Indications/Uses
For external use in the treatment of pain, inflammation and swelling associated with:

• injuries to tendons, ligaments, muscles and joints, e.g. sprains, contusions, muscle strains and back pain following sporting activity or an accident.
• localised rheumatism, (tennis elbow), shoulder-hand, syndrome, bursitis, periarthropathies;
• and for the symptomatic treatment of osteoarthritis of the small and medium-sized superficial e.g., orjoints, finger knee joints.

Dosage/Administration
The product is for external use only.

Adults and adolescents aged 12 years and above
Depending on the size of the painful area to be treated, gently rub 2-4 g of Voltaren Emulgel into the skin (an amount the size of a cherry to a walnut is enough to treat an area of approximately 400- 800 cm2) 3 to 4 times per day.

Treatment duration depends on the indication and the response elicited. It is recommended to review treatment after 2 weeks if the symptoms have not improved. Voltaren Emu Igel should not be used for more than 14 days

 

After use

• Wipe hands with a dry paper towel, then wash them thoroughly (except when treating the of paper towel with the household waste.fingers). Dispose the household waste.
•  The patient must wait for the Emulgel to dry on the skin before taking a shower or a bath.

Children under 12 years of age
The use and safety of Voltaren Emulgel in children under 12 years of age have not yet been studied systematically and its use is therefore not recommended in this age group.

Patients over 65 years ofage
The normal daily dose for adults can be used

Contraindications - Known hypersensitivity to diclofenac (active substance) or to any of the excipients (e.g. isopropanol or propylene glycol); see full list under "Composition"). - patients who react with an asthma attack, angioedema, urticaria or acute rhinitis to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, such as ibuprofen - During the third trimester of pregnancy (see the note in the "Pregnancy/ Lactation " section).

Warnings and precautions
Only apply Voltaren Emulgel to undamaged, healthy skin with no lesions or open wounds.
Avoid contact between the product and the eyes and mucous membranes. Do not swallow.
Immediately stop treatment if a rash appears after use.
Voltaren Emulgel contains propylene glycol and benzyl benzoate: these excipients may cause mild,
localised skin irritation in some patients.
Voltaren Emulgel must not be used with airtight, occlusive dressings

When Voltaren Emulgel is applied to a larger area and for a longer period of time than recommended (see "Dosage/Administration"), the occurrence of systemic adverse effects cannot be completely ruled out. In such cases, refer to the information for healthcare professionals on oral forms of diclofenac.

Interactions
It is unlikely that interactions will occur considering the low systemic absorption when applied topically. See also the last paragraph of the "Warnings and precautions" and the "Undesirable effects” sections

Pregnancy/Lactation
Pregnancy
No controlled studies are available on pregnant women. Therefore, Voltaren Emulgel should not be used on pregnant women.
Voltaren Emulgel is contraindicated during the third trimester of pregnancy owing to the potential risk of premature closure of the ductus arteriosus, possible inhibition of uterine contractions, as well as possible impairment of foetal renal function that may progress to renal failure with oligohydramnios.
In animal studies, no direct or indirect adverse effects on pregnancy, embryonic/foetal development, delivery or postnatal development have been identified (see "Preclinical data").

Breastfeeding
It is not known whether topically applied diclofenac is excreted in breast milk. Therefore, Voltaren Emulgel should not be used on breastfeeding women. Where indicated as a matter of necessity, do not apply Voltaren Emulgel to the breasts, to large areas of skin or over a prolonged period of time.

Not applicable

Undesirable effects
Undesirable effects are listed by system organ class and by frequency. Within each frequency grouping, undesirable effects are classed in order of decreasing severity.

Frequencies

" Very common" (21/10), “common" (21/100, <1/10), "uncommon" (21/1,000, <1/100),
"rare" (21/10,000, <1/1,000), “very rare" (<1/10,000).
Infections and infestations
Very rare: pustular skin eruption.
Immune system disorders
Very rare: angioedema, hypersensitivity reactions (including urticaria).
Respiratory, thoracic and mediastinal disorders
Very rare: asthma.
Skin and subcutaneous tissue disorders
Common: dermatitis (including contact dermatitis), rash, redness, eczema, pruritus.

Rare: bullous dermatitis.

Very rare: photosensitisation.

