VOLTAREN FORTE 24 HOURS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VOLTAREN FORTE 24 HOURS

Composition:

Active ingredient: diclofenac sodium;

1 patch contains sodium diclofenac 140 mg;

Excipients: polyacrylate dispersion, tributyl citrate, butylhydroxyanisole, non-woven material made of 100 % polyester, silicone-coated paper.

Dosage form. Therapeutic patch.

Main physicochemical properties: white patch consisting of silicone-coated paper (protective liner) and an adhesive film applied onto a backing layer made of white non-woven material, in a sealed pouch. After removal of the protective liner, the adhesive film appears translucent.

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

ATC code M02A A15.

Pharmacological properties.

Pharmacodynamics.

Diclofenac is a non-steroidal anti-inflammatory agent with pronounced analgesic and anti-inflammatory effects. Its main mechanism of action is the inhibition of prostaglandin biosynthesis.

Pharmacokinetics.

Diclofenac is slowly and incompletely absorbed from topical medicinal products. The plasma concentration of diclofenac is maintained by its continuous absorption from the patch, regardless of whether the patch is applied in the morning or evening. After application, diclofenac accumulates in the skin, which acts as a reservoir, from which the substance is gradually released into adjacent tissues. From there, diclofenac predominantly reaches deeper inflamed tissues, such as joints and ligaments.

The observed therapeutic efficacy is mainly explained by therapeutically relevant concentrations of the drug in the tissues beneath the application site. Penetration to the site of action may vary depending on the extent and nature of the disease, as well as on the site and duration of application.

Systemic absorption of the active substance from the topically applied medicinal product is approximately 2–10% of that following oral administration of the same dose of the drug. The average plasma concentration of the substance is approximately 1 ng/mL. The amount of diclofenac absorbed from the patch is similar to that absorbed when using Voltaren Emulgel (with application of a comparable amount of diclofenac).

Diclofenac binding to plasma proteins is high, exceeding 99%. Metabolism and elimination of diclofenac following topical use are similar to those after oral administration. Following rapid hepatic metabolism (hydroxylation and glucuronidation), the majority of the active substance is excreted in the urine.

Clinical characteristics.

Indications.

Local symptomatic short-term treatment (maximum 7 days) of pain due to severe sprains, dislocations, or contusions of limbs resulting from closed trauma in children aged 16 years and older, and adults.

Contraindications.

Hypersensitivity to diclofenac or any of the other components of the medicated plaster, to acetylsalicylic acid or other NSAIDs. History of asthma attacks, angioedema, urticaria, or acute rhinitis induced by acetylsalicylic acid or other NSAIDs. Active phase of peptic ulcer disease. Skin damage, regardless of the type of lesion: exudative dermatitis, eczema, infected lesions, burns, or wounds. Third trimester of pregnancy. Children under 16 years of age.

Interaction with other medicinal products and other forms of interaction.

Since systemic absorption of diclofenac when using the plaster as directed is very low, the occurrence of clinically significant interactions is unlikely.

Special precautions for use

To minimize the risk of adverse reactions, it is recommended to use the lowest effective dose for the shortest duration necessary to relieve symptoms. The patch should not be used concomitantly with topical or systemic medicinal products containing diclofenac or other NSAIDs.

Although systemic effects of diclofenac during treatment with Voltaren Forte 24 hours are minimal, the possibility of systemic adverse reactions cannot be excluded when the medicinal product is applied topically over larger skin areas or for longer durations than recommended. Therefore, the patch should be used with caution in patients with renal, cardiac, or hepatic impairment and in those with a history of peptic ulcer, inflammatory bowel disease, or hemorrhagic diathesis. NSAIDs should be used with caution in elderly patients, as they are more likely to develop adverse reactions.

In patients suffering from bronchial asthma or allergic diseases, attacks of bronchospasm may occur during use of the patch.

Contact of the medicinal product with eyes and mucous membranes should be avoided. The patch should be applied only to intact, undamaged skin areas and should not be applied to open wounds or damaged skin. If any skin rash occurs, application of the patch should be discontinued.

Exposure to solarium or direct sunlight on the area of application should be avoided to reduce the risk of photosensitization.

The medicinal product Voltaren Forte 24 hours contains butylhydroxyanisole, which may cause local skin reactions (e.g., contact dermatitis) or irritation of eyes and mucous membranes.

