Aceclofenac For Throat Pain


Aceclofenac For Throat Pain
Comparison of an Aceclofenac + Paracetamol combination medicine with a Paracetamol 650 mg –

Aceclofenac + Paracetamol Paracetamol 650 mg
Composition Aceclofenac + Paracetamol is made of Aceclofenac & Paracetamol. It contains 650 mg of Paracetamol.
Uses It is a pain reliever and works effectively in arthritis, osteoarthritis and ankylosing spondylitis. It also reduces back pain, throat pain, etc. It reduces pain and fever. It is used more commonly to relieve common colds, toothaches, headaches, etc.
Side Effects

Mouth ulcer Fatigue Constipation Allergic skin reactions Abdominal pain Bloody and cloudy urine

Dizziness Drowsiness Constipation Fainting Malaise

Aceclofenac + Paracetamol works effectively against the pain as well as the fever. It is advisable to strictly follow the prescription, and patients with pre-existing medical conditions should be more careful with their intake. References: Disclaimer: The information provided here is not meant to substitute an advice from a healthcare professional.

  1. The information is not intended to cover all the possible uses, side-effects, precautions, and drug interactions.
  2. This information is not intended to suggest that using a specific drug is suitable, safe, or efficient for you or anyone else.
  3. The absence of any information or warning regarding the drug should not be interpreted as an implicit guarantee from the organisation.

We strongly advise you to consult a doctor if you have any concerns about the drug and never use the medication without a doctor’s prescription.

Can aceclofenac be used for throat pain?

Abstract – Aceclofenac (Almirall Prodesfarma SA) is an oral NSAID that is effective in the treatment of painful inflammatory diseases and has been used to treat > 75 million patients worldwide. It has proved as effective as diclofenac, naproxen and piroxicam in patients with osteoarthritis, diclofenac, ketorolac, tenoxicam and indomethacin in patients with rheumatoid arthritis and tenoxicam, naproxen and indomethacin in patients with ankylosing spondylitis. It also provides effective analgesia in other indications, such as dental or gynaecological pain, lower back pain and ear, nose and throat indications. Aceclofenac appears to be particularly well-tolerated amongst the NSAIDs, with a lower incidence of gastrointestinal adverse effects. This good tolerability profile results in a reduced withdrawal rate and hence greater compliance with treatment.

Is diclofenac good for a sore throat?

2. Anti-inflammatories – In addition to having analgesic action, anti-inflammatories can also help to reduce swelling which commonly occurs with sore throats. Some examples include ibuprofen, diclofenac and meloxicam. These should ony be used as prescribed by the doctor.

What is aceclofenac used to treat?

