DICLOFENAC VIATRIS 1 % Gel en fl pressurisé Fl/100ml

Gel.

Soft, white, shiny and homogeneous gel with an isopropanol odour.

Diclofenac diethylamine .........................................................................................................................1,16 g

Quantity corresponding to diclofenac sodium .........................................................................................1,00 g

For 100 g of gel.

Excipient(s) with known effect: propylene glycol (E1520) (5 g per 100 g of gel).

Allergens contained in the fragrance: benzyl alcohol, benzyl benzoate, citral, coumarin, limonene, farnesol, geraniol, linalool.

Excipients:

In adults (from 15 years of age):

• Short-term local treatment of minor trauma: sprain (strain), contusion,

• Adjunctive local treatment of pain of muscular and tendino-ligamentous origin,

• Symptomatic treatment of painful flare-ups of osteoarthritis, after at least one medical opinion.

Dosage

Reserved for adults (from 15 years of age).

The dosage depends on the indication. The occurrence of undesirable effects can be minimised by using the lowest possible dose for the shortest treatment duration necessary to relieve symptoms (see section Warnings and precautions).

Minor trauma: sprain, contusion

1 local application, 2 to 3 times a day, for a maximum duration of 4 days. If the pain persists beyond this, a doctor must be consulted.

On medical advice, the maximum duration of treatment is 7 days.

The dose administered with each application must not exceed 2,5 g of gel (i.e. approximately 6 cm of gel).

Pain of muscular and tendinous-ligamentous origin

As adjunctive treatment: 1 local application, 3 to 4 times a day, for a maximum duration of 7 days. If the pain persists beyond this, a doctor must be consulted.

On medical advice, the maximum duration of treatment is 14 days.

The dose administered with each application must not exceed 2,5 g of gel (i.e. approximately 6 cm of gel).

Painful flare-ups of osteoarthritis

Only after at least one medical opinion.

1 local application, 3 to 4 times a day, for a duration of 7 days. Treatment may be continued, if necessary, for a maximum duration of 14 days. If the pain persists beyond this, a doctor must be consulted.

The dose administered with each application must not exceed 4 g of gel (i.e. approximately 10 cm of gel).

Special populations

Paediatric population

This medicine is contraindicated in children aged under 15 years (see section Contraindications).

Elderly patients

This medicine should be used with caution in elderly people who are more prone to adverse effects (see sections Warnings and precautions and Adverse effects).

Method of administration

Topical use.

Apply the gel to the affected areas of the body and work the gel in with gentle massage. Then, the hands must be wiped with paper towel and washed, unless the hands are the area being treated.

If too much gel is accidentally applied, the excess should be wiped off with paper towel.

The paper towel should be thrown in the bin to prevent unused product from ending up in the aquatic environment.

Before applying a dressing, allow the gel to dry for a few minutes in the open air.

This medicine is contraindicated in the following cases:

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition,

• Allergy to diclofenac or substances with similar activity such as other NSAIDs, aspirin,

• Pregnancy, from the beginning of the 6th month (24 weeks of amenorrhoea) (see section Fertility, pregnancy and breastfeeding),

• Damaged skin, whatever the lesion: weeping dermatoses, eczema, infected lesion, burn or wound,

• History of asthma, angioedema, urticaria or acute rhinitis triggered by diclofenac or a substance with similar activity such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),

• In children and adolescents under 15 years of age.

Special warnings

Do not apply to mucous membranes, nor to the eyes.

The appearance of a skin rash after application requires immediate discontinuation of treatment.

Special precautions for use

Wearing gloves by the physiotherapist is recommended in case of intensive use.

Excipients

This medicine contains 20 mg of propylene glycol (E1520) per dose of 4 g of gel (equivalent to approximately 10 cm).
Propylene glycol may cause skin irritation. This medicine contains propylene glycol; do not use it on open wounds or large areas of damaged or injured skin (such as burns) without informing your doctor or pharmacist.

Due to the presence of benzyl benzoate, this medicine may cause irritation of the skin, eyes and mucous membranes.

