Patients suffering from dizziness, dizziness or other adverse effects of the central nervous system when taking NSAIDs should refrain from driving a vehicle or handling dangerous machinery. >

Acéclofénac is contraindicated in the following situations

· Patients with a history of hemorrhage or gastrointestinal perforation associated with previous NSAID treatment

· Patients with active peptic ulcer, history of peptic ulcer or recurrent hemorrhage (2 distinct episodes, or more haemorrhage or ulceration, objectivated)

· Patients with active hemorrhage or bleeding disorders

· Patients with severe impairment of liver or kidney function

· Patients with severe heart failure

Pregnancy, especially during the third trimester of pregnancy (see section Pregnancy and lactation)

Patients with prior sensitivity to aceclofenac, to any of the excipients or to the administration of acetylsalicylic acid or NSAIDs precipitates the onset of asthma, rhinitis, acute or Or patients hypersensitive to these drugs

· Patients with a history of kidney transplant

· Patient suffering from nephrotic syndrome

It is possible to minimize adverse reactions by using the lowest effective dose for the shortest possible period of time necessary to control the symptoms (see Dosage and Mode of Administration). >

Concomitant use of Aceclofenac EG with other NSAIDs, including selective cyclooxygenase 2 (cox-2) inhibitors, should be avoided.

At the gastrointestinal level

Close medical surveillance is required in patients with the following conditions because they may become worse (see section 4.4):
· Symptoms indicative of gastrointestinal disorders, involving the upper or lower gastrointestinal tract

· Symptoms suggestive of ulceration, haemorrhage or gastrointestinal perforation

· Ulcerative colitis

· Crohn's disease

· Hematological abnormalities.

Hemorrhages, gastrointestinal ulcerations or perforations, sometimes fatal, have been reported with all NSAIDs at any point in the treatment, without necessarily having warning signs or antecedents Severe gastrointestinal adverse events

The risk of hemorrhage, ulceration, or gastrointestinal perforation increases with the dose of NSAIDs used in patients with a history of ulcer, particularly in the case of complications such as haemorrhage or Perforation (see section Contraindications) as well as in the elderly. In these patients, treatment should be started at the lowest possible dosage

An associated mucosal protective treatment (eg misoprostol or proton pump inhibitor) should be considered for these patients, as well as for patients requiring treatment, by low doses of aspirin or treated with other drugs , Drugs likely to increase risk, gastrointestinal (see below and section Interactions with other medicines and other forms of interactions).
Patients with a gastrointestinal history, especially in elderly patients, should report any unusual abdominal symptoms (especially bleeding, gastrointestinal), especially at the start of treatment. Particular attention should be paid to patients receiving associated therapies that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, oral anticoagulants such as warfarin, selective Serotonin reuptake inhibitors (SSRIs) and antiplatelet agents such as aspirin (see section Interactions with other medicinal products and other forms of interaction). >
In the event of hemorrhage or ulceration in a patient receiving aceclofenac, treatment should be discontinued.

NSAIDs should be administered with caution and under close surveillance in patients with a history of gastrointestinal illness (Hemorrhagic Recto-Colitis, Crohn's Disease) due to a risk of aggravation of the pathology (See section Effects, undesirable).

Hypersensitivity and skin reactions

As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, may also occur without prior exposure to the drug. Severe skin reactions, some of which are fatal and include exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Side effects). The risk of developing these reactions is highest at the beginning of the therapy and in most cases the onset of the reaction occurs during the first month of treatment. Stop treatment with aceclofenac from the first signs of rash, lesions, mucous membranes or any other signs of hypersensitivity

Exceptionally, chicken pox can trigger infectious complications, severe skin and soft tissue. To date, it is impossible to exclude a contribution from NSAIDs in the worsening of these infections. It is therefore advisable to avoid the use of aceclofenac in the case of chicken pox

At the renal level

The administration of an NSAID can cause a dose-dependent reduction in the formation of prostaglandins and precipitate the onset of renal insufficiency. Consider the importance of prostaglandins in maintaining renal blood flow in patients with impaired cardiac or renal function, hepatic dysfunction, and in patients treated with diuretics or recovering from Major surgery, as well as in elderly patients

Keep under surveillance patients with mild to moderate renal impairment as the use of NSAIDs may cause deterioration of renal function. Use the lowest possible effective dose and monitor renal function regularly. The effects on renal function are generally reversible upon discontinuation of treatment with aceclofenac.


Close medical surveillance is required in patients with mild to moderate hepatic impairment

Stop treatment with aceclofenac if abnormal liver function tests persist or worsen if clinical signs or symptoms suggestive of liver disease develop or if other manifestations occur (eosinophilia, rash , Cutaneous).

Hepatitis can occur without prodromal symptoms.

