Active ingredients: Aceclofenac
Airtal 100 mg coated tablets
Airtal 100 mg powder for oral suspension
Indications Why is Airtal used? What is it for?
It is a non-steroidal anti-inflammatory and antirheumatic drug
Airtal is indicated in the
- treatment of inflammatory rheumatic diseases, such as arthrosis, rheumatoid arthritis, ankylosing spondylitis and extra-articular rheumatism such as periarthritis, bursitis, tendinitis, enthesitis.
- treatment of acute painful states of different etiology such as sciatica, lumbago, myalgia, primary dysmenorrhea, pain resulting from various types of trauma, odontalgia.
Contraindications When Airtal should not be used
Do not use Airtal
If you are allergic to aceclofenac or to non-steroidal anti-inflammatory drugs, including acetylsalicylic acid or to any of the other ingredients of this medicine. Like other non-steroidal anti-inflammatory drugs, Airtal is contraindicated in patients who have occurred after taking acetylsalicylic acid or other NSAIDs, asthma attacks or other allergic reactions (urticaria, rhinitis, edema, rash, bronchospasm).
If you have heart and / or cerebrovascular disease, for example if you have had a heart attack, stroke, mini-stroke (TIA) or blockage of blood vessels in the heart or brain or surgery to clear these blockages or a bypass.
If you have or have had blood circulation problems (peripheral arterial disease).
Airtal is contraindicated in the presence of an ongoing gastroduodenal ulcer or haemorrhages in the gastrointestinal tract and in subjects with active bleeding and bleeding disorders. Airtal is contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous treatments or with a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Airtal is contraindicated in patients with severe hepatic or renal impairment.
The drug should not be used in children.
Airtal is also contraindicated in pregnancy, particularly in the third trimester, and during breastfeeding unless there are valid reasons for taking it. In this case the lowest effective dosage should be used (see "Warnings and precautions").
Precautions for use What you need to know before taking Airtal
Talk to your doctor or pharmacist or nurse before using Airta
The use of Airtal should be avoided in conjunction with other NSAIDs including selective COX-2 inhibitors.
Tell your doctor before you are prescribed aceclofenac
- if you smoke
- if you have diabetes
- if you have "angina, blood clots, high blood pressure, high cholesterol or high triglycerides
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 3 "How to use Airtal").
Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 3 "How to use Airtal").
Gastro-intestinal system. Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see "Do not use Airtal"), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increased doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of gastroprotective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients requiring concomitant low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see "Other medicines and Airtal ").
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be exercised in patients taking concomitant medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as "aspirin (see" Other medicines and Airtal ") .
When gastrointestinal bleeding or ulceration occurs in patients taking Airtal the treatment should be discontinued.
NSAIDs should be administered with caution in patients with symptoms suggestive of gastrointestinal disease, related to the upper or lower gastrointestinal tract, history of gastrointestinal ulcer, bleeding or perforation, ulcerative colitis, Crohn's disease or haematological changes as these conditions may be exacerbated (see "Possible Side Effects").
Cardiovascular and cerebrovascular system: Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID therapy.
An increased risk of heart attack (myocardial infarction) may be associated with medicines such as Airtal. Side effects can be minimized by using the lowest effective dose for the shortest period necessary. Do not exceed the recommended dose or treatment period.Aceclofenac should be administered with caution and under close medical supervision in patients with a history of cerebrovascular bleeding.
Hypersensitivity reactions and skin reactions. As with other NSAIDs, allergic reactions, including anaphylactic and anaphylactoid reactions, are possible even in the absence of previous exposure to the medicinal product.
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 (see "Possible Side Effects"). In the early stages of therapy i patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Airtal should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Exceptionally, chickenpox can cause severe infectious skin and soft tissue complications. To date, it is not possible to exclude the role of NSAIDs in the aggravation of these infections. It is therefore advisable to avoid the use of aceclofenac in case of chickenpox.
Renal function. Subjects with mild to moderate renal impairment should be monitored as the use of NSAIDs may lead to deterioration of renal function. In such subjects the lowest effective dose should be used and renal function should be regularly monitored.
Administration of an NSAID can cause a dose-dependent reduction in prostaglandin formation and aggravate renal insufficiency. The importance of prostaglandins in regulating renal blood flow should always be taken into consideration in subjects with impaired cardiac or renal function, hepatic dysfunction. , in those treated with diuretics and in those who have undergone major surgery and in the elderly. Effects on renal function are generally reversible with discontinuation of aceclofenac.
