility
The use of naproxen, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended for women intending to become pregnant.
Naproxen administration should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
Since ocular changes have been detected in animal studies with non-steroidal anti-inflammatory drugs, it is recommended, in case of prolonged treatments, to carry out periodic ophthalmological checks.
04.5 Interactions with other medicinal products and other forms of interaction
Due to naproxen's high plasma protein binding, patients receiving concomitant highly protein bound drugs such as hydantoin, barbiturates, anticoagulants or sulfonamides should be carefully monitored to rule out overdose effects of these drugs.
Beta blockers : naproxen and other non-steroidal anti-inflammatory drugs may reduce the antihypertensive effect of propanolol and other beta-blockers.
Lithium: Inhibition of lithium elimination with consequent increase in its plasma concentration has been reported.
Probenecid: probenecid, administered concurrently, produces an elevation in plasma levels of naproxen and considerably prolongs its plasma half-life.
Methotrexate: caution is advised in the case of concomitant administration of methotrexate due to the possible increase in its toxicity caused by the reduction of tubular secretion.
Corticosteroids : increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anticoagulants : NSAIDs may increase the effects of anticoagulants such as warfarin (see section 4.4).
Although clinical studies do not seem to indicate that naproxen has effects on anticoagulants, isolated cases of increased risk of bleeding have been observed with the combined use of naproxen sodium and anticoagulant therapy. Close surveillance of these patients is recommended.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs) : increased risk of gastrointestinal bleeding (see section 4.4).
Diuretics, ACE inhibitors and Angiotensin II antagonists : NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or antagonist angiotensin II and agents that inhibit the cyclooxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking naproxen concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy.
Furosemide : naproxen and other non-steroidal anti-inflammatory drugs can inhibit the diuretic activity of furosemide.
Alcohol
Avoid alcohol intake.
Acetylsalicylic acid or other NSAIDs
Use at the same time as acetylsalicylic acid or other NSAIDs is not recommended.
Quinolones
The use of non-steroidal anti-inflammatory drugs at the same time as quinolone drugs is not recommended.
Naproxen sodium may decrease the effectiveness of intrauterine devices.
It is suggested to temporarily suspend administration of naproxen 48 hours before performing adrenal function tests, as it may interfere with some tests for the determination of 17-ketosteroids.
Similarly, naproxen can interfere with urinary 5-hydroxyindolacetic acid detection.
04.6 Pregnancy and breastfeeding
Pregnancy
Naproxen is contraindicated in the last trimester of pregnancy due to the risk of cardiopulmonary and renal toxicity to the fetus. It should not be used in the first and second months unless considered essential by the treating physician. childbirth (it is not known whether this effect also occurs in men).
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 absolute risk of cardiac malformations increased from less than 1% up to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and of 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 unless strictly necessary.
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 expose 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
Naproxen has been found in breast milk, therefore the use of naproxen should be avoided in breastfeeding patients.
04.7 Effects on ability to drive and use machines
Caution is recommended in those patients whose activity requires vigilance if they notice lightheadedness, somnolence or dizziness or depression while taking naproxen sodium.
04.8 Undesirable effects
The side effects seen with naproxen are generally common to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs.
The most frequently reported undesirable effects are: constipation, heartburn, abdominal pain, nausea, headache, dizziness, somnolence, itching, tinnitus, edema and dyspnoea. As with other analgesics, antipyretics, non-steroidal anti-inflammatory drugs, serious side effects such as bleeding (haematemesis, melaena) or gastrointestinal perforation, gastrointestinal ulceration, nephrotoxicity, hepatotoxicity and hypersensitivity reactions (such as rash, angioedema or bronchospasm) have also been reported with naproxen. ).
The most commonly observed adverse events are gastrointestinal in nature, peptic ulcers, gastrointestinal perforation or haemorrhage may occur, sometimes fatal, particularly in the elderly (see section 4.4).
Nausea, heartburn, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of naproxen (see section 4.4).
Gastritis has been observed less frequently.
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely).
Clinical studies and epidemiological data suggest that the use of 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).
Gastrointestinal effects
The most frequent are: nausea, vomiting, constipation, abdominal pain, heartburn, dyspepsia, esophagitis, stomatitis, diarrhea, epigastric pain.
The rare effects are: colitis, ulcerative stomatitis, pancreatitis.
The most serious effects are gastrointestinal bleeding, peptic ulcer (sometimes with perforation and bleeding) and colitis.
Gastric upset can be reduced by taking the drug on a full stomach.
Systemic effects
Common: feeling of thirst.
