Amelotex gel d / outside. apply. 1% tube 50g

Amount in a package

50 g

Dosage form

gel for external use

Structure

Active substance: meloxicam (in terms of 100% substance) - 1.0 g

Excipients: methylpyrrolidone - 15.0 g, ethanol 95% - 25.0 g, carbomer - 0.9 g, trometamol - 2.0 g to 3.0 g (up to pH 7.5-8.9 g), orange blossom oil - 0.015 g, lavender oil - 0.01 g, purified water - up to 100.0 g

pharmachologic effect

Amelotex® gel contains meloxicam, a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory effects.

The anti-inflammatory effect is associated with inhibition of the enzymatic activity of cyclooxygenase-2 (COX-2), which is involved in the biosynthesis of prostaglandins in the area of ​​inflammation.

To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), which is involved in the synthesis of prostaglandin, which protects the mucous membrane of the gastrointestinal tract and is involved in the regulation of blood flow in the kidneys.

Meloxicam is a chondroneutral" drug, does not have a negative effect on cartilage tissue, does not affect proteoglycan synthesis by chondrocytes of the articular cartilage.

When applied topically, the drug reduces or eliminates pain in the area of ​​application of the gel, including joint pain at rest and during movement.

Promotes increased range of motion.

Indications

Symptomatic therapy of osteoarthritis, accompanied by pain.

It is used for symptomatic therapy, reducing pain and inflammation

does not affect the progression of the disease.

Contraindications

Hypersensitivity to meloxicam and other components of the drug (including other NSAIDs)

complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including in history), violation of the integrity of the skin in the places of intended application

children's age (up to 18 years) (effectiveness and safety have not been established)

pregnancy.

With care: gastric ulcer and 12 duodenal ulcer (in the acute phase), active gastrointestinal bleeding

progressive kidney disease, severe liver failure or active liver disease, confirmed hyperkalemia, inflammatory bowel disease, old age, coagulation disorders, chronic heart failure.

Side effects

For drugs that are NSAIDs for external use, the following side effects are described.

On the part of the skin: hyperemia, papular-vesicular rash, peeling, photosensitivity.

Allergic reactions: itching and burning of the skin, erythema multiforme, urticaria, systemic anaphylactic reactions.

In the event of adverse reactions, including those not mentioned above, you should stop using the gel, and also inform your doctor.

Interaction

Amelotex® gel should not be used together with other drugs for external use.

It is not recommended to use the gel simultaneously with other NSAIDs.

When combined with other dosage forms of meloxicam (tablets, injections), the daily dose should not exceed 15 mg.

How to take, course of administration and dosage

Outwardly.

Do not use internally!

A strip of gel about 4 cm long (2 g) is applied 2 times a day with a thin layer on clean, dry skin over the lesion and rubbed lightly for 2-3 minutes.

The duration of the course of therapy is determined individually, it can vary depending on the site of the lesion and the observed therapeutic effect and is no more than 4 weeks.

Overdose

Due to the low systemic absorption during the application of Amelotex® gel, an overdose with external use is unlikely.

Special instructions

Doctor's supervision is necessary when prescribing Amelotex® gel to elderly patients with impaired renal and liver function, chronic heart failure

Name ENG

AMELOTEX

Clinical and pharmacological group

NSAIDs for external use

ATX code

Non-steroidal anti-inflammatory drugs for external use

Dosage

100 g 1 g

Structure

Active substance: meloxicam (in terms of 100% substance) - 1.0 g

Excipients: methylpyrrolidone - 15.0 g, ethanol 95% - 25.0 g, carbomer - 0.9 g, trometamol - 2.0 g to 3.0 g (up to pH 7.5-8.9 g), orange blossom oil - 0.015 g, lavender oil - 0.01 g, purified water - up to 100.0 g

Indications

Symptomatic therapy of osteoarthritis, accompanied by pain.

It is used for symptomatic therapy, reducing pain and inflammation

does not affect the progression of the disease.

Contraindications

complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history)

violation of the integrity of the skin in the places of the intended application

children and adolescents under 18 years of age (efficacy and safety have not been established)

hypersensitivity to meloxicam and other components of the drug (including other NSAIDs).

The drug should be used with caution in case of gastric ulcer and duodenal ulcer (in the acute phase)

active gastrointestinal bleeding

progressive kidney disease

severe liver failure or active liver disease

confirmed hyperkalemia

inflammatory bowel disease

violation of coagulation

chronic heart failure

in elderly patients.

Carefully:

with severe liver failure or active liver disease

with progressive kidney disease

use the drug in elderly patients.

Storage conditions and periods

The drug should be stored out of reach of children at a temperature not exceeding 25C.

Do not freeze.

Shelf life is 2 years.

INN / Active ingredient

meloxicam

Specifications

Category

Anesthesia and muscle relaxants

,

Bruises, sprains

Scope of the drug

Musculoskeletal system

Release form

Gel

Manufacturer country

Russia

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Sotex

The amount of the dosage form in the primary package

50 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Dosage form

Gel for external use

Expiration date in days

24

Drug action

Pain reliever

,

Anti-inflammatory

Dosage (volume) of the substance in the preparation

meloxicam - 1 g

Package weight, g

65

Mode of application

:

Outwardly.

Do not use internally!

< br> A strip of gel about 4 cm long (2 g) is applied 2 times a day with a thin layer on clean, dry skin over the lesion and lightly rubbed for 2-3 minutes.

The duration of the course of therapy is determined individually, it can vary depending on the site of the lesion and the observed therapeutic effect and is no more than 4 weeks.

Pharmaco-therapeutic group

:

Non-steroidal anti-inflammatory drug for external use

Anatomical and therapeutic characteristics

:

M02AA Topical non-steroidal anti-inflammatory drugs

Information on technical characteristics, delivery set, country of manufacture "