NAPROSYN
NAPROSYN "250 MG GRANULES FOR ORAL SUSPENSION" 30 SACHETS"
NAPROSYN "250 MG GRANULES FOR ORAL SUSPENSION" 30 SACHETS"
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Description
Description
Name
Naprosyn 250 mg granules for oral suspension
Naproxen
What is it and what is it used for?
Naprosyn contains the active substance naproxen.
Naproxen belongs to a class of medicines called nonsteroidal anti-inflammatory/antirheumatic drugs (NSAIDs) that have numerous actions, with an important role in pain control.
Naprosyn is used to treat the symptoms of:
• an inflammatory disease of the joints (rheumatoid arthritis)
• a degenerative joint disease (osteoarthritis or degenerative arthritis)
• an inflammatory disease of the spine (ankylosing spondylitis)
• a disease due to the presence of uric acid crystals in the joints (gouty arthropathy)
• diseases affecting the joints, bones, tendons (lumbosciatica, myalgia, neuralgia, radicular syndromes, periarthritis, fibromyositis).
Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.
What you need to know before taking the medicine
Do not take Naprosyn
• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a lesion of the stomach or duodenum wall (current gastroduodenal ulcer and peptic ulcer);
• if you suffer from inflammation of the colon (ulcerative colitis);
• if you have a history of bleeding or perforation of the stomach or intestine due to previous treatments or a history of frequent bleeding/injury of the stomach wall (peptic ulcer) (two or more distinct episodes);
• if you have serious heart problems (severe heart failure);
• if you have had allergic reactions such as asthma, itching (urticaria), allergic cold (rhinitis), severe and rapid general allergic reaction (anaphylactic or anaphylactoid reactions), presence of drop-shaped lumps inside the nose (nasal polyps), associated with the use of aspirin (acetylsalicylic acid) and/or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if it is for a child under 2 years old;
• if you are pregnant or breastfeeding;
• if you have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naprosyn.
In particular, inform your doctor:
• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have a history of stomach wall injury with bleeding/perforation (gastrointestinal bleeding, ulceration or perforation);
• if you have or have ever had acute inflammation of the gastrointestinal tract or if you have had stomach or intestinal problems after using medicines for rheumatic diseases;
• if you have a history of stomach or intestinal toxicity: report any unusual symptoms to your doctor, especially at the beginning of treatment;
• if you are taking anti-inflammatory medicines (oral corticosteroids), medicines to thin the blood (anticoagulants such as warfarin), medicines for depression (selective serotonin reuptake inhibitors) or medicines such as aspirin or similar (see "Other medicines and Naprosyn");
• if you suffer from a chronic inflammatory disease of the stomach and intestine (ulcerative colitis or Crohn's disease);
• if you have heart problems;
• if you have liver problems;
• if you have kidney problems;
• if you suffer from high blood pressure and/or heart problems (heart failure), known ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
• if you have a history of swelling of the legs, arms, face, mouth or tongue (angioedema) or breathing difficulties (bronchospasm, asthma and rhinitis) and the presence of drop-shaped lumps inside the nose (nasal polyps);
• if you have severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions);
• if you have bleeding problems (haemostasis disorders);
• if you are planning a pregnancy;
• if you have fertility problems or are undergoing fertility investigations.
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Naprosyn. If you notice any of the symptoms of these serious skin reactions, described in section 4, stop taking Naprosyn and contact your doctor immediately.
If you notice any skin rash, mucosal lesions, or any other signs of an allergic reaction (hypersensitivity) while using Naprosyn, stop treatment immediately and contact your doctor.
Medicines like Naprosyn may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems or a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss your treatment with your doctor or pharmacist.
In the elderly and in patients with a history of ulcers, especially if complicated by bleeding or perforation (see section "Do not take Naprosyn"), the risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing doses. These patients should start treatment on the lowest available dose.
If you use Naprosyn for prolonged treatments you must have periodic eye checks.
