Full Prescribing Info
Each capsule contains: Acemetacin 60 mg.
Each retard capsule contains: Acemetacin 90 mg.
Anti-rheumatic, anti-inflammatory and analgesic.
Acemetacin, non-steroidal anti-inflammatory analgesic is well tolerated and it is therefore, suitable for treating rheumatic symptoms.
Pain and inflammatory processes (e.g. associated with rheumatic diseases or after operations or blunt injuries) are rapidly and reliably eliminated or alleviated; this contributes to rapid restoration of the mobility of diseased joints.
Rheumatoid Arthritis, Osteoarthritis, Low back pain and for post-operative pain and inflammation.
Dosage/Direction for Use
Acemet should be used at the lowest effective dose for shortest possible time.
Capsule: The recommend dosage given as follows apply to adults and should be adjusted for the nature and severity of disease.
Acemet Cap. 60 mg 1 capsule to be taken 1-3 times a day.
Retard capsule: Unless directed otherwise by the doctor, adults should take 90 mg one time/day, depending on the disorder and its severity. If necessary, daily dosage can be taken one capsule twice a day.
If necessary, daily dosage can be increased up to 180 mg. Dosage may be individualized.
Method of Use: Swallow the capsules whole with liquid during meals.
Unresolved dyshaematopoiesis and hypersensitivity to acemetacin or indomethacin are absolute contraindications.
Patients who have shown hypersensitivity reactions (eg, asthma attacks, skin reactions or acute rhinitis) to non-steroidal anti-inflammatory/analgesics should not take Acemetacin unless certain precautions are taken (readiness for an emergency). Patients who suffer from asthma, hay fever, swollen nasal mucosa or chronic respiratory disease are at particular risk of hypersensitivity reactions.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; active, or history of recurrent peptic ulcer/haemorrhage.
Acemet is contraindicated: i) in patients with severe heart failure and ii) for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
Use in pregnancy & lactation: Although no evidence of teratogenic, mutagenic or carcinogenic effects has emerged from animal studies with acemetacin or from the considerable period of clinical experience with Acemetacin, it should not be used in the first 6 months of pregnancy or during breastfeeding. During the final 3 months of pregnancy, it is contraindicated.
Capsule: In patients with gastric and duodenal ulcers (or a history of such ulcers) the benefit-risk ratio must be considered carefully before using Acemetacin.
In rare cases, Acemetacin has been associated with serious liver injury.
Special Precautions
Patients with evidence of gastric or duodenal ulcers in their case history or with gastric or duodenal ulcers in their case history or with gastrointestinal symptoms, patients with impaired liver or kidney function, hypertension and/or heart failure and elderly patients require careful medical observation.
In patients with an increased haemorrhagic tendency, platelet aggregation may be affected.
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of Acemet in patients with advanced renal disease. Therefore, treatment with Acemet is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Effects on the Ability to Drive or Operate Machinery: Since Acemetacin can induce central nervous side effects, eg dizziness, vertigo and drowsiness, fitness to drive a vehicle or to operate machinery may be impaired.
Use in Children: Use of Acemetacin in children is inadvisable since there is no experience with Acemetacin in this age group.
Side Effects
The following side effects occasionally occur: Nausea, vomiting, abdominal pain, diarrhea; headaches, dizziness, vertigo, sleepiness/fatigue.
The following side effects are rare: Gastrointestinal ulcers (possibly with hemorrhaging and perforation), anxiety states, confusion, psychoses, hallucinations, tinnitus, loss of appetite, muscular weakness, peripheral neuropathies, kidney damage, edema, hypertension, hyperkalaemia, hypersensitivity with erythematic, urinary (60 mg cap only) and itching (60 mg cap only), alopecia, anaphylactic reactions and leucopenia.
Capsule: The following may occur in isolated cases: Thrombocytopenia, agranulocytosis, aplastic anaemia, auditory disturbances, severe skin reactions, acute kidney failure, toxic hepatitis and live damage, hyperglycaemia and glucosuria, angina symptoms, vaginal haemorrhages, and after long-term use, retinal pigment degeneration and clouding of the cornea.
Drug Interactions
Simultaneous administration of Acemetacin and digoxin preparations can raise the serum digoxin level.
In patients receiving lithium treatment, lithium clearance must be monitored.
No interactions of Acemetacin with other active substances that are strongly bound to plasma proteins have been reported.
Since it inhibits thromboxane synthesis, the risk of hemorrhage may be increased when anticoagulants are taken simultaneously.
The excretion of Acemetacin is accelerated by furosemide.
Like other NSAIDs, Acemetacin may attenuate the antihypertensive activity of diuretics and antihypertensive.
In patients receiving potassium-retaining diuretics, serum potassium levels must be monitored because Acemetacin can cause hyperkalaemia.
Capsule: Do not store above 25°C.
Retard capsule: Store below 30°C.
ATC Classification
M01AB11 - acemetacin ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
Cap 60 mg x 1,000's. Retard cap 90 mg x 500's.
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