Aceclofenac tablets Uses, Dosage, Side Effects, Precautions & Warnings
Therapeutic class: Anti-inflammatory
active ingredients: Aceclofenac
what is aceclofenac tablets TREAT ?
- Aceclofenac stills pain, reduces inflammation and lowers fever.
- In rheumatoid arthritis, Bechterew’s disease and osteoarthritis (worn joints).
- The pain will be less within 3 hours. This effect lasts for about 12 hours. Redness and swelling decrease within a week.
- Note: chances of gastrointestinal ulcers and bleeding. Are you over 70 years of age, have you had a stomach or intestinal ulcer before or do you use anti-coagulation medication? Then you need a stomach protector. Ask your doctor or pharmacist about this.
- Watch out with alcohol. Alcohol increases the risk of stomach problems.
- Many interactions with other medications. Ask your pharmacist if you can safely use aceclofenac with your other medicines. Even if you bought it without a prescription.
What is Aceclofenac used for and indication?
Symptomatic treatment of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
aceclofenac dosage for adults
- The maximum recommended dose is 200 mg daily, divided into two doses of 100 mg, one tablet in the morning and one tablet in the evening.
aceclofenac in elderly
- In general, it is not necessary to reduce the dosage; however, precautions should be taken (see section warnings and precautions for use).
aceclofenac kidney dose
- The safety and efficacy of the product have not been demonstrated in children and adolescents.
– Hepatic insufficiency:
- In patients with mild to moderate hepatic impairment, the dose will be reduced. The recommended starting dose is 100 mg daily.
– Patients with renal
- impairment : In patients with mild renal impairment, there is no need to decrease the dosage; however, precautions should be taken.
- – The occurrence of adverse effects may be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms (see section on warnings and precautions for use).
Aceclofenac is contraindicated in the following situations:
- Patients with a history of gastrointestinal bleeding or perforation, associated with previous treatment with NSAIDs,
- Patients with an active peptic ulcer, a history of peptic ulcer or recurrent bleeding (2 or more distinct episodes of bleeding or ulceration objectified),
patients with active bleeding or bleeding disorders,
- Patients with severely impaired liver or kidney function
Patients with severe heart failure
- Pregnancy, especially during the third trimester of pregnancy (see section Pregnancy and breast-feeding ),
- Patients with prior sensitivity to aceclofenac, to any of the excipients or in whom the administration of acetylsalicylic acid or NSAIDs precipitates the onset of asthma attacks, acute rhinitis or urticaria, or patients hypersensitive to these drugs,
patients with a history of kidney transplants,
- Patient suffering from nephrotic syndrome.
How Aceclofenac works?
- ANTI-INFLAMMATORY, ANTIRHUMATISMAL, NON-STEROID, ATC code: M01AB16.
Aceclofenac is a nonsteroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. Its mechanism of action is related to an inhibition of prostaglandin synthesis.
what are the side effects of aceclofenac tablets?
In addition to the desired effect, this can cause drug side effects.
The main side effects are the following.
Rarely (from 1 to 10 in 100 people)
- Stomach complaints: stomach irritation, abdominal pain, nausea, vomiting, feeling full, lack of appetite, farmers and heartburn. You have less chance if you take this medicine with some food and a glass of water or milk. Do not use alcohol or other foods that irritate the stomach, such as sharp herbs. Do you suffer from esophageal inflammation due to rising stomach acid? The complaints can worsen. Contact your doctor if you notice. People over 70 years are more likely to experience side effects with this medication. Doctors therefore usually also prescribe a stomach protector. Even if you will only use this medicine for a few days.
- Do you have an esophageal stenosis, a narrowing of the esophagus? You are more likely to have damage to the esophagus. Discuss this with your doctor. Maybe you can switch to a different medication.
- Intestinal complaints: diarrhea, constipation and flatulence. If you suffer from chronic intestinal inflammation , such as Crohn’s disease or ulcerative colitis, this medication can make the symptoms worse. Discuss with your doctor whether this medication is suitable for you. Usually your doctor also prescribes a stomach-protecting medicine in addition to this medication. Even if you will only use this medicine for a few days.
- Twisting and dizziness. This is usually about if you have become accustomed to this medication.
- Liver disorders . You may notice this by a sensitive swollen belly or a yellow discolouration of the whites or the skin. Then warn a doctor.
Very rare (affects less than 1 in 100 people)
- A stomach or intestinal ulcer or other severe damage to the stomach, intestines or esophagus . You notice that with nagging pain in the upper abdomen, severe stomach pain or pain behind the sternum. These damages can cause bleeding in the stomach and intestines. This can be seen in bloody diarrhea or black, tarry stools . Then discontinue use and contact a doctor. With a stomach haemorrhage it can happen that you vomit blood. Contact a doctor immediately. Have you ever had a stomach or intestinal ulcer?If you have had a severe stomach or intestinal disorder, such as gastrointestinal bleeding, you are more likely to have side effects on the stomach and intestines. Discuss with your doctor whether this medication is suitable for you. Your doctor may also prescribe a stomach-protecting medication in addition to this medication. Even if you will only use this medicine for a few days.
