Biofenac (Aceclofenac)

Description

Aceclofenac, also known as the brand Biofenac in some places, is an oral medication used to alleviate pain and inflammation associated with osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults.

Aceclofenac comes in 100 mg film-coated tablets.

Directions

Aceclofenac should be taken as prescribed.

Carefully read the medication guide for further usage instructions, including storage information.

Any questions or concerns may be referred to your doctor or pharmacist.

Ingredients

Aceclofenac is the active ingredient.

Excipients may include 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), and polyoxyl 40 (Macrogol)stearate.

See the product label for a full list of ingredients.

Contraindications

Do not take aceclofenac if you:

• Are hypersensitive to any of its ingredients or excipients, or if you are hypersensitive to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
• Have an active or history of recurrent peptic ulcer or bleeding
• Are actively bleeding or have a tendency to easily bleed/bruise
• Have severe liver or kidney failure
• Have congestive heart failure, ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
• Have a history of gastrointestinal (GI) perforation or bleeding due to previous NSAID therapy
• Are pregnant, especially if you are in your last trimester

Cautions

• Before you begin taking aceclofenac, tell your doctor about:
• All the medications you take, including prescription and nonprescription medications
• Your allergies
• Your current health conditions
• Your past medical history
• Your status of pregnancy or breastfeeding
• Aceclofenac is associated with the following warnings and precautions:
• The lowest effective dose should be used for the shortest duration to help decrease the occurrence of side effects.
• Do not take aceclofenac with other NSAIDs.
• The frequency of adverse reactions to NSAIDs, including potentially fatal GI perforation and bleeding, is increased in elderly patients.
• Caution should be exercised in patients with or who have had bronchial asthma.
• Patients with kidney or liver dysfunction or cardiac impairment; elderly patients; and patients taking diuretics are at greatest risk of potentially decreased prostaglandin formation and kidney failure from NSAIDs. These patients should be monitored for kidney problems when taking aceclofenac.
• Patients with mild to moderate liver dysfunction should be closely monitored. Hepatitis may occur.
• Aceclofenac may trigger an attack in patients with hepatic (liver) porphyria.
• The use of aceclofenac in patients with significant cardiovascular event risk factors and in patients with congestive heart failure should be carefully considered.
• Patients with a history of high blood pressure and/or congestive heart failure should receive appropriate monitoring and advice. NSAIDs can cause fluid retention and swelling.
• Caution should be exercised and close monitoring should occur in patients who have had cerebrovascular bleeding.
• Potentially fatal GI perforation, bleeding, or ulceration can occur.
• Patients with symptoms of GI disorders; a history of GI ulceration, with Crohn’s disease or ulcerative colitis, bleeding tendencies, or perforation; or blood disorders should receive close monitoring.
• Increased NSAID doses, patients who have had an ulcer, and elderly patients are associated with an increased risk of GI perforation, bleeding, or ulceration.
• Caution should be exercised in patients who are taking other medications that can increase the risk of bleeding or ulceration.
• The risk of aseptic meningitis may be increased in patients with systemic lupus erythematosus and mixed connective tissue disorders.
• Serious skin reactions that can be fatal can occur.
• Aceclofenac is not recommended for patients with varicella.
• Female fertility may become impaired; therefore, women who are trying to conceive should be advised not to take aceclofenac.
• Allergic reactions, including anaphylaxis and anaphylactoid reactions, can occur.
• The formation of clots by platelets may be inhibited.
• Aceclofenac should be avoided in patients with anemia, low white blood cell counts, and low platelet counts secondary to metamizol or NSAIDs.

Side Effects

Aceclofenac side effects may include but are not limited to dizziness, indigestion, abdominal pain, nausea, diarrhea, gas, gastritis, constipation, vomiting, mouth ulcers, increased liver enzymes, itching, rash, dermatitis, hives, increased blood urea, and increased blood creatinine.

Immediately inform your doctor of any bothersome or persistent side effects you experience while taking aceclofenac.

Ask your doctor about aceclofenac.

References

1. Aceclofenac 100 mg Film-coated Tablets. Electronic Medicines Compendium. 2023.
2. Biofenac. PharmaCompass.

About Dr. Savannah Muncy (Page Author)

Dr. Muncy (PharmD) studied science and education as an undergraduate before attending the Appalachian College of Pharmacy where she completed her PharmD in three years. She is currently using her pharmacy and healthcare expertise to write medical content for clients all around the world. She is focused on delivering the most current, accurate, and engaging information to healthcare professionals and patients. Read More....