My Account Area – 1. Name of the medicinal product Aceclofenac 100 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 100 mg of aceclofenac For the full list of excipients, see section 6.1.3. Pharmaceutical form Film-coated tablet. White, round, biconvex film-coated tablets, 8 mm diameter.4. Clinical particulars 4.1 Therapeutic indications Aceclofenac 100 mg Film-coated Tablets is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults.4.2 Posology and method of administration Posology Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Adults The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening. Children There are no clinical data on the use of Aceclofenac 100 mg Tablets in children and therefore it is not recommended for use in children. Elderly The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. The pharmacokinetics of Aceclofenac 100 mg Tablets are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency. Patients with renal impairment There is no evidence that the dosage of Aceclofenac 100 mg Tablets needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see section4.4). Patients with liver impairment There is some evidence that the dose of Aceclofenac 100 mg Tablets should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used. Method of administration Aceclofenac 100 mg Film-coated Tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. To be taken preferably with or after food. When Aceclofenac 100 mg Tablets was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected 4.3 Contraindications Hypersensitivity to aceclofenac or to any of the excipients listed in section 6.1 Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. Patients with active bleeding or bleeding diathesis. Severe hepatic failure and renal failure (see section 4.4). Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Aceclofenac 100 mg Tablets should not be prescribed during pregnancy, especially during the last trimester of pregnancy, in women attempting to conceive and lactation unless there are compelling reasons for doing so. The lowest effective dosage should be used (see section 4.6).4.4 Special warnings and precautions for use Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below). The use of Aceclofenac 100 mg Tablets with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5). Elderly : The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2). Respiratory disorders : Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. Cardiovascular, Renal and Hepatic Impairment : The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (see also section 4.3). Renal : Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function monitored regularly. Effects on renal function are usually reversible on withdrawal of Aceclofenac 100 mg Tablets. Hepatic : If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Aceclofenac 100 mg Tablets should be discontinued. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Hepatitis may occur without prodromal symptoms. Use of Aceclofenac 100 mg Tablets in patients with hepatic porphyria may trigger an attack. Cardiovascular and cerebrovascular effects : Patients with congestive heart failure (NYHA-I) and patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with aceclofenac after careful consideration. Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild congestive heart failure (NYHA-I) as fluid retention and oedema have been reported in association with NSAID therapy. As the cardiovascular risks of aceclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically. Aceclofenac should also be administered with caution and under close medical surveillance to patients with a history of cerebrovascular bleeding Gastrointestinal bleeding, ulceration and perforation : GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. Close medical surveillance is imperative in patients with symptoms indicative of gastro-intestinal disorders involving either the upper or lower gastrointestinal tract, with a history suggestive of gastro-intestinal ulceration, with ulcerative colitis or with Crohn’s disease, bleeding diathesis or perforation, or haematological abnormalities, as these conditions may be exacerbated (see section 4.8). The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be advised in patients receiving concomitant medications which could 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 GI bleeding or ulceration occurs in patients receiving aceclofenac, the treatment should be withdrawn. SLE and mixed connective tissue disease : In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8). Dermatological : 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). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Aceclofenac 100 mg Film-coated Tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Exceptionally, varicella can trigger serious cutaneous and soft tissues infections complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of aceclofenac in case of varicella. Impaired female fertility : The use of Aceclofenac 100 mg Tablets may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac 100 mg Film-coated Tablets should be considered. Hypersensitivity reactions : As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug. Haematological : Aceclofenac 100 mg Tablets may reversibly inhibit platelet aggregation (see section 4.5 anticoagulants under ‘Interactions’). Aceclofenac should be avoided in patients who have developed anaemia, agranulocytosis or thrombocytopenia secondary to NSAIDs or metamizol. Long term treatment : All patients who are receiving NSAIDs should be monitored as a precautionary measure e.g. renal failure, hepatic function (elevation of liver enzymes may occur) and blood counts.4.5 Interaction with other medicinal products and other forms of interaction Other analgesics including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects, including GI bleeding (see section 4.4). Anti-hypertensives: Reduced anti-hypertensive effect. The risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE- inhibitors or angiotensin II receptor antagonists are combined with NSAIDs. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs. Although it was not shown to affect blood pressure control when co-administered with bendrofluazide, interactions with other diuretics cannot be ruled out. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored. Cardiac glycosides like digoxin:: NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels. The combination should be avoided unless frequent monitoring of glycoside levels can be performed. Lithium: Several NSAIDs drugs inhibit the renal clearance of lithium, resulting in increased serum concentration of lithium. The combination should be avoided unless frequent monitoring of lithium can be performed. Methotrexate: The possible interaction between NSAIDs and methotrexate should be born in mind also when low doses of methotrexate are used, especially in patients with decreased renal function. When combination therapy has to be used, the renal function should be monitored. Caution should be exercised if NSAIDs and methotrexate are administered within 24 hours of each other, since NSAIDs may increase plasma levels, resulting in increased toxicity. Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anti-coagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). Close monitoring of patients on combined anti-coagulants and Aceclofenac 100 mg Film-coated Tablets therapy should be undertaken. Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions. Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs) : Increased risk of gastrointestinal bleeding (see section 4.4). Ciclosporin,tacrolimus: Administration of NSAID drugs together with cyclosporin or tacrolimus is thought to increase the risk of nephrotoxicity due to decreased synthesis of prostacyclin in the kidney. During combination therapy it is therefore important to carefully monitor renal function. Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen. Antidiabetic agents: Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. Thus with Aceclofenac 100 mg Film-coated Tablets, consideration should be given to adjustment of the dosage of hypoglycaemic agents. Other NSAIDs: Concomitant therapy with aspirin or other NSAIDs may increase the frequency of adverse reactions, including the risk of GI bleeding.4.6 Fertility, pregnancy and lactation Pregnancy : There is no information on the use of aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5 %. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, aceclofenac should not be given unless clearly necessary. If aceclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: – cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); – renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to: – possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses. – inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, aceclofenac is contraindicated during the third trimester of pregnancy (see section 4.3). Lactation There is no information on the secretion of aceclofenac to breast milk; there was however no notable transfer of radio labelled (14C) aceclofenac to the milk of lactating rats. The use of aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus. Fertility The use of aceclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac 100 mg Film-coated Tablets should be considered.4.7 Effects on ability to drive and use machines Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances or other central nervous system disorders are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.4.8 Undesirable effects Gastrointestinal: The most commonly-observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (See section 4.4) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely. Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme). Cardiovascular and cerebrovascular: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Aceclofenac is both structurally related and metabolised to diclofenac for which a greater amount of clinical and epidemiological data consistently point towards an increased risk of general arterial thrombotic events (myocardial infarction or stroke, particularly at high doses and in long treatment). Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac, (see section 4.3 and 4.4). Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment. Other adverse reactions reported less commonly include: Renal: Interstitial nephritis. Hepatic: abnormal liver function, hepatitis and jaundice. Neurological and special senses: Optic neuritis, reports of aseptic meningitis (especially in patients with existing auto immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (See section 4.4), confusion, hallucinations, and drowsiness. Haematological: Agranulocytosis, aplastic anaemia. Dermatological: Bullous reactions including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity. If serious adverse reactions occur, Aceclofenac 100 mg film-coated Tablets should be withdrawn. Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common ((≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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System organ class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare/ isolated reports (<1/10,000)
Blood and lymphatic system disorders Anaemia Bone Marrow depression Granulocytopenia Thrombocytopenia Neutropenia Haemolytic anaemia
Immune system disorders Anaphylactic reaction (including shock) Hypersensitivity
Metabolism and nutrition disorders Hyperkalemia
Psychiatric disorders Depression Abnormal dreams Insomnia
Nervous system disorders Dizziness Paraesthesia Tremor Somnolence Headache Dysgeusia (abnormal taste)
Eye disorders Visual disturbance
Ear and labyrinth disorders Vertigo Tinnitus
Cardiac disorders Cardiac failure Palpitations
Vascular disorders Hypertension Flushing Hot flush Vasculitis
Respiratory, thoracic and mediastinal disorders Dyspnoea Bronchospasm Stridor
Gastrointestinal disorders Dyspepsia Abdominal pain Nausea Diarrhoea Flatulence Gastritis Constipation Vomiting Mouth ulceration Melaena Gastrointestinal haemorrhage Gastrointestinal ulceration Stomatitis Intestinal perforation Exacerbation of Crohn’s disease and Colitis Ulcerative Haematemesis Pancreatitis
Hepatobiliary disorders Hepatic enzyme increased Hepatic injury (including hepatitis) Jaundice Blood alkaline phosphatase increased
Skin and subcutaneous tissue disorders Pruritus Rash Dermatitis Urticaria Angioedema Purpura Severe mucocutaneous skin reaction (including Stevens Johnson Syndrome and Toxic Epidermal Necrolysis)
Renal and urinary disorders Blood urea increased Blood creatinine increased Renal failure Nephrotic syndrome
General disorders and administration site conditions Oedema Fatigue Cramps in legs
Investigations Weight increase

