Diclofenac, gel 1% 40 g

Non-steroidal anti-inflammatory drug, a derivative of phenylacetic acid, has anti-inflammatory and analgesic effect.

Indiscriminately inhibiting cyclooxygenase 1 (COX1) and cyclooxygenase 2 (COX2), affects the metabolism of arachidonic acid, reduces the number of prostaglandins (Pg) in the inflammation.

Pharmacokinetics

When applied topically it is partially absorbed through the skin, bioavailability – 6%.

Plasma protein binding is 99.7%. It is excreted by kidneys.

In patients with polyarthritis who receive local therapy (in the area of the inflamed joint), the concentration in synovial fluid and tissue is higher than the concentration in plasma.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis; rheumatic lesions of soft tissues; gouty arthritis);

traumatic inflammation of tendons, ligaments, muscles and joints (as a result of sprains, stress and bruises).

Pharmacological effect

A non-steroidal anti-inflammatory drug, a derivative of phenylacetic acid, has anti-inflammatory and analgesic effects.

By indiscriminately inhibiting cyclooxygenase 1 (COX1) and cyclooxygenase 2 (COX2), it affects the metabolism of arachidonic acid, reduces the amount of prostaglandins (Pg) in the area of ​​inflammation.

Pharmacokinetics

When applied topically, it is partially absorbed through the skin, bioavailability is 6%.

Bonding with plasma proteins is 99.7%. Excreted by the kidneys.

In patients with polyarthritis who receive local therapy (in the area of ​​the inflamed joint), the concentration in the synovial fluid and tissue is higher than the concentration in plasma.

Special instructions

The gel is applied only to undamaged areas of the skin.

After application, do not apply an occlusive dressing.

When applied to large surface areas of the skin for a long time, the risk of systemic side effects increases.

Avoid contact of the drug with the eyes, mucous membranes or open wounds. Use only as an external remedy.

Active ingredient

Diclofenac

Composition

1 g of gel contains the active substance
Diclofenac diethylamine 11.60 mg (respectively diclofenac sodium 10 mg);
Excipients:
Isopropanol
Carbomer 940
Polysorbate 80
Benzyl alcohol
Sodium disulfite
Sorbitol
Trolamine
Purified water

Contraindications

Hypersensitivity to diclofenac or other components of the drug, acetylsalicylic acid or other NSAIDs.

Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (history).

Pregnancy (III trimester), lactation period, childhood (up to 12 years), violation of the integrity of the skin.

With caution

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the acute phase), severe liver and kidney dysfunction, chronic heart failure,

blood clotting (including hemophilia, prolongation of bleeding time, tendency to bleed); bronchial asthma, old age, pregnancy I and II trimester.

Side Effects

From the skin:

eczema, photosensitivity, contact dermatitis (itching, hyperemia, swelling of the treated skin area, papular-vesicular rashes, peeling).

Allergic reactions

(itching and burning of the skin, erythematous skin rash, urticaria, angioedema, systemic anaphylactic reactions (including shock).

Interaction

With the simultaneous use of Diclofenac with digoxin, phenytoin or lithium preparations, it is possible to increase the plasma concentrations of these drugs; with diuretics and antihypertensives

means – it is possible to reduce the effect of these drugs; with potassium-sparing diuretics – hyperkalemia may develop; with acetisalicylic acid – a decrease in the concentration of diclofenac in the blood plasma and an increased risk of side effects.

Diclofenac may enhance the toxic effect of cyclosporine on the kidneys.

Diclofenc can cause hypo- or hyperglycemia, therefore, when used simultaneously with hypoglycemic agents, monitoring of blood glucose concentrations is required.

When using methotrexate within 24 hours before or after taking Diclofenac, the concentration of methotrexate may increase and its toxic effect may increase.

When used simultaneously with anticoagulants, regular monitoring of blood clotting parameters is necessary.

Storage conditions

At temperatures from 15 to 25°C.

Keep out of the reach of children!

Shelf life

3 years.

Manufacturer

Hemofarm A.D., Serbia