Diclofenac-viola

I N S T R U C T I O N for medical use of the medicinal product Diclofenac-Viola (Diclofenac-Viola)

Composition:

active substance: sodium diclofenac;

1 g of gel contains 10 mg of sodium diclofenac;

excipients: propylene glycol, ethanol 96%, macrogol 400, carbomer 980, purified water, methylparaben (E 218).

Pharmaceutical form. Gel.

Main physicochemical properties: homogeneous, colorless, transparent or slightly opalescent gel.

Pharmacotherapeutic group. Products used locally for joint and muscular pain. Topical non-steroidal anti-inflammatory drugs. Diclofenac.

ATC code M02A A15.

Pharmacological properties.

Pharmacodynamics.

Diclofenac is a non-steroidal anti-inflammatory agent with pronounced anti-rheumatic, analgesic, anti-inflammatory, and antipyretic effects. The main mechanism of action is inhibition of prostaglandin biosynthesis.

In inflammation caused by injuries or rheumatic diseases, Diclofenac-Viola reduces pain, tissue swelling, and shortens the recovery period of functions in damaged joints, ligaments, tendons, and muscles. Clinical data have shown that Diclofenac-Viola reduces acute pain within 1 hour after the initial application. 94% of patients responded to Diclofenac-Viola within 2 days of treatment, compared to 8% who responded to placebo. Relief of pain and functional impairments was achieved after 4 days of treatment with Diclofenac-Viola. Due to its water-alcohol base, the preparation also produces a local anesthetic and cooling effect.

Pharmacokinetics.

The amount of diclofenac absorbed through the skin is proportional to the application area and depends on both the total dose of the applied drug and the degree of skin hydration. After topical application of 2.5 g of Diclofenac-Viola to a skin surface area of 500 cm², the extent of diclofenac absorption is approximately 6%. Application of an occlusive dressing for 10 hours results in a threefold increase in diclofenac absorption.

After application of Diclofenac-Viola to the skin over the wrist and knee joints, diclofenac is detected in blood plasma (where its maximum concentration is approximately 100 times lower than after oral administration), in the synovial membrane, and in synovial fluid. Protein binding of diclofenac is 99.7%.

Diclofenac accumulates in the skin, which acts as a reservoir from which the substance is gradually released into adjacent tissues. From there, diclofenac primarily penetrates into deeper inflamed tissues, such as joints, where it continues to act and is found at concentrations up to 20 times higher than in blood plasma.

Diclofenac is predominantly metabolized via hydroxylation, forming several phenolic derivatives, two of which are pharmacologically active, although to a much lesser extent than diclofenac.

Diclofenac and its metabolites are primarily excreted in urine. Total systemic plasma clearance of diclofenac is 263 ± 56 ml/min, and the mean terminal half-life is 1–3 hours.

In renal or hepatic insufficiency, the metabolism and elimination of diclofenac are not altered.

Clinical characteristics.

Indications. Local treatment of pain and inflammation of joints, muscles, ligaments, and tendons of rheumatic or traumatic origin.

Contraindications. Hypersensitivity to diclofenac or to any of the excipients. History of bronchial asthma, angioedema, urticaria, or acute rhinitis attacks induced by acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs; third trimester of pregnancy.

Interaction with other medicinal products and other forms of interaction.

Since systemic absorption of diclofenac following topical application of the product is very low, the likelihood of interactions is very low.

Special precautions for use

Use with caution when administered concomitantly with oral nonsteroidal anti-inflammatory drugs.

The possibility of developing systemic adverse effects (which occur with systemic forms of diclofenac) should be considered when the drug is applied over larger skin areas or for longer durations than recommended. In such cases, the medicinal product should be used cautiously in patients with hepatic, renal, or cardiac insufficiency, as well as in those with active peptic ulcer disease.

Diclofenac-Viola should be applied only to intact, undamaged areas of skin, avoiding contact with inflamed, wounded, or infected skin. Contact of the product with eyes and mucous membranes should be avoided. The product must not be ingested.

If any skin rash occurs, treatment with the drug should be discontinued. Diclofenac-Viola should not be used under occlusive, air-impermeable dressings; however, its use under non-occlusive dressings is permitted.