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal products. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Overdose Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures. a) Symptoms Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal irritation, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, hypotension, respiratory depression, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible. b) Therapeutic measure Patients should be treated symptomatically as required. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Specific therapies such as dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism. Good urine output should be ensured. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition. Management of acute poisoning with oral aceclofenac essentially consists of supportive and symptomatic measures for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression.5. Pharmacological properties 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids, acetic acid derivatives and related substances ATC code: M01AB16. Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins.5.2 Pharmacokinetic properties After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 57% of those in plasma. The volume of distribution is approximately 25 L. The mean plasma elimination half-life is around 4 hours. Aceclofenac is highly protein- bound (>99%). Aceclofenac circulates mainly as unchanged drug.4′- Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two- thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites. Aceclofenac is partially metabolised to diclofenac. No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.5.3 Preclinical safety data The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs. The principal target organ was the gastro-intestinal tract. No unexpected findings were recorded. Aceclofenac was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse. Aceclofenac was not found to be carcinogenic in either the mouse or rat. Animal studies indicate that there was no evidence of teratogenesis in rats although the systemic exposure was low and in rabbits treatment with aceclofenac (10 mg/kg/day) resulted in a series of morphological changes in some fetuses.6. Pharmaceutical particulars 6.1 List of excipients Core: Microcrystalline cellulose (E460i) Croscarmellose Sodium Copovidone Talc (E553b) Silica colloidal anhydrous Glicerol distearate Film-coating Opadry O3A0280002: HPMC 2910/Hypromellose Microcrystalline Cellulose Titanium dioxide (E171) Polyoxyl 40 (Macrogol)stearate 6.2 Incompatibilities None known 6.3 Shelf life 24 months 6.4 Special precautions for storage This medicinal product does not require any special storage conditions.6.5 Nature and contents of container Aceclofenac 100 mg Film-Coated Tablets are packaged in Aluminium/aluminium blisters placed into cardboard boxes containing 20, 30, 40, 60, 90, 100 or 180 tablets, Not all pack sizes may be marketed.6.6 Special precautions for disposal and other handling No special requirements.7. Marketing authorisation holder Rivopharm UK Ltd., 100 Bishopsgate London EC2N 4AG United Kingdom 8. Marketing authorisation number(s) PL 33155/0029 9. Date of first authorisation/renewal of the authorisation 11/02/2015 10. Date of revision of the text 25/05/2023

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Can I take Aceclo plus for throat infection?

