Voltaren Emulgel 2%, 150g

Х Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica),
Х Joint pain (finger joints, knee joints, etc.) in osteoarthritis,
Х Muscle pain (due to sprains, strains, bruises, injuries ),
Х Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues, wrist syndrome).

Outwardly.
For adults and children over 12 years of age, the drug is applied to the skin 2 times a day (every 12 hours: preferably in the morning and evening), lightly rubbing into the skin.
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 cherry or a walnut, respectively) is sufficient to treat an area of ??400-800 cm2. If the hands are not the area of ??pain localization, then after applying the drug they must be washed. The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days for post-traumatic inflammation and rheumatic soft tissue diseases without a doctor's recommendation. If after 7 days of use, the therapeutic effect is not observed or the condition worsens, you should consult a doctor.
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.

100 g of the drug contain:

Active ingredient: 2.32 g of diclofenac diethylamine, which corresponds to 2 g of diclofenac sodium.
Excipients: carbomers 1.1-1.7 g, cetostearomacrogol 2.0 g, cocoyl caprilocaprate 2.50 g, diethylamine 0.89-1.37 g, isopropanol 17.50 g, liquid paraffin 2.50 g, oleyl alcohol 0.75 g, eucalyptus flavor 0.10 g, propylene glycol 5.0 g, butyl hydroxytoluene 0.02 g, purified water * 64.22-65 32 g
* when using various production equipment and different batch sizes (1000 kg and 2500 kg), the amounts of carbomers, diethyleneamine and purified water can be slightly adjusted within the indicated figures.

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), breastfeeding; 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, bleeding disorders (including hemophilia, prolonged bleeding time, bleeding tendency), chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID).

Pharmacological properties

Pharmacodynamics The
active ingredient diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic, anti-inflammatory and antipyretic properties. By indiscriminately inhibiting cyclooxygenase of types 1 and 2, it disrupts the metabolism of arachidonic acid.
VoltarenЃ EmulgelЃ is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.
Thanks to its water-alcohol base, VoltarenЃ EmulgelЃ has a calming and cooling effect.

Pharmacokinetics The
amount of diclofenac absorbed through the skin is proportional to the area of ??the treated surface and depends on both the total dose of the applied drug and the degree of skin hydration. After applying VoltarenЃ EmulgelЃ, 2% gel for external use (2 applications per day) to the skin surface of 400 cm2, the concentration of the active substance in the plasma corresponds to its concentration when using 1% diclofenac gel (4 applications per day). On the 7th day, the relative bioavailability of the drug (AUC ratio) is 4.5% (for an equivalent dose of diclofenac sodium salt). Absorption did not change when the moisture-permeable dressing was worn.
The concentration of diclofenac in plasma, synovial membrane and synovial fluid was measured when the drug was applied to the area of ??the affected joint. The maximum plasma concentrations were approximately 100 times lower than after oral administration of the same amount of diclofenac. 99.7% of diclofenac binds to plasma proteins, mainly albumin (99.4%).
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.
Diclofenac metabolism is carried out in part by glucuronidation of the unchanged molecule, but mainly through single and repeated hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates. Two phenolic metabolites are biologically active, but to a significantly lesser extent than diclofenac.
The total systemic plasma clearance of diclofenac is 263 ± 56 ml / min. The terminal half-life is 1-2 hours.The half-life of metabolites, including two pharmacologically active ones, is also short and is 1-3 hours. One of the metabolites (3'-hydroxy-4'-methoxydiclofenac) has a longer half-life, however, this the metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.

Indications for use

Х Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica),
Х Joint pain (finger joints, knee joints, etc.) in osteoarthritis,
Х Muscle pain (due to sprains, strains, bruises, injuries ),
Х Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues, wrist syndrome).

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), breastfeeding; 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, bleeding disorders (including hemophilia, prolonged bleeding time, bleeding tendency), chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

Application during pregnancy during breastfeeding

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 a decrease in the tone of the uterus, impaired renal function of the fetus, 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.

Method of administration and dosage

Outwardly.
For adults and children over 12 years of age, the drug is applied to the skin 2 times a day (every 12 hours: preferably in the morning and evening), lightly rubbing into the skin.
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 cherry or a walnut, respectively) is sufficient to treat an area of ??400-800 cm2. If the hands are not the area of ??pain localization, then after applying the drug they must be washed. The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days for post-traumatic inflammation and rheumatic soft tissue diseases without a doctor's recommendation. If after 7 days of use, the therapeutic effect is not observed or the condition worsens, you should consult a doctor.
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.

Side effect

Infectious and parasitic diseases:
Very rare: pustular rash.
Immune system disorders:
Very rare: hypersensitivity reactions (including urticaria), angioedema.
Respiratory, chest and mediastinal disorders:
Very rare: asthma.
Skin and subcutaneous tissue disorders:
Often: dermatitis (including contact dermatitis), rash, erythema, eczema, pruritus.
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 listed in the instructions, inform your doctor.

Overdose

Due to the low systemic absorption during gel application, overdose is unlikely. In case of accidental ingestion, systemic adverse reactions may develop. Treatment of overdose by accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to blood plasma proteins (about 99%).

Interaction with other medicinal products

A drug can enhance the effects 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. Do not allow the drug to get into the mouth, eyes or mucous membranes. After application of the drug, a bandage may be applied, but airtight occlusive dressings should not be applied. If a skin rash develops after application of the drug, its use should be discontinued.
This product contains propylene glycol, which may cause mild local irritation in some people. It also contains butylhydroxytoluene, which can cause local skin reactions (eg contact dermatitis) or irritation to the eyes and mucous membranes.

Influence on the ability to drive and operate machinery

Does not affect.