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NSAID Pregnancy: Contraindicated during the third trimester; avoid in the first and second trimesters unless clearly necessary. There is no information on the use of aceclofenac during pregnancy. Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal development; epidemiological data suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy (absolute risk of cardiovascular malformation increased from under 1% to approximately 1.5%), with risk believed to increase with dose and duration. From the 20th week of pregnancy onward use may cause oligohydramnios from foetal renal dysfunction, and ductus arteriosus constriction has been reported after second-trimester treatment; consider antenatal monitoring for oligohydramnios and ductus arteriosus constriction after exposure for several days from gestational week 20 onward, and discontinue if either is found. In the third trimester all prostaglandin synthesis inhibitors may expose the foetus to cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension) and renal dysfunction, and the mother and neonate to prolonged bleeding time and inhibition of uterine contractions. Breastfeeding: there is no information on secretion into human breast milk; use should be avoided in pregnancy and lactation unless the potential benefits outweigh the possible risks. Fertility: use may impair female fertility and is not recommended in women attempting to conceive (this sentence is cut off at the source-fetch limit in the bundle).

Aceclofenac

Brand names: Preservex

Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Adult dose

Dose: 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.' Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. INDICATION SCOPE: this SPC's posology section gives one adult regimen and is not subdivided by indication; the licensed-indications section of the label was not captured in this source bundle, so confirm the licensed indication before prescribing.
Route: Oral — 'To be taken preferably with or after food. The tablets should be swallowed whole with a sufficient quantity of liquid.' (When given to fasting and fed healthy volunteers, only the rate and not the extent of aceclofenac absorption was affected.)
Frequency: Twice daily — one 100 mg tablet in the morning and one 100 mg tablet in the evening
Max: 200 mg daily is the only adult dose given in the posology section and no higher dose is stated anywhere in it; in hepatic impairment 'there is some evidence that the dose of Preservex should be reduced ... and it is suggested that an initial daily dose of 100 mg be used'.
SOURCE: UK SPC via the eMC, product 'Preservex 100 mg film-coated tablets' (eMC product 6578), section 4.2 — quoted in full and NOT truncated. ELDERLY: the pharmacokinetics are not altered in elderly patients, 'therefore it is not considered necessary to modify the dose or dose frequency', but the elderly are at increased risk of serious adverse reactions — if an NSAID is considered necessary the lowest effective dose should be used for the shortest possible duration and the patient monitored regularly for GI bleeding. RENAL: 'There is no evidence that the dosage of Preservex needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised.' PAEDIATRIC: 'There are no clinical data on the use of Preservex in children and therefore it is not recommended for use in children' — no paediatric dose is published for this page for that reason. TRUNCATION: sections 4.4 (warnings), 4.6 (pregnancy/fertility) and 4.8 (adverse reactions) in this bundle end at the source-fetch limit, so those lists are partial; the posology used for the dose above is complete.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance 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)
  • Previous hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs
  • Hepatic failure and renal failure
  • Established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
  • History of gastrointestinal bleeding or perforation related to previous NSAID therapy
  • Active bleeding or bleeding disorders
  • Pregnancy — should not be prescribed during pregnancy, especially during the last trimester, unless there are compelling reasons; contraindicated during the third trimester

Side effects

  • Gastrointestinal (most commonly observed): peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly
  • Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis; exacerbation of colitis and Crohn's disease; less frequently gastritis; very rarely pancreatitis
  • Hypersensitivity reactions — non-specific allergic reactions and anaphylaxis; asthma, aggravated asthma, bronchospasm or dyspnoea; rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses including epidermal necrolysis and erythema multiforme
  • Cardiovascular and cerebrovascular: oedema, hypertension and cardiac failure reported in association with NSAID treatment; epidemiological data have found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac (which is structurally related to and metabolised to diclofenac)
  • Serious cutaneous and soft tissue infection complications during varicella (exceptionally)
  • Renal: interstitial nephritis
  • Neurological and special senses: optic neuritis; aseptic meningitis (especially in patients with existing autoimmune disorders such as SLE or mixed connective tissue disease)
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Monitor regularly for gastrointestinal bleeding during NSAID therapy, particularly in the elderly
  • Monitor renal function in patients at greatest risk of NSAID-induced renal failure — impaired renal function, cardiac impairment, liver dysfunction, patients taking diuretics or recovering from major surgery, and the elderly
  • Patients with mild to moderate renal impairment should be kept under surveillance; use the lowest effective dose and monitor renal function regularly (effects are usually reversible on withdrawal)
  • Monitor liver function — if abnormal liver function tests persist or worsen, review treatment
  • This list may be incomplete — check the full SPC.

Clinical monograph

How it works

It inhibits cyclo-oxygenase enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation and pain.

Prescribing in practice

  • Use the lowest effective dose for the shortest duration because of dose-related gastrointestinal, cardiovascular and renal risks; consider gastroprotection in those at risk.
  • Avoid in active gastrointestinal bleeding or ulceration, severe heart failure, and significant renal impairment, and use caution in the elderly.
  • The MHRA advises NSAIDs such as aceclofenac are contraindicated in established cardiovascular disease in line with diclofenac restrictions.

Monitoring

Monitor blood pressure, renal function and for gastrointestinal symptoms, particularly in older patients and those on long-term treatment.

Counselling the patient

  • Take it with or after food and report any black stools, vomiting blood or severe indigestion.
  • Do not combine with other NSAIDs including over-the-counter ibuprofen.
  • Seek advice if you develop ankle swelling, breathlessness or reduced urine output.

Evidence & guidelines

MHRA reviews of NSAID cardiovascular safety inform the contraindications and minimum effective dose advice applied to aceclofenac.

Reference: MHRA Drug Safety Update June 2013 (Diclofenac CV risk — class effect); EMA NSAID Safety Review 2013; NICE CKS NSAIDs; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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