Diclac, gel 5% 50 g

The active ingredient diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic and anti-inflammatory properties.

Inhibiting cyclooxygenase type 1 and 2 (COX 1 and COX 2) indiscriminately, it interferes with arachidonic acid metabolism and synthesis of prostaglandins which are the main link in development of inflammation.

Diclofenac is used to reduce inflammation and pain syndrome and to decrease swelling associated with inflammation.

Pharmacokinetics

In the recommended route of administration, no more than 6% of diclofenac is absorbed. When applied to the area of the affected joint, the concentration in synovial fluid is higher than in blood plasma.

Particular groups of patients

In patients with impaired renal function accumulation of diclofenac and its metabolites does not occur.

In patients with chronic hepatitis or subcompensated cirrhosis the pharmacokinetics and metabolism of diclofenac are comparable to those of healthy patients.

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Indications

– Diseases of the musculoskeletal system: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of peripheral joints and spine; rheumatic soft tissue lesions.
– Muscle pain of rheumatic and non-rheumatic origin.
– Traumatic soft tissue injuries.

Active ingredient

Composition

100 g of the drug contains:

the active ingredient:

diclofenac sodium ˗ 5.0 g;

excipients:

Isopropyl alcohol ˗ 45.0 g;

purified water ˗ 40.8 g;

macrochol-7-glycerolcoat – 6.0 g;

hypromellose – 3.0 g;

“Bouquet” fragrance oil WN 4507 – 0.2 g

How to take, the dosage

Externally. Adults and children over 6 years of age apply the drug to the skin 2-3 times a day and gently rub it in. The required amount of the drug depends on the size of the painful area.

A single dose of the drug is up to 2 g (about 4 cm with the tube neck fully open). After applying the drug the hands should be washed.

The duration of treatment depends on the indication and the observed effect. After 2 weeks of use the drug should be consulted with the doctor.

Interaction

Diclac® may increase the effect of drugs that cause photosensitization. No clinically significant interaction with other drugs has been described.

Special Instructions

Diclac® should be applied only to intact skin, avoiding contact with open wounds. No occlusive dressing should be applied after application. Avoid contact of the drug with eyes and mucous membranes.

Impact on the ability to drive vehicles, machinery

It is not applicable.

Special precautions for disposal of unused product

There is no need for special precautions for disposal of unused product.

Contraindications

Hypersensitivity to diclofenac or other components of the drug, acetylsalicylic acid or other NSAIDs, “aspirin” asthma, pregnancy (III trimester), lactation, children (under 6 years), skin integrity disorders.

With caution: hepatic porphyria (exacerbation), erosive-ulcerative lesions of the gastrointestinal tract, severe liver and renal function disorders, chronic heart failure, bronchial asthma, older age, pregnancy I and II trimester.

Side effects

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: Very common (≥1/10), common (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000); frequency unknown – the incidence could not be determined from available data.

Immune system disorders very rare: allergic reactions, hypersensitivity (including urticaria, angioedema, bronchospasm).

Respiratory system disorders very rare: bronchial asthma.

Skin and subcutaneous tissue disorders frequently: dermatitis (including contact dermatitis), erythema, eczema, itching, swelling of the treated skin area, rash (papules, vesicles), peeling; rarely: bullous dermatitis, pustular rash; very rarely: photosensitization, generalized skin rash.

Overdose

The extremely low systemic absorption of the active ingredient when used topically makes overdosing almost impossible.

Similarities