TAKS Gastro-resistant tablet Ref.[28264] Active ingredients: Diclofenac

Source: Υπουργείο Υγείας (CY)  Revision Year: 2020  Publisher: Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus.

4.1. Therapeutic indications

Adults and Elderly

For the relief of all grades of pain and inflammation in a wide range of conditions, including:

  • arthritic conditions, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout
  • acute musculo-skeletal disorders, such as periarthritis (e.g. frozen shoulder), tendinitis, tenosynovitis, bursitis
  • other painful conditions as a result of trauma, including fracture, low back pain, sprains and strains, dislocations, orthopaedic, dental and other minor surgical procedures.

Children

Taks 50mg is not recommended for use in children.

4.2. Posology and method of administration

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

Posology

Adults

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

The recommended maximum daily dose is 150mg.

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 should be used in frail elderly patients or those with low body weight (see also section 4.4). The patients should be monitored for GI bleeding during NSAID therapy.

Paediatric population

Not recommended.

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 sections 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 sections 4.3 and 4.4).

Method of administration

For oral administration. Taks should be swallowed whole, with a little water if desired, preferably before meals.

4.9. Overdose

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.

Management

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.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, in the original package.

6.5. Nature and contents of container

Taks tablets are presented in aluminium/polyvinylchloride blisters of ten tablets in packs of two, three, ten or 100 blisters.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

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