Aceclo Plus Tablet is a pain-relieving medicine. It is used to reduce pain and inflammation in conditions like rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis. It may also be used to relieve muscle pain, back pain, toothache, or pain in the ear and throat. This item requires prescription Why?

What is a fast drug for sore throat?

Is Tylenol or Advil better for sore throat? – Either acetaminophen (Tylenol) or ibuprofen (Advil) can help with the pain of a sore throat, But Advil or ibuprofen also helps relieve inflammation, so you may score more sore throat relief by taking that.

Will antiinflammatory help sore throat?

Ibuprofen (generic Advil or Motrin) Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). It soothes a sore throat by blocking substances in the body that help create pain and inflammation. It’s often a go-to OTC medication to help relieve mild fevers, pain, and inflammation.

What is the difference between diclofenac and aceclofenac?

Diclofenac is a potent inhibitor of cyclooxygenase in vitro and in vivo, thereby reducing the synthesis of prostaglandins, prostacyclin, and thromboxane products. On the other hand, aceclofenac is an orally administered phenylacetic acid derivative with effects on a variety of inflammatory mediators.

What tablets can I take for inflamed throat?

A pharmacist can help with sore throats – You can ask a pharmacist about ways of relieving the pain and discomfort of a sore throat, such as:

  • paracetamol or ibuprofen
  • medicated lozenges containing a local anaesthetic, antiseptic, or anti-inflammatory medicine
  • anaesthetic spray (although there’s little proof they help)

You can buy these treatments from a supermarket or from a pharmacist without a prescription.

Is aceclofenac stronger than ibuprofen?

On intergroup analysis, patients in the ibuprofen group having a better relief of pain compared with those in the aceclofenac group.

Does aceclofenac reduce inflammation?

Abstract – Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic properties. Although there are some differences in the authorized indications between countries, aceclofenac is mainly recommended for the treatment of inflammatory and painful processes, such as low back pain (LBP), scapulohumeral periarthritis, extraarticular rheumatism, odontalgia, and osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS).

The analgesic properties and tolerability profile of aceclofenac in musculoskeletal disorders are reviewed, focusing on relevant and recent studies. The efficacy and safety comparison of aceclofenac with other analgesics and anti-inflammatory agents in OA, AS, RA, and LBP is described. Relevant studies were identified following a literature search of PubMed using the terms “aceclofenac” and “clinical trials” published from 1 Jan 1992 to 1 Jan 2020.

Aceclofenac is at least as effective as other NSAIDs in reducing pain and/or improving functional capacity in chronic pain conditions (OA, AS, RA, and LBP). It is generally well tolerated and appears to have a more favorable GI profile than other NSAIDs.

Which is better for sore throat paracetamol or diclofenac?

‘Painkillers best option for sore throats’ say new NHS guidelines “Doctors should not prescribe ‘precious’ antibiotics for most people with sore throats and should recommend drugs like paracetamol, new guidelines say,” BBC News reports. Antibiotics are medicines used to treat infections caused by bacteria.

Respiratory tract infections like coughs, colds and sore throats are the most common reason for prescribing antibiotics. But many of these infections are caused by viruses rather than bacteria – and neither need nor respond to antibiotics. The body can often fight these infections by itself if a person is otherwise healthy.

Over the years, using antibiotics in the wrong way has allowed some bacteria to become resistant to them. This has made them less effective in treating some serious bacterial infections. Increasing means we could reach a point where even simple infections or surgical procedures could become hazardous.

  • If you have a sore throat, there are a number of ways you can help yourself.
  • Paracetamol can help with the pain, and gargling with warm, salty water may help shorten the infection (but this isn’t recommended for children).
  • In most cases, you only need to see your GP if your sore throat doesn’t improve after a week.

Which is better paracetamol or aceclofenac?

How Does It Work? – Paracetamol works by interfering with the formation of an inflammatory mediator prostaglandin. Prostaglandin is responsible for pain and swelling. Aceclofenac acts by inhibiting certain enzymes res. Read more

Can I take amoxicillin and aceclofenac?

