Interactions

Active ingredient Aceclofenac interacts in the following cases:

Corticosteroids

Increased risk of gastrointestinal ulceration or bleeding by concomitant use of NSAIDS and corticosteroids.

Mild to moderate renal dysfunction

The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of Aceclofenac Tablets.

Mild to moderate hepatic dysfunction

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 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.

Antidiabetic agents

Clinical studies have shown that aceclofenac 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 Tablets, consideration should be given to adjustment of the dosage of hypoglycaemic agents.

Anticoagulants

NSAIDs may enhance the effects of anti-coagulants, such as warfarin. Close monitoring of patients on combined anti-coagulants and aceclofenac therapy should be undertaken. 2

Antiplatelet agents and/or SSRIs

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

Cardiac glycosides

NSAIDs may exacerbate cardiac failure, reduce GFR (glomerular filtration rate) and increase plasma glycoside levels. 2

Anti-hypertensives

NSAIDs may reduce anti-hypertensive effect of anti-hypertensives.

Diuretics

The nephrotoxicity of NSAIDs increases when co-administered with diuretics, while NSAIDs inhibit the activity of 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. 2

Potassium-sparing diuretics

Possible increased risk of hyperkalaemia when NSAIDs given with potassium-sparing diuretics and aldosterone antagonists. 2

Quinolones

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. 2 3

Breastfeeding

In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

Ciclosporin

The nephrotoxicity of ciclosporin may be increased by the effect of NSAIDs on prostaglandins of kidneys. 2 3

Lithium

Aceclofenac reduces excretion of lithium, leading to increased concentrations of lithium and increased risk of toxicity. 2 3

Methotrexate

Decreased elimination of methotrexate. 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. 23

Tacrolimus

Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

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.

Bronchial asthma

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.

Female 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 Tablets should be considered.

Hepatic porphyria

Use of Aceclofenac Tablets in patients with hepatic porphyria may trigger an attack.

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/foetal 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 postimplantation 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 women attempting to conceive, or during the first the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

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. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus) and on the possible risk of persistent pulmonary hypertension of the new born, use in the last trimester of pregnancy is contraindicated. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.

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.

Ī¤he 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 with an increased bleeding tendency in both mother and child.

Consequently, aceclofenac is contraindicated during the third trimester of pregnancy.

Nursing Mothers

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.

Carcinogenesis, Mutagenesis and Fertility

Fertility

NSAIDs may impair fertility and are not recommended in women trying to conceive. The temporary discontinuation of aceclofenac should be considered in women having difficulties to conceive or undergoing investigations for infertility.

Effects on Ability to Drive and Use Machines

Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.