Voltaren Emulgel 2%, 50g
Expiration Date: 05/2027
Russian Pharmacy name:
Вольтарен Эмульгель 2%, 50г
back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);
joint pain (including finger joints, knee joints) in case of rheumatoid arthritis, osteoarthritis;
muscle pain (due to sprains, overexertion, bruises, injuries);
inflammation and swelling of soft tissues and joints due to trauma and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues, wrist syndrome).
Gel for external use 2%
For adults and children over 12 years of age, the drug is applied to the skin 2 times / 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 enough 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, the patient 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.
Tubes can have both a regular cap (round shape) and an innovative cap (triangular shape), which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries.
Active substance:
diclofenac diethylamine - 2.32 g, which corresponds to the content of diclofenac sodium - 2 g
Excipients : carbomers - 1.1-1.7 g, cetostearomacrogol - 2 g, cocoyl caprylocaprate - 2.5 g, diethylamine - 0.89-1.37 g, isopropanol - 17.5 g, liquid paraffin - 2.5 g, oleyl alcohol - 0.75 g, eucalyptus flavor - 0.1 g , propylene glycol - 5 g, butylhydroxytoluene - 0.02 g, purified water * - 64.22-65.32 g.
* when using different 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;
violation of the integrity of the skin at the intended site of application;
III trimester of pregnancy;
lactation period (breastfeeding);
children under 12 years of age.
With caution , the drug should be prescribed for hepatic porphyria (in the acute phase), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, chronic heart failure, bronchial asthma, as well as in the first and second trimesters of pregnancy and elderly patients.
Gel for external use 2% homogeneous, creamy, from white to white with a yellowish sheen.
Clinical and pharmacological group: NSAIDs for external use
Pharmaco-therapeutic group: NSAIDs
pharmachologic effect
NSAIDs for external use. Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic effect. By indiscriminately inhibiting COX-1 and COX-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
Suction
The amount of diclofenac absorbed through the skin is proportional to the area of ??the treated surface and depends both on the total dose of the applied drug and on 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.
Distribution
When applying the drug to the area of ??the affected joint, the concentration of diclofenac in plasma, synovial membrane and synovial fluid was determined. Cmax in plasma was approximately 100 times lower than after oral administration of the same amount of diclofenac.
The binding of diclofenac to plasma proteins is 99.7%, mainly to 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.
Metabolism
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.
Withdrawal
The total systemic plasma clearance of diclofenac is 263 ± 56 ml / min.
The final T1 / 2 is 1-2 hours. T1 / 2 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 T1 / 2, however, this metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.
Indications
back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica);
joint pain (including finger joints, knee joints) in case of rheumatoid arthritis, osteoarthritis;
muscle pain (due to sprains, overexertion, bruises, injuries);
inflammation and swelling of soft tissues and joints due to trauma and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues, wrist syndrome).
Dosage regimen
Gel for external use 2%
For adults and children over 12 years of age, the drug is applied to the skin 2 times / 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 enough 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, the patient 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.
Tubes can have both a regular cap (round shape) and an innovative cap (triangular shape), which is especially convenient for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries.
Side effect
Determination of the frequency of adverse reactions: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10 000, <1 / 1000), very rarely (<1/10 000), including individual messages.
Infectious and parasitic diseases: very rare: pustular rash.
From the immune system: very rarely - hypersensitivity reactions (including urticaria), angioedema.
From the respiratory system: very rarely - asthma.
Skin and subcutaneous tissue disorders: often - dermatitis (including contact dermatitis), rash, erythema, eczema, itching; rarely, bullous dermatitis; very rarely - photosensitivity reactions.
If any of the above adverse reactions are aggravated, or the patient has noticed any other adverse reactions, the doctor should be informed.
Contraindications for use
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;
violation of the integrity of the skin at the intended site of application;
III trimester of pregnancy;
lactation period (breastfeeding);
children under 12 years of age.
With caution , the drug should be prescribed for hepatic porphyria (in the acute phase), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, chronic heart failure, bronchial asthma, as well as in the first and second trimesters of pregnancy and elderly patients.
Application during pregnancy and lactation
Due to the lack of data on the use of the drug VoltarenЃ EmulgelЃ during pregnancy, the use of the drug in the first and second trimesters 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 release of the active substance of the drug VoltarenЃ EmulgelЃ with 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 effect of the drug on fertility.
Application for violations of liver function
Prescribed with caution in severe liver dysfunction.
Application for impaired renal function
It is prescribed with caution in severe renal impairment.
Application in children
Contraindicated: children under 12 years of age.
Use in elderly patients
The drug should be prescribed with caution to elderly patients.
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 eyes and mucous membranes.
After applying the 1% topical gel, do not apply an occlusive dressing.
After application of 2% gel for external use, a bandage may be applied, but an airtight occlusive dressing 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 (such as contact dermatitis) or irritation to the eyes and mucous membranes.
Influence on the ability to drive vehicles and mechanisms
Does not affect.
Overdose
Due to the extremely low systemic absorption during gel application, overdose is unlikely.
Symptoms : 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 plasma proteins (about 99%).
Drug interactions
VoltarenЃ EmulgelЃ can enhance the effect of drugs that cause photosensitization.
No clinically significant interactions with other drugs have been described.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 30 ? C.
Shelf life
Shelf life is 3 years.
Terms of sale
The drug is dispensed without a prescription.
Contacts for inquiries
GLAXOSMITKLINE HELSKER AO (Russia)