- Do you have a blood clotting disorder . You are more likely to bleed. Talk to your doctor or pharmacist before using this medicine.
- Inflammation in the oral cavity and on the tongue.
- Hair loss and skin rash with itching, not caused by hypersensitivity. The rash can worsen or develop under the influence of strong sunlight or UV light from tanning beds.
- Blurred vision or double vision. This is usually about if you have become accustomed to this medication.
- Headache and trembling.
- Thick ankles or wrists by retaining fluid in the arms and legs (edema) . Tightnessdue to fluid accumulation in the lungs. Especially people with heart failure can suffer from this. Talk to your doctor if your symptoms, such as tightness and fluid retention, increase.
- Psychological complaints such as fatigue, drowsiness, nightmares, insomnia unrest, agitation, confusion, memory disorders, nervousness, anxiety, depression and hallucinations.
- If you suffer from psoriasis : you may have more problems with this condition. Contact your doctor if you suffer from red scaling or shiny patches on the skin, skin damage, itching, pitting in the nails and joint complaints.
- Hypersensitivity to this medication. This can manifest itself in skin rashes with hives and itching. Consult your doctor. Very rarely, a severe rash can develop with fever or blisters. Then contact a doctor immediately. Severe hypersensitivity can also manifest itself in anxiety or a swollen face. Then go immediately to a doctor. In both cases you can not use this medicine afterwards. Therefore, tell the pharmacist that you are hypersensitive to aceclofenac. The pharmacy team can then ensure that you do not get this medicine or any other anti-inflammatory painkiller again. People with asthmaare more often hypersensitive to this drug. This can manifest itself in a sudden anxiety attack. Do not use this medicine anymore. Have you previously experienced a breathlessness after using an anti-inflammatory analgesic? Do not use this medicine, but contact your doctor.
- Impairment of the kidneys . You will notice this by swollen ankles and feet. Contact your doctor or pharmacist if this occurs.
- Blood disorders, inflammation of the pancreas or liver inflammation . Consult your doctor for one or more of the following symptoms: sudden severe upper abdominal pain, jaundice, unexplained bruising, extreme fatigue, sore throat with fever and blisters in the mouth. Also talk to your doctor if you suffer from your liver or pancreas. The complaints can worsen.
Very rare, when used for several weeks and high dose
- Cardiovascular diseases, such as higher risk of heart attack or stroke. The risk of cardiovascular disease is greater in people who are more likely to have cardiovascular disease. People with high blood pressure, high cholesterol, diabetes, angina pectoris, window bones, narrowing or closing of the leg artery, people who smoke and people who have ever had a heart attack or thrombosis: consult your doctor before using this medicine . Your doctor may be able to prescribe another anti-inflammatory analgesic.
Consult your doctor if you suffer too much from one of the above mentioned side effects or if you experience other side effects that you are worried about.
No pharmacokinetic interaction studies (except with warfarin) have been performed.
Aceclofenac is metabolized via cytochrome P450 2C9 and in vitro data indicate 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 drugs strongly bound to plasma proteins must be taken into account.
Due to the lack of pharmacokinetic interaction studies, the following recommendations are based on information with other NSAIDs.
Associations advised against
Methotrexate (high doses)
- NSAIDs inhibit tubular secretion. A slight metabolic interaction by reducing the clearance of methotrexate can be observed.
- Therefore, NSAID prescription should always be avoided during treatment with high dose methotrexate.
Methotrexate (low doses)
- Any interaction between NSAIDs and methotrexate even at low doses should be considered, particularly in patients with decreased renal function.
- If the combination can not be avoided within the same 24-hour period, renal function should be monitored because of increased methotrexate levels that may reach toxic levels.
Lithium and digoxin
- Several NSAIDs inhibit the renal clearance of lithium, increasing the serum concentration of both drugs.
- If the combination can not be avoided, increased monitoring of lithium and digoxin levels should be performed.
- Like other NSAIDs, aceclofenac can inhibit the activity of diuretics. Although no alteration in blood pressure has been observed when co-administered with bendrofluazide, interactions with other diuretics can not be ruled out.
- Concomitant administration with potassium diuretics may be accompanied by elevation of serum potassium. The latter must then be monitored.
- NSAIDs may decrease the effect of antihypertensives. The risk of acute renal failure, which is usually reversible, may increase in some patients with impaired renal function (eg, dehydrated patients or elderly patients) when ACE inhibitors or angiotensin II with NSAIDs.
