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Renal Effects

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.

Skin Reactions

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.

Precautions

General

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

reduced slowly.

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.

Inpre-existing asthma

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.

Information for

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 -

cardiovascular effects)

• 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

shouldreceivemedical treatment.

• 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

precautions for).

• Naproxen sodium shouldbe taken, such as other NSAIDs, in the final period of pregnancy

notbecause the ductus may cause premature closure of the arteriosus.

Laboratory tests

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.

Excipients:

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

observed.

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.

administering

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.

Since Mifepristone

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

increaselevels.

When

tacrolimus NSAIDs are co-administered with tacrolimus, there is a risk of possible nephrotoxicity.

When zidavudine

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.

SSRIs When

selective serotonin reuptake inhibitors (SSRIs) and NSAIDs are combined, the

risk of gastrointestinal bleeding increases.

Steroids As with

other NSAIDscombined with corticosteroids, with increased