4.1 Therapeutic indications:
For the topical treatment of pain, inflammation and swelling for:
· injuries to tendons, ligaments, muscles and joints, e.g. sprains, bruises, strains and back pain after sports or accidents;
· localised forms of soft tissue rheumatism, such as tendinitis (tennis elbow), shoulder-hand syndrome, bursitis, periarthropathies;
· and for the symptomatic treatment of arthrosis in small and medium-sized joints close to the skin, e.g. finger joints or knees.

The product is intended for topical use only.
Adults and adolescents aged 12 years and older
Depending on the size of the painful area to be treated, 2-4 g of Voltaren Emulgel (a cherry to walnut-sized amount, sufficient to cover an area to be treated of about 400-800 cm²) is applied to the affected parts of the body 3-4 times a day and rubbed in gently.
The duration of use depends on the indication and the success of the treatment. Reviewing the treatment after two weeks is recommended if the symptoms have not improved. Voltaren Emulgel should not be used for more than 14 days.
After use
·The patient should wipe their hands with a dry paper towel, then wash them thoroughly (except when treating their fingers). The paper towelshould be disposed of in the household waste.
·The patient should wait until the gel has dried on their skin before showering or bathing.
Special dosage instructions
Children under 12 years of age
The safety and efficacy of Voltaren Emulgel for use in children under 12 years of age have not been systematically tested. Therefore, it is not recommended for use.
Elderly patients
The normal daily dose for adults can be used.
Patients with hepatic or renal impairment
It is not necessary to adjust the dose due to low systemic availability.

Known hypersensitivity to the active substance diclofenac or to any of the excipients (e.g. isopropyl alcohol or propylene glycol; for a complete listsee “Composition”). ·For patients in whom acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (such as ibuprofen) trigger asthma attacks, angioedema,urticaria or acute rhinitis. ·During the third trimester of pregnancy (see “Pregnancy, lactation”).

Voltaren Emulgel should only be applied to intact skin, and not to diseased skin, skin wounds or open injuries.
The eyes and mucous membranes should not come into contact with the product. For topical use only. Do not swallow.
The treatment must be stopped immediately if a skin rash occurs after using the product.
Voltaren Emulgel should not be used with an airtight, occlusive dressing.
If Voltaren Emulgel is used on larger areas of skin and for longer than recommended (see “Dosage/Administration”), the occurrence of systemic undesirable effects cannot be completely excluded. In such cases, the summary of product characteristics for the oral forms of diclofenac should be read.
Information on the excipients
Voltaren Emulgel contains propylene glycol (E1520)) and benzyl benzoate. Propylene glycol may cause skin irritation. Benzyl benzoate may cause localised skin irritation.
Voltaren Emulgel contains viscous paraffin. Fabrics (clothing, bedding, dressings, etc.) that have come into contact with the product are more flammable and pose a fire hazard with the risk of severe burns. The patient should be instructed not to smoke or go near open flames when using Voltaren Emulgel. Paraffin is never completely removed from clothing or bed linen, even after washing.

This medicinal product contains a fragrance with linalool, benzyl alcohol, geraniol, citronellol, benzyl benzoate, coumarin, citral and eugenol. These excipients may cause allergic reactions

Due to the low systemic absorption with topical application, the probability of interactions is very low. See also the last paragraph in the “Warnings and precautions” or “Undesirable effects” section.

Pregnancy
No controlled studies have been conducted on pregnant women. Therefore, Voltaren Emulgel should not be used during pregnancy. Voltaren Emulgel is contraindicated in the third trimester of pregnancy due to possible premature closure of the ductus arteriosus botalli, possible obstruction of labour and possible renal impairment of the foetus, which may progress to renal failure with oligohydramnios.
Animal studies have shown no direct or indirect adverse effects on pregnancy, embryonic/foetal development, birth or postnatal development (see “Preclinical data”).
Lactation
It is not known whether diclofenac passes into breast milk when applied topically. Therefore, Voltaren Emulgel should not be used by lactating women. If there is a compelling indication, Voltaren Emulgel should not be used on the chest, over extensive areas of the skin and over a long period of time

Not applicable.

The undesirable effects are listed according to MedDRA system organ classes and frequencies. The undesirable effects are given in decreasing order of severity within each frequency group:
Frequency
very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000).
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), skin rash, erythema, eczema, pruritus.
Rare: bullous dermatitis.
Very rare: pustular skin eruption, photosensitisation.
The likelihood of systemic adverse reactions occurring with topical use of diclofenac is low compared to the incidence of adverse reactions with oral treatment with diclofenac.
If Voltaren Emulgel is used on larger areas of skin and for longer than recommended, the occurrence of systemic undesirable effects cannot be completely excluded. In such cases, read the summary of product characteristics for the oral forms of Voltaren.

