Reparil®-gel n

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REPARILâ-GEL N (REPARILâ-GELN)

Composition:

Active substances: escin, diethylamine salicylate;

10 g of gel contains escin 100 mg (0.1 g) and diethylamine salicylate 500 mg (0.5 g);

Excipients: macrogol glyceryl caprylocaprate, disodium edetate, trometamol, carbomers, isopropyl alcohol, purified water, lavender oil, neroli oil.

Pharmaceutical form. Gel.

Main physicochemical properties: transparent, colorless to pale yellow gel with the odor of lavender and isopropyl alcohol.

Pharmacotherapeutic group.

Topical preparations for joint and muscular pain. Preparations containing derivatives of salicylic acid.

ATC Code M02AC.

Pharmacological properties.

Pharmacodynamics.

Salicylates belong to the group of nonsteroidal anti-inflammatory agents/analgesics, which have demonstrated efficacy in standard experimental models of inflammation in animals. Their efficacy is due to inhibition of prostaglandin synthesis. In clinical practice, salicylates exert analgesic effects in pain syndromes of inflammatory origin. In addition, salicylates reversibly inhibit ADP-dependent platelet aggregation induced by collagen.

Aescin is a mixture of approximately 30 saponins. Saponins possess anti-inflammatory properties. Even in small amounts, saponins exhibit hemolytic activity.

Pharmacokinetics.

After topical application, salicylates/aescin are likely absorbed into the skin and subcutaneous adipose tissue and slowly released from there into the systemic circulation. The rate of dermal absorption (bioavailability) of salicylate, determined in studies, is approximately 15%.

The observed therapeutic efficacy is primarily explained by the presence of a therapeutically significant concentration of the drug in the tissues beneath the site of application. Penetration to the site of action may vary depending on the extent and nature of the lesion, as well as on the site and conditions of application.

Clinical characteristics.

Indications.

For local short-term symptomatic treatment of moderate pain due to acute blunt injuries (e.g., contusions, ligament sprains).

Contraindications.

Hypersensitivity to the active substances salicylate and/or escin, as well as to d-limonene, farnesol, and linalool—components of lavender oil and neroli oil—or to any of the excipients of the medicinal product, or to other analgesic and anti-rheumatic agents (non-steroidal anti-rheumatic drugs).

Reparil®-Gel H must not be applied to open wounds, mucous membranes, areas of inflamed or infected skin, in cases of eczema, or on skin areas previously subjected to radiation therapy.

Interaction with other medicinal products and other forms of interaction.

No interactions of Reparil®-Gel H with other medicinal products have been reported when used appropriately.

Nevertheless, the physician should be informed about concomitant and/or recently administered medicinal products.

Special precautions for use.

Use with caution in patients with a history of asthma, hay fever, nasal mucosal edema (so-called nasal adenoids), chronic obstructive respiratory diseases, or chronic respiratory infections (especially in combination with symptoms of hay fever), as well as in patients with hypersensitivity to nonsteroidal anti-inflammatory drugs (so-called "aspirin" asthma), or a history of angioedema (Quincke's edema) or urticaria. These patients may use Reparil®-Gel N only upon physician's recommendation and under medical supervision. This also applies to patients who are hypersensitive to other components of the product and may experience skin reactions, itching, or urticaria.

In acute conditions associated with pronounced redness, swelling, or hyperthermia of joints, or if the condition worsens, medical advice must be sought.

Reparil®-Gel N contains lavender oil and neroli oil with d-limonene, farnesol, and linalool as fragrance components. These substances may cause allergic reactions.

Contact of Reparil®-Gel N with the eyes must be avoided.

Care should be taken to ensure that children do not touch skin areas to which the product has been applied.

Use in elderly patients. Dose adjustment is not required. However, due to the potential adverse effect profile, special attention should be paid to the condition of elderly patients.

Use in patients with renal impairment. Dose reduction is not necessary in patients with impaired kidney function.

Use in patients with hepatic impairment. Dose reduction is not necessary in patients with impaired liver function.

Use during pregnancy or breastfeeding.

There are no available data on the use of Reparil®-Gel N during pregnancy. Adequate experimental studies on reproductive toxicity of the components of Reparil®-Gel N in animals have not been conducted. Therefore, the use of Reparil®-Gel N during pregnancy is not recommended, and particularly, application to large skin areas should be avoided.

It is unknown whether the components of Reparil®-Gel N are excreted in breast milk. There are no experimental data in animals on excretion of the components into breast milk. Therefore, the use of Reparil®-Gel N during breastfeeding is not recommended, and particularly, application to the breast areas should be avoided.

Ability to affect reaction speed when driving or operating machinery.

Reparil®-Gel N has no effect or has a negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage.

For external use only! Do not swallow!

Apply Reparil®-Gel N three times daily. Depending on the size of the affected area to be treated, apply a small amount of gel (approximately the size of a cherry or walnut), equivalent to approximately 2.5–6.0 g of the preparation (81–195 mg of salicylate).

The maximum daily dose is 20 g of gel, equivalent to approximately 650 mg of salicylate.

Apply a thin layer of gel to the affected areas of the skin, spreading it evenly over the entire area.

Allow the gel to dry on the skin for several minutes before applying a dressing. The use of occlusive dressings is not recommended.

The duration of treatment should be determined by a physician. Usually, application for 1–2 days is sufficient. If symptoms persist for more than two days or if worsening occurs, consult a physician.

Children. The product should not be administered to children under 12 years of age, as there is insufficient experience with its use in this patient group.

Overdose.

If the recommended dose for topical application is exceeded, wipe off the gel and wash the skin with water. Inform a physician if Reparil®-Gel N is used in excessive amounts or accidentally ingested.

There is no specific antidote.

Adverse reactions.

Criteria for assessing the frequency of adverse drug reactions:

Skin and subcutaneous tissue disorders:

Very rare: skin dehydration, eczema, including pustule formation or scarring, erythema, dermatitis (including contact dermatitis), pruritus, urticaria, crust formation.

When applying Reparil®-Gel N to large areas of skin, systemic adverse reactions affecting a specific organ system (e.g., liver, kidneys, or gastrointestinal tract) or even the entire organism (e.g., hypersensitivity reactions, asthma), as may occur with systemic administration of medicinal products containing salicylates, cannot be excluded.

Reporting of adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua

Shelf life.

For aluminum tubes – 5 years. For laminated tubes – 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Do not freeze.

Packaging.

40 g of gel in an aluminum or laminated tube. One tube per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

MADAUS GmbH.

Manufacturer's address and place of business.

Lutticher Strasse 5, 53842 Troisdorf, Germany.

Marketing Authorization Holder.

Viatris Healthcare GmbH

Address of the Marketing Authorization Holder.

Luetticher Strasse 5, 53842 Troisdorf, Germany.

If you become aware of any adverse reactions related to the use of a company product, including use during pregnancy or breastfeeding, or those arising from medical errors, incorrect use, misuse, overdose, interactions with other medicinal products or food, off-label use, or due to occupational or non-occupational exposure, suspected transmission of infectious agents, lack of efficacy, or those associated with quality defects, please report this to the person responsible for pharmacovigilance at the following email address: [email protected]