For external use in the treatment of pain, inflammation and swelling in:

·       injuries to tendons, ligaments, muscles and joints, e.g. sprains, bruises, strains or backpain as a result of sports or accidents;

·       localised forms of soft tissue rheumatism such as tendinitis (tennis elbow), shoulder-handsyndrome, bursitis, periarthritis;

·       and for symptomatic treatment of osteoarthritis of small and medium-sized joints close tothe skin, such as the joints of the fingers or knees.

The gel is only intended for external use.

Adults and adolescents aged 14 years and older

Depending on the size of the painful area to be treated, apply 2 times a day, preferably in the morning and in the evening, 2 to 4 g of Voltaren Forte 2% (amount the size of a cherry or nut is sufficient for treatment with an area of approximately 400-800 cm2) on the areas concerned and massage gently to penetrate.

The duration of use depends on the indication and the treatment results seen. The treatment should be reassessed after 1 week, if the symptoms have not improved or have worsened. Do not use Voltaren Forte 2%for more than 14 days.

Wash hands thoroughly after use (except in cases of treatment of fingers). Children under 14 years of age

The use and safety of Voltaren Forte 2% in children under the age of 14 years has not been systematically evaluated to date. Therefore, use of the product is not recommended in this age group.

Patients over 65 years of age

The normal daily dose for adults can be used

Known hypersensitivity to diclofenac (active substance) or to any of the excipients (e.g. isopropanol or propylene glycol); see full list under "Composition"). In patients who react to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs such as ibuprofen for asthmatic attacks, angio-oedema, hives or acute rhinitis. During the 3rd trimester of pregnancy (see the note under “Pregnancy / Lactation”).

Only apply Voltaren Forte 2% to intact, healthy skin, without lesions or open wounds.

Avoid contact of the product with the eyes and mucous membranes. Do not swallow. Stop the treatment immediately if a skin rash develops after applying the product.

Voltaren Forte 2% contains propylene glycol and butylhydroxytoluene: propylene glycol can cause mild, localised skin irritation in some patients. Butylhydroxytoluene (E321) can cause local skin reactions (e.g. contact eczema) or irritation of the eyes and mucous membranes.

Voltaren Forte 2% should not be used with airtight, occlusive bandages.

When Voltaren Forte 2% is applied over a larger area and for a longer period than that recommended (see "Posology and method of administration"), the appearance of systemic side effects cannot be entirely excluded. In such cases, the information for professionals on the oral forms of diclofenac should be consulted.

Interactions are unlikely to occur, given the low systemic absorption observed with topical application. Also see the last passage in the “Special warnings and precautions for use” and “Undesirable effects” sections.

Pregnancy

No controlled studies in pregnant women are available. Consequently, Voltaren Forte 2% should not be used in pregnant women. Voltaren Forte 2% is contraindicated during the 3rd trimester of pregnancy due to the possible risk of premature closure of the ductus arteriosus, possible inhibition of uterine contractions, as well as possible impaired renal function of the foetus which may progress to renal failure with oligo-hydramnios.

Studies in animals have not shown any direct or indirect harmful effects on gestation, embryo/foetal development, birth and postnatal development (see "Preclinical safety data").

Lactation

It is not known whether topically applied diclofenac is excreted in breast milk. Therefore, Voltaren Forte 2% should not be used in breastfeeding women. Where indicated as a matter of necessity, do not apply Voltaren Forte 2% to the breasts, to large areas of skin or over a prolonged period of time.

Not applicable.

Adverse reactions are listed by system organ classes and by frequency.

In each frequency group, the undesirable effects are classified according to the decreasing degree of severity.

Frequencies

"Very common" (≥1/10), "common" (≥1/100, <1/10), "uncommon" (≥1/1,000, <1/100), "rare" (≥1/10,000, <1/1,000), "very rare" (<1/10,000).

Infections and infestations Very rare: rash pustular.

Immune system disorders

Very rare: angio-oedema, hypersensitivity reactions (including hives). Respiratory, thoracic and mediastinal disorders

Very rare: asthma.

Skin and subcutaneous tissue disorders

Common: dermatitis (including contact dermatitis), rash, redness, eczema, pruritus.

 

Rare: dermatitis.bullous. Very rare: photosensitivity.

The likelihood of systemic adverse effects with the topical form of diclofenac is low compared to the frequency of adverse effects seen with oral treatment with diclofenac.