Generic Name Aceclofenac DrugBank Accession Number DB06736 Background Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studies 2, 3, 5, Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever.

Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubility 2, It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammation 1,

  • Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions 7,
  • In 1991, aceclofenac was developed as an analog of a commonly prescribed NSAID, Diclofenac, via chemical modification in effort to improve the gastrointestinal tolerability of the drug.

It is a more commonly prescribed drug in Europe. Type Small Molecule Groups Approved, Investigational Structure Weight Average: 354.18 Monoisotopic: 353.0221633 Chemical Formula C 16 H 13 Cl 2 NO 4 Synonyms

  • 2-benzeneacetic acid carboxymethyl ester
  • 2-phenylacetoxyacetic acid
  • 2-phenylacetoxyacetic acid
  • Aceclofenac
  • Acéclofénac
  • Aceclofenac betadex
  • Aceclofenaco
  • Aceclofenacum
  • glycolic acid acetate ester

Indication Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Reduce drug development failure rates Build, train, & validate machine-learning models with evidence-based and structured datasets. Build, train, & validate predictive machine-learning models with structured datasets. Associated Conditions

  • Ankylosing Spondylitis (AS)
  • Osteoarthritis (OA)
  • Rheumatoid Arthritis

Contraindications & Blackbox Warnings Avoid life-threatening adverse drug events Improve clinical decision support with information on contraindications & blackbox warnings, population restrictions, harmful risks, & more. Avoid life-threatening adverse drug events & improve clinical decision support. Pharmacodynamics Aceclofenac is a NSAID that inhibits both isoforms of COX enzyme, a key enzyme involved in the inflammatory cascade. COX-1 enzyme is a constitutive enzyme involved in prostacyclin production and protective functions of gastric mucosa whereas COX-2 is an inducible enzyme involved in the production of inflammatory mediators in response to inflammatory stimuli. Aceclofenac displays more selectivity towards COX-2 (IC50 of 0.77uM) than COX-1 (IC50 of >100uM), which promotes its gastric tolerance compared to other NSAIDs. The primary metabolite, 4′-hydroxyaceclofenac, also minimally inhibits COX-2 with IC50 value of 36uM 2, Although the mode of action of aceclofenac is thought to mainly arise from the inhibition of synthesis of prostaglandins (PGE2), aceclofenac also inhibits the production of inflammatory cytokines, interleukins (IL-1β, IL-6), and tumor necrosis factors (TNF) 1, 2, It is also reported that aceclofenac also affects the cell adhesion molecules from neutrophils 8, Aceclofenac also targets the synthesis of glycosaminoglycan and mediates chrondroprotective effects 1, Mechanism of action Through COX-2 inhibition, aceclofenac downregulates the production of various inflammatory mediators including prostaglandin E2 (PGE2), IL-1β, and TNF from the arachidonic acid (AA) pathway. Inhibition of IL-6 is thought to be mediated by diclofenac converted from aceclofenac 6, Suppressed action of inflammatory cytokines decreases the production of reactive oxygen species. Aceclofenac is shown to decreased production of nitrous oxide in human articular chondrocytes 2, In addition, aceclofenac interferes with neutrophil adhesion to endothelium by decreasing the expression of L-selectin (CD62L), which is a cell adhesion molecule expressed on lymphocytes 8, Aceclofenac is proposed to stimulate the synthesis of glycosaminoglycan in human osteoarthritic cartilage which may be mediated through its inhibitory action on IL-1 production and activity 1, The chrondroprotective effects are generated by 4′-hydroxyaceclofenac which suppresses IL-1 mediated production of promatrix metalloproteinase-1 and metalloproteinase-3 and interferes with the release of proteoglycan from chrondrocytes 1, 2, 7,

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Target Actions Organism
A Prostaglandin G/H synthase 2 inhibitor Humans
A Prostaglandin G/H synthase 1 inhibitor Humans