- This combination should be used with caution, especially in elderly patients. Be sure to hydrate patients properly and consider monitoring renal function after concomitant therapy and then periodically.
- Like other NSAIDs, aceclofenac can increase the activity of anticoagulants. Closely monitor patients receiving combined anticoagulant and aceclofenac therapy.
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs)
- In association with NSAIDs, they may increase the risk of gastrointestinal bleeding (see Warnings and Precautions section ).
- In clinical studies, it has been shown that diclofenac can be administered in combination with oral antidiabetic agents without influencing their clinical efficacy. However, isolated cases of hypoglycemia and hyperglycemia have been reported with aceclofenac. Drug doses that may cause hypoglycaemia should therefore be adjusted if combined with aceclofenac.
- Concomitant treatment with acetylsalicylic acid and other NSAIDs may increase the frequency of adverse events.
- Seizures may occur due to the interaction between quinolones and NSAIDs. These may occur in patients with or without a history of seizures or epilepsy.
- Increased risk of ulceration or gastrointestinal bleeding (see Warnings and Precautions section ).
- The combination of an NSAID with ciclosporin or tacrolimus increases the risk of nephrotoxicity, due to decreased renal prostacyclin synthesis.
- In case of association, it is important to control the renal function.
- There is an increased risk of hematologic toxicity if NSAIDs are co-administered with zidovudine.
- An increased risk of haemato-arthrosis and hematoma has been shown in HIV (+) hemophiliacs receiving zidovudine and ibuprofen simultaneously.
Aceclofenac Warnings and Precautions
Undesirable effects can be minimized by using the lowest effective dose for as short a time as necessary to control symptoms.
Concomitant use of ACECLOFENAC EG with other NSAIDs, including selective cyclooxygenase 2 (cox-2) inhibitors, should be avoided.
At the gastrointestinal level
Close medical supervision is required in patients with the following conditions as they may worsen :
- Symptoms indicative of gastrointestinal conditions involving the upper or lower gastrointestinal tract,
suggestive of ulceration, haemorrhage or gastrointestinal perforation,
- Ulcerative colitis,
- Crohn’s disease,
- Hematological abnormalities.
Gastrointestinal bleeding, ulceration or perforation, sometimes fatal, has been reported with all NSAIDs at any time during treatment, without necessarily warning signs or a history of adverse effects. gastrointestinal symptoms.
The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with the dose of NSAIDs used in patients with a history of ulcer disease, particularly in the case of complications such as bleeding or perforation . Contraindications ) as well as in the elderly subject. In these patients, treatment should be started at the lowest dose possible.
A protective mucosal combination therapy (eg misoprostol or proton pump inhibitor) should be considered for these patients, as for patients requiring treatment with low doses of aspirin or treated with other drugs that may increase gastrointestinal risk (see below and section Interactions with other drugs and other forms of interaction ).
Patients with a gastrointestinal history, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly at the beginning of treatment. Special attention should be paid to patients receiving combination therapies that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, oral anticoagulants such as warfarin, selective reuptake inhibitors, and Serotonin (SSRI) and antiplatelet agents such as aspirin.
If bleeding or ulceration develops in a patient receiving aceclofenac, treatment should be discontinued.
NSAIDs should be administered with caution and under close supervision in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), due to a risk of aggravation of the disease.
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 very rarely reported in association with the use of NSAIDs (see section 4.8 ). 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 taking aceclofenac at the first signs of rash, mucosal lesions or any other sign of hypersensitivity.
- Exceptionally, chickenpox can trigger severe infectious complications in the skin and soft tissues. To date, it is impossible to rule out a contribution of NSAIDs in worsening these infections. It is therefore advisable to avoid the use of aceclofenac in case of chickenpox.
At the renal level
- Administration of NSAIDs may cause a dose-dependent reduction in prostaglandin formation and precipitate renal failure. Take into account the importance of prostaglandins in maintaining renal blood flow in patients with impaired cardiac or renal function, liver dysfunction, and in patients treated with diuretics or recovering from major surgery, as well as in elderly patients.
- Keep patients with mild to moderate renal impairment under surveillance as NSAID use may cause deterioration of renal function. Use the lowest effective dose and monitor kidney function regularly. Effects on renal function are generally reversible upon discontinuation of aceclofenac.
At the hepatic level
- Close medical supervision is required in patients with mild to moderate impairment of liver function.
- Discontinue aceclofenac if abnormal liver function tests persist or worsen, clinical signs or symptoms suggestive of liver disease develop, or if other manifestations occur (eosinophilia, rash).
- Hepatitis can occur without prodromal symptoms.
- The use of NSAIDs in patients with hepatic porphyria can trigger a seizure.
At the cardiovascular and cerebrovascular level
- Adequate monitoring and precautions are required in patients with a history of hypertension and / or mild to moderate heart failure, with cases of fluid retention and edema associated with NSAID therapy.
