VOVIN-50 Tablet

Relief of all grades of pain and inflammation in a wide range of conditions, including:

(1) Arthritic conditions rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout

(2) Acute musculo-skeletal disorders such as periarthritis (for example frozen shoulder), tendinitis, tenosynovitis, bursitis,

(3) Other painful conditions resulting from trauma, including fracture, low back pain, sprains, strains, dislocations, orthopaedic, dental and other minor surgery.

Children (aged 1-12 years): Juvenile chronic arthritis (25mg tablet only)

Dosage

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

For Oral administration 75-150mg daily in 2-3 divided doses.

The recommended maximum daily dose of is 150mg.

Children (aged 1-12 years): 1-3mg/kg/day in divided doses (25mg only).

See the package insert about the details below:

- Elderly: No dosage adjustment is necessary for elderly patients. Caution should be exercised in elderly patients.

- Renal impairment

- Hepatic impairment

・Hypersensitivity to the active substance or any of the excipients.

・Active, gastric or intestinal ulcer, bleeding or perforation

・History of gastrointestinal bleeding or perforation, relating to previous HSAID therapy

・Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding)

・Last trimester of pregnancy

・Severe hepatic, renal or cardiac failure

・Like other NSAIDs, diclofenac is also contraindicated in patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other NSAIDs.

・Established congestive heart failure (NYHAⅡ-Ⅳ), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

See the package insert about the details below:

- Lithium

- Digoxin

- Diuretics and antihypertensive agents (e.g. beta-blockers, angiotensin converting enzyme (ACE)). Especially the elderly should have their blood pressure periodically monitored. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.

- Potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim

- Anticoagulants and anti-platelet agents

- Other NSAIDs including cyclooxygenase-2 selective inhibitors and corticosteroids

- SSRIs

- Antidiabetics

- Methotrexate

- Ciclosporin

- Tacrolimus

- Quinolone antibacterials

- Phenytoin

- Colestipol and cholestyramine

- Cardiac glycosides

- Mifepristone

- Potent CYP2C9 inhibitors

Last trimester of pregnancy: Contraindicated.

General undesirable effects may be ministered by using the lowest effective dose for the shortest duration necessary to control symptoms. The concomitant use of Vovin with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects. Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in trail elderly patients or those with a low body weight.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug. Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties.

Vovin 25mg and 50mg gastro-resistant tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, severe lactose deficiency or glucose-galactose malabsorption.

See the package insert about the details below:

- Gastrointestinal effects

- Hepatic effects

- Renal effects

- SLE and mixed connective tissue disease

- Cardiovascular and cerebrovascular effects

- Haematological effects

- Pre-existing asthma

- Female fertility

VOVIN is a nonsteroidal agent with marked analgesic/anti-inflammatory properties. It is an inhibitor of prostaglandin synthetase (cyclo-oxygenase). Diclofenac sodium in vitro does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to the concentrations reached in human beings.