Absorption Aceclofenac is rapidly and completely absorbed from the gastrointestinal tract and circulates mainly as unchanged drug following oral administration. Peak plasma concentrations are reached around 1.25 to 3 hours post-ingestion, and the drug penetrates into the synovial fluid where the concentration may reach up to 60% of that in the plasma 11, There is no accumulation in regular dosing, with similar maximum plasma concentration (Cmax) and time to reach peak plasma concentration (Tmax) after single and multiple doses 2, Volume of distribution The volume of distribution is approximately 25 L 11, Protein binding It is reported to be highly protein-bound (>99%) 11, Metabolism 4′-hydroxyaceclofenac is the main metabolite detected in plasma however other minor metabolites include diclofenac, 5-hydroxyaceclofenac, 5-hydroxydiclofenac, and 4′-hydroxydiclofenac 2, It is probable that the metabolism of aceclofenac is mediated by CYP2C9 9, Hover over products below to view reaction partners Route of elimination The main route of elimination is via the urine where the elimination accounts for 70-80% of clearance of the drug 2, Approximately two thirds of the administered dose is excreted via the urine, mainly as glucuronidated and hydroxylated forms of aceclofenac 11, About 20% of the dose is excreted into feces 6, Half-life The mean plasma elimination half-life is approximately 4 hours 11, Clearance The mean clearance rate is approximately 5 L/h 9, Adverse Effects Improve decision support & research outcomes With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. Improve decision support & research outcomes with our structured adverse effects data.

  1. Toxicity Some common adverse effects include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness 12,
  2. Oral LD50 value in rats is 130 mg/kg MSDS,
  3. Pathways Not Available Pharmacogenomic Effects/ADRs Not Available Drug Interactions This information should not be interpreted without the help of a healthcare provider.

If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

  • Approved
  • Vet approved
  • Nutraceutical
  • Illicit
  • Withdrawn
  • Investigational
  • Experimental
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Drug Interaction
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Abacavir Aceclofenac may decrease the excretion rate of Abacavir which could result in a higher serum level.
Abciximab The risk or severity of bleeding and hemorrhage can be increased when Aceclofenac is combined with Abciximab.
Acebutolol Aceclofenac may decrease the antihypertensive activities of Acebutolol.
Acemetacin The risk or severity of adverse effects can be increased when Aceclofenac is combined with Acemetacin.
Acenocoumarol The risk or severity of bleeding and hemorrhage can be increased when Aceclofenac is combined with Acenocoumarol.
Acetaminophen The risk or severity of adverse effects can be increased when Acetaminophen is combined with Aceclofenac.
Acetazolamide Acetazolamide may increase the excretion rate of Aceclofenac which could result in a lower serum level and potentially a reduction in efficacy.
Acetohexamide The protein binding of Acetohexamide can be decreased when combined with Aceclofenac.
Acetylsalicylic acid The risk or severity of adverse effects can be increased when Acetylsalicylic acid is combined with Aceclofenac.
Aclidinium Aceclofenac may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Food Interactions

Take with or without food.

Drug product information from 10+ global regions Our datasets provide approved product information including: dosage, form, labeller, route of administration, and marketing period. Access drug product information from over 10 global regions. International/Other Brands Cincofen / Clanza / Hifenac Brand Name Prescription Products

Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image
Clanza CR Tablet, film coated 200 mg/1 Oral United Douglas Pharm., Inc. 2011-05-12 Not applicable

ATC Codes M01AB16 — Aceclofenac

  • M01AB — Acetic acid derivatives and related substances

M02AA25 — Aceclofenac

  • M02AA — Antiinflammatory preparations, non-steroids for topical use

Drug Categories Chemical Taxonomy Provided by Classyfire Description This compound belongs to the class of organic compounds known as dichlorobenzenes. These are compounds containing a benzene with exactly two chlorine atoms attached to it. Kingdom Organic compounds Super Class Benzenoids Class Benzene and substituted derivatives Sub Class Halobenzenes Direct Parent Dichlorobenzenes Alternative Parents Aniline and substituted anilines / Dicarboxylic acids and derivatives / Aryl chlorides / Carboxylic acid esters / Amino acids / Secondary amines / Carboxylic acids / Organopnictogen compounds / Organochlorides / Organic oxides show 2 more Substituents 1,3-dichlorobenzene / Amine / Amino acid / Amino acid or derivatives / Aniline or substituted anilines / Aromatic homomonocyclic compound / Aryl chloride / Aryl halide / Carbonyl group / Carboxylic acid show 13 more Molecular Framework Aromatic homomonocyclic compounds External Descriptors monocarboxylic acid, carboxylic ester, secondary amino compound, dichlorobenzene, amino acid ( CHEBI:31159 ) Affected organisms Not Available UNII RPK779R03H CAS number 89796-99-6 InChI Key MNIPYSSQXLZQLJ-UHFFFAOYSA-N InChI InChI=1S/C16H13Cl2NO4/c17-11-5-3-6-12(18)16(11)19-13-7-2-1-4-10(13)8-15(22)23-9-14(20)21/h1-7,19H,8-9H2,(H,20,21) IUPAC Name 2-acetic acid SMILES OC(=O)COC(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl General References

