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Aprowell 20 Tablets ingredient Naproxen Sodium
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Prolonged use of NSAIDs results in renal papillary necrosis and other renal damage.
Renalincompensatory efficacy of prostaglandins in providing renal perfusion
toxicity was also observedpatients with. The use of non-steroidal anti-inflammatory drugs in these patients may
lead to a decrease in the production of prostaglandins in a dose-dependent manner and, secondly,
by decreasing renal blood flow, whichlead to a clearly accelerated renal decompensation
may. Thewith renal dysfunction, heart failure, liver failure,
risk of this reaction is higher in patientsdiuretic and ACE inhibitors, and in elderly patients.
With the discontinuation of NSAID treatment, it is usually returned to the pre-treatment state.
Advanced Kidney Disease
controlledon the use of APROWELL in patients with advanced renal disease
There is noclinical trial data. Therefore, APROWELL ispatients with advanced kidney disease
not recommended for. If APROWELL is to be used,renalpatients is
close monitoring offunction ofappropriate.
Anaphylactoid Reactions As withanaphylactoid
other NSAIDs,who have not previously been exposed to
reactions may occur in patientsAPROWELL. APROWELL shouldto patients with aspirin triage
not be given. This symptom complex typicallywith or without nasal polyps,rhinitis
patients with, or patients with potentiallyaspirin or other NSAIDs
develops in patientsfatal, severe bronchospasm when taking. (see
CONTRAINDICATIONS and PRECAUTIONS - pre-existing asthma). Inanaphylactoid
cases withreaction, emergency intervention should be considered.Ocular effects in
studies. The ocular changes that canbased on naproxen application are not
beshown. In rare cases.such as papillitis retrobulbar optic neuritis and papilledema have
undesirable ocular disordersNSAID drug users, including naproxen
been reported by, but the causal and effect relationship has not been determined; Therefore,naproxen
ophthalmologic examination should be performed in patients with impaired vision duringtreatment.
NSAIDs, including APROWELL,exfoliative dermatitis, Stevens-, which can be fatal
severe adverse skin events such asJohnson syndrome (SJS) and toxic epidermal necrosis (TEN)
can cause. These serious events can occur without warning. Patientssevere skin disease
should be warned of signs and symptoms ofandskin rash or other hypersensitivity
drug use should be discontinued if one of the symptoms ofoccurs.
Pregnancy In the
last stage of pregnancy, other NSAIDs, such as APROWELL,prematureductus arteriosus and
may causeclosure of theshould be avoided.
APROWELL is notto replace corticosteroids or to treat corticosteroid insufficiency
used. An abrupt discontinuation of corticosteroids may lead to an exacerbation of the disease. Iflong
corticosteroid therapy is recommended for patients who have been on corticosteroid therapy for atime, treatment should be
The pharmacological activity of APROWELL for the reduction of fever and inflammation may reduce the
usefulness of diagnosticidentification of non-infectious, painful complications
findings for the.Hepatic Effects
Up to 15% of patients receiving NSAIDs, including APROWELL,liver
may have borderline increases in one or more of thetests. These laboratory abnormalities
may progress, not change, or be temporary. In clinicalNSAIDs
studies of, significant increases in ALT and AST (of normalapproximately 1% of patients
three or more times the upper limitvalue) have been reported in. Also rarejaundice and fatal
fulminant hepatitis, liver necrosis and liver failure (some of which result in fatal)
rare liver reactions have been reported, including.
During treatment with APROWELL,patients with signsliver dysfunction
more severeand / or signs of, or in patients with abnormal liver tests
evidence for the development ofliver reactions should be examined in.associated with liver disease
clinical signs or symptomsor systemic symptoms (eg eosinophilia, skin rash, etc.) occur
APROWELL treatment should be discontinued if.
Hematological Effects In
patients receiving NSAIDs, including APROWELL, sometimes anemia can be observed. This is
because fluid retention, hidden or apparent GI is not fullyon blood loss or erythropoiesis
defined effects. In patients receiving long-term NSAIDs, including APROWELL,
hemoglobin and hematocrit valuesany signs or symptoms of anemia are observed
should be checked if.
NSAIDs inhibit platelet aggregation and some patients have beenlonger bleeding times
shown to have. Unlike aspirin, its effects on platelet function are quantitatively
less, short-term and reversible. Aswith coagulation disorders or anticoagulants
in patients, patientsare adverselychanges in platelet function
receiving APROWELL, whichaffected by, should be carefully monitored.
patients withAsthma may be aspirin-sensitive asthma. Thein patients withsensitive asthma has
use of aspirinaspirin-been associated with severe bronchospasm, which can be fatal. Since
aspirin and other non-steroidal anti-inflammatory drugs,bronchospasmbronchospasm
including, have been reported in this cross-reaction, including, APROWELL should not be administered and
should be used with caution in patients with asthma.
patients Patients shouldfollowing points before starting treatment and during treatment
be informed by the.
• Like other NSAIDs, Naproxen sodiumcausethatcause hospitalization or even death
cansevere KV side effects such as myocardial infarction or strokecan.
