Diclac, gel 5%, 100g

Composition

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of 100 g of the drug contains:

Active ingredient:

diclofenac sodium – 5.0 g;

excipients:

isopropyl alcohol-45.0 g;

purified water-40.8 g;

macrogol-7-glycerol cocoate-6.0 g;

hypromellose-3.0 g;

aromatic oil “Bouquet” WN 4507-0.2 g

Pharmacological action

Pharmacotherapy group:

nonsteroidal anti-inflammatory drug (NSAID). ATX Code: M 02 AA 15

Pharmacodynamics

The active ingredient of diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) with pronounced analgesic and anti-inflammatory properties. By indiscriminately inhibiting cyclooxygenase types 1 and 2 (COX 1 and COX 2), it disrupts arachidonic acid metabolism and prostaglandin synthesis, which is the main link in the development of inflammation.

Diclofenac is used to relieve inflammation and eliminate pain, as well as reduce swelling associated with the inflammatory process.

Pharmacokinetics

With the recommended method of application of the drug, no more than 6% of diclofenac is absorbed. When applied to the affected joint area, the concentration in synovial fluid is higher than in blood plasma. Individual patient groups

In patients with impaired renal function, the 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 in healthy patients.

Indications

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

Contraindications

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

With caution: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney function disorders, chronic heart failure, bronchial asthma, elderly age, pregnancy of the first and second trimester.

Side effects

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (

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

From the respiratory system very rarely: bronchial asthma.

From the skin and subcutaneous tissue often: dermatitis (including contact dermatitis), erythema, eczema, itching, swelling of the treated area of the skin, rash (papules, vesicles), peeling; rarely: bullous dermatitis, pustular rashes; very rare: photosensitivity, generalized skin rash.

Interaction

Concomitant use of Diclac with digoxin, phenytoin or lithium preparations may increase the plasma concentrations of these drugs; with diuretics and antihypertensive agents, the effect of these drugs may decrease; with potassium-sparing diuretics, hyperkalemia may develop; with acetysalicylic acid, a decrease in the concentration of diclofenac in blood plasma and an increased risk of side effects.

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

Diclofenac can cause hypo – or hyperglycemia, so when used concomitantly with hypoglycemic agents, monitoring of blood glucose concentration is required.

When using methotrexate for 24 hours before or after taking Diclofenac, it is possible to increase the concentration of methotrexate and increase its toxic effect.

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

How to take, course of use and dosage

Externally. For adults and children over 6 years of age, the drug is applied to the skin 2-3 times a day and lightly rubbed.

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, your hands should be washed.

The duration of treatment depends on the indications and the observed effect.

After 2 weeks of using the drug, you should consult your doctor.

Overdose

Extremely low systemic absorption of the active component of the drug with external use makes overdose almost impossible.

Special instructions

Diclac ® should only be applied to undamaged skin, avoiding contact with open wounds.

After application, do not apply an occlusive dressing.

Do not allow the drug to get on the eyes and mucous membranes.

Influence on the ability to drive vehicles and mechanisms

Not applicable.

Special precautions when disposing of an unused product

There is no need for special precautions when disposing of an unused drug.

Product form

transparent, colorless or slightly yellowish gel, homogeneous and bubble-free, with a characteristic smell of isopropyl alcohol

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Diclofenac

Dosage form

gel for external use

Description

Children over 6 years of age, For adults, Pregnant women in the first and second trimester as prescribed by a doctor

Indications

Bursitis, Sciatica, Osteoarthritis, Periarthritis, Arthritis, Tendon Inflammation, Rheumatoid Arthritis, Adnexitis, Lumbago, Osteoarthritis