Tradename
Olfen Gel
Generic Name
Diclofenac sodium
Category
Musculoskeletal System
Form
Gel
Composition
Diclofenac sodium..........10 mg
Base is an aqueous-alcoholic gel without any fatty substances.
Description
Nonsteroidal anti-inflammatory agent for local use.
Properties/Actions
Properties
Olfen Gel is an anti-inflammatory and analgesic preparation for external application. It contains, in a new pharmaceutical dosage form, 1% diclofenac sodium which is the active substance, in a non-fatty base that is well tolerated by the skin.
This gel can be easily rubbed into the skin and due to its aqueous-alcoholic base, it has a cooling and soothing effect.
Thanks to its non-fatty nature, this colourless gel is non-greasy, and it does not soil the clothes of the patient.
When Olfen Gel is applied locally, diclofenac penetrates the skin, accumulates in the underlying tissues where it combats the acute and chronic inflammatory reactions. By this effect and in the presence of traumatic or rheumatic inflammatin, Olfen Gel has a clinical response shown by pain relief, a marked decrease in inflammatory swelling through its analgesic and anti-inflammatory properties. This rapid and effective relief from tenderness and pain on movement leads to improvement or normalization of impaired functions.

Pharmacokinetics
When Olfen Gel is applied to the skin, diclofenac is absorbed through the skin and its presence can be shown in the plasma. The amount of diclofenac absorbed following the local application of Olfen Gel to the skin in healthy subjects, as compared with oral administration, is equivalent to approximately 9% of the dose applied and it is higher than other diclofenac gels of the same concentration, but of a different gel base. It was found that following repeated use of Olfen Gel in patients with rheumatoid arthritis, diclofenac concentration in both the synovial fluid and the synovial tissues was higher than its plasma concentration.
Diclofenac metabolites appearing after topical application are similar to those determined after oral administration.
Indications
For the local treatment of:
  • Traumatically induced inflammation of tendos, ligaments, muscles and joints (e.g. due to sprains, strains and contusions).
  • Localized forms of non-articular soft tissue rheumatism (e.g. tendovaginitis, bursitis, tendinitis and shoulder-hand syndrome).
  • Localized forms of rheumatic disease (e.g. osteoarthritis of peripheral joints and of the vertebral column and peri-arthropathy).
Contraindications
Drug Interactions
No interactions have been observed to date.
Side Effects/Adverse Effects
Olfen Gel is generally well tolerated. There may be occasional reports of itching, reddening of the skin, skin rash or smarting of the treated area. The incidece of systemic side effects cannot be excluded in the case of long-term application on large areas of the skin.
Pregnancy & Lactation
Dosage & Administration
Depending on the size of the area to be treated, 2-3 kg of Olfen Gel should be applied to the skin 3-4 times daily and rubbed in lightly.
Olfen Gel should only be applied to intact skin surfaces. Wounds, open injurries, eyes and mucous membranes should not come into contact with the preparation. Olfen Gel may also be given in addition to fruther treatment with other dosage forms of Olfen.
Overdosage
Warnings
The preparation should not be used where there is hypersensitivity to diclofenac or to the el base, to acetylsalicylic acid o to other nonsteroidal anti-inflammatory agents.
In view of insufficient clinical data, Olfen Gel is not recommended during pregnancy,.
Olfen Gel should not be used under occlusive, aritight dressings, and is not to be taken by mouth.
Notes
Storage
Packaging
Tubes of 15 g and 50 g.
Manufacturer
Medical Union Pharmaceuticals
Price
Date Added/Updated
24th May 2011 2:48 pm

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