The probability of systemic undesirable effects occurring with the topical form of diclofenac is low in
comparison with the frequency of undesirable effects observed during treatment with oral diclofenac.
However, the occurrence of systemic adverse effects cannot be completely ruled out when Voltaren
Emulgel is applied to a larger area and for a prolonged period of time. In this case, refer to the
information for healthcare professionals on oral forms of Voltaren.
It is very important to report suspected adverse effects after authorisation. This enables the benefitratio
of the medicinal product to be monitored continuously. Healthcare professionals are obliged
to report any new or serious suspected adverse effects via the EIViS (Electronic Vigilance System)
online reporting portal. Information about this topic can be found at www.swissmedic.ch.

An overdose is unlikely, considering the low systemic absorption of diclofenac when applied topically.
The expected adverse effects following accidental ingestion of Voltaren Emulgel (one 100g tube corresponds to 1g sodium diclofenac) are similar to those observed following overdose with diclofenac tablets. If significant systemic undesirable effects occur following misuse or accidental consumption (e.g. in children), the general therapeutic measures recommended for intoxication with non-steroidal anti-inflammatory drugs should be adopted, as applicable, in consultation with Tox Info Suisse

Properties/Effects
ATC code M02AA15

Mechanism of action and pharmacodynamics
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with significant analgesic, antiinflammatory and antipyretic properties. Voltaren Emulgel is an anti-inflammatory and analgesic product for external use. The Emulgel is a non-greasy, white cream and is easily absorbed into the skin. As a result of its water-alcohol base, it has a soothing and cooling effect.
The proven inhibition by diclofenac of prostaglandin biosynthesis is considered to be a significant component of its mechanism of action.
Voltaren Emulgel relieves the pain and reduces the oedema associated with inflammation of traumatic origin.

Pharmacokinetics
Absorption
The quantity of diclofenac absorbed by the skin is proportional to the time Voltaren Emulgel is in
contact with the skin, and to the surface area treated; it also depends on the total dose applied and
skin hydration. Approximately 6% of the diclofenac dose is absorbed after topical application of
2.5 g of Voltaren Emulgel over a skin surface area of 500 cm?, calculated in relation to total renal
elimination compared with that obtained with Voltaren tablets. Diclofenac absorption is tripled if the
treated area is covered by an occlusive dressing for 10 hours.

Distribution
After topical application of Voltaren Emulgel to hand and knee joints, diclofenac levels can be
measured in plasma, synovial tissue and synovial fluid. Maximum plasma concentrations of
diclofenac obtained after topical application of Voltaren Emulgel are approximately 100 times lower
than those obtained with Voltaren tablets. 99.7% of diclofenac is bound to serum proteins, primarily to
albumin (99.4%).

Metabolism
Diclofenac biotransformation is partly by glucuronidation of the whole molecule, but especially by simple or multiple hydroxylation, leading to the formation of phenolic metabolites, which are then eliminated mostly in glucuronidated form. Two of these phenolic metabolites are biologically active, but to a much lower degree than diclofenac.

Elimination
The total plasma clearance of diclofenac is 263 + 56 mL/min (mean + standard deviation). Terminal
plasma half-life is 1-2 hours. Four of the metabolites, including the active two, also have a short
plasma half-life of 1-3 hours. Another metabolite, 3'-hydroxy-4'-methoxydiclofenac, has a significantly
longer half-life, but is practically inactive. Diclofenac and its metabolites are excreted mainly in the urine.

Kinetics in specific patient groups
Diclofenac and its metabolites are unlikely to accumulate in patients with renal failure.
The kinetics and metabolism of diclofenac are the same in patients with chronic hepatitis or
compensated cirrhosis as in patients without liver disease.

Preclinical data
Preclinical data from studies with diclofenac on acute toxicity, repeated dose toxicity, genotoxicity, mutagenicity and carcinogenicity did not identify any specific risk to humans at the recommended therapeutic doses.
No teratogenic effect was observed in mice, rats and rabbits. Diclofenac had no effect on the fertility
of the parents (rats) or the pre-, peri- or post-natal development of the offspring.
Different studies did not provide any indications that Voltaren Emulgel induces phototoxicity or skin sensitisation

Excipients
Carbomer, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, ether, paraffin wax, propylene glycol (50 mg/g), fragrance (containing benzyl benzoate), purified water

Not applicable

Other information Shelflife The medicinal product must not be used after the date that appears on the container after "EXP". Information on storage Store at 15-30°C.

Keep out of the reach of children.
 

Packs
Tubes of 50 g and 100 g [D]

Information on handling
Do not dispose of the medicine in the sewers (e.g., do not throw it down the toilet or sink). This helps to protect the environment