Diclac gel for external approx. 5% tube 50g

Release form, composition and packaging

?

Gel for external use 5% colorless or slightly yellowish, transparent, homogeneous and free of bubbles, with a characteristic smell of isopropyl alcohol.

1 g

diclofenac sodium 50 mg

isopropanol (isopropyl alcohol), macrogol glyceryl cocoate (macrogol-7-glyceryl cocoate), hypromellose, aromatic oil, purified water.

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

100 g - aluminum tubes (1) - cardboard boxes.

pharmachologic effect

NSAIDs for external use.

It has a pronounced analgesic and anti-inflammatory effect.

By indiscriminately inhibiting COX-1 and COX-2, it disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

In the field of application, Diclac® eliminates pain and reduces swelling associated with the inflammatory process.

Pharmacokinetics

Data on the pharmacokinetics of Diclac® are not available.

Indications for use

- diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine

- rheumatic lesions of soft tissues

- muscle pains of rheumatic and non-rheumatic origin

- traumatic injuries of soft tissues.

Contraindications for use

- aspirin" asthma

- violation of the integrity of the skin

- III trimester of pregnancy

- lactation period (breastfeeding)

- children under 6 years old

- hypersensitivity to drug components

- hypersensitivity to acetylsalicylic acid or other NSAIDs.

The drug should be used with caution in hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, in chronic heart failure, in bronchial asthma, in elderly patients, in the first and second trimesters of pregnancy.

Dosage regimen

The drug is used externally.

For adults and children over 6 years old, the drug is applied to the skin and rubbed lightly, the frequency of application is 2-3 times / day.

The required amount of the drug depends on the size of the affected area.

A single dose of the drug is up to 2 g (about 4 cm with a completely open tube mouth).

Wash your hands after applying the drug.

The duration of treatment depends on the indications and the observed effect.

After 2 weeks of using the drug, the patient should consult a doctor.

Overdose

The extremely low systemic absorption of the active component of the drug when applied externally makes an overdose almost impossible.

Side effect

Local reactions: eczema, photosensitization, contact dermatitis (itching, redness, swelling of the treated skin area, papules, vesicles, peeling).

Systemic reactions: generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions), photosensitivity.

Drug interactions

Diclac® can enhance the effect of drugs that cause photosensitization.

No clinically significant interaction with other drugs has been described.

Application during pregnancy and lactation

The drug is contraindicated in the third trimester of pregnancy.

The doctor determines the necessity of prescribing the drug in the first and second trimesters of pregnancy individually.

There is no experience of using the drug Diclac® during lactation (breastfeeding).

Special instructions Diclac® should be applied only to intact skin, avoiding contact with open wounds.

After application, do not apply an occlusive dressing.

Avoid contact of the drug on the eyes and mucous membranes.

Name ENG

DICLAC

Clinical and pharmacological group

NSAIDs for external use

ATX code

Diclofenac

Dosage

5% x 50g

Structure

100 g of the drug contains: active ingredient: diclofenac sodium?

5.0 g

excipients: isopropyl alcohol?

45.0 g

purified water ?

40.8 g

macrogol-7-glycerol cocoate - 6.0 g

hypromellose - 3.0 g

aromatic oil "Bouquet" WN 4507 - 0.2 g

Indications

Diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, osteoarthritis of the peripheral joints and spine

rheumatic lesions of soft tissues.

Muscle pains of rheumatic and non-rheumatic origin.

Traumatic soft tissue injuries.

Contraindications

Hypersensitivity to diclofenac or other components of the drug, acetylsalicylic acid or other NSAIDs, "aspirin" asthma, pregnancy (III trimester), lactation, childhood (up to 6 years), violation of the integrity of the skin.

With care: hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, chronic heart failure, bronchial asthma, old age, pregnancy I and II trimester.

INN / Active ingredient

diclofenac sodium

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Specifications

Category

Anesthesia and muscle relaxants

,

Bruises, sprains

Scope of the drug

Leather

Release form

Gel

Manufacturer country

Germany

Package quantity, pcs

one

Minimum age from

6 years

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Hexal

The amount of the dosage form in the primary package

50 g

Primary packaging type

Aluminum tube

Type of consumer packaging

Cardboard box

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA15 Diclofenac

Dosage form

Gel for external use

Dosage (volume) of the substance in the preparation

5.0 g

The target audience

Children

Expiration date in days

1095

Package weight, g

70

Mode of application

:

Outwardly.

For adults and children over 6 years of age, the drug is applied to the skin 2-3 times a day and rubbed lightly.

The required amount of the drug depends on the size of the painful area.

A single dose of the drug is up to 2 g (about 4 cm with a completely open tube mouth).

Wash your hands after applying the drug.

The duration of treatment depends on the indications and the observed effect.

After 2 weeks of using the drug, you should consult your doctor.

Drug action

:

Pain reliever

,

Anti-inflammatory

,

Analgesic

,

Decongestant

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