Liver function. Aceclofenac should be discontinued in the event of persistent abnormalities or worsening of liver function tests or if typical signs or symptoms of liver disease occur or in the presence of other manifestations (eosinophilia, rash). Hepatitis can occur without warning signs. The use of aceclofenac in people with hepatic porphyria can lead to an attack. Close medical supervision is required for patients with mild to moderate hepatic impairment.
Hematological. Aceclofenac can reversibly inhibit "platelet aggregation (see" -Other medicines and Airtal ").
Respiratory disorders. Caution is required when administering to patients with or who have suffered from bronchial asthma as NSAIDs can aggravate bronchospasm.
Long-term treatments. As a preventive measure, subjects undergoing long-term NSAID treatment should be monitored for blood cell counts and parameters of kidney and liver function.
Interactions Which drugs or foods can modify the effect of Airtal
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Although no influence on blood pressure control was observed when administered concomitantly with bendrofluazide, interactions with other diuretics cannot be excluded. In the case of concomitant administration. with potassium-sparing diuretics, serum potassium should be monitored.
Antihypertensives. NSAIDs may reduce the effect of antihypertensive drugs. In some patients with impaired renal function (eg dehydrated patients or elderly patients) co-administration of an ACE inhibitor or angiotensin II antagonist and NSAIDs may increase the risk of acute renal failure, usually reversible. These interactions should be considered in patients taking Airtal concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see "Warnings and precautions").
Anticoagulants. Like other NSAIDs, aceclofenac may increase the activity of anticoagulant drugs such as warfarin (see 'Warfarin') and therefore patients undergoing combination therapy should be closely monitored.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs). Concomitant use with NSAIDs may increase the risk of gastrointestinal bleeding (see "Warnings and precautions").
Antidiabetics. Clinical studies show that diclofenac can be administered with oral antidiabetic agents without influencing their clinical effects. Isolated cases of hypoglycaemic and hyperglycemic effects have been reported: it is therefore advisable to consider the possibility of dose adjustment of hypoglycaemics concomitantly with aceclofenac.
Methotrexate. The possible interaction between NSAIDs and methotrexate should be kept in mind even when low doses of methotrexate are administered, especially in patients with impaired renal function. When combination therapy is to be administered, renal function should be monitored. Particular caution should be exercised when administering NSAIDs and methotrexate concomitantly over a 24-hour period, as an increase in plasma concentrations of the anticancer agent can be determined with a consequent increase in the toxicity of the latter.
Lithium and digoxin. Several NSAIDs inhibit the renal clearance of lithium and digoxin resulting in an increase in plasma concentration. The combination should therefore be avoided unless frequent monitoring of lithium and digoxin levels is possible.
Other NSAIDs. Concomitant use of acetylsalicylic acid and other NSAIDs may increase the frequency of side effects.
Ciclosporin, tacrolimus. It is believed that concomitant administration of NSAIDs with cyclosporine or tacrolimus may increase the risk of nephrotoxicity due to decreased synthesis of prostacyclin in the kidney. It is therefore important to closely monitor renal function during combination therapy.
Zidovudine. When NSAIDs are given with zidovudine, the risk of blood toxicity increases; there are indications of an increased risk of haemarthrosis and hematoma in HIV (+) haemophiliacs receiving concomitant treatment with zidovudine and ibuprofen.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is no information on the use of aceclofenac in pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development.
Data from epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to result in increased pre- and post-implantation loss and embryo-fetus mortality.
Furthermore, the increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, aceclofenac should not be administered unless absolutely necessary. If aceclofenac is given to women who are trying to conceive or who are in the first and second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction which can progress to renal failure with oligohydroamnios.
The mother and the newborn at the end of pregnancy to:
- possible prolongation of bleeding time and antiplatelet effect which can occur even at very low doses;
- inhibition of uterine contractions resulting in delayed and prolonged labor.
Consequently, aceclofenac is contraindicated in the third trimester of pregnancy (see "Do not use Airtal").
