Description
Description
Gel for external use 1% uniform, creamy, white to yellowish.
Release form
75 g each in an aluminum tube equipped with an aluminum protective membrane, with a screw-on plastic cover (white or blue), having a protrusion for perforating the membrane from the outside.
Tube along with instructions for use are placed in a cardboard box.
Pharmacological action
NSAIDs for external use. Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic effect.
Not selectively inhibiting COX-1 and COX-2, disrupts the metabolism of arachidonic acid.
Voltaren ® Emulgel ® is used to eliminate pain and inflammation in joints, muscles and ligaments of a traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.
Thanks to its water-alcohol base, Voltaren ® Emulgel ® has a calming and cooling effect.
Indications
– Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthrosis, lumbago, sciatica)
– joint pain (including knee joints of the fingers, knee) with rheumatoid arthritis, osteoarthrosis
– muscle pain (due to sprains, overstrain, bruises, injuries)
– inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, damage to periarticular tissues, wrist syndrome).
Contraindications
– Hypersensitivity to diclofenac or other components of the
preparation – a tendency to cause asthma attacks, skin rashes or acute rhinitis with acetylsalicylic acid or other NSAIDs
– violation of the integrity of the skin of the skin – lactation (breastfeeding)
– children under 12 years old.
Caution is advised to prescribe the drug for hepatic porphyria (in the acute phase), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidneys, chronic heart failure, bronchial asthma, as well as in the first and second trimesters of pregnancy and elderly patients.
Use during pregnancy and lactation
Due to the lack of data on the use of the drug Voltaren ® Emulgel ® during pregnancy, the use of the drug in the I and II trimesters of pregnancy is recommended only as prescribed by the doctor, comparing the benefits for the mother and the risk to the fetus.
The drug is contraindicated in the III trimester of pregnancy due to the possibility of lowering the tone of the uterus, impaired renal function of the fetus, followed by the development of oligohydramnios and / or premature closure of the arterial duct of the fetus.
Due to the lack of data on the release of the active substance of Voltaren ® Emulgel ® with breast milk, the drug is not recommended for use during breastfeeding. If you still need to use the drug, then it should not be applied to the mammary glands or to 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.
Special instructions
Voltaren ® Emulgel ® should only be applied to intact skin, avoiding contact with open wounds.
Avoid contact with eyes and mucous membranes.
After applying the gel for external use of 1%, do not apply an occlusive dressing. After applying the gel for external use of 2%, a bandage dressing is allowed, however, airtight occlusive dressings should not be applied. If skin rash develops after application of the drug, its use must be discontinued.
The drug contains propylene glycol, which in some people can cause mild local irritation. It also contains butylhydroxytoluene, which can cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Impact on ability to drive vehicles and mechanisms
Not affected.
Composition of
100 g of gel contains
diclofenac diethylamine 1.16 g, which is resp. 1 g of diclofenac sodium
Gel base:
fat emulsion in an aqueous gel with the addition of isopropanol and propylene glycol.
Other ingredients:
diethylamine,
acrylic acid polymer,
cetomacrogol 1000,
caprylic alcohol / capric acid,
isopropyl alcohol,
propylene glycol,
liquid paraffin, srdlkrp paraffin srd.
Dosage and administration
The drug is used externally.
For adults and children over 12 years of age, the drug is applied to the skin 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 is 2-4 g (which is comparable in volume to the size of cherries or walnuts, respectively).
Wash hands after application. 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 Voltaren ®). If there is no therapeutic effect after 2 weeks, you should consult your doctor.
Laminated tubes: to remove the protective membrane, use a screw cap as a key (recess with protrusions on the outside of the cap). Align the recess on the outside of the lid with the curly protective membrane of the tube and turn. The membrane should separate from the tube.
Laminated tubes can have either a regular cap (round shape) or an innovative cap (triangular shape), which is especially suitable for use with limited mobility of the joints of the hands due to osteoarthritis or other joint diseases or injuries, as well as an applicator cap.
Aluminum tubes: Before first use, pierce the tube s protective membrane with a special protrusion on the outside of the polypropylene screw cap.
It is not recommended to wash the applicator cap with water or use abrasive cleaners. After full use of the contents of the tube, it is recommended to dispose of the applicator cap with the tube. Do not use the applicator cap with another tube.
Side effects
Adverse reactions are mainly characterized by mild and passing skin manifestations at the site of application of the gel. In very rare cases, the development of allergic reactions is possible.
Determination of the incidence of adverse reactions: very often (> 10%), often (? 1%, but? 10%), infrequently (? 0.1%, but? 1%), rarely (? 0.01%, but? 0.1%) very rarely (? 0.01%).
Infectious and parasitic diseases: very rarely – pustular rashes.
On the part of the immune system: very rarely – generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema).
From the respiratory system: very rarely – asthma attacks, bronchospastic reactions.
From the skin: often – erythema, dermatitis, including contact dermatitis (symptoms: eczema, itching, swelling of the treated area of the skin, rash, papules, vesicles, peeling) rarely – bullous dermatitis is very rare – photosensitivity reactions.
Drug Interactions
Voltaren ® Emulgel ® may enhance the effects of photosensitizing drugs.
No clinically significant interaction with other drugs has been described.
Overdose
Due to low systemic absorption upon gel application, overdose is unlikely.
Symptoms: systemic adverse reactions may occur with accidental ingestion.
Treatment of overdose with accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective because of the high degree of binding of diclofenac to plasma proteins (about 99%).
Storage conditions
Keep out of the reach and sight of children at temperatures not exceeding 30 ° C.
Shelf life
3 years.
Deystvuyushtee substance
Diclofenac
Terms and conditions
without prescription
Dosage
form gel for external use
Possible product names
Voltaren Emulgel 1% with an applicator cap 75 g