Use during pregnancy or breastfeeding

There are no clinical data on the use of the medicinal product Voltaren Forte 24 hours during pregnancy. Even though systemic effects are lower compared to oral administration, it is unknown whether the systemic exposure achieved after topical application may be harmful to the embryo/fetus. During the first and second trimesters of pregnancy, the medicinal product should not be used unless clearly necessary. If used, 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 the medicinal product Voltaren Forte 24 hours, may cause cardiopulmonary and renal toxicity in the fetus. At late stages of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be delayed. Therefore, the medicinal product is contraindicated during the last trimester of pregnancy (see section "Contraindications").

It is unknown whether diclofenac can pass into breast milk following topical application; therefore, use of the medicinal product Voltaren Forte 24 hours during breastfeeding is recommended only if the expected benefit to the mother outweighs the potential risk to the infant. In such cases, during breastfeeding, the patch should not be applied to the mammary glands and should not be used in higher amounts or for longer durations than recommended.

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

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

Method of Administration and Dosage

The patch is intended for topical application to the skin.

For adults and children aged 16 years and older, apply one patch to intact skin over the affected area only, once daily.

Before use, open the pouch by tearing or cutting along the dotted line. Remove the patch from the pouch and peel off one part of the protective film, taking care not to touch the adhesive surface. Immediately apply the patch to the painful area of skin, then remove the remaining protective film. Gently press the patch with the palm of the hand to ensure complete adhesion to the skin.

If necessary, the patch may be secured with an elastic mesh bandage. Do not use the patch while bathing. Do not use the patch under occlusive dressings.

To remove the patch after use, moisten it slightly with water if needed and gently peel it off by pulling at its edge. To remove any residual product, wash the area with water, gently rubbing the application site in circular motions with fingers.

Maximum daily dose: one patch, even if more than one area is affected. Thus, only one painful area may be treated at a time.

Voltaren Forte 24 hours should be used for the shortest duration necessary to relieve symptoms. If the patient's condition does not improve or worsens after 7 days of treatment, medical advice should be sought.

The medicinal product should be used with caution in elderly patients, as they are more likely to develop adverse reactions.

Children. Voltaren Forte 24 hours is not recommended for use in children under 16 years of age.

Overdose.

Overdose is unlikely due to the low systemic absorption of diclofenac when the patch is used as directed.

There are no reported cases of overdose with the medicinal product Voltaren Forte 24 hours. However, in the event of significant systemic adverse reactions due to incorrect use or accidental overdose (e.g., in children or by ingestion of the patch), precautionary measures should be taken as recommended for poisoning with non-steroidal anti-inflammatory drugs.

Adverse Reactions

The adverse reactions listed below are classified by frequency: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

Infections and infestations:

Rare: pustular rash.

Immune system disorders:

Rare: hypersensitivity reactions (including urticaria), angioedema, anaphylactic reactions.

Respiratory, thoracic and mediastinal disorders:

Rare: bronchial asthma.

Skin and subcutaneous tissue disorders:

Common: rash, eczema, erythema, dermatitis (including allergic and contact dermatitis), pruritus, burning sensation at the application site.

Uncommon: petechiae.

Rare: bullous dermatitis, dry skin.

Very rare: photosensitivity reactions.

General disorders and administration site conditions:

Common: reactions at the application site.

Uncommon: sensation of warmth.

The risk of systemic adverse reactions during use of the patch is low. However, systemic adverse reactions are possible in case of incorrect use of the medicinal product (e.g., if the patch is applied to more than one skin area and/or for longer than recommended).

Shelf life. 2 years.

Storage conditions. Store at temperatures not exceeding 30 °C, in a light-protected place. Keep out of the reach and sight of children.

Packaging. 1 patch per sachet. 2, 5 or 10 sachets in a cardboard box with labeling in Ukrainian.

Prescription status. Over-the-counter (non-prescription).

Manufacturer.

Fidia Farmaceutici S.p.A. / Fidia Farmaceutici S.p.A.

Manufacturer's address and address of the place of business activity.

Via Andrea Maria Ampere 29, Paderno Dugnano, 20037, Italy / Via Andrea Maria Ampere 29, Paderno Dugnano, 20037, Italy.