Feeding time
It is unknown whether aceclofenac is excreted in human milk and no passage of labeled aceclofenac (C14) has been detected in the milk of lactating rats. However, the use of aceclofenac should be avoided during pregnancy and lactation therefore the use of the product during the breastfeeding period is not recommended unless the potential benefit to the mother outweighs the possible risk to the fetus.
Fertility
NSAIDs can impair fertility and use, is not recommended in women intending to become pregnant. Aceclofenac should be discontinued in women who have fertility problems or are undergoing fertility investigations.
Driving and using machines
As with other NSAIDs and in particularly predisposed patients, administration of aceclofenac could give rise to dizziness, vertigo or other central nervous system disorders; those engaged in driving a vehicle or operating machinery requiring integrity of vigilance should be informed of this
Airtal oral suspension contains sorbitol
The sachets contain sorbitol (E420) so if your doctor has diagnosed you with an intolerance to some sugars, contact your doctor before taking this medicine.
Airtal oral suspension contains aspartame
The sachets contain aspartame (E951) as a source of phenylalanine and can therefore be dangerous for patients with phenylketonuria.
Dosage and method of use How to use Airtal: Dosage
Coated tablets
Adults
The recommended daily dose is 2 tablets per day (200 mg / day), 1 tablet every 12 hours.
The coated tablets should be swallowed whole with a sufficient amount of water.
Powder for oral suspension
The daily dose is 2 sachets per day (200 mg / day), 1 sachet every 12 hours.
Dissolve the contents of one sachet in a glass of water and swallow immediately. Both the coated tablets and the powder for oral suspension should be taken with meals.
Overdose What to do if you have taken too much Airtal
In case of accidental ingestion / intake of an excessive dose of Airtal, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of Airtal, ask your doctor or pharmacist.
There is currently insufficient information on the clinical picture resulting from overdose with Airtal.
Therefore the therapeutic measures to be adopted in case of acute poisoning with oral aceclofenac are those commonly used in case of acute NSAID poisoning:
- absorption should be prevented as soon as possible by gastric lavage and treatment with activated charcoal;
- Supportive and symptomatic treatments should be used in case of complications (hypotension, renal failure, convulsions, gastrointestinal irritation and respiratory depression);
- specific therapies, such as forced diuresis, dialysis or haemoperfusion, do not allow the elimination of non-steroidal anti-inflammatory drugs, due to the high percentage of binding to plasma proteins and their considerable metabolism.
Side Effects What are the side effects of Airtal
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most commonly reported side effects are gastrointestinal upset. Peptic ulcers, gastrointestinal perforation or bleeding, sometimes fatal, may occur, particularly in the elderly (see "Warnings and Precautions"). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of aceclofenac (see "Warnings and precautions").
Gastritis has been observed less frequently.
Dermatological disorders, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely) have been reported.
Exceptionally, severe infectious skin and soft tissue complications have been reported in conjunction with NSAID treatment during chickenpox. To date, it is not possible to exclude the role of NSAIDs in the aggravation of these infections.
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Aceclofenac is structurally related and has a similar metabolism to diclofenac for which multiple clinical and epidemiological studies are available showing an increased risk of thrombotic events (e.g. myocardial infarction or stroke). Epidemiological data have also indicated an increased risk of acute coronary syndrome and non-fatal myocardial infarction following the use of aceclofenac (see "Warnings and precautions").
In the following table, adverse reactions reported during clinical trials and from post-registration experience with Airtal are presented and grouped by systemic and organ class (SOC) and by frequency. Very common (> 1/10); common (> 1/100, 1 / 1,000, 1 / 10,000,
See "Warnings and precautions" and "Other medicines and Airtal"
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Italian Medicines Agency, website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date indicated refers to the product in intact packaging, correctly stored.
WARNING: Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of that month.
Airtal 100 mg coated tablets: store at a temperature not exceeding 30 ° C.
Airtal 100 mg powder for oral suspension: no special storage precautions.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children
Contents of the pack and other information
What Airtal 100 mg coated tablets contain:
One coated tablet contains 100 mg aceclofenac
Excipients:
Microcrystalline cellulose, croscarmellose sodium, glyceryl palmitostearate, povidone, hypromellose, polyoxyethylene stearate, titanium dioxide.
What Airtal 100 mg powder for oral suspension contains:
One sachet contains 100 mg aceclofenac
Excipients:
sorbitol (E420), sodium saccharin, caramel flavor, cream flavor, milk flavor, anhydrous colloidal silica, aspartame (E951), hypromellose, titanium dioxide (E171).