Diclofenac-Viola contains propylene glycol, which may cause mild localized skin irritation.

Due to the potential for photosensitivity reactions, exposure to direct sunlight and use of tanning beds should be avoided during treatment and for 2 weeks after discontinuation of treatment.

Use during pregnancy or breastfeeding

Clinical data on the use of Diclofenac-Viola during pregnancy are lacking. Even though systemic effects may be lower compared to oral administration, it is unknown whether the systemic exposure to diclofenac achieved after topical application could be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, Diclofenac-Viola should not be used unless clearly necessary. If use is required, the dose should be as low as possible and the duration of treatment as short as possible.

During the third trimester of pregnancy, systemic use of prostaglandin synthesis inhibitors, including Diclofenac-Viola, may cause cardiopulmonary and renal toxicity in the fetus, disturbances in fetal kidney function leading to oligohydramnios, and/or cardiopulmonary toxicity with premature closure of the ductus arteriosus and pulmonary hypertension. At late stages of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be delayed. Therefore, Diclofenac-Viola is contraindicated during the last trimester of pregnancy (see section "Contraindications").

It is unknown whether diclofenac is excreted in breast milk following topical application; therefore, use of Diclofenac-Viola during breastfeeding is permitted only if the expected benefit outweighs the potential risk to the infant. If there are strong reasons for using the drug during breastfeeding, the product should not be applied to the breasts or large skin areas, and should not be used in higher amounts or for longer durations than recommended.

Data on the effect of topical diclofenac on human fertility are lacking.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage

The product is intended for topical use only.

For adults and children aged 14 years and older, Diclofenac-Viola should be applied 3–4 times daily, gently rubbed into the skin at the site of pain. The amount of product used depends on the size of the affected area (for example, 2–4 g, corresponding in size to a cherry or walnut, is sufficient for application to an area of 400–800 cm²).

After application, hands should be washed unless the hands themselves are the area being treated.

The duration of treatment depends on the nature of the disease and the treatment response.

The product should not be used for longer than 14 consecutive days in cases of injuries or soft tissue rheumatism, or for longer than 21 days in cases of arthritic pain, unless otherwise directed by a physician.

Medical advice should be sought if symptoms do not improve or worsen after 7 days of treatment.

Elderly patients may use the standard adult dosage.

Children. Diclofenac-Viola is not recommended for use in children under 14 years of age. If the product is used in children over 14 years of age for longer than 7 days, or if symptoms worsen, medical advice should be sought.

Overdose.

Overdose is unlikely due to the low systemic absorption of diclofenac when applied topically. However, adverse effects similar to those seen with overdose of diclofenac-containing tablets may occur if the product is accidentally ingested. In such a case, it should be noted that one 40 g or 100 g tube contains the equivalent of 0.4 g or 1 g of diclofenac sodium, respectively.

In case of accidental ingestion, the stomach should be emptied immediately and an adsorbent administered. Symptomatic treatment is indicated, using therapeutic measures appropriate for poisoning with nonsteroidal anti-inflammatory agents.

Adverse reactions.

The following adverse reactions have been observed with the medicinal product Diclofenac-Viola.

Infections and infestations

Rare (<1/10,000): pustular rashes.

Immune system disorders

Rare (<1/10,000): hypersensitivity reactions (including urticaria), angioedema.

Respiratory system disorders

Rare (<1/10,000): bronchial asthma.

Skin and connective tissue disorders

Common (≥1/100; <1/10): rash, pruritus, eczema, erythema, dermatitis, including contact dermatitis.

Uncommon (≥1/10,000; <1/1,000): bullous dermatitis.

Rare (<1/10,000): photosensitivity reactions.

If adverse reactions occur, treatment should be discontinued and medical advice should be sought.

Reporting suspected adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C; do not freeze. Keep out of reach and sight of children.

Packaging.

Tubes of 40 g or 100 g; 1 tube per carton or without carton.

Availability. Over-the-counter.

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's address and place of business.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.

Marketing authorization holder. JSC Pharmaceutical Factory "Viola".

Address of the marketing authorization holder.

75 Amosova Akademika Street, Zaporizhzhia, Ukraine, 69063.