Children and adolescents
The medicine is not intended for use in children. Your doctor may prescribe Naprosyn only when absolutely necessary and for children over 2 years of age.
Elderly people
If you are elderly, you are more likely to experience some of the side effects caused by Naprosyn such as bleeding/perforation of the stomach and intestines.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Naprosyn and contact your doctor immediately if you notice any of the following side effects:
Not known: frequency cannot be estimated from the available data
- Extensive skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2;
- A distinctive allergic skin reaction known as a fixed drug eruption, which usually recurs at the same site or sites with re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, a rash with blisters (hives), and an itching sensation.
• The most commonly observed adverse events are gastrointestinal in nature. Injury, bleeding, or perforation of the stomach and intestines (peptic ulcers, gastrointestinal perforation or haemorrhage), sometimes fatal, particularly in the elderly, may occur (see Warnings and precautions). Nausea, vomiting, diarrhea, flatulence (gas leakage from the anus), constipation, indigestion (dyspepsia), abdominal and stomach pain, heartburn, blood in the stool (melena), vomiting blood (haematemesis), inflammation of the mouth (ulcerative stomatitis), worsening of chronic inflammatory bowel disease (exacerbation of colitis and Crohn's disease), inflammation of the esophagus (esophagitis), inflammation of the pancreas (pancreatitis) have been reported after administration of Naprosyn.
Other side effects that may occur with the use of Naprosyn are:
• alteration in the concentration of some types of cells present in the blood (thrombocytopenia, granulocytopenia, leukopenia, eosinophilia, aplastic or haemolytic anaemia);
• severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions);
• high concentration of potassium in the blood (hyperkalemia);
• abnormal dreams;
• depression;
• insomnia;
• dizziness;
• disorientation;
• convulsions;
• headache (cephalalgia);
• drowsiness;
• inflammation of the optic nerve (retrobulbar optic neuritis);
• cognitive dysfunctions;
• difficulty concentrating;
• inflammation of the membranes surrounding the brain (aseptic meningitis);
• visual disturbances (papillitis, papilloedema, visual impairment, corneal opacity);
• hearing disorders (hearing impairment, ringing in the ear, tinnitus, vertigo);
• irregular or strong heartbeat (palpitations);
• rapid heartbeat (tachycardia);
• heart function problems (congestive heart failure, heart failure, myocardial infarction);
• damage to the blood vessels of the brain (stroke);
• high blood pressure (hypertension);
• inflammation of the blood vessels (vasculitis);
• swelling (edema);
• breathing difficulties (dyspnea, asthma and bronchospasm);
• inflammation of the lungs (eosinophilic pneumonia);
• increased fluid in the lungs (pulmonary edema);
• swelling of the throat (laryngeal edema);
• yellow skin (jaundice);
• inflammation of the liver (hepatitis);
• skin rashes;
• itching;
• hives;
• bruises (ecchymosis);
• rapid swelling of the legs, arms, face or tongue (angioedema);
• appearance of red, swollen nodules under the skin (erythema multiforme, erythema nodosum, lichen planus);
• red spots on the body (purpura);
• blister reactions including a disease called Stevens-Johnson syndrome with severe lesions on the skin, mouth and other parts of the body with high fever, vomiting, diarrhoea and joint pain;
• death of the skin (toxic epidermal necrolysis);
• abnormal and exaggerated reaction of the skin to light (photosensitivity reactions);
• hair loss (alopecia);
• muscle pain (myalgia);
• muscle weakness;
• blood in the urine (hematuria);
• reduction in renal function, renal damage (interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis);
• infertility in women;
• mild swelling of the extremities (peripheral edema);
• excessive thirst;
• fever and chills;
• malaise;
• alteration of laboratory tests to evaluate liver function;
• increase in creatinine in the blood (hypercreatinemia).
Medicines like Naprosyn may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
Naprosyn 250 mg granules for oral suspension
Naproxen
What is it and what is it used for?