  1. Raza K, Kumar M, Kumar P, Malik R, Sharma G, Kaur M, Katare OP: Topical delivery of aceclofenac: challenges and promises of novel drug delivery systems. Biomed Res Int.2014;2014:406731. doi: 10.1155/2014/406731. Epub 2014 Jun 18.
  2. Legrand E: Aceclofenac in the management of inflammatory pain. Expert Opin Pharmacother.2004 Jun;5(6):1347-57.
  3. Pareek A, Chandurkar N: Comparison of gastrointestinal safety and tolerability of aceclofenac with diclofenac: a multicenter, randomized, double-blind study in patients with knee osteoarthritis. Curr Med Res Opin.2013 Jul;29(7):849-59. doi: 10.1185/03007995.2013.795139. Epub 2013 Apr 30.
  4. Moore RA, Derry S, McQuay HJ: Single dose oral aceclofenac for postoperative pain in adults. Cochrane Database Syst Rev.2009 Jul 8;(3):CD007588. doi: 10.1002/14651858.CD007588.pub2.
  5. Pareek A, Chandurkar N, Gupta A, Sirsikar A, Dalal B, Jesalpura B, Mehrotra A, Mukherjee A: Efficacy and safety of aceclofenac-cr and aceclofenac in the treatment of knee osteoarthritis: a 6-week, comparative, randomized, multicentric, double-blind study. J Pain.2011 May;12(5):546-53. doi: 10.1016/j.jpain.2010.10.013. Epub 2011 Feb 1.
  6. Brogden RN, Wiseman LR: Aceclofenac. A review of its pharmacodynamic properties and therapeutic potential in the treatment of rheumatic disorders and in pain management. Drugs.1996 Jul;52(1):113-24. doi: 10.2165/00003495-199652010-00008.
  7. Dooley M, Spencer CM, Dunn CJ: Aceclofenac: a reappraisal of its use in the management of pain and rheumatic disease. Drugs.2001;61(9):1351-78.
  8. Gonzalez-Alvaro I, Carmona L, Diaz-Gonzalez F, Gonzalez-Amaro R, Mollinedo F, Sanchez-Madrid F, Laffon A, Garcia-Vicuna R: Aceclofenac, a new nonsteroidal antiinflammatory drug, decreases the expression and function of some adhesion molecules on human neutrophils. J Rheumatol.1996 Apr;23(4):723-9.
  9. Ghosh S, Barik BB: A Comparative Study of the Pharmacokinetics of Conventional and Sustained-release Tablet Formulations of Aceclofenac in Healthy Male Subjects Tropical Journal of Pharmaceutical Research.2010 September 1;9(4):395-399.
  10. Dahiya S, Kaushik A, Pathak K: Improved Pharmacokinetics of Aceclofenac Immediate Release Tablets Incorporating its Inclusion Complex with Hydroxypropyl-beta-Cyclodextrin. Sci Pharm.2015 Feb 2;83(3):501-10. doi: 10.3797/scipharm.1509-07. Print 2015 Jul-Sep.
  11. UK Medicines and Healthcare products Regulatory Agency: ACECLOFENAC 100MG TABLETS product information
  12. DailyMed Label: Clanza CR (Aceclofenac) Oral Tablets

External Links KEGG Drug D01545 PubChem Compound 71771 PubChem Substance 347827785 ChemSpider 64809 BindingDB 50109016 RxNav 16689 ChEBI 31159 ChEMBL CHEMBL93645 ZINC ZINC000003805798 PharmGKB PA166049185 Wikipedia Aceclofenac MSDS Clinical Trials

Phase Status Purpose Conditions Count
4 Completed Basic Science Rheumatoid Arthritis 1
4 Completed Prevention NSAID-associated Gastroduodenal Injury 1
4 Completed Treatment Osteoarthritis (OA) 1
4 Completed Treatment Osteoarthritis of the Knee 1
3 Completed Treatment Disorder of Urinary Stent 1
2, 3 Completed Prevention Irreversible Pulpitis (Toothache) 1
2, 3 Completed Prevention Symptomatic Irreversible Pulpitis (SIP) 1
1 Active Not Recruiting Other Bioequivalence 1
1 Completed Treatment Anti-Ulcer Agents 1
1 Completed Treatment Healthy Subjects (HS) 1