Description of what Airtal looks like and contents of the pack
Coated tablets
Powder for oral suspension
Airtal 100 mg coated tablets: 40 tablets
Airtal 100 mg coated tablets: 10 tablets
Airtal 100 mg powder for oral suspension: 30 sachets
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
AIRTAL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
AIRTAL 100 mg coated tablets
Each coated tablet contains:
Active ingredient: aceclofenac 100 mg.
AIRTAL 100 mg powder for oral suspension
Each sachet contains:
Active ingredient: aceclofenac 100 mg.
Excipients with known effects:
sorbitol (E420), aspartame (E951).
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Coated tablets.
Powder for oral suspension.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Aceclofenac is a non-steroidal anti-inflammatory drug belonging to the phenylacetic acid analogue class.
Treatment of chronic osteo-articular diseases such as osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and extra-articular rheumatism such as periarthritis, tendinitis, bursitis, enthesitis.
Treatment of acute painful states of different etiology such as sciatica, lumbago, myalgia, primary dysmenorrhea, pain resulting from various types of trauma, odontalgia.
04.2 Posology and method of administration
AIRTAL 100 mg coated tablets
Adults
The recommended daily dose is 2 coated tablets per day (200 mg / day), one coated tablet every 12 hours.
The coated tablets should be swallowed with a sufficient amount of water.
AIRTAL 100 mg powder for oral suspension
The daily dose is 2 sachets per day (200 mg / day) 1 sachet every 12 hours. The sachets should be dissolved in 40-60ml of water and swallowed immediately.
Both coated tablets and sachets should be taken preferably with meals.
Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).
Children
Clinical data on the use of the drug in pediatrics are not currently available, therefore its administration is not recommended.
Senior citizens
In elderly patients, the pharmacokinetic profile of aceclofenac is not modified, therefore it is not considered necessary to modify the posology. However, as with other NSAIDs, care should be taken when treating elderly patients with impaired renal or hepatic function, with cardiovascular changes or undergoing concomitant drug treatments.
Patients with mild renal insufficiency
As with other NSAIDs, the drug should be administered with caution even if there is no clinical evidence to induce a dose reduction.
Patients suffering from hepatic insufficiency
In patients with hepatic insufficiency it is advisable to reduce the starting dose to 100 mg / day.
04.3 Contraindications
Hypersensitivity to the active substance or to non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, or to any of the excipients listed in section 6.1.
Like other non-steroidal anti-inflammatory drugs, aceclofenac is contraindicated in patients in whom they have occurred, after taking acetylsalicylic acid or other NSAIDs, asthma attacks or other allergic reactions (urticaria, acute rhinitis, edema, rash, bronchospasm).
The product should not be used in cases of gastro-duodenal ulcer or bleeding in the gastrointestinal tract and in subjects with active bleeding or bleeding disorders.
AIRTAL is contraindicated in patients with a history of gastrointestinal bleeding or perforation related to previous NSAID treatment or with a history / active phase of recurrent peptic haemorrhage / ulcer (two or more distinct episodes of proven ulceration or bleeding).
Furthermore, the drug is contraindicated in patients with severe hepatic impairment or renal impairment, and in patients with overt congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease and / or cerebral vascular disease.
AIRTAL is also contraindicated in pregnancy, especially in the last 3 months, and during lactation unless there are valid reasons for taking it. In this case the lowest effective dosage should be used (see section 4.6).
04.4 Special warnings and appropriate precautions for use
Warnings
The use of AIRTAL should be avoided in conjunction with other NSAIDs, including selective COX-2 inhibitors.
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks).
Senior citizens. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).
Gastro-intestinal system
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events.
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients requiring concomitant low dose aspirin or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5 ).
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients taking AIRTAL the treatment should be discontinued.
NSAIDs should be administered with caution in patients with symptoms suggestive of upper or lower intestinal gastrointestinal disease, history of gastrointestinal ulcer, bleeding or perforation, ulcerative colitis, Crohn's disease and haematological abnormalities as these conditions may be exacerbated (see section 4.8).
Cardiovascular and cerebrovascular system
Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment.
Patients with congestive heart failure (NYHA class I) and patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with aceclofenac after careful consideration.