Rare: anaphylactic reaction (possible symptoms of an anaphylactic reaction are: severe and sudden hypotension, rapid or slow heart rate, unusual tiredness or weakness, anxiety, agitation, dizziness, loss of consciousness, difficulty in breathing [from laryngeal obstruction or bronchospasm] or swallowing, generalized itching [especially on the soles of the feet or palms] of the lips], redness of the skin [especially around the ears] cyanosis, profuse sweating, nausea, vomiting, crampy abdominal pain, diarrhea). Fever.
Anaphylactic reactions to naproxen and naproxen sodium preparations have been reported in patients with or without prior hypersensitivity to non-steroidal anti-inflammatory drugs.
Dermatological effects
Skin rash, urticaria and angioedema, bruising, sweating, purpura, itching.
Rare: alopecia, photosensitivity dermatitis, bullous reactions including Stevens-Johnson syndrome and Lyell's syndrome (toxic epidermal necrolysis), erythema multiforme, erythema nodosum.
Allergic reactions to naproxen and naproxen sodium preparations, skin necrosis and photo-sensitization including rare cases of pseudoporphyria or epidermolysis bullosa may also occur.
Kidney effects
Renal reactions are not limited to glomerular nephritis but also include interstitial nephritis, nephrotic syndrome, hematuria, papillary necrosis, fluid retention, hyperkalaemia and renal failure.
Hepatic effects
The rare effects are: abnormal liver function tests, jaundice.
Very rare: severe hepatitis.
Effects on the central nervous system
Headache, light-headedness, insomnia, convulsions, difficulty concentrating, confusion and lightheadedness, hearing and visual disturbances, dizziness, drowsiness, tinnitus.
Rare: depression, difficulty concentrating, feeling unwell, aseptic meningitis, cognitive disorders.
Musculoskeletal and connective tissue effects
Myalgia, muscle weakness.
Hematological effects
Rarely, agranulocytosis, eosinophilia, leukopenia, thrombocytopenia, granulocytopenia, aplastic anemia and haemolytic anemia may occur..
Cardiovascular and cerebrovascular effects
Common: palpitations.
Rare: congestive heart failure, vasculitis, tachycardia.
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Respiratory effects
Rare: eosinophilic pneumonia, bronchospasm, alveolitis, edema of the larynx, asthma, dyspnoea.
Endocrine and metabolic effects
Rare: hyperglycemia, hypoglycemia.
Others
Disturbance of vision, hearing loss, middle peripheral edema.
04.9 Overdose
Symptoms of overdose are: sleepiness, heartburn, dyspepsia, nausea, vomiting.
In the case of taking large quantities of naproxen, the stomach should be emptied and normal supportive measures adopted. Immediate administration of adequate amounts of charcoal tends to significantly reduce drug absorption.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-inflammatory and antirheumatic drugs
ATC code: M01AE02
Classical pharmacological tests on animals have shown that naproxen has anti-inflammatory, analgesic and antipyretic properties; the anti-inflammatory effect in adrenalectomized animals indicates that its action is not mediated by the adrenopituitary axis.
Naproxen has also been shown to inhibit prostaglandinsynthetase.
05.2 Pharmacokinetic properties
The bioavailability of naproxen is complete both orally and rectally. Blood levels increase with increasing dose: from about 50 mcg / ml with 250 mg / day to about 100 mcg / ml with 1000 mg / day.
The plasma half-life of naproxen is 12 - 15 hours; plasma protein binding is 99%. Naproxen is excreted via the urine in part unchanged (about 10%) and partly metabolised (6-O-desmethyl naproxen ), in free and conjugated form.
Food does not alter the absorbed amount of naproxen, but causes a slight slowdown in its absorption.
05.3 Preclinical safety data
The pharmaco-toxicological tests carried out in different species of animals (mouse, rat, rabbit, dog) allowed to verify the good local and general tolerability of the active ingredient naproxen. In fact, it does not cause toxic effects and is well tolerated after rectal administration in rabbits, oral in rats, rectal and oral in dogs.
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Stearic acid, magnesium stearate, hydroxypropylcellulose type LF, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, indigo dye.
06.2 Incompatibility
None.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C, in the original package, to protect the medicine from heat and moisture.
06.5 Nature of the immediate packaging and contents of the package
Al / PVC / PVDC blisters contained in cardboard boxes.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
DOC Generici S.r.l. - Via Manuzio, 7 - 20124 Milan.
08.0 MARKETING AUTHORIZATION NUMBER
NAPROXENE SODIUM DOC Generici 550 mg Coated tablets - 30 tablets: A.I.C. n. 034792010.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: July 2011.
10.0 DATE OF REVISION OF THE TEXT
March 2012.