However, the appearance of systemic adverse effects cannot be entirely excluded when Voltaren Forte 2% is applied over a wider area and for a period longer than that recommended. In such cases, the information for professionals on the oral forms of Voltaren should be consulted.

To reports any side effect(s): Saudi Arabia:

·  The National Pharmacovigilance Centre (NPC):

-  SFDA Call Center: 19999

-  E-mail: npc.drug@sfda.gov.sa

-  Website: https://ade.sfda.gov.sa/

Overdose is unlikely, given the low systemic absorption of diclofenac observed following topical application.

The foreseeable adverse effects from accidental ingestion of Voltaren Forte 2% (1 tube of 100 g

 

corresponds to 2 g of diclofenac sodium) are similar to those observed following overdose of diclofenac tablets. If significant systemic adverse effects occur as a result of inappropriate or accidental use (e.g. in children), general therapeutic measures recommended following intoxication with non-steroidal anti-inflammatory drugs should be used, if necessary, in consultation with Tox Info Switzerland.

ATC Code: M02AA15

Mechanism of action and pharmacodynamics

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) with pronounced analgesic, anti- inflammatory and antipyretic properties.

Voltaren Forte 2% is an anti-inflammatory and analgesic preparation for external use. The gel is white, cream-coloured, non-greasy and easily penetrates the skin. Due to an aqueous- alcoholic base the gel exerts a soothing and cooling effect.

The proven inhibition of prostaglandin biosynthesis by diclofenac is considered to be an important part of its mechanism of action.

Voltaren Forte 2% relieves pain and reduces oedema in cases of trauma-related inflammation.

Absorption

The amount of diclofenac absorbed by the skin is proportional to the duration of contact with the skin and the size of the skin area to which Voltaren Forte 2% is applied; it also depends on the total topical dose as well as the degree of hydration of the skin.

After topical use on approximately 400 cm² of skin, the magnitude of the systemic exposure measured by the plasma concentration reached with Voltaren Forte 2% (2 applications per day) corresponded to that measured for Diclofenac Emulgel 1.16% (4 applications per day).

Compared to that observed with the tablet formulation, the relative bioavailability of diclofenac (AUC quotient) in Voltaren Forte 2% was 4.5% on day 7 (for an equivalent diclofenac sodium dose). The absorption remained unchanged upon application of a watertight bandage.

Distribution

After topical application of Voltaren Forte 2% to hand and knee joints, diclofenac can be measured in plasma, synovial tissue and synovial fluid. After topical application of Voltaren Forte 2%, peak plasma concentrations of diclofenac are approximately 100 times lower than those obtained after oral administration of Voltaren tablets. Diclofenac is 99.7% bound to serum proteins, mainly albumin (99.4%).

Metabolism

Diclofenac is metabolised partially by glucuronidation of the intact molecule, but mainly by simple or multiple hydroxylation followed by glucuronidation of most of the resulting phenolic metabolites. Two of these phenolic metabolites are biologically active, although to a much lower degree than diclofenac.

Elimination

The total systemic plasma clearance of diclofenac is 263 ± 56 ml/min (mean ± standard deviation). The terminal plasma half-life time is 1 to 2 hours. Four of the metabolites, including the two

 

active ones, also have a short plasma half-life of 1 to 3 hours. One of the metabolites, 3'- hydroxy- 4'-methoxy-diclofenac, has a significantly longer half-life, but this metabolite is practically inactive. Diclofenac and its metabolites are mainly eliminated via the urine.

Kinetics in specific patient groups

Diclofenac and its metabolites are not expected to accumulate in kidney 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 based on studies with diclofenac of acute toxicity, repeat-dose toxicity, genotoxicity, mutagenicity and carcinogenicity have not identified any specific risk for humans at the recommended therapeutic doses.

No teratogenic effects were seen in mice, rats or rabbits. Diclofenac has no influence on the fertility of parents (rats) or the pre-, peri- or postnatal development of young animals.

The various studies did not reveal any sign of phototoxicity or sensitisation of the skin induced by Voltaren Forte 2%.

Excipients: carbomers, cocoyl caprylocaprate, diethylamine, isopropanol, macrogol cetostearyl ether, oleic alcohol, paraffin, propylene glycol, fragrance (containing eucalyptus), antiox.: butylhydroxytoluene (E321), purified water.

Not applicable

36 Months

Do not use this medicine after the expiry date ("EXP") stated on the container.

Store at 30 °C.

Keep this medicine out of the sight and reach of children.

50 g and 100 g tubes [D]

Not applicable