To report any side effect(s):

Kingdom of Saudi Arabia

-National Pharmacovigilance centre (NPC)Fax: +966-11-205-7662Reporting Hotline: 19999E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa,-Haleon Saudi Arabia

- Head Office, JeddahTel: +966-12-601-5444Mobile: +966-53-553-3647Email: mystory.sa@haleon.com P.O. Box 48034, Jeddah 21572, Saudi Arabia

For any information about this medicinal product, please contact:Haleon Saudi Arabia - Head Office, JeddahTel: +966-12-601-5444Email: mystory.sa@haleon.com P.O. Box 48034, Jeddah 21572, Saudi Arabia

Due to the low systemic absorption of diclofenac with topical application, an overdose is unlikely.
Undesirable effects similar to those of an overdose with diclofenac tablets are to be expected if Voltaren Emulgel is swallowed (1 tube of 100 g corresponds to 1 g of diclofenac sodium). If significant systemic adverse reactions occur as a result of inappropriate use or accidental ingestion (e.g. in children), the general therapeutic measures commonly used for the treatment of poisoning with non-steroidal anti-inflammatory drugs should be applied; if necessary, may cause allergic reactions.
This medicinal product contains a fragrance with linalool, benzyl alcohol, geraniol, citronellol, benzyl benzoate, coumarin, citral and eugenol. These excipients in consultation with Tox Info Suisse.

ATC code
M02AA15
Mechanism of action
Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti-inflammatory and antipyretic properties.

Voltaren Emulgel is an anti-inflammatory and analgesic product for external use. The white, cream-like, non-greasy Emulgel is easy to rub into the skin and
has a soothing, cooling effect thanks to its aqueous-alcohol base.
The proven inhibition of prostaglandin biosynthesis by diclofenac is considered an important component of its mechanism of action.
In the case of inflammation caused by trauma, Voltaren Emulgel relieves pain and causes regression of oedema.
Pharmacodynamics
See the “Mechanism of action” section.
Clinical efficacy
No further information.

Absorption
The amount of diclofenac absorbed through the skin is proportional to the duration of skin contact and the area of skin covered with Voltaren Emulgel and is dependent on the total topical dose and the hydration of the skin. After topical application of 2.5 g Voltaren Emulgel per 500 cm² of skin, approximately 6% of the diclofenac dose is absorbed, as determined by total renal elimination compared to Voltaren tablets. Wearing an occlusive dressing for 10 hours
increases the absorption of diclofenac threefold.
Distribution
After topical application of Voltaren Emulgel to hand and knee joints, diclofenac is detectable in plasma, synovial tissue and synovial fluid. The maximum plasma concentrations of diclofenac after topical application of Voltaren Emulgel are about 100 times lower than after oral administration of Voltaren tablets. Diclofenac is 99.7% bound to serum proteins, primarily albumin (99.4%).
Metabolism
The biotransformation of diclofenac occurs partly via glucuronidation of the intact molecule, but mainly via single or multiple hydroxylation with subsequent glucuronidation of most of the phenolic metabolites formed in the process. Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.
Elimination
The total systemic clearance of diclofenac from plasma is 263 ± 56 ml/min (mean ± standard deviation), and the terminal plasma half-life is 1-2 hours. Four of the metabolites, including the two active ones, also have a short plasma half-life of 1-3 hours. One metabolite, 3'-hydroxy-4'-methoxy-diclofenac, has a much longer half-life. However, this metabolite has practically no pharmacological activity. Diclofenac and its metabolites are excreted mainly in urine.
Kinetics in specific patient groups
Renal impairment
In renal insufficiency, accumulation of diclofenac and its metabolites is not expected.
Hepatic impairment
The pharmacokinetics of diclofenac in patients with chronic hepatitis or compensated hepatic cirrhosis are the same as in patients without liver disease.

Preclinical data based on studies with diclofenac on acute toxicity, repeated dose toxicity, genotoxicity, mutagenicity and carcinogenicity did not indicate any specific hazard to humans at the recommended therapeutic doses. No teratogenic effects were observed in mice, rats and rabbits. Diclofenac has no effect on the fertility of parent animals (rats) or the pre-, peri- and postnatal development of the young.
In various studies, there was no evidence that Voltaren Emulgel causes phototoxicity or skin sensitisation.

carbomer, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, macrogol cetostearyl ether, paraffin wax, propylene glycol, fragrance (containing benzyl
benzoate), purified water.

Not applicable

36 Months Do not use this medicine after the expiry date (“EXP”) stated on the pack.

Store below 30 C°.
Keep out of the reach of children.

 

50 g and 100 g Tubes.Not all pack sizes may be marketed.

 

Instructions for handling
Voltaren Emulgel should not be used near open flames or heat.
Medicines must not be disposed of via wastewater (e.g. via the toilet or washbasin). This will help protect the environment.