Since the cardiovascular risks of aceclofenac may increase with dose and duration of exposure, the shortest possible duration and the lowest effective daily dose should be used. The patient's response to therapy and the need for improvement in symptoms should be reassessed periodically. .
Aceclofenac should be administered with caution and under close medical supervision in patients with a history of cerebrovascular bleeding.
Liver function
Close medical supervision is required for patients with mild to moderate hepatic impairment. Aceclofenac should be discontinued in the event of persistent abnormalities or worsening of liver function tests or if typical signs or symptoms of liver disease occur or in the presence of other manifestations (eosinophilia, rash). Hepatitis can occur without prodromal signs. The use of aceclofenac in subjects with hepatic porphyria can lead to an attack.
Hypersensitivity reactions and skin reactions
As with other NSAIDs, allergic reactions, including anaphylactic and anaphylactoid reactions, are possible even in the absence of previous exposure to the medicinal product. 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 (see section 4.8). In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. AIRTAL should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Exceptionally, chickenpox can cause severe infectious skin and soft tissue complications. To date, it is not possible to exclude the role of NSAIDs in the aggravation of these infections. It is therefore advisable to avoid the use of aceclofenac in case of chickenpox.
Precautions :
Renal function
Subjects with mild to moderate renal impairment should be monitored as the use of NSAIDs may lead to deterioration of renal function. In such subjects the lowest effective dose should be used and renal function should be regularly monitored.
Administration of an NSAID can cause a dose-dependent reduction in prostaglandin formation and aggravate renal insufficiency. The importance of prostaglandins in regulating renal blood flow should always be taken into account in subjects with impaired cardiac or renal function, hepatic dysfunction. , in those treated with diuretics and in those who have undergone major surgery and in the elderly. Effects on renal function are generally reversible with discontinuation of aceclofenac.
Hematological
Aceclofenac can reversibly inhibit platelet aggregation (see anticoagulants in section 4.5).
Respiratory pathologies
Caution is required when administering to patients with or who have suffered from bronchial asthma as NSAIDs can aggravate bronchospasm.
Long-term treatments
As a preventive measure, subjects undergoing long-term NSAID treatment should be monitored for blood cell counts and parameters of kidney and liver function.
Important information about some of the ingredients
The sachets contain sorbitol (E420), therefore patients with rare hereditary problems of fructose intolerance should not take this medicine.
The sachets contain aspartame (E951) as a source of phenylalanine and can therefore be dangerous for patients with phenylketonuria.
04.5 Interactions with other medicinal products and other forms of interaction
Diuretics: Aceclofenac, like other NSAIDs, can inhibit the activity of diuretics
Although no influence on blood pressure control was observed when administered concomitantly with bendrofluazide, interactions with other diuretics cannot be excluded. In case of concomitant administration with potassium-sparing diuretics, serum potassium should be monitored.
Antihypertensives
NSAIDs may reduce the effect of antihypertensive drugs. In some patients with impaired renal function (eg dehydrated patients or elderly patients) co-administration of an ACE inhibitor or angiotensin II antagonist and NSAIDs may increase the risk acute renal failure, usually reversible. These interactions should be considered in patients taking AIRTAL concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy and periodically thereafter.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anticoagulants: Like other NSAIDs, aceclofenac may increase the activity of anticoagulant drugs such as warfarin (see section 4.4) and therefore patients undergoing combination therapy should be closely monitored.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): concomitant use with NSAIDs may increase the risk of gastrointestinal bleeding (see section 4.4).
Antidiabetics: Clinical studies show that diclofenac can be administered with oral antidiabetic agents without influencing their clinical effects. Isolated cases of hypoglycemic and hyperglycemic effects have been reported: it is therefore recommended to consider the possibility of dose adjustment of hypoglycemic agents concomitantly with aceclofenac.
Methotrexate: The possible interaction between NSAIDs and methotrexate should be kept in mind even when low doses of methotrexate are administered, especially in patients with impaired renal function. When combination therapy is to be administered, renal function should be monitored. Particular caution should be exercised when administering NSAIDs and methotrexate concomitantly over a 24-hour period as an increase in plasma concentrations of the antitumor agent can be determined with a consequent increase in the toxicity of the latter.
