Administration: For oral administration.
To be taken whole with liquid, preferably with food or after food.
Dosage: STADLOFEN 50 GASTRO-RESISTANT TABLETS 50MG should be used at the lowest effective dose for the shortest possible time.
Adults: 75 mg to 100 mg daily in two or three divided doses.
The recommended maximum daily dose of diclofenac sodium is 100 mg.
Patients requiring a smaller dosage or dosages not in multiples of 50 mg should consult their physician for alternative commercial preparations.
Special populations: Elderly: Although the pharmacokinetics of diclofenac sodium are not impaired to any clinically relevant extent in elderly patients, non-steroidal anti-inflammatory drugs should be used with particular caution in such patients who generally are more prone to adverse reactions. In particular, it is recommended that the lowest effective dosage be used in frail elderly patients or those with a low body weight, and the patient should be monitored for gastrointestinal (GI) bleeding during non-steroidal anti-inflammatory drug (NSAID) therapy.
Cardiovascular and significant cardiovascular risk factors: Diclofenac is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Patients with congestive heart failure (NYHA I) or significant risk factors for cardiovascular disease should be treated with diclofenac only after careful consideration. Since cardiovascular risks with diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used and for the shortest duration possible.
Renal impairment: Diclofenac is contraindicated in patients with renal failure.
No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate renal impairment.
Hepatic impairment: Diclofenac is contraindicated in patients with hepatic failure.
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering diclofenac to patients with mild to moderate hepatic impairment.
Paediatric population: STADLOFEN 50 GASTRO-RESISTANT TABLETS 50MG is not suitable for children.