Aertal cream for outside. apply. 1.5% tube 60g

Release form, composition and packaging

Cream for external use 1.5% white, homogeneous

1 g

aceclofenac (100% micronized) 15 mg

emulsion wax - 0.1 g, liquid paraffin - 0.04 g, methyl parahydroxybenzoate - 0.002 g, propyl parahydroxybenzoate - 0.0005 g, water - 0.8425 g

60 g - aluminum tubes (1) - cardboard packs.

pharmachologic effect

Aceclofenac is an NSAID with anti-inflammatory and analgesic effects.

The drug suppresses the development of edema and erythema, regardless of the etiology of inflammation.

Aceclofenac inhibits the formation of prostaglandins and leukotrienes by reversibly suppressing COX-1 and COX-2

The established clinical efficacy of the drug is complemented by good tolerability

The use of Aertal cream is advisable in patients with traumatic injuries or inflammatory diseases of the musculoskeletal system.

Pharmacokinetics

Suction Aceclofenac is absorbed from the application area, quickly reaching saturation.

It accumulates in the absorption zone, which contributes to an increase in anti-inflammatory activity, and gradually enters the systemic circulation in small quantities, and therefore the risk of side effects, incl.

on the gastrointestinal tract, minimized

Distribution Aceclofenac is distributed throughout the body

Metabolism and excretion Aceclofenac is metabolized in the liver and excreted slowly by the kidneys and through the intestines, partially unchanged.

Indications for use

treatment of local pain due to traumatic injuries and inflammatory diseases of the musculoskeletal system, incl.

sports injuries

to reduce inflammation of tendons, ligaments, muscles and joints in cases of sprains, overexertion and bruises

lumbago

torticollis

periarthritis.

Contraindications for use

hypersensitivity to drug components an indication of a history of intolerance to NSAIDs (including diclofenac) an indication in the history of attacks of bronchial asthma, urticaria rash or acute rhinitis while taking acetylsalicylic acid (ASA) or other NSAIDs violation of the integrity of the skin at the site of the intended application the presence of an infection caused by the Varicella zoster virus pregnancy children under 18 years of age With care: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the exacerbation phase), severe liver and kidney dysfunction, chronic heart failure bronchial asthma, urticaria or acute rhinitis provoked by the intake of ASA or other NSAIDs bleeding disorders (including hemophilia, prolonged bleeding time, bleeding tendency), advanced age,lactation period.

Dosage regimen

Aertal cream is intended for external use only.

Do not apply cream under occlusive dressings

Aertal should be applied with light massaging movements to the affected area 3 times / day.

The applied dose depends on the size of the affected area: 1.5-2 g of Aertal cream (approximately corresponds to a 5-7 cm long strip of cream)

There is no experience of using the drug in children, therefore, Aertal cream is contraindicated for use in children.

Correction of the dosage regimen in elderly patients is not required.

Overdose

Overdose cases of aceclofenac are unknown

Symptoms: The exact symptoms of an aceclofenac overdose are unknown.

In case of improper use or accidental ingestion of the drug, arterial hypotension, renal failure, convulsions, irritation of the gastrointestinal mucosa, as well as respiratory depression may develop

Treatment: symptomatic and supportive therapy.

The absorption of the drug should be prevented as soon as possible by gastric lavage and the appointment of activated charcoal.

Forced diuresis or hemoperfusion is ineffective due to the high degree of binding of aceclofenac to blood plasma proteins and its intensive metabolism.

Side effect

Below are unwanted

Name ENG

AIRTAL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Aceclofenac

Dosage

1.5% x 60g

Structure

1 g of cream contains: Active ingredient: aceclofenac 100% micronized 0.015 g. Excipients: emulsion wax 0.1 g, liquid paraffin 0.04 g, methyl parahydroxybenzoate 0.002 g, propyl parahydroxybenzoate 0.0005 g, water 0.8425 g.

Indications

Treatment of local pain due to traumatic injuries and inflammatory diseases of the musculoskeletal system, including sports injuries

the drug can be used to reduce inflammation of tendons, ligaments, muscles and joints in cases of sprains, overexertion or bruises, as well as to treat lumbago, torticollis and periarthritis.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Contraindications

Hypersensitivity to the components of the drug (aceclofenac) or any of the excipients

the presence in the past of intolerance to NSAIDs, including diclofenac

the presence in the past of attacks of bronchial asthma, urticaria rash or acute rhinitis while taking acetylsalicylic acid (ASA) or other NSAIDs

the presence of an infection with the varicella-zoster virus.

pregnancy.

children under 18 years of age.

violation of the integrity of the skin at the intended site of application.

With care: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the exacerbation phase), severe liver and kidney dysfunction, CHF

bronchial asthma, urticaria or acute rhinitis provoked by the intake of ASA or other NSAIDs

blood clotting disorders (including hemophilia, lengthening of bleeding time, tendency to bleeding), advanced age, lactation period.

INN / Active ingredient

aceclofenac

Specifications

Category

Bruises, sprains

Scope of the drug

General

Release form

Cream

Manufacturer country

Hungary

Package quantity, pcs

one

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

ALMIRALL

The amount of the dosage form in the primary package

60 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA25 Aceclofenac

Dosage form

Cream for external use

Dosage (volume) of the substance in the preparation

aceclofenac 100% micronized 0.015 g.

Drug action

Pain reliever

,

Anti-inflammatory

Expiration date in days

730

Package weight, g

2

Mode of application

:

Aertal cream is intended for external use only and should not be applied under occlusive dressings.

Aertal should be applied with light massaging movements to the affected area three times a day.

The applied dose depends on the size of the affected area: 1.5-2 g of Aertal cream (approximately corresponds to a strip of cream 5-7 cm long).

Information on technical characteristics, delivery set, country of manufacture