Voltaren Emulgel 1%, 75g

• Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago sciatica);

• joint pain (knuckles, knee joints, etc.) with osteoarthritis;

• muscle pain (due to sprains, overexertions, bruises, injuries);

• inflammation and swelling of soft tissues and joints due to trauma and in rheumatic diseases (tendovaginitis bursitis lesions of periarticular tissues).

Outwardly.

For adults and children over 12 years of age, the drug is applied to the skin 3-4 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 2-4 g (which is comparable in volume to the size of a cherry or a walnut, respectively).

After applying the drug, wash your hands.

The duration of treatment depends on the indications and the observed effect (to enhance the effect, the gel can be used together with other dosage forms of VoltarenЃ). Consult a doctor after 2 weeks if there is no therapeutic effect.

Laminated Tubes: To remove the protective membrane, use the screw cap as a key (groove on the outside of the cap). Align the indentation on the outside of the lid with the shaped protective membrane of the tube and twist. The membrane should separate from the tube. Laminated tubes can have both a regular (round) cap and an innovative (triangular) cap, which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries.

Aluminum tubes: before the first use, pierce the protective membrane of the tube using a special protrusion on the outside of the polypropylene screw cap.

100 g of the drug contain:

Active ingredient: 1.16 g of diclofenac diethylamine, which corresponds to 1 g of diclofenac sodium.

Excipients: carbomers (carbopol 974 R) 1.20 g, macrogol cetostearate (cetomacrogol 1000) 2.00 g, cocoyl caprylocaprate (cetiol LC) 2.50 g, diethylamine 0.90 g, isopropanol 20.00 g, liquid paraffin 2.50 g, aroma cream 45 (contains benzyl benzoate) 0.10 g, propylene glycol 5.00 g, water 64.64 g.

• Hypersensitivity to diclofenac or other components of the drug;

• a tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs;

• pregnancy (III trimester)

• breast-feeding;

• children's age (up to 12 years old);

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

Carefully:

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

Trade name of the drug

VoltarenЃ EmulgelЃ

International non-proprietary name

Diclofenac

Dosage form

gel for external use

Composition

100 g of the drug contain:

Active ingredient: 1.16 g of diclofenac diethylamine, which corresponds to 1 g of diclofenac sodium.

Excipients: carbomers (carbopol 974 R) 1.20 g, macrogol cetostearate (cetomacrogol 1000) 2.00 g, cocoyl caprylocaprate (cetiol LC) 2.50 g, diethylamine 0.90 g, isopropanol 20.00 g, liquid paraffin 2.50 g, aroma cream 45 (contains benzyl benzoate) 0.10 g, propylene glycol 5.00 g, water 64.64 g.

Description

Homogeneous, creamy gel, white to yellowish color.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID)

ATX code

S01BC03

Pharmacodynamics:

The active ingredient diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting type 1 and 2 cyclooxygenase disrupts the metabolism of arachidonic acid.

VoltarenЃ EmulgelЃ is used to eliminate pain and reduce swelling associated with the inflammatory process.

Thanks to its water-alcohol base, VoltarenЃ EmulgelЃ has a calming and cooling effect.

Pharmacokinetics:

With the recommended method of application of the drug, no more than 6% of diclofenac is absorbed. When applied to the area of ??the affected joint, the concentration in the synovial fluid is higher than in the plasma. Diclofenac is predominantly distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in plasma.

Indications:

• Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago sciatica);

• joint pain (knuckles, knee joints, etc.) with osteoarthritis;

• muscle pain (due to sprains, overexertions, bruises, injuries);

• inflammation and swelling of soft tissues and joints due to trauma and in rheumatic diseases (tendovaginitis bursitis lesions of periarticular tissues).

Contraindications:

• Hypersensitivity to diclofenac or other components of the drug;

• a tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs;

• pregnancy (III trimester)

• breast-feeding;

• children's age (up to 12 years old);

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

Carefully:

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

Pregnancy and lactation:

Due to the lack of data on the use of VoltarenЃ EmulgelЃ in pregnant women, the use of the drug during the I and II trimester of pregnancy is recommended only as directed by a doctor, comparing the benefits to the mother and the risk to the fetus.

The drug is contraindicated in the third trimester of pregnancy due to the possibility of lowering the tone of the uterus, impaired fetal renal function, followed by the development of oligohydramnios and / or premature closure of the fetal ductus arteriosus.

Due to the lack of data on the penetration of VoltarenЃ EmulgelЃ into breast milk, the drug is not recommended for use during breastfeeding. If it is nevertheless necessary to use the drug, then it should not be applied to the mammary glands or on a large surface of the skin and should not be used for a long time.

There are no data on the use of VoltarenЃ EmulgelЃ and its effect on fertility in humans.

Method of administration and dosage:

Outwardly.

For adults and children over 12 years of age, the drug is applied to the skin 3-4 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 2-4 g (which is comparable in volume to the size of a cherry or a walnut, respectively).

After applying the drug, wash your hands.

The duration of treatment depends on the indications and the observed effect (to enhance the effect, the gel can be used together with other dosage forms of VoltarenЃ). Consult a doctor after 2 weeks if there is no therapeutic effect.

Laminated Tubes: To remove the protective membrane, use the screw cap as a key (groove on the outside of the cap). Align the indentation on the outside of the lid with the shaped protective membrane of the tube and twist. The membrane should separate from the tube. Laminated tubes can have both a regular (round) cap and an innovative (triangular) cap, which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries.

Aluminum tubes: before the first use, pierce the protective membrane of the tube using a special protrusion on the outside of the polypropylene screw cap.

Side effects:

Infectious and parasitic diseases:

Very rare: pustular rash.

Immune system disorders:

Very rare: hypersensitivity reactions (including urticaria) angioedema.

Respiratory system disorders of the chest and mediastinal organs:

Very rare: asthma.

Skin and subcutaneous tissue disorders:

Often: dermatitis (including contact dermatitis), rash, erythema, eczema, itching.

Rare: bullous dermatitis.

Very rare: photosensitivity reactions.

If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not indicated in the instructions, inform your doctor.

Overdose:

The extremely low systemic absorption of the active components of the drug when applied externally makes an overdose almost impossible. However, if you accidentally use 100 g of gel equivalent to 1000 mg of diclofenac, undesirable reactions similar to side reactions may occur.

First aid consists in gastric lavage and intake of activated charcoal. Inpatient treatment, if necessary.

Interaction:

VoltarenЃ EmulgelЃ can enhance the effect of drugs that cause photosensitization. No clinically significant interactions with other drugs have been described.

Special instructions:

VoltarenЃ EmulgelЃ should only be applied to intact skin, avoiding contact with open wounds.

After application, do not apply an occlusive dressing.

Do not allow the drug to get into the eyes and mucous membranes.

The drug contains propylene glycol and benzyl benzoate, which in some cases may cause mild local skin irritation. Treatment should be discontinued if a skin rash develops after application of the drug.

Impact on the ability to drive vehicles. Wed and fur .:

Does not affect.