The instruction for medical use
of EMULGEL VOLTARENUM medicine
the Trade name
Emulgel Mezhdunarodnoye Voltarenum the unlicensed
name Diclofenac Dosage Form Gel for external use of 1%
of 100 g of drug contain
active agent of diclofenac diethyl amine of 1.16 g 1.00 g of diclofenac of sodium
excipients are equivalent: carbomers (karbopol 974 P), a macrogoal cetostearyl ether (tsetomakrogol 1000), kokoit kaprilokaprat (tsetiol HP), diethyl amine, isopropyl alcohol, liquid paraffin, mineral oil (heavy liquid paraffin), cream aromatic 45, propylene glycol (1.2 propylene glycol distilled), the water purified.
Soft, uniform creamy gel from white till yellowish color.
Musculoskeletal system group. Drugs for topical administration in articulate and muscular pain. Anti-inflammatory drugs, nonsteroid, for topical administration. Diclofenac.
The ATX M02AA15 code
Pharmacokinetics At properties the recommended way of drawing Emulgelya Voltarenum is absorbed no more than 6% of diclofenac. At local putting drug of 99.7% of diclofenac contacts proteins of serum and generally (99.4%) albumine. Diclofenac collects in the skin operating as a source of the slowed-down release of substance in the subject fabrics. From there diclofenac is distributed and remains mainly in the deep inflamed fabrics where reaches concentration by 20 times exceeding concentration in plasma. Biotransformation of diclofenac is carried out partially by a glyukoronidation of an invariable molecule, however, the most part of the arrived substance is exposed to single or multiple hydroxylation with formation of phenolic metabolites which turn into glucuronic conjugates. The general system clearance of diclofenac in blood plasma averages 263±, 56 ml/min., and final elimination half-life of diclofenac make 1-2 hours, are removed mainly with urine.
Active component diclofenac the non-steroidal anti-inflammatory drug having analgeziruyushchy and anti-inflammatory properties. The main mechanism of effect of diclofenac consists in suppression of biosynthesis of prostaglandins, namely, not selectively oppressing type cyclooxygenase 1 and 2, breaks metabolism of arachidonic acid.
Emulgel Voltarenum is used for elimination of a pain syndrome and reduction of puffiness connected with inflammatory process.
At the expense of an emulsion form Emulgel Voltarenum easily gets through skin, quickly reaching effective concentration, and the gel component possesses the cooling and calming action.
Topical treatment of pain, inflammation and hypostasis at:
– traumatic (including sports) injuries of sinews, ligaments, muscles and joints without disturbance of integrity of integuments (bruises, stretchings, dislocations), a dorsodynia
– the localized rheumatism forms: a tendinitis (so-called tennis elbow), an algodistrofichesky syndrome of an upper extremity (a syndrome a shoulder hand), a bursitis, a periarthritis
– osteoarthrites of peripheral joints (for example, knees or fingers of hands).
Route of administration and doses
To adults and children 12 years 3-4 times a day are more senior, slightly rubbing in skin on sore parts of the body. After putting drug it is recommended to wash up hands.
A single dose – 2-4 g. Duration of treatment depends on indications and efficiency of therapy. It is not necessary to use drug more than 14 days. In case of use of drug without appointment, it is necessary to see a doctor if within 7 days use, the condition of the patient did not change.
Often (& ge, 1/100, but & lt, 1/10)
– contact dermatitis (rash, an erythema, eczema of naggers)
it is rare (& ge, 1/10000, but & lt, 1/1000)
– bullous dermatitis
Very seldom (& lt, 1/10000)
– pustulous rashes
– reactions of hypersensitivity (urticaria, a Quincke’s edema)
– bronkhospastichesky reactions, asthma
– reactions of a photosensitization
of the Contraindication
– hypersensitivity to diclofenac or other components of drug
– tendency to emergence of attacks of bronchial asthma, urticaria or acute rhinitises at use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (aspirinovy asthma)
– disturbance of integrity of integuments
– pregnancy and the period of a lactation
– children’s age up to 12 years
As system absorption of a diklovenak at topical administration of drug very low, emergence of interaction is improbable.
instructions Voltarenum Emulgel should be applied only to the uninjured healthy skin, avoiding hit on the inflamed sites and open wounds.
It is not necessary to allow hits of drug in eyes and on mucous membranes.
It is not necessary to apply inside. It is not necessary to apply under an occlusive occlusive bandage.
Emulgel Voltarenum contains benzyl benzoate as a part of cream aromatic 45 and also propylene glycol which can cause weak local irritation of skin in some patients.
The feature of influence of drug on ability to run the vehicle or potentially dangerous mechanisms
does not influence ability to run the vehicle or other potentially dangerous mechanisms.
Symptoms: the overdose at topical administration of drug is improbable. At accidental intake such complications as hypotonia, a renal failure, spasms, irritation of digestive tract and respiratory depression can be observed. Treatment: gastric lavage, intake of activated carbon, symptomatic therapy.
A form of release and packing
On 20 g, 50 g of drug in aluminum tubas with a protective aluminum membrane, with the screw-on plastic cover having a ledge for perforation of a membrane from outer side or in the laminated tubas (polyethylene of low density, aluminum, polyethylene of high density) with a shoulder and a tselnolity figured protective membrane from polyethylene of high density and the polypropylene screw-on cover. The cover from outer side is supplied with a key (deepening with ledges) for opening of a protective membrane of a tuba.
On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature not over 30 With
to Store out of children’s reach!
not to apply a period of storage after an expiration date.
of Proizvoditel Novartis Konsyyumer Hels SA, Switzerland
the Name and the country of the owner of the registration certificate
of Novartis Konsyyumer Hels SA, Switzerland
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers and responsible for post-registration observation of safety of medicine:
GSC KH KAZAKHSTAN LLP
Almaty, Manas St., 32A.
ph. +7 (727) 2446999, fax +7 (727) 2446997