Voltaren forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VOLTAREN FORTE

Composition:

Active substance: diclofenac diethylamine;

1 g of emulgel contains 23.2 mg of diclofenac diethylamine, equivalent to 20 mg of sodium diclofenac;

Excipients: isopropyl alcohol, propylene glycol, caprylocaproyl macrogol-8 glycerides, mineral oil, cetostearyl polyglycol ether, carbomers, diethylamine, oleyl alcohol, eucalyptus flavor, butylated hydroxytoluene (E 321), purified water.

Pharmaceutical form. Emulgel for external use.

A soft, homogeneous cream-like gel ranging from white to yellowish in color.

Pharmacotherapeutic group. Agents used locally for joint and muscular pain. Topically acting 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 the inhibition of prostaglandin biosynthesis.

Pharmacokinetics.

The amount of diclofenac absorbed through the skin is proportional to the application area and depends on both the total applied dose of the drug and the degree of skin hydration. After topical application of Voltaren Forte (twice daily) to a skin surface area of 400 cm², the extent of systemic absorption of the drug, determined as the concentration of the active substance in blood plasma, is equivalent to that achieved with four daily applications of a gel containing 1.16% diclofenac diethylamine.

The relative systemic bioavailability of diclofenac following application of Voltaren Forte on day 7 is 4.5% compared to 50 mg tablets (at the same dose of sodium diclofenac). Absorption is not affected by the use of an occlusive, moisture- and vapor-permeable dressing.

After application of Voltaren Forte to the skin over the wrist and knee joints, diclofenac is detected in plasma (where its maximum concentration is approximately 100 times lower than after oral administration of the same amount of diclofenac), as well as in the synovial membrane and synovial fluid.

Diclofenac accumulates in the skin, which acts as a reservoir, allowing gradual release of the substance into adjacent tissues. From there, diclofenac predominantly reaches deeper inflamed tissues such as joints and ligaments. There, it continues to exert its effect and is found at concentrations up to 20 times higher than in plasma.

Diclofenac is partially metabolized via glucuronidation and primarily 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. The terminal elimination half-life of diclofenac from blood plasma averages 1–2 hours. Four metabolites, including two active ones, also have short elimination half-lives of 1–3 hours. One metabolite—3´-hydroxy-4´-methoxydiclofenac—has a longer half-life but is practically inactive.

Accumulation of diclofenac and its metabolites does not occur in patients with renal impairment. In chronic hepatitis or decompensated liver cirrhosis, the kinetics and metabolism of diclofenac remain unchanged.

Clinical characteristics.

Indications.

Treatment of pain, inflammation, and swelling associated with:

• Soft tissue injuries: injuries of tendons, ligaments, muscles, and joints (e.g., due to dislocation, strain, contusion) and back pain (sports injuries);
• Localized forms of soft tissue rheumatism: tendinitis (including "tennis elbow"), bursitis, shoulder syndrome, and periarthropathy.

Symptomatic treatment of osteoarthritis of small and medium superficially located joints, such as finger joints or knee joints.

Contraindications. Hypersensitivity to diclofenac or any of the excipients. History of bronchial asthma, angioedema, urticaria, or acute rhinitis attacks after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). Last trimester of pregnancy.

Interaction with other medicinal products and other forms of interaction.

Since systemic absorption of diclofenac following topical application is very low, drug interactions are unlikely. Concomitant use of Voltaren Forte with other systemic nonsteroidal anti-inflammatory drugs or corticosteroids may increase the frequency of adverse effects.

Special precautions for use.

Use with caution in combination with oral nonsteroidal anti-inflammatory drugs.

The possibility of developing systemic adverse effects (which occur when systemic forms of diclofenac are used) should be considered when applying the drug to larger skin areas or for longer durations than recommended.

Voltaren Forte should be applied only to intact, undamaged skin areas, avoiding contact with injured (wounded or infected) skin. Contact of the drug with eyes and mucous membranes should be avoided. The drug must not be ingested.

If any skin rash develops, treatment with the drug should be discontinued. Voltaren Forte should not be used under occlusive air-impermeable dressings, but application under non-occlusive dressings is permitted.

Voltaren Forte contains propylene glycol, which may cause mild localized skin irritation in some individuals, and butylated hydroxytoluene, which may cause localized skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

Use during pregnancy or breastfeeding.

Clinical experience with use in pregnant women is limited. Like other nonsteroidal anti-inflammatory drugs, Voltaren Forte is contraindicated during the third trimester of pregnancy due to the potential risk of uterine inertia, fetal renal impairment leading to oligohydramnios, and/or cardiopulmonary toxicity with premature closure of the ductus arteriosus and pulmonary hypertension.

It is unknown whether diclofenac is excreted in breast milk following topical administration; therefore, use of Voltaren Forte is not recommended during breastfeeding. However, if there are strong clinical reasons for using the drug during breastfeeding, the drug should not be applied to the breast area or large skin areas, and should not be used in large amounts or for prolonged periods.

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

Ability to influence reaction rate while driving or operating machinery. No effect.

Dosage and Administration

The product is intended for topical use only.

For adults and children aged 14 years and older, apply the product twice daily. The analgesic effect lasts up to 12 hours. Voltaren Forte should be applied twice daily, in the morning and evening, gently rubbed into the skin at the site of pain. The amount of product used depends on the size of the affected area (e.g., 2–4 g, corresponding in size to a cherry or a walnut, is sufficient for application to an area of 400–800 cm²).

Hands should be washed after application, except when the hands themselves are the treated area.

The duration of treatment depends on the indication and 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 joint pain, unless otherwise directed by a physician.

If the patient's condition does not improve or worsens after 7 days of treatment, medical advice should be sought.

Elderly patients do not require dose adjustment.

Children. Voltaren Forte is not recommended for use in children under 14 years of age.

Overdose.

Overdose is unlikely due to the low systemic absorption of diclofenac when applied topically.

However, if the product is accidentally ingested, adverse effects typical of diclofenac overdose may occur (the contents of one 50 g tube of Voltaren Forte are equivalent to 1 g of sodium diclofenac). In such cases, symptomatic treatment should be initiated, applying therapeutic measures used for poisoning with nonsteroidal anti-inflammatory drugs.

Side effects

Side effects include mild, temporary skin reactions at the application site. In rare cases, allergic reactions may occur.

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 subcutaneous tissue disorders

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

Uncommon (≥1/1,000; <1/100): bullous dermatitis.

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

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

Shelf life. 3 years.

Storage conditions. Store out of reach of children at a temperature not exceeding 30 °C.

Packaging. 50 g or 100 g of the preparation in laminated aluminum tubes, sealed with screw-on polymer caps in white or blue color, round or triangular in shape, or with polymer caps with flip-top lid. One tube per cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer.

1. Haleon CH S.a.r.l. / Haleon CH S.a.r.l.

(manufacturing of the medicinal product, primary and secondary packaging, quality control, batch release).

1. Haleon Italy Manufacturing S.r.l. / Haleon Italy Manufacturing S.r.l.

(primary and secondary packaging, quality control, batch release).

Manufacturer's address and place of business.

1. Route De L’etraz 2, Nyon, 1260, Switzerland.
2. Via Nettunense, 90, Aprilia, 04011, Italy.