Although severe CV side effects may occur without any warning symptoms,
patientssymptoms andsuch as chest pain, shortness of breath, weakness, speech distortion and
should be cautious in terms ofsignsshouldindicator of the diseaseanyor
consult with the physician when theobservessignssymptoms. Patientsimportance of this follow-up
should be informed about the. (See section 4.4 Special warnings and precautions for use -
• As with other NSAIDs, Naproxen sodiumGI discomfort and rarelyin the hospital
may cause serious GI side effects such as ulcers and bleeding, which may causedeathor even death
. Although severe GI system ulceration and bleedingany warning symptoms
may occur without, patientssymptoms andulceration and bleeding
should be cautious in terms ofsigns of, andepigastric pain, dyspepsia, melena, and hematemesis
physician if any signs or signs of the disease such asare observed
consult with their. Patients should be informed about the importance of this follow-up. (See
section 4.4 Special warnings and precautions for use - Gastrointestinal Effects - Ulceration,
Risk of Bleeding and Perforation)
• Like other NSAIDs, Naproxen sodiumcausewhichleadhospitalization or even death
canserious dermatological side effects such as exfoliative dermatitis, SJS and TEN,canto
. Although serious skin reactions can occur without any stimulation
, patientsskin rash and blisters, fever symptoms and signs, or itching
should be cautious with respect to other signs of hypersensitivity such as, anddisease
consult with the physician when the indicator of theobserves any symptoms or signs.
Should any rash develop in patients, itdiscontinue the drug andpossible
should be advised that theyconsult the physician as soon as.
• Patients should quicklysigns and symptoms of an unexplained weight gain or payment
inform their physicians about the.
• Patients should be informed about symptoms and signs of hepatotoxicity
(nausea, fatigue, lethargy, jaundice, tenderness in the right upper quadrant, and cold-
like symptoms). If these occur, patientsstop treatment andrapid
• Patients should be informed of the signs of anaphylactic reaction (difficulty breathing
, swelling of the face and throat). When these occur, patients should bequicklyemergency room
advised togo to the(see section 4.4 Special warnings anduse
• Naproxen sodium shouldbe taken, such as other NSAIDs, in the final period of pregnancy
notbecause the ductus may cause premature closure of the arteriosus.
severe GI can cause ulceration and bleeding without any warning symptoms
Physicians should closely monitor GI bleeding symptoms and signs, since. InNSAIDs
patients with long-term treatment with, complete blood count and chemical profilea regular basis
should be monitored on. If clinical symptoms and signs compatible with liver or kidney disease
develop, systemic symptoms occur (eosinophilia, rash etc.) or abnormal liver tests
continue or worsen, naproxen sodium treatment should be discontinued.
Sodium: This medicinal product contains 4 mg (less than 1 mmol (23 mg)) of sodium in each tablet
; ie it does not contain sodium.
4.5. Interactions with other medicinal products and other forms of interaction
Due to the cumulative risk of triggering serious adverse events associated with
NSAIDs, the combined application of APROWELL and other NSAIDs is not recommended.
Co-administration with anti-acid or cholestyramine mayabsorption of naproxen sodium
delay, but does not affect the amount of absorption.
Naproxen sodium is highly bound to plasma albumin; therefore itcoumarin-
type anticoagulants, sulfonylureas, hydantoins, other NSAIDs andalbumin, such as aspirin
has the potential to interact theoretically withother drugs that bind to. Patients receiving APHWELL together with
a hydantoin, sulfonamide or sulfonylurea should befor dose adjustment if necessary
significantbetween naproxen sodium and coumarin-type anticoagulants was observed in clinical studies
Although nointeraction, NSAIDs mayeffects of anticoagulants such as warfarin
enhance the. Naproxen sodium reduces platelet aggregation andbleeding
prolongstime. When determining the bleeding time, this effect should not be forgotten.
Caution should be exercised whenprobenecid with probenecid, as it increases the plasmanaproxen sodium
concentrations ofand an increase in the half-life of naproxen has been
reported.Cyclosporine As with
all NSAIDsincreasednephrotoxicity when used in conjunction with cyclosporine
, caution should be exercised due to therisk of.
NSAIDs can reduce the effect of mifepristone8-12after mifepristone administration
, NSAIDs should not be used fordays.Beta-blockers
APROWELL may reduce the anti-hypertensive effects of beta-blockers.Cardiac glycosides
NSAIDs are administered together with cardiac glycosides. It cancardiac failure
exacerbate, reduce glomerular filtration rate andplasma cardiac glycoside
tacrolimus NSAIDs are co-administered with tacrolimus, there is a risk of possible nephrotoxicity.
NSAIDs are given with zidavudine, the risk of hematological toxicity may increase.zidavudine and
hemarthrosis and hematoma in HIV (+) hemophilia patients treated concurrently withibuprofen
There is evidence of an increased risk of.
selective serotonin reuptake inhibitors (SSRIs) and NSAIDs are combined, the
risk of gastrointestinal bleeding increases.
Steroids As with
other NSAIDscombined with corticosteroids, with increased
, caution should be exercised whenrisk of gastrointestinal ulceration or bleeding. Iftreatment
the dosage of the steroid will be reduced or discontinued during the. steroid dosage should be reduced slowly and
patientsadverse effects such as exacerbation of symptoms of adrenal insufficiency and arthritis
should be closely monitored for.
Data from animal studies have shown that NSAIDsassociated with quinolone antibiotics
may increase the risk of convulsions. Patients using quinoloneconvulsions
may be at increased risk of developing.
been reported that ACE inhibitors can reduce the antihypertensive efficacy of ACE Inhibitors.
This interaction should be considered in patients receiving ADE inhibitors with NSAIDs.
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