Manufacturers Not Available Packagers Not Available Dosage Forms

Form Route Strength
Tablet, film coated Oral 100 MG
Tablet Oral 100 mg
Injection, powder, lyophilized, for solution Parenteral 0.15 g
Tablet, film coated Oral 0.1 g
Tablet, film coated Oral 100 mg/1
Cream Topical 1.5 g
Tablet, film coated Oral 200 mg/1
Cream Topical 1.5 %
Cream Topical 1.5 G/100G
Injection, powder, for solution Intramuscular 150 MG/4ML
Powder, for suspension Oral 100 MG
Suppository 200 MG
Tablet, film coated Oral
Tablet, extended release Oral 200 mg
Tablet, coated Oral 100 mg

Prices Not Available Patents Not Available State Solid Experimental Properties

Property Value Source
melting point (°C) 149-153 MSDS
water solubility Insoluble Wikipedia
logP 2.170 Dahiya S, Kaushik A, and Pathak K, 2015

Predicted Properties

Property Value Source
Water Solubility 0.00199 mg/mL ALOGPS
logP 4.88 ALOGPS
logP 3.88 Chemaxon
logS -5.2 ALOGPS
pKa (Strongest Acidic) 3.44 Chemaxon
pKa (Strongest Basic) -2.1 Chemaxon
Physiological Charge -1 Chemaxon
Hydrogen Acceptor Count 4 Chemaxon
Hydrogen Donor Count 2 Chemaxon
Polar Surface Area 75.63 Å 2 Chemaxon
Rotatable Bond Count 7 Chemaxon
Refractivity 86.32 m 3 ·mol -1 Chemaxon
Polarizability 32.76 Å 3 Chemaxon
Number of Rings 2 Chemaxon
Bioavailability 1 Chemaxon
Rule of Five Yes Chemaxon
Ghose Filter Yes Chemaxon
Veber’s Rule No Chemaxon
MDDR-like Rule No Chemaxon

Predicted ADMET Features Not Available Mass Spec (NIST) Not Available Spectra

Spectrum Spectrum Type Splash Key
Predicted MS/MS Spectrum – 10V, Positive (Annotated) Predicted LC-MS/MS Not Available
Predicted MS/MS Spectrum – 20V, Positive (Annotated) Predicted LC-MS/MS Not Available
Predicted MS/MS Spectrum – 40V, Positive (Annotated) Predicted LC-MS/MS Not Available
Predicted MS/MS Spectrum – 10V, Negative (Annotated) Predicted LC-MS/MS Not Available
Predicted MS/MS Spectrum – 20V, Negative (Annotated) Predicted LC-MS/MS Not Available
Predicted MS/MS Spectrum – 40V, Negative (Annotated) Predicted LC-MS/MS Not Available
LC-MS/MS Spectrum – LC-ESI-QTOF, positive LC-MS/MS splash10-0udi-0094000000-f8c3fec999613f33dcf4
LC-MS/MS Spectrum – LC-ESI-QTOF, positive LC-MS/MS splash10-0gb9-0090000000-4e970fdc8b34b418dfb4
LC-MS/MS Spectrum – LC-ESI-QTOF, positive LC-MS/MS splash10-014i-0090000000-4ea83e6670ee0480c3f0
LC-MS/MS Spectrum – LC-ESI-QTOF, positive LC-MS/MS splash10-014i-0090000000-5eed5bf9db2e212a1e81
LC-MS/MS Spectrum – LC-ESI-QTOF, positive LC-MS/MS splash10-03di-0090000000-3024a6130ab2a3ec552a
MS/MS Spectrum -, positive LC-MS/MS splash10-03xr-2390000000-7e1719951982f5715ecd

Is paracetamol or ibuprofen better for sore throat?

It’s better to take medicines such as paracetamol to address symptoms like pain, and to rest and drink lots of fluids to stay well hydrated. In a small number of cases, a sore throat may be part of a more serious illness.

What painkillers can I take for Covid throat?

How is COVID-19 treated and how do I relieve my symptoms? – Most adults with a mild case of COVID-19 can treat their symptoms in a similar way to how they treat a seasonal flu. That is, rest at home, take paracetamol or ibuprofen to relieve pain and fevers, to keep hydrated and take cough medicine if needed.

  • However, the Therapeutic Goods Administration (TGA) has approved certain medicines for the treatment of COVID-19 in Australia.
  • Learn more here about COVID-19 medications,
  • Adults with severe COVID-19 symptoms may need to be treated in hospital with corticosteroids, antivirals, and other drugs depending on how severe their symptoms are.

Medicines such as antibiotics, ivermectin and hydroxychloroquine are not effective against the coronavirus that causes COVID-19 and are not approved for the treatment of COVID-19 in Australia. ANTIVIRAL ELIGIBILITY — Use the COVID-19 Symptom and Antiviral Eligibility Checker to find out if you may be eligible for antiviral medication.