Description
Briefly about the product
Voltaren Emulgel 100g – is intended for pain in joints, back, muscles, as well as inflammation and swelling of soft tissues and joints.
Voltaren Emulgel has a triple effect!
1: anti-pain
2: anti-inflammatory *
3: to accelerate recovery **
The active substance diclofenac, a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties, penetrates deep under the skin, acting on pain and its cause – inflammation. *
* Instructions for medical use, RU No Ñ N016030 / 01 dated 09.09.2009
** Limit. Musculoskeletal disorders. 2013, 14: 250. Compared to using a placebo.
Description
Gel for external use 1% uniform, creamy, white to yellowish.
Latin name
VOLTAREN EMULGEL
Release form
Gel for external use 1%
Pharmacological action of
NSAIDs for external use. Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic effect.
Indiscriminately 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 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, osteoarthritis in the muscles (srdlp pain , overstrain, bruises, injuries)
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
preparation, the tendency to occur asthma attacks, skin rashes or acute rhinitis with acetylsalicylic acid or other NSAIDs
violation of the integrity of the skin three times the expected period of pregnancy feeding)
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 first and second 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, but 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 contain:
Active ingredients:
1 g of diclofenac diethylamine
Excipients:
carbomers (carbopol 974 ),
macrogol cetostearate (cetomacroglaprocolcol krpoltol (cetacrocolcol krpolcrdolc), cetacrocolcol krpolcdolc (150) isopropanol,
liquid paraffin,
aromatic cream 45,
propylene glycol,
water.
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, consult a doctor after 2 weeks.
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 generally characterized by moderately pronounced and transient skin manifestations at the site of gel application. In very rare cases, allergic reactions may develop.
Determination of incidence of adverse reactions: very common (> 10%), often ( 1%, but 10%), infrequent ( 0.1%, but 1%), rare ( 0.01%, but 0.1%) very rare ( 0.01%).
Infectious and parasitic diseases: very rarely pustular rashes.
From the immune system: very rarely – generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioneurotic edema).
From the respiratory system: very rarely – attacks of suffocation, bronchospastic reactions.
On the part of the skin: often – erythema, dermatitis, incl. contact dermatitis (symptoms: eczema, itching, swelling of the treated area of the skin, rash, papules, vesicles, peeling) rarely – bullous dermatitis very rarely – photosensitization reactions.
Drug Interaction
Voltaren ® Emulgel ® may enhance the effects of photosensitization agents.
No clinically relevant interaction with other medicinal products has been reported.
Overdose
Due to the low systemic absorption during application of the gel, an overdose is unlikely.
Symptoms: with accidental ingestion, systemic adverse reactions may develop.
Overdose treatment for 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%).
Storage conditions
The product should be stored out of the reach of children at a temperature not exceeding 30 ° C.
Term hodnosty
3 years
active substance
Diclofenac
Pharmacy terms
Pharmacy vacation terms
Pharmacy
79 pharmacy s18lkp79
Novartis Farma Stein AG, Switzerland