Naprosyn contains the active substance naproxen.
Naproxen belongs to a class of medicines called nonsteroidal anti-inflammatory/antirheumatic drugs (NSAIDs) that have numerous actions, with an important role in pain control.
Naprosyn is used to treat the symptoms of:
• an inflammatory disease of the joints (rheumatoid arthritis)
• a degenerative joint disease (osteoarthritis or degenerative arthritis)
• an inflammatory disease of the spine (ankylosing spondylitis)
• a disease due to the presence of uric acid crystals in the joints (gouty arthropathy)
• diseases affecting the joints, bones, tendons (lumbosciatica, myalgia, neuralgia, radicular syndromes, periarthritis, fibromyositis).
Talk to your doctor if you do not feel better or if you feel worse after a short time of treatment.
What you need to know before taking the medicine
Do not take Naprosyn
• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a lesion of the stomach or duodenum wall (current gastroduodenal ulcer and peptic ulcer);
• if you suffer from inflammation of the colon (ulcerative colitis);
• if you have a history of bleeding or perforation of the stomach or intestine due to previous treatments or a history of frequent bleeding/injury of the stomach wall (peptic ulcer) (two or more distinct episodes);
• if you have serious heart problems (severe heart failure);
• if you have had allergic reactions such as asthma, itching (urticaria), allergic cold (rhinitis), severe and rapid general allergic reaction (anaphylactic or anaphylactoid reactions), presence of drop-shaped lumps inside the nose (nasal polyps), associated with the use of aspirin (acetylsalicylic acid) and/or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if it is for a child under 2 years old;
• if you are pregnant or breastfeeding;
• if you have severe kidney problems.
Warnings and precautions
Talk to your doctor or pharmacist before taking Naprosyn.
In particular, inform your doctor:
• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have a history of stomach wall injury with bleeding/perforation (gastrointestinal bleeding, ulceration or perforation);
• if you have or have ever had acute inflammation of the gastrointestinal tract or if you have had stomach or intestinal problems after using medicines for rheumatic diseases;
• if you have a history of stomach or intestinal toxicity: report any unusual symptoms to your doctor, especially at the beginning of treatment;
• if you are taking anti-inflammatory medicines (oral corticosteroids), medicines to thin the blood (anticoagulants such as warfarin), medicines for depression (selective serotonin reuptake inhibitors) or medicines such as aspirin or similar (see "Other medicines and Naprosyn");
• if you suffer from a chronic inflammatory disease of the stomach and intestine (ulcerative colitis or Crohn's disease);
• if you have heart problems;
• if you have liver problems;
• if you have kidney problems;
• if you suffer from high blood pressure and/or heart problems (heart failure), known ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
• if you have a history of swelling of the legs, arms, face, mouth or tongue (angioedema) or breathing difficulties (bronchospasm, asthma and rhinitis) and the presence of drop-shaped lumps inside the nose (nasal polyps);
• if you have severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions);
• if you have bleeding problems (haemostasis disorders);
• if you are planning a pregnancy;
• if you have fertility problems or are undergoing fertility investigations.
Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Naprosyn. If you notice any of the symptoms of these serious skin reactions, described in section 4, stop taking Naprosyn and contact your doctor immediately.
If you notice any skin rash, mucosal lesions, or any other signs of an allergic reaction (hypersensitivity) while using Naprosyn, stop treatment immediately and contact your doctor.
Medicines like Naprosyn may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems or a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss your treatment with your doctor or pharmacist.
In the elderly and in patients with a history of ulcers, especially if complicated by bleeding or perforation (see section "Do not take Naprosyn"), the risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing doses. These patients should start treatment on the lowest available dose.
If you use Naprosyn for prolonged treatments you must have periodic eye checks.
Children and adolescents
The medicine is not intended for use in children. Your doctor may prescribe Naprosyn only when absolutely necessary and for children over 2 years of age.
