Qualitative and quantitative composition :
100 9 of voltaren Emulgel contains 1.16 9 of the active substance dictofenac diethylamine which I corresponds to 1 9 diclofenac sodium
Pharmaceutical form :
The base of Vottaren Emulgel is an oily emulsion in an aqueous gel. The white, creamy, non- greasy preparation is applied to the skin
Clinical particulars : Therapeutic Indications :
– Post -traumatic inflammation of tendons, ligaments, muscles, and joints, e,g.due to strains, and bruises
-Localised forms of soft- tissue rheumatism ,e.g. ten- X dovaginitis, bursitis, shoulder-hand syndrome, and periarthropathy.
– Localised forms of degenerative rheumatism, e.g. osteoarthrosis of the peripheral joints and of the vertebral column. 1
Posology and method 0f administration :
Voltaren Emulgel is applied locally to the skin 3 or 4 c times daily and rubbed in gently. The amount needed depends on the size of the painful site. For example, 2-4 9 Voltaren Emulgel ( a quantity ranging in size from a cherry to a walnut) is sufficient to treat an area: of about 400-800 erne. After application,the hands should be washed, unless they are the site being treated. The duration treatment depends on the in dication and the response obtained. It is recommended that treatment be reviewed after 2 weeks. )
Dosage recommendations and indications for the use of Voltaren Emulegel in children have not been established.
Known hypersensitivity to dicJofenac, propylene glycol, isopropyl alcohol, or other ingredients. Voltaren Emulgel is also contra- indicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are Precipitated by acetylsalicylic acid or other non-steroidal
Special warnings and precautions for use warning :
The likelihood of systemic side effects occurring under topical didofenac is small compared with the frequency of side effects under oral diclofenac. However, when Voltaren Emulgel is applied to ret- ativety large areas of skin and over a prolonged period of time, the possibility of systemic side effects cannot be excluded. In the event of Voltaren Emulgel being prescribed for chronic uses or in quantities which substantially exceed lhe recommended doses,
elevation of one or more liver enzymes may be found. Where this occurs, regular monitoring of hepatic function is recommended as a precautionary measure. If abnormal liver function tests persists or worsen, if clinical signs or symptoms consistent with liver disease develop, treatment wilh Diclofenac should be discontinued.
Voltaren Emugel should be applied only to healthy and intact skin surfaces (absence of open wounds or injuries ). It should not be allowed to come into contact with the eyes or with mucous membranes. Not to be taken by mouth.
Interaction with other drugs and other types of Interaction :
Pregnancy and lactation :
Since no experience has been obtained with Voltaren Emulgel in pregnant women, the preparation is not recommended for use during pregnancy.
No measurable amounts of the active substance are to be expected in the breast milk of nursing mothers. However, there is no experience with Voltaren Emulgel during breast-feeding.
Effects on ability to drtve and use machines :
Undesirable effects :
Local reactions :
Occasional : allergic or non-allergic contact dermatitis (with symptoms and signs such as itching. Reddening, oedema, papules, vesicles, bullae, or scaling of the skin).
Systemic reactions :
In isolated cases: generalised skin rash, hypersensitivity reactions ( e.g. Asthmatic attack, angioedema) photosensitively reactions.
The low systemic absorption of topical diclofenac makes over2osage very unlikely.
Pharmacological properties :
Pharmacodynamic properties :
Pharmacotherapeutic group :
Non-steroidal anti-inflammatory drugs (NSAIDs).
Mechanism of action :
Inhibition of prostaglandin biosynthesis by diclofenac has been demonstrated in experiment and is regarded as an important component of its mechanism of action.
Pharmacodynamic effects :
In inOammation of traumatic or rheumatic origin, vor taren Emulgel, has been shown to relieve pain, reduce oedema, and shorten the time to return of normal function.
Pharmacoklnetlc properties :
The amount of diclofenac absorbed through the skin is proportional to the contact time and skin area covered with Voltaren Emulgel,and depends on the total topical dose and the hydration of the skin.
Absorption amounts to about 6 % of the dose of dlclofenac after topical application of 2.5 9 Voltaren Emulgel per 500 erne skin, determined by reference to the total renal elimination compared With Vottaren tablets.
Occlusion over a period of 10 hours leads to a threefold increase in the amount of diclofenac absorbed.
After topical administration of Voltaren Emulgel to hand and knee joints diclofenac can be measured in plasma, synovial tissue, and synovial fluid. Maximum plasma concentrations of diclofenac after topical administration of Voltaren Emulgel are about 100 times
lower than after oral administration of Voltaren tablets 99.7% of dictofenac binds to serum proteins, chiefly to albumin (99.4 %).
Biotransformation of diclofenac involves partly glucuronidation of the intact molecule. But mainly single and multiple hydroxytation resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Tow of these phenolic me-
tabolites are biologically active, however, to a much smaller extent than diclofenac.
The total systemic clearance of diclofenac from plasma is 263+1-56 ml 1 mint. mean value+I-50). The terminal plasma halt- life is 1-2 hours. Four of the metaboHtes, including the two active ones, also have short plasma half-lives of 1-3 hours. One metabelite, 3hydroxy -4 -methoxy- diclolenac, has a t much longer plasma half- life. Howevert tabolite is virtually inactive. Diclofenac and its met tabolites are excreted mainly in the urine.
Characteristics In patients :
No accumulation of diclofenac and metabolites is to be expected in patients suffering from renal impairment. In patients with chronic hepatitis or non decompensated cirrhosis, the kinetics and me-
tabolism of diclo1enac are the same as in patients without liver disease.
Preclinical Salety Data :
Preclinical studies conducted with Voltaren Emulgel did not reveal any clinically relevant toxicological effects.
Pharmaceutical particulars :
List 01 Exclpients :
Diethylamine, acrylic acid polymer, cetomacrogoI1000, capryllicl capric acid fatty alcohol ester, isopropyl alcohol, liquid paraffin, perfume, propylene glycol, water.
Special precautions lor storage:
Protect from heat (store below 30″ C). Voltaren Emulgel should be kept out the reach of children.
Nature and contents 0f container :
Aluminium tubes with protective inner coating. available in 15 g, 25 g and 50 g
Instructions for use / handling :
Produced by :
Novartls Pharma S.A.E. Cairo under licence from
Novartls Consumer Health SA, Nyon, Switzerland