- Acecofenac should be administered with caution and under close medical supervision in patients with a history of cerebrovascular bleeding.
- Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially at high doses and over a long period of time) may be associated with a small increase in the risk of arterial thrombotic events (eg, myocardial infarction or stroke). cerebral). There is currently insufficient data to rule out this increased risk for aceclofenac.
- Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should be treated with aceclofenac only after careful evaluation. A similar assessment should be made before initiating long-term treatment in patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidemia, diabetes or smoking).
At the hematological level
- Aceclofenac can reversibly inhibit platelet aggregation (see section Interactions with other medicinal products and other forms of interaction “Interactions”, section “anticoagulants”).
- Caution should be exercised when administering aceclofenac to patients with or with history of bronchial asthma, since NSAIDs have been reported to induce bronchospasm in these patients.
- Elderly patients have an increased risk of adverse effects to NSAIDs, particularly gastrointestinal bleeding and potentially fatal perforations .
- Gastrointestinal bleeding or perforation occurs more severely and without warning signs or a history of adverse effects at any time during treatment. Elderly patients are also more prone to impaired renal, hepatic or cardiac function.
- For patients treated with NSAIDs for prolonged periods, it is recommended to check the liver, kidney and hematological functions. Aceclofenac should be administered with caution and under close medical supervision in patients with a history of systemic lupus erythematosus, porphyria, coagulation disorders or hematopoiesis.
- The use of A CECLOFENAC EG, as any drug that inhibits 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 with reproductive difficulties, or in whom reproductive function investigations are ongoing, discontinuation of A CECLOFENAC EG should be considered.
Aceclofenac and PREGNANCY / BREAST FEEDING / FERTILITY
aceclofenac in pregnancy
There is no information regarding the use of aceclofenac during pregnancy. Inhibitors of prostaglandin synthesis may affect pregnancy and / or embryo-fetal development. Data from epidemiological studies show an increased risk of spontaneous abortion, cardiac malformation or gastroschisis after the use of prostaglandin synthesis inhibitors in early pregnancy. The absolute risk of cardiac malformation increases from less than 1% to about 1.5%. This risk seems to increase with the dose and duration of treatment. In animals, the administration of prostaglandin synthesis inhibitors has been shown to be related to pre- and post-implantation loss and embryo-fetal lethality.
In addition, the increase in the incidence of various malformations (eg cardiovascular) has been reported in animals receiving inhibitors of prostaglandin synthesis during organogenesis. During the 1 st and 2 etrimesters, NSAIDs should be administered only when necessary clearly identified. If NSAIDs are administered in women wishing to become pregnant or during the 1 st and 2 nd trimester of pregnancy, doses and treatment durations should be the lowest possible.
During the 3 rd trimester of pregnancy, the administration of inhibitors of prostaglandin synthesis exposes the fetus to:
- Cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- Renal dysfunction may progress to renal failure with oligohydroamnios.
The administration of prostaglandin synthesis inhibitors at the end of pregnancy exposes the mother and the future newborn to:
- Possible prolongation of bleeding, an anti-platelet aggregation effect that may occur even at low doses;
- Inhibition of uterine contractions resulting in delay and prolongation of labor.
Consequently, NSAIDs are cons-indicated during the 3 th trimester of pregnancy (see Contraindications ).
- There is no information regarding the secretion of aceclofenac in breast milk; no significant passage of aceclofenac radiolabeled ( 14 C) in the milk of lactating rats, however, has been found.
- Therefore, continuation of breastfeeding or treatment with aceclofenac should be considered if the potential benefits of treatment for the mother outweigh the potential risks of breastfeeding for the child.
- NSAIDs can impair fertility and their use is therefore not recommended for women trying to conceive a child. Consider a temporary interruption of aceclofenac treatment in women who have difficulty conceiving a child or undergoing infertility testing.
What should I do if I miss a dose?
With chronic pain it is important to consistently take this medication. If you have forgotten a dose: if you take this medicine twice a day :
does it take more than 4 hours before you take the next dose normally?
Take the forgotten dose as yet.
Does it take less than 4 hours?
Skip the dose you missed.
What happens if I overdose from Aceclofenac ?
- There is insufficient data available on the consequences of an overdose of aceclofenac in humans.
- The treatment of acute intoxication with nonsteroidal anti-inflammatory drugs consists mainly of symptomatic and supportive treatment to prevent complications such as hypotension, renal failure, seizures, gastrointestinal irritation and respiratory depression. .
- Management of acute intoxication with oral aceclofenac consists of prevention of absorption, as soon as possible after ingestion and by means of gastric lavage, as well as treatment with charcoal.
- Forced diuresis, dialysis, and hemoperfusion do not eliminate NSAIDs because of their high plasma protein binding and metabolism.
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