Diclofenac-Teva gel for outside. approx. 1% tube 40g

pharmachologic effect

NSAID, a derivative of phenylacetic acid.

It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect.

The mechanism of action is associated with inhibition of the activity of COX, the main enzyme of the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever.

The analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).

Inhibits the synthesis of proteoglycan in cartilage.

In rheumatic diseases, it reduces joint pain at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase the range of motion.

Reduces post-traumatic and postoperative pain, as well as inflammatory edema.

Suppresses platelet aggregation.

With prolonged use, it has a desensitizing effect.

When applied topically in ophthalmology, it reduces edema and pain in inflammatory processes of non-infectious etiology.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis

rheumatic lesions of soft tissues

gouty arthritis)

traumatic inflammation of the tendons, ligaments, muscles and joints (as a result of sprains, stress and bruises).

Contraindications

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

- violation of the integrity of the skin

- pregnancy (III trimester)

- lactation period

- children's age (up to 12 years old)

- hypersensitivity to diclofenac or other components of the drug, acetylsalicylic acid or other NSAIDs.

Carefully

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the exacerbation phase), severe liver and kidney dysfunction, chronic heart failure, bleeding disorders (including hemophilia, prolonged bleeding time, tendency to bleed)

bronchial asthma, advanced age, pregnancy I and II trimester.

Application during pregnancy and lactation

Use during pregnancy (III trimester) and lactation is contraindicated.

With care: pregnancy I and II trimester.

special instructions

The gel is applied only to intact skin areas.

After application, do not apply an occlusive dressing.

When applied to large skin surfaces for a long time, the risk of developing systemic side effects increases.

Avoid getting the drug in the eyes, mucous membranes or open brines.

Use as an external agent only.

Structure

100 g of gel contains:

Active substance

Diclofenac diethylamine 1.16 g.

Which corresponds to diclofenac sodium 1.00 g.

Excipients

Isopropyl alcohol, carbopol 940, polysorbate 80, gasoline alcohol, sodium metabisulfite, sorbitol 70% non-crystallizing, triethanolamine, purified water.

Method of administration and dosage

Outwardly.

For adults and children over 12 years old, the drug is applied in a thin layer over the focus of inflammation 3-4 times / day and rubbed lightly.

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

Single dose of the drug: 2-4 g (which is comparable in volume to the size of a large cherry).

After applying the drug, you must wash your hands.

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

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

Side effects

From the digestive system: nausea, vomiting, anorexia, pain and discomfort in the epigastric region, flatulence, constipation, diarrhea

in some cases - erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract

rarely - liver dysfunction.

With rectal administration, in isolated cases, there was inflammation of the colon with bleeding, exacerbation of ulcerative colitis.

From the side of the central nervous system and peripheral nervous system: dizziness, headache, agitation, insomnia, irritability, fatigue

rarely - paresthesias, visual impairments (blurred, diplopia), tinnitus, sleep disorders, convulsions, irritability, tremors, mental disorders, depression.

From the hematopoietic system: rarely - anemia, leukopenia, thrombocytopenia, agranulocytosis.

From the urinary system: rarely - impaired renal function

edema is possible in predisposed patients.

Dermatological reactions: rarely - hair loss.

Allergic reactions: skin rash, itching

when applied in the form of eye drops - itching, redness, photosensitivity.

Local reactions: at the place of intramuscular injection, burning is possible, in some cases - the formation of infiltration, abscess, necrosis of adipose tissue

with rectal administration, local irritation, the appearance of mucous secretions mixed with blood, painful defecation are possible

when applied externally in rare cases - itching, redness, rash, burning

when applied topically in ophthalmology, a transient burning sensation and / or temporary blurred vision may occur immediately after instillation.

With prolonged external use and / or application to extensive body surfaces, systemic side effects are possible due to the resorptive action of diclofenac.

Drug interactions

The drug can enhance the effect of drugs that cause photosensitization.

No clinically significant interaction with other drugs has been described.

Storage conditions

Keep out of the reach of children, at a temperature of 15 В° to 25 В° C.

Shelf life

3 years

Active substance

Diclofenac

Name ENG

DICLOFENAC

Clinical and pharmacological group

NSAIDs for external use

ATX code

Diclofenac

Dosage

1% x 40g

Structure

100 g of gel contains: Active ingredient. Diclofenac diethylamine 1.16 g. Which corresponds to diclofenac sodium 1.00 g. Excipients. Isopropyl alcohol, Carbopol 940, Polysorbate 80, gasoline alcohol, sodium metabisulfite, sorbitol 70% non-crystallizing, triethanolamine, purified water.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis

rheumatic lesions of soft tissues

gouty arthritis)

traumatic inflammation of the tendons, ligaments, muscles and joints (as a result of sprains, stress and bruises).

INN / Active ingredient

Diclofenac

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 4 years

after opening - 1 year

Contraindications

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

violation of the integrity of the skin

pregnancy (III trimester)

lactation period

children's age (up to 12 years old)

hypersensitivity to diclofenac or other components of the drug acetylsalicylic acid or other NSAIDs., With caution, Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract (in the exacerbation phase), severe liver and kidney dysfunction, chronic heart failure, blood clotting disorders ( including hemophilia, lengthening of bleeding time, tendency to bleeding)

bronchial asthma, advanced age, pregnancy I and II trimester.

Specifications

Category

Bruises, sprains

Scope of the drug

Musculoskeletal system

Release form

Gel

Manufacturer country

Germany

Package quantity, pcs

one

Scope of application

Orthopedics

Minimum age from

12 years

Way of introduction

Locally

,

Outwardly

Vacation conditions

Without recipe

Brand name

Teva

The amount of the dosage form in the primary package

40 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA15 Diclofenac

Dosage form

Gel for external use

Packaging

Cardboard box

Expiration date in days

1095

The target audience

Children

Dosage (volume) of the substance in the preparation

diclofenac sodium 10 mg

Package weight, g

twenty

Mode of application

:

Outwardly. < br> For adults and children over 12 years of age, the drug is applied in a thin layer over the focus of inflammation 3-4 times / day and rubbed lightly.

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

A single dose of the drug: 2-4 g (which is comparable in volume to the size of a large cherry). < br> After applying the drug, you need to wash your hands. < br> The duration of treatment depends on the indications and the therapeutic effect.

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

Information on technical characteristics, delivery set, country of manufacture