The use of NSAIDs in patients with hepatic porphyria may trigger a seizure

Cardiovascular and vascular cerebral

Adequate surveillance and precautions are required in patients with a history of hypertension and / or mild to moderate heart failure, retention, hydrosodic and edema having been reported in combination with treatment By NSAIDs.
Acefenac should be administered with caution and under close medical supervision in patients with a history of haemorrhage or cerebrovascular disease.
Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially at high doses, over a long period of time) may be associated with mild, increased risk of thrombotic events, arterial (eg, Myocardial infarction or accident, cerebral vascular). The data are currently insufficient to rule out this increase, the risk for aceclofenac

Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebral vascular disease should be treated with aceclofenac only after careful assessment. A similar evaluation should be carried out before initiating a long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes or smoking)
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At the hematological level

Aceclofenac may reversibly inhibit platelet aggregation (see Interactions with other medicinal products and other forms of interaction, "Interactions", paragraph "anticoagulants"). >

Respiratory diseases

Caution should be exercised when administering aceclofenac to patients with or having a history of bronchial asthma because NSAIDs have been reported to trigger bronchospasm In these patients.

The elderly

Elderly subjects are at increased risk of adverse reactions to NSAIDs, particularly gastrointestinal haemorrhage and potentially fatal perforations (see Dosage and Administration).
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Gastrointestinal haemorrhages, or perforations, occur more severely and without necessarily having warning signs or a history of adverse effects at any point in the treatment . Elderly subjects are also more prone to impaired renal, hepatic or cardiac function.


For patients taking prolonged NSAIDs, hepatic, renal and haematological functions should be monitored Aceclofenac should be administered with caution and under close medical supervision in patients with a history of , Systemic lupus erythematosus, porphyria, clotting or hematopoiesis disorders

The use of A ceclofenac EG, as any drug inhibiting the synthesis of cyclooxygenases and prostaglandins, may impair fertility and its use is not recommended, in women who wish to conceive a child. In women who have difficulty in procreating or in which investigations of reproductive function are in progress, discontinuation of A ceclofenac should be considered. >

None, pharmacokinetic interaction study (except with warfarin) was performed.
Aceclofenac is metabolized via cytochrome P450 2C9 and in vitro data indicates that aceclofenac may be an inhibitor of this enzyme. There is therefore a risk of pharmacokinetic interaction with phenytoin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole.



As with other NSAIDs, there is a risk of pharmacokinetic interaction with drugs with active renal elimination, such as methotrexate and lithium.

Aceclofenac is almost completely bound to plasma proteins (albumin). The possibility of interaction with highly protein-bound plasmatic drugs should be taken into account.

Due to the lack of pharmacokinetic interaction studies, the following recommendations are based on information with other NSAIDs

Associations, deprecated

+ Methotrexate (high doses)

NSAIDs inhibit its tubular secretion. Mild metabolic interaction by decreased clearance methotrexate can be observed

As a result, NSAIDs should be avoided during treatment with high-dose methotrexate.

+ Methotrexate (low doses)

Possible interaction between NSAIDs and methotrexate even at low doses should be considered especially in patients with impaired renal function

If the combination can not be avoided during the same 24-hour period, renal function should be monitored because of the increase in methotrexate levels that may reach toxic values. >

+; Lithium and digoxin

Several NSAIDs inhibit renal clearance of lithium, thus increasing the serum concentration of both drugs.

If the combination can not be avoided, increased monitoring of lithium and digoxin levels should be performed.

+; Diuretics

Like other NSAIDs, aceclofenac may inhibit the activity of diuretics. Although no alterations in blood pressure were observed in concomitant administration with bendrofluazide, interactions with other diuretics can not be ruled out.
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Concomitant administration with potassium diuretics may be accompanied by an elevated serum potassium concentration. The latter must then be monitored.

+ Antihypertensive drugs

NSAIDs may decrease the effect of antihypertensive drugs. The risk of acute renal failure, which is generally reversible, may increase in some patients with impaired renal function (eg, patients, dehydrated or elderly patients) when combined with ACE inhibitors or antagonists Receptors of angiotensin II with NSAIDs. This combination should therefore be administered with caution, especially in elderly patients. Ensure proper hydration of patients and consider renal function monitoring after the initiation of concomitant therapy and then periodically.


As with other NSAIDs, aceclofenac may increase the activity of anticoagulants. Carefully monitor patients receiving combination therapy with anticoagulant and aceclofenac.

+ Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs)

In combination with NSAIDs, they may increase the risk of gastrointestinal haemorrhage (see Warnings and Precautions for Use). >
+ Antidiabetics

In clinical studies it has been shown that diclofenac can be administered in combination with oral antidiabetics without influencing their clinical efficacy. However, isolated cases of hypoglycemia and hyperglycemia have been reported with aceclofenac. Doses of medicinal products which may lead to hypoglycemia should therefore be adjusted if combined with aceclofenac

+ Other NSAIDs

A concomitant treatment with acids, acetylsalicylic and other NSAIDs may increase the frequency of adverse effects.

