Renal effects Renal prostaglandins may play a compensatory role in the maintenance of renal perfusion. Therefore, under conditions of compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, and thereby impair renal function.

Patients at greatest risk of this response are those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis. Monitoring of renal function in such patients should be considered.

Fluid retention, oedema and hypertension As with other medicinal products known to inhibit prostaglandin synthesis, fluid retention, oedema and hypertension have been observed in patients taking etoricoxib.

For information regarding a dose related response for etoricoxib see section 5. Caution should be exercised in patients with a history of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema from any other reason.

If there is clinical evidence of deterioration in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken. Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, hypertension should be controlled before treatment with etoricoxib see section 4.

Blood pressure should be monitored within two weeks after initiation of treatment and periodically thereafter. If blood pressure rises significantly, alternative treatment should be considered. If signs of hepatic insufficiency occur, or if persistently abnormal liver function tests three times the upper limit of normal are detected, etoricoxib should be discontinued.

General If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of etoricoxib therapy should be considered. Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, hepatic, or cardiac dysfunction.

Caution should be used when initiating treatment with etoricoxib in patients with dehydration. It is advisable to rehydrate patients prior to starting therapy with etoricoxib.

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 and some selective COX-2 inhibitors during post-marketing surveillance see section 4. Patients appear to be at highest risk for these reactions early in the course of therapy with the onset of the reaction occurring in the majority of cases within the first month of treatment. Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving etoricoxib see section 4.

Some selective COX-2 inhibitors have been associated with an increased risk of skin reactions in patients with a history of any drug allergy. Etoricoxib should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Arcoxia is not recommended in women attempting to become pregnant. Etoricoxib may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke.

If you think any of these are relevant to you, do not take the tablets until you have consulted your doctor. Talk to your doctor or pharmacist before taking Arcoxia if: Arcoxia can increase blood pressure in some people, especially in high doses, and your doctor will want to check your blood pressure from time to time. Arcoxia can mask or hide a fever, which is a sign of infection.

These can increase your risk of heart disease. If you are not sure if any of the above apply to you, talk to your doctor before taking Arcoxia to see if this medicine is suitable for you. Driving and using machines Dizziness and sleepiness have been reported in some patients taking Arcoxia.

Do not drive if you experience dizziness or sleepiness. Medicul dumneavoastra v-a prescris aceste comprimate pentru combaterea simptomelor bolii artrozice, poliartritei reumatoide sau gutei. Substanta activa din comprimatul filmat Arcoxia este etoricoxib.

Nu luati Arcoxia daca prezentati una dintre urmatoarele situatii: Etoricoxib poate creste usor riscul dumneavoastra de atac cardiac si accident vascular cerebral si de aceea nu trebuie utilizat la cei care au avut deja probleme cardiace sau accident vascular cerebral.

La fel ca si celelalte medicamente, la unii dintre pacienti, Arcoxia poate avea efecte neintentionate sau nedorite, asa numitele reactii adverse. Reactiile adverse care au aparut in studiile clinice, la pacienti tratati cu Arcoxia, au fost urmatoarele: Prezentati-va la medicul dumneavoastra daca prezentati oricare dintre reactiile adverse mentionate mai sus sau orice alt simptom neobisnuit pe care nu vi-l puteti explica si mai ales daca acesta este persistent, deranjant sau se agraveaza.

Este util ca in momentul cand un astfel de simptom se instaleaza sa va notati evolutia lui - cand s-a instalat, cat a durat - si ceea ce ati simtit dumneavoastra. These can increase your risk of heart disease. If you are not sure if any of the above apply to you, talk to your doctor before taking ARCOXIA to see if this medicine is suitable for you.

If you are over 65 years of age, your doctor will want to appropriately keep a check on you. No dosage adjustment is necessary for patients over 65 years of age. Children and adolescents Do not give this medicine to children and adolescents under 16 years of age.

Other medicines and ARCOXIA Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. In particular if you are taking any of the following medicines, your doctor may want to monitor you to check that your medicines are working properly, once you start taking ARCOXIA: If you forget to take the tablet at your usual time, take it as soon as you remember.

If you do not remember until the following day, leave out the forgotten dose from the previous day and take the dose that is due as normal. Do not take two doses at the same time to make up for a missed dose. Getting the most from your treatment Your doctor will try to prescribe you the lowest dose for the shortest time to reduce the risk of side-effects.

If you need to take etoricoxib for a long time, your doctor may also want to prescribe another medicine for you to take along with etoricoxib to protect your stomach from irritation. Try to keep any regular appointments with your doctor. This is so your progress can be checked. Your doctor will want to check your blood pressure from time to time while you are taking etoricoxib.

If you have asthma, symptoms such as wheeze or breathlessness can be made worse by anti-inflammatories such as etoricoxib. If this happens to you, you should stop taking the tablets and see your doctor as soon as possible.

There is known to be a small increased risk of heart and blood vessel problems in people taking anti-inflammatory painkillers like etoricoxib. Your doctor will explain this to you and will prescribe the lowest suitable dose for the shortest time in order to reduce the risk. Do not take more than the recommended dose for your condition.

If you buy any medicines, check with a pharmacist that they are suitable for you to take.

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