Elderly people
If you are elderly, you are more likely to experience some of the side effects caused by Naprosyn such as bleeding/perforation of the stomach and intestines.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Naprosyn and contact your doctor immediately if you notice any of the following side effects:
Not known: frequency cannot be estimated from the available data
- Extensive skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2;
- A distinctive allergic skin reaction known as a fixed drug eruption, which usually recurs at the same site or sites with re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, a rash with blisters (hives), and an itching sensation.
• The most commonly observed adverse events are gastrointestinal in nature. Injury, bleeding, or perforation of the stomach and intestines (peptic ulcers, gastrointestinal perforation or haemorrhage), sometimes fatal, particularly in the elderly, may occur (see Warnings and precautions). Nausea, vomiting, diarrhea, flatulence (gas leakage from the anus), constipation, indigestion (dyspepsia), abdominal and stomach pain, heartburn, blood in the stool (melena), vomiting blood (haematemesis), inflammation of the mouth (ulcerative stomatitis), worsening of chronic inflammatory bowel disease (exacerbation of colitis and Crohn's disease), inflammation of the esophagus (esophagitis), inflammation of the pancreas (pancreatitis) have been reported after administration of Naprosyn.
Other side effects that may occur with the use of Naprosyn are:
• alteration in the concentration of some types of cells present in the blood (thrombocytopenia, granulocytopenia, leukopenia, eosinophilia, aplastic or haemolytic anaemia);
• severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions);
• high concentration of potassium in the blood (hyperkalemia);
• abnormal dreams;
• depression;
• insomnia;
• dizziness;
• disorientation;
• convulsions;
• headache (cephalalgia);
• drowsiness;
• inflammation of the optic nerve (retrobulbar optic neuritis);
• cognitive dysfunctions;
• difficulty concentrating;
• inflammation of the membranes surrounding the brain (aseptic meningitis);
• visual disturbances (papillitis, papilloedema, visual impairment, corneal opacity);
• hearing disorders (hearing impairment, ringing in the ear, tinnitus, vertigo);
• irregular or strong heartbeat (palpitations);
• rapid heartbeat (tachycardia);
• heart function problems (congestive heart failure, heart failure, myocardial infarction);
• damage to the blood vessels of the brain (stroke);
• high blood pressure (hypertension);
• inflammation of the blood vessels (vasculitis);
• swelling (edema);
• breathing difficulties (dyspnea, asthma and bronchospasm);
• inflammation of the lungs (eosinophilic pneumonia);
• increased fluid in the lungs (pulmonary edema);
• swelling of the throat (laryngeal edema);
• yellow skin (jaundice);
• inflammation of the liver (hepatitis);
• skin rashes;
• itching;
• hives;
• bruises (ecchymosis);
• rapid swelling of the legs, arms, face or tongue (angioedema);
• appearance of red, swollen nodules under the skin (erythema multiforme, erythema nodosum, lichen planus);
• red spots on the body (purpura);
• blister reactions including a disease called Stevens-Johnson syndrome with severe lesions on the skin, mouth and other parts of the body with high fever, vomiting, diarrhoea and joint pain;
• death of the skin (toxic epidermal necrolysis);
• abnormal and exaggerated reaction of the skin to light (photosensitivity reactions);
• hair loss (alopecia);
• muscle pain (myalgia);
• muscle weakness;
• blood in the urine (hematuria);
• reduction in renal function, renal damage (interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis);
• infertility in women;
• mild swelling of the extremities (peripheral edema);
• excessive thirst;
• fever and chills;
• malaise;
• alteration of laboratory tests to evaluate liver function;
• increase in creatinine in the blood (hypercreatinemia).
Medicines like Naprosyn may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
NAPROSYN
NAPROSYN "250 MG GRANULES FOR ORAL SUSPENSION" 30 SACHETS"
NAPROSYN "250 MG GRANULES FOR ORAL SUSPENSION" 30 SACHETS"
MINSAN code: 023177090
Previous price: €9,28
Regular price
€9,40
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€9,40
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