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Nicoflex (Ointment) Instructions for Use

ATC Code

M02AB (Capsaicin and similar agents)

Clinical-Pharmacological Group

Drug with local irritant and analgesic action

Pharmacotherapeutic Group

Local irritant

Pharmacological Action

A combined drug that has a local irritant, analgesic, and absorbent effect. It contains substances that cause prolonged dilation of superficial vessels at the site of application, increase skin temperature, and cause a sensation of warmth.

The action is associated with the irritating and distracting effects of capsaicin, the analgesic and anti-inflammatory activity of glycol salicylate (international nonproprietary name recommended by Ph.Eur. – Hydroxyethyl salicylate (Vidal note)), and the absorbent capacity of ethyl nicotinate.

Indications

Contusions; sprains; arthrosis; myalgia; neuralgia; chronic neuritis; polyarthritis (chronic and subacute); sciatica; tenosynovitis (in the phase of incomplete remission); for warming up muscles before and after sports activities.

ICD codes

ICD-10 code Indication
M05 Seropositive rheumatoid arthritis
M13.9 Arthritis, unspecified
M15 Polyosteoarthritis
M19.9 Unspecified arthrosis
M54.1 Radiculopathy
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
M79.2 Neuralgia and neuritis, unspecified
T14.0 Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
ICD-11 code Indication
8B93.Z Radiculopathy, unspecified
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
EH92 Dermatoses provoked by friction or mechanical impact
EH92.1 Blister due to friction
FA05 Polyosteoarthritis
FA0Z Osteoarthritis, unspecified
FA20.0 Seropositive rheumatoid arthritis
FA2Z Inflammatory arthropathies, unspecified
FB40.Z Tenosynovitis, unspecified
FB50.1 Bursitis associated with use, overuse or pressure
FB50.Z Bursitis, unspecified
FB56 Specified soft tissue diseases, not elsewhere classified
FB56.2 Myalgia
ME84.20 Lumbago with sciatica
ME84.3 Sciatica
ND56.0 Superficial injury of unspecified body region
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.

Ointment

For external use. Wash the skin surface with warm water and soap beforehand, wipe dry, and then apply a thin layer of the ointment to it. It is applied to intact skin areas. Use 1-2 times/day.

For joint diseases – 1 time/day for 3 days, then – 2 times/day (morning and evening).

For warming up muscles in athletes during massage – a 3-5 cm long strip of ointment is thoroughly rubbed into the skin.

Adverse Reactions

Skin allergic reactions, irritation at the site of application.

Contraindications

Hypersensitivity; impaired skin integrity; children’s age (under 6 years); pregnancy; lactation period (breastfeeding).

With caution “aspirin” bronchial asthma, children’s age (6-12 years).

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and lactation.

Pediatric Use

Contraindicated in children under 6 years of age.

With caution children’s age (6-12 years).

Special Precautions

After rubbing in the ointment, it is necessary to thoroughly wash your hands with warm water and soap.

Do not use with warming compresses.

In case of skin irritation, it is recommended to discontinue the drug.

Avoid contact with mucous membranes (including eyes), areas of skin irritation.

Drug Interactions

It enhances the absorption of other topical drugs when used simultaneously (due to reflex enhancement of blood flow).

Storage Conditions

Store at 2°C (36°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

Reanal (Hungary)

Dosage Form

Bottle Rx Icon Nicoflex Ointment: tube 50 g

Dosage Form, Packaging, and Composition

Ointment 50 g
Capsaicin 7.5 mg
Hydroxyethyl salicylate 4.5 g
Ethyl nicotinate 1 g

50 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Medimex, LLC (Russia)

Manufactured By

Reanal (Hungary)

Dosage Form

Bottle OTC Icon Nicoflex Ointment for external use: tube 50 g

Dosage Form, Packaging, and Composition

Ointment for external use white in color, homogeneous, with a specific odor.

100 g
Natural capsaicin 0.015 g
Ethyl nicotinate 2 g
Hydroxyethyl salicylate 9 g

Excipients : propylparahydroxybenzoate – 0.03 g, methylparahydroxybenzoate – 0.07 g, lavender oil – 0.1 g, ethanol 96% – 0.735 g, sodium lauryl sulfate – 1.6 g, liquid paraffin – 8 g, cetearyl octanoate – 14.4 g, white petrolatum – 16 g, purified water – 48.05 g.

50 g – aluminum tubes (1) – cardboard boxes.

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