Lithium and digoxin: several NSAIDs inhibit the renal clearance of lithium and digoxin resulting in an increase in plasma concentration. The combination should therefore be avoided unless frequent monitoring of lithium and digoxin levels is possible.
Other NSAIDs: Concomitant use of acetylsalicylic acid and other NSAIDs may increase the frequency of side effects.
Ciclosporin, tacrolimus: it is believed that LConcomitant administration of NSAIDs with cyclosporine or tacrolimus may increase the risk of nephrotoxicity due to decreased synthesis of prostacyclin in the kidney. It is therefore important to closely monitor renal function during combination therapy.
Zidovudine: when NSAIDs are administered with zidovudine, the risk of blood toxicity increases; there are indications of an increased risk of haemarthrosis and hematoma in HIV (+) haemophiliacs receiving concomitant treatment with zidovudine and ibuprofen.
04.6 Pregnancy and lactation
PREGNANCY
There is no information on the use of aceclofenac in pregnancy. Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development.
Data from epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformations increased from less than 1% to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and of embryo-fetal mortality.
Furthermore, the increased incidence of various malformations, including cardiovascular malformations, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, aceclofenac should not be administered unless absolutely necessary. If aceclofenac is given to women who are trying to conceive or who are in the first and second trimester of pregnancy, the dose should be as low as possible and the duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct in the uterus and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
the mother and the newborn at the end of pregnancy to:
- possible prolongation of bleeding time and antiplatelet effect which can occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, aceclofenac is contraindicated in the third trimester of pregnancy (see section 4.3).
Pregnancy
It is unknown whether aceclofenac is excreted in human milk and no passage of labeled aceclofenac (C14) has been detected in the milk of lactating rats. However, the use of aceclofenac should be avoided during pregnancy and lactation unless the potential benefit to the mother outweighs the possible risk to the fetus.
FERTILITY
NSAIDs can impair fertility and are not recommended for use in women planning to become pregnant.
Suspension of aceclofenac administration should be considered in women who have fertility problems or who are undergoing fertility investigations.
04.7 Effects on ability to drive and use machines
As with other NSAIDs and in particularly predisposed patients, the administration of aceclofenac could give rise to dizziness, vertigo or other central nervous disorders: those who are engaged in driving a vehicle or operating machinery requiring grade integrity should be informed of this. of supervision.
04.8 Undesirable effects
The most commonly reported side effects are gastrointestinal upset. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4).
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of aceclofenac (see section 4.4).
Gastritis has been observed less frequently.
Dermatological disorders, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely) have been reported. Exceptionally, severe infectious skin and soft tissue complications have been reported in conjunction with NSAID treatment during chickenpox. To date, it is not possible to exclude the role of NSAIDs in the aggravation of these infections.
Edema, hypertension and heart failure have been reported in association with NSAID treatment.
Aceclofenac is structurally related and has a similar metabolism to diclofenac for which more clinical and epidemiological data are available showing an increased risk of general arterial thrombotic events (myocardial infarction or stroke, particularly at high doses and in long-term treatment) . Epidemiological data have also shown an increased risk of acute coronary syndrome and myocardial infarction following the use of aceclofenac (see sections 4.3 and 4.4 Contraindications and Special Warnings and Precautions for Use).
In the following table the adverse reactions reported during clinical studies and in post-registration experience with AIRTAL are presented and grouped by systemic and organ class (SOC) and by frequency. Very common (≥1 / 10); common (≥1 / 100,
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Italian Medicines Agency. , website: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
There is currently insufficient information on the clinical picture resulting from overdose with AIRTAL.
Therefore the therapeutic measures to be adopted in case of acute poisoning with oral aceclofenac are those commonly used in case of acute NSAID poisoning:
- absorption must be prevented as soon as possible by gastric lavage and treatment with activated charcoal;
- Supportive and symptomatic treatments should be adopted in case of complications (hypotension, renal insufficiency, convulsions, gastrointestinal irritation and respiratory depression);
- specific therapies, such as forced diuresis, dialysis or haemoperfusion, do not allow the elimination of non-steroidal anti-inflammatory drugs, due to the high percentage of binding to plasma proteins and their considerable metabolism.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: non-steroidal anti-inflammatory and antirheumatic drug.
ATC code M01AB16.
Aceclofenac is a non-steroidal anti-inflammatory drug belonging to the phenylacetic acid analogue class.
