Each film-coated tablet contains mg of Aceclofenac. Aceclofenac film- coated tablets are indicated for the relief of pain and inflammation in osteoarthritis . Page 1 of PRODUCT MONOGRAPH. Pr. VOLTAREN*. VOLTAREN* SR. ( diclofenac sodium). 50 mg Enteric-Coated Tablets. 75 and Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) with marked anti- inflammatory and analgesic properties. It is reported to have a higher.

Author: Aralrajas Mikajora
Country: Swaziland
Language: English (Spanish)
Genre: Science
Published (Last): 17 November 2004
Pages: 483
PDF File Size: 8.84 Mb
ePub File Size: 9.91 Mb
ISBN: 170-3-27446-441-5
Downloads: 67697
Price: Free* [*Free Regsitration Required]
Uploader: Mikataxe

The risk is believed to increase with dose and duration of therapy. Increased risk of gastrointestinal ulceration or bleeding see section 4.

Patients appear to be at highest risk of 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. Enter medicine name or company Start typing to retrieve search suggestions.

Aceclofenac 100 mg film-coated Tablets

If an NSAID is considered necessary, monogrsph lowest effective dose should be used and for the shortest possible duration. Swallow the tablet whole with a glass of water. 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.

Hepatitis Jaundice Hepatic injury including hepatitis Blood alkaline phosphatase increased. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

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 aceclogenac section 4. Aceclofenwc use of Aceclofenac with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided see section 4. 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 aceclofehac rats.

Aceclofenac film-coated tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms see section 4. In patients with systemic lupus erythematosus SLE and mixed connective tissue disorders there may be an increased risk of aseptic meningitis see section 4.


NEWT Guidelines – Drug Monographs – Aceclofenac

In cases of significant poisoning acute renal failure and liver damage are possible. Oedema Fatigue Cramps in legs.

Effects on renal function are usually reversible on withdrawal of Aceclofenac. Aceclofenac is both structurally aceclofenad and metabolised to diclofenac for which a greater amount of clinical and aeclofenac data consistently point towards an increased risk of general arterial thrombotic events myocardial infarction or stroke, particularly at high doses and in long treatment. Back to top Accord Healthcare Limited contact details. Aceclofenac was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse.

The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, liver dysfunction, those being treated with diuretics or recovering acelcofenac major surgery.

Clinical trial and epidemiological data suggest that use of some NSAIDs particularly at high doses and in long term treatment may be associated with a small increased risk of arterial thrombotic events for example myocardial infarction or stroke.

In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality.

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 serious consequences of adverse reactions. NSAIDs monlgraph be given with care to patients with a history of gastrointestinal disease ulcerative colitis, Crohn’s monogrzph as these conditions may be exacerbated see section 4. Decreased elimination of methotrexate. Patients should be adequately hydrated mohograph consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.

If monkgraph liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur eosinophilia, rashAceclofenac Tablets should be discontinued. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored. Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern.


Qualitative and quantitative composition 3. These patients should commence treatment on the lowest dose qceclofenac. Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.


Other measures may be indicated by the patient’s clinical condition. Patients with a history of GI toxicity, particularly when elderly, should report aceclofrnac unusual abdominal symptoms especially GI bleeding particularly in the initial stages of treatment.

Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: For a full list of excipients, see section 6.

Aceclofenac – Drug Monograph –

Continue typing to refine. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms see section 4.

Caution aceclofemac be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such acelcofenac warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin see section 4. There are insufficient data to exclude such a risk for aceclofenac. Adults The recommended dose is mg daily, taken as two separate mg doses, one tablet in the morning and one in the evening.

There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of age. The use of Aceclofenac Tablets should aceclofenax be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus.

Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised aceclofenxc Section 4.

Method of administration Swallow the tablet whole with a glass of water. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Jonson syndrome, and toxic epidermal necrolysis, have been reporting very rarely in association with the use of NSAIDs see section 4. Each film-coated tablet contains mg of Aceclofenac. Depression Aceclofenxc dreams Insomnia.