KRISBUMOL Hard gelatin capsule Ref.[115690] Active ingredients: Diclofenac

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

Adults

The recommended daily dose is 100-150 mg in two or three divided doses. For milder cases, 75-100 mg daily in two or three divided doses is usually sufficient. In migraine an initial dose of 50 mg should be taken at the first signs of an impending attack. In cases where relief 2 hours after the first dose is not sufficient, a further dose of 50 mg may be taken. If needed, further doses of 50 mg may be taken at intervals of 4-6 hours, not exceeding a total dose of 200 mg per day.

Special populations

Pediatrics

For children over 14 years of age, the recommended daily dose is 75-100 mg in two or three divided doses. diclofenac Capsules are not recommended for children under 14 years of age. The use of diclofenac tablet in migraine attacks has not been established in children. Elderly Although the pharmacokinetics of diclofenac are not impaired to any clinically relevant extent in elderly patients, nonsteroidal 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 (see also precautions) and the patient should be monitored for GI bleeding during 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.

Method of administration

Oral use.

For oral administration. The Capsules should be swallowed whole with liquid, preferably before meals, and must not be chewed or divided.

Symptoms

There is no typical clinical picture resulting from diclofenac over dosage. Over dosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the case of significant poisoning acute renal failure and liver damage are possible.

Therapeutic measures

Management of acute poisoning with NSAIDs, including diclofenac, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression. Special measures such as forced diuresis, dialysis or haemo-perfusion are probably of no help in eliminating NSAIDs, including diclofenac, due to high protein binding and extensive metabolism. Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life threatening overdose.

36 months.

Store below 30°C, protect from light and moisture.

KEEP OUT OF REACH OF CHILDREN.

Pack style: 2 x 10 blister pack.

Primary packing: 10 capsules are packed in blister pack.

Secondary packing: 2 blister pack is packed in a carton along with package insert.

No special requirements.