REMETHAN Gastro-resistant tablet Ref.[28321] Active ingredients: Diclofenac

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use).

Posology

Remethan 25 mg & 50 mg gastro-resistant tablets:

Adults

75-150 mg daily in two or three divided doses.

The recommended maximum daily dose of Remethan is 150 mg.

Special populations

Elderly

Although the pharmacokinetics of Remethan 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 (see also Precautions) and the patient should be monitored for GI bleeding during NSAID therapy.

Renal impairment

Diclofenac is contraindicated in patients with severe renal impairment (see section 4.3). 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 (see section 4.3 and 4.4).

Hepatic impairment

Diclofenac is contraindicated in patients with severe hepatic impairment (see section 4.3). 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 (see section 4.3 and 4.4).

Paediatric population

Remethan 25 mg gastro-resistant tablets:

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

Remethan 50 mg gastro-resistant tablets:

Not recommended.

Method of administration

Oral administration.

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 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.

5 years.

Store below 25°C, protected from light and moisture.

Remethan 25 mg gastro-resistant tablets:

PVC-PE-PVDC/Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets.

PP containers with PE closure. Pack sizes of 100 and 1000 tablets.

Remethan 50 mg gastro-resistant tablets:

PVC-PE-PVDC/Aluminium blisters. Pack sizes of 20, 100 and 1000 tablets.

PP containers with PE closure. Pack sizes of 100 and 1000 tablets.

Not all pack-sizes may be marketed.

No special requirements.