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Reparil®-gel N (Gel) Instructions for Use

ATC Code

C05CX (Drugs reducing capillary permeability, other)

Active Substances

Aescine (DCF adopted for use in France)

Diethylamine salicylate (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Drug with anti-inflammatory and angioprotective action for external use

Pharmacotherapeutic Group

Venotonic agent of plant origin

Pharmacological Action

A combined medicinal product for external use.

Aescine reduces capillary permeability during inflammatory processes, leading to a reduction in inflammatory edema and pain. Aescine helps to normalize impaired microcirculation.

Diethylamine salicylate has anti-inflammatory and analgesic effects, penetrates tissues well, and potentiates the effect of aescine.

Indications

Soft tissue contusions, hematomas; sports injuries with ligament damage without breaking the skin; pain syndrome associated with spinal diseases (lumbago, sciatica); phlebitis of superficial veins; varicose veins.

ICD codes

ICD-10 code Indication
I80.0 Phlebitis and thrombophlebitis of superficial vessels of lower extremities
I83 Varicose veins of lower extremities
M54.3 Sciatica
M54.4 Lumbago with sciatica
M65 Synovitis and tenosynovitis
M70 Soft tissue disorders related to use, overuse, and pressure
M71 Other bursopathies
M79.1 Myalgia
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
ICD-11 code Indication
BD70.0 Superficial thrombophlebitis of lower extremities
BD74.1Z Varicose veins of lower extremities, unspecified
FB40.Z Tenosynovitis, unspecified
FB50.1 Bursitis associated with use, overuse or pressure
FB50.Z Bursitis, unspecified
FB56.2 Myalgia
ME84.20 Lumbago with sciatica
ME84.3 Sciatica
ND56.3 Dislocation, sprain or strain of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the gel externally only to intact skin. Use a thin layer, covering the entire affected area.

Administer the gel one to three times daily. The frequency depends on the severity of symptoms.

Gently massage the gel into the skin until fully absorbed. Do not apply under occlusive dressings.

Wash hands thoroughly after application, unless the hands are the treated area. Avoid contact with eyes, mucous membranes, and open wounds.

For acute conditions like contusions or sprains, initiate application as soon as possible after the injury occurs.

The typical treatment duration is up to 10 days. Consult a physician if symptoms persist beyond this period or worsen.

Discontinue use immediately if skin irritation, redness, or itching develops. Do not use with heating pads or warming compresses.

In pediatric patients aged 12 years and older, apply the same adult dosage regimen under adult supervision to ensure proper use.

Adverse Reactions

Rarely allergic reactions.

Contraindications

Hypersensitivity to the components of this product; severe chronic renal failure; open wounds, skin irritation; children under 12 years of age; third trimester of pregnancy.

With caution

First and second trimesters of pregnancy; breastfeeding; history of bronchial asthma provoked by the intake of acetylsalicylic acid or other NSAIDs.

Use in Pregnancy and Lactation

Use is contraindicated in the third trimester of pregnancy.

Use with caution in the first and second trimesters of pregnancy and during breastfeeding.

Use in Renal Impairment

Use is contraindicated in severe chronic renal failure.

Pediatric Use

Use is contraindicated in children under 12 years of age.

Special Precautions

For external use only.

Do not use with warming compresses.

If skin irritation occurs, discontinue use.

Avoid contact with eyes, mucous membranes, and areas of skin irritation.

Drug Interactions

This product may lead to increased absorption of simultaneously used topical preparations.

Due to the presence of diethylamine salicylate in the product, its use in large quantities may increase the toxicity of methotrexate and reduce the therapeutic effect of hypoglycemic agents.

Concomitant use with oral anticoagulants is not recommended.

Storage Conditions

Store at 8°C (46°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Madaus GmbH (Germany)

Dosage Form

Bottle OTC Icon Reparil®-gel N Gel for external use 5 g+1 g/100 g: tubes 40 g or 100 g

Dosage Form, Packaging, and Composition

Gel for external use from colorless to pale yellow, transparent, with the smell of lavender and isopropyl alcohol.

100 g
Aescin 1 g
Diethylamine salicylate 5 g

Excipients: lavender oil, orange flower oil, carbomers, macrogolglycerol caprylocaprate, disodium edetate, trometamol, isopropanol, water.

40 g – varnished aluminum tubes (1) – cardboard boxes.
100 g – varnished aluminum tubes (1) – cardboard boxes.

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Madaus GmbH (Germany)

Dosage Form

Bottle OTC Icon Reparil®-gel N Gel for external use 5 g+1 g/100 g: tubes 40 g or 100 g

Dosage Form, Packaging, and Composition

Gel for external use from colorless to pale yellow, transparent, with the smell of lavender and isopropyl alcohol.

100 g
Aescin 1 g
Diethylamine salicylate 5 g

Excipients: lavender oil, orange flower oil, carbomers, macrogolglycerol caprylocaprate, disodium edetate, trometamol, isopropanol, water.

40 g – varnished aluminum tubes (1) – cardboard boxes.
100 g – varnished aluminum tubes (1) – cardboard boxes.

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