MERVAN

Aceclofenac

Description:

Aceclofenac, a phenylacetic acid derivative, is a non-steroid substance, which belongs to anti-rheumatic anti-inflammatory drugs with analgesic & antipyretic properties. Aceclofenac is generally well tolerated and is indicated for the treatment of rheumatic diseases of either inflammatory or degenerative origin. It is also recommended for the treatment of painful conditions not associated with rheumatic disease. The film coating of Mervan tablets is resistant to gastric acid and therefore the active substance of Aceclofenac is released in the small intestine.

Composition:

Each film-coated tablet contains 100 mg Aceclofenac BP.

Indications:

Rheumatology: Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, low back pain & other acute musculosketal disorders such as periarthritis, tendinitis, tenosynovitis,

Surgery & Traumatology: Bursitis, Sprains, strains, and dislocation, control pain and inflammation in orthopedic, dental and other minor surgery & postoperative pain.

Obstetrics & Gynaecology: Primary dysmenorrhoea, episiotomy, adnexitis, endometritis, parametritis, salpingitis, and mastitis.

Other indications: For the treatment of pain and inflammation and swelling of patients operated in the urogenital tract, renal & billiary colic. Feverish conditions and as an adjuvent to chemotherapy of infections diseases and painful conditions not associated with rheumatic disease.

Dosage & administration:

Adults: 1 tablet (100 mg) twice daily - 1 tablet in morning & 1 tablet in the evening. Reduce the dosage to 100 mg once daily initially in patient with hepatic dysfunction.

Children: Not recommended.

Contraindication:

Aceclofenac is contraindicated in patients with peptic ulceration and in pregnancy & lactation. It is also contraindicated in patients with a history of hypersensitivity to any ingredient of the product, gastro-intestinal bleeding, moderate to severe renal impairment, aspirin anti-inflammatory induced allergy.

Drug Interaction:

Anticoagulants, lithium, methorexate, antacids, probenecid, frusemide, digoxin, corticosteroids, antidiabetics & quinolone antibiotics.

Adverse effects:

Aceclofenac is generally well tolerated. In the initial stage of therapy, gastrointestinal disorders, headace, or nausea may appear. These effects are usually mild and disappear with the continuation of the treatment. In the very rare cases in which treatment with Aceclofenac is associated with peptic ulceration or gastrointestinal bleeding, patients usually had history of such disorders or they were taking other medications responsible for the appearance of such disorders.

Precautions:

Various tests and clinical research on diclofenac result to the belief that Aceclofenac has on the hematopoietic system. Patients with a history of gastrointestinal disorders or peptic ulceration, as well as those with severe liver or renal impairment should be under close medical supervision.

Use in pregnancy:

Use of Aceclofenac should be avoided during the first trimester of pregnancy, unless there is an absolute necessity.

Use in children: Not recommended.

Storage:

§         Store in a cool and dry place, protected from light.

§         Keep out of the reach of the children.

Packing:

Box containing 5 X 10's tablets in blister packs.