This medicine contains a perfume containing the following substances: benzyl alcohol, benzyl benzoate, citral, coumarin, limonene, farnesol, geraniol and linalool. These substances may cause allergic reactions.

Due to the low systemic absorption during normal use of the gel, drug interactions reported for oral diclofenac are unlikely.

Pregnancy

There are no clinical data on the use of DICLOFENAC VIATRIS 1 %, gel in pressurised container during pregnancy. Even though systemic exposure to DICLOFENAC VIATRIS 1 %, gel in pressurised container after topical administration is lower compared with that observed following oral administration, the risk of possible harmful effects in the embryo or foetus is not known.

During the first 5 months of pregnancy, DICLOFENAC VIATRIS 1 %, gel in pressurised container must not be used unless absolutely necessary. If used, the dose must be the lowest and the duration of treatment as short as possible.

From the beginning of the 6th month of pregnancy (24 weeks of amenorrhea), systemic use of prostaglandin synthesis inhibitors such as diclofenac may induce cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding time in the mother and child may occur, and labor may be delayed.

Consequently, any use of DICLOFENAC VIATRIS 1 %, gel in pressurised container, is contraindicated from the beginning of the sixth month of pregnancy (24 weeks of amenorrhoea) (see section Contraindications.).

Breast-feeding

As NSAIDs pass into breast milk, this medicine is not recommended for women who are breastfeeding.

In case of breastfeeding, this medicine must under no circumstances be applied to the breast.

Fertility

As with all NSAIDs, the use of this medicine may temporarily impair female fertility by affecting ovulation; it is therefore not recommended for women wishing to conceive a child. In women having difficulty conceiving or undergoing fertility testing, discontinuation of treatment should be considered.

Undesirable effects are classified by decreasing frequency, according to the following conventions: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10 000 to < 1/1000); very rare (< 1/10 000), frequency not known: cannot be estimated from the available data. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System organ class	Adverse reaction	Frequency
Infections and infestations	Pustular rash	Very rare
Immune system disorders	Angioedema (Quincke's edema hypersensitivity reactions (including urticaria)	Very rare
Respiratory, thoracic and mediastinal disorders	Asthma attack*	Very rare
Skin and subcutaneous tissue disorders	Dermatitis (including contact dermatitis), skin rashes, erythema, eczema, pruritus.	Common
	Bullous dermatitis	Rare
	Photosensitivity reactions, purpura and local ulceration	Very rare
	Burning sensation at the application site, skin dryness.	Frequency not known

 

*The occurrence of an asthma attack may in some patients be related to an allergy to aspirin or an NSAID. In this case, this medicinal product is contraindicated.

Other systemic effects of NSAIDs : they depend on the transdermal passage of the active ingredient and therefore on the quantity of gel applied, the surface treated, the degree of skin integrity, the duration of treatment and whether or not an occlusive dressing is used (digestive and renal effects).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Centres of Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/.

In case of overdose, wipe off excess gel with absorbent paper then rinse thoroughly with water.

In case of accidental or voluntary ingestion, effects similar to those observed in cases of oral diclofenac overdose and resulting in adverse effects may occur. The necessary therapeutic measures are those generally adopted in cases of poisoning with NSAIDs. The recommendations to follow will be those indicated by the regional Poison Control Centre, depending on the quantities ingested and the characteristics of the patient.

Pharmacotherapeutic class: NON-STEROIDAL ANTI-INFLAMMATORY DRUG FOR TOPICAL USE, ATC code: M02AA15.

Diclofenac is a non-steroidal anti-inflammatory drug (NSAID), derived from phenylacetic acid of the arylcarboxylic acid group, with analgesic, anti-inflammatory and antipyretic properties. As with all NSAIDs, the exact mechanism of action of diclofenac is not fully elucidated but is essentially based on the inhibition of prostaglandin biosynthesis, substances playing a major role in the genesis of inflammation, pain and fever, through the inhibition of the two cyclooxygenases (COX-1 and COX-2).

In the form of a gel, it has local anti-inflammatory and analgesic activity.

Applied