+; Quinolones

Convulsions may occur due to interaction between quinolones and NSAIDs. These may appear in patients with or without a history of convulsions or epilepsy

+ Corticosteroid

Increased risk of ulceration or gastrointestinal haemorrhage (see Warnings and Precautions for Use).

+; Ciclosporin, tacrolimus

The association of an NSAID with ciclosporin or tacrolimus increases the risk of nephrotoxicity due to decreased synthesis of prostacyclines and kidneys
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In case of combination, it is important to check renal function.

+; Zidovudine

There is an increased risk of haematological toxicity if NSAIDs are administered concomitantly with zidovudine.
An increased risk of haemato-arthritis and haematomas in HIV (+) hemophiliacs receiving simultaneous treatment with zidovudine and ibuprofen has been shown
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There is insufficient data available on the consequences of an overdose of aceclofenac in humans.

The treatment of acute drug poisoning, nonsteroidal anti-inflammatory drugs consists mainly of symptomatic and supportive treatment to prevent complications such as hypotension, kidney failure, convulsions, irritation, gastrointestinal Gastrointestinal tract and respiratory depression

The management of acute intoxication with oral aceclofenac consists of prevention of absorption, as soon as possible after ingestion and by gastric lavage, and Treatment with activated charcoal

Forced diuresis, dialysis and haemoperfusion do not allow for the elimination of NSAIDs because of their high binding to plasma proteins and their important metabolism

Pregnancy

There is no information regarding the use of aceclofenac during pregnancy. Prostaglandin synthesis inhibitors may affect pregnancy and / or embryofoetal development Data from epidemiological studies show an increased risk of spontaneous abortion, cardiac malformation or gastroschisis after use of Inhibitors of the synthesis of prostaglandins in early pregnancy. The absolute risk of cardiac malformation increases from less than 1% to about 1.5%. This risk appears to increase with dose and duration of treatment. In animals, it has been shown that administration of inhibitors of prostaglandin synthesis has been linked to pre- and post-implantation loss and embryofoetal lethality.
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On the other hand, the increase in the incidence of various malformations (eg, cardiovascular) has been reported in animals receiving inhibitors of prostaglandin synthesis during organogenesis. In the first and second trimesters of pregnancy, NSAIDs should be administered only in cases of clearly identified need. In the case where NSAIDs are administered in women who wish to be pregnant or during the first and second trimesters of pregnancy, the dose and duration of treatment should be the lowest possible. >

During the third trimester of pregnancy, administration of prostaglandin synthesis inhibitors exposes the fetus to

Cardiopulmonary toxicity (with closure, premature ductus arteriosus and pulmonary hypertension)

Renal dysfunction that can progress to renal failure with oligo-hydroamnios

The administration of inhibitors of the synthesis of prostaglandins at the end of pregnancy exposes the mother and the future, newborn to

· A possible prolongation of the hemorrhage, an effect, anti-platelet aggregation may occur even at low dose

· Inhibition of uterine contractions resulting in delayed and prolonged labor

Therefore, NSAIDs are contraindicated during the 3 rd trimester of pregnancy (see section Contraindications).


There is no information regarding the secretion of aceclofenac in breast milk, any significant passage of radio-labeled aceclofenac (14 C), in the milk of lactating rats, however, has been found. Code>
Therefore, continued breastfeeding or treatment with aceclofenac should be considered if the potential benefits of treatment for the mother offset the possible risks of breastfeeding to the child.
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Fertility

NSAIDs can alter fertility and therefore their use is discouraged in women attempting to conceive a child. Consider temporary discontinuation of aceclofenac in women with conception difficulties or undergoing infertility tests.

Gastrointestinal

The most commonly reported adverse reactions are gastrointestinal.


Skin, subcutaneous tissue

Pruritus, rash, dermatitis, urticaria
Edema of Quincke

Purpura, eczema, mucocutaneous and severe reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis)

Renal and urinary system

Increase in blood urea levels Increase in blood creatinine levels

Nephrotic syndrome, renal insufficiency

Hepatobiliary disorders

Increased levels of liver enzymes

Hepatic impairment (including hepatitis) Increase in blood levels of alkaline phosphatase

System, general

Edema, tiredness, cramps in the legs

Biological examinations

Weight gain

The most common adverse reactions reported in clinical trials are gastrointestinal disorders (dyspepsia: 7.5%, abdominal pain: 6.2%, nausea: 1.5%, and diarrhea: 1.5 %) And occasional occurrence of dizziness

Dermatological assignments such as pruritus and rash have been reported. Abnormal levels of liver enzymes and creatinine and plasma have also been reported.

See Warnings and Precautions for Use and Interactions with other medicines and other forms of interactions for warnings, precautions and interactions.

Reporting of suspected adverse reactions

The reporting of suspected adverse effects after authorization of the drug is important. It provides continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and network of Regional Centers, Pharmacovigilance -