In studies conducted on different animal species, aceclofenac has shown in experimental models of acute and chronic inflammation an "analgesic and anti-inflammatory activity, in terms of both therapeutic and prophylaxis, similar to that of indomethacin and diclofenac.
The analgesic power evaluated on painful states experimentally induced by stimuli of different types was found to be comparable to that of indomethacin and diclofenac.
Aceclofenac, in the experimental models used, was also endowed with antipyretic activity.
No functional alterations were found in the cardiovascular, respiratory and central nervous systems. The effects on the kidney are comparable to those induced by other NSAIDs.
Mechanism of action
Aceclofenac was found to be a potent inhibitor of cyclooxygenase, an enzyme that catalyzes the conversion of arachidonic acid into the precursors of prostaglandins and thromboxane.
05.2 Pharmacokinetic properties
Absorption
Pharmacokinetic studies conducted in various animal species (rat, dog and monkey) show that aceclofenac administered orally and intramuscularly is rapidly absorbed in the form of unchanged drug.
Distribution
Peak plasma (Cmax) is reached approximately 2 hours (tmax) after oral administration of the drug. Bioavailability is close to 100%. The plasma half-life is 4 hours. No accumulation in the plasma compartment was observed after repeated administration.
Aceclofenac electively penetrates the synovial fluid, where concentrations reach approximately 57% of plasma levels.
Metabolism
Aceclofenac and its metabolites have a "high affinity for plasma proteins (> 99%).
Aceclofenac is mainly present in the circulation as an unchanged drug.
Elimination
About two thirds of the administered dose is excreted in the urine, mainly in the form of hydroxymetabolites.
The pharmacokinetic profile of aceclofenac is comparable in adults and the elderly.
05.3 Preclinical safety data
The results of preclinical studies conducted with aceclofenac are consistent with those of NSAIDs. The primary target organ is the gastrointestinal tract.
The toxicity of aceclofenac was evaluated in different animal species (mouse, rat, monkey) using different routes of administration and adopting single and repeated treatment regimens.
Acute toxicity (LD50): mouse i.v. 149-169 mg / kg, p.o. 211 mg / kg; rat i.v. 94-137 mg / kg (male-female).
Toxicity after repeated administration (p.o.): rat 4 weeks: no toxicity up to 3 mg / kg / day.
After repeated treatment there was evidence of gastrointestinal toxicity only at the highest doses, which resulted in the rat 3-6 times, in the monkey 5-10 times higher than the therapeutic dose in humans. These toxic effects were reversible in both species. .
Aceclofenac did not show mutagenic or carcinogenic activity.
Animal studies show no evidence of teratogenesis in rats, although systemic exposure was low, and in rabbits; treatment with aceclofenac (10 mg / kg / day) resulted in a number of morphological changes in some fetuses.
There is no further information on preclinical data of prostaglandin synthesis inhibitors other than those already reported elsewhere in this SmPC (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Coated tablets:
Microcrystalline cellulose, croscarmellose sodium, glyceryl palmitostearate, povidone, hypromellose, polyoxyethylene stearate, titanium dioxide.
Powder for oral suspension:
sorbitol (E420), sodium saccharin, caramel flavor, cream flavor, milk flavor, anhydrous colloidal silica, aspartame (E951), hypromellose, titanium dioxide (E171).
06.2 Incompatibility
None.
06.3 Period of validity
Coated tablets: 3 years.
Powder for oral suspension: 4 years.
06.4 Special precautions for storage
Coated tablets
Store at a temperature not exceeding 30 ° C.
Powder for oral suspension
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
AIRTAL 100 mg coated tablets - 40 tablets: Al / Al blister
AIRTAL 100 mg coated tablets - 10 tablets: Al / Al blister
AIRTAL 100 mg powder for oral suspension - 30 sachets: aluminum / polyethylene paper sachets.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Almirall S.p.A.
Via Messina, 38 - Tower C
20154 Milan
08.0 MARKETING AUTHORIZATION NUMBER
40 coated tablets 100 mg AIC n ° 032773020
10 coated tablets 100 mg AIC n ° 032773069
30 sachets powder for oral suspension 100 mg AIC n ° 032773032
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
26 July 2000 / last renewal 2009
10.0 DATE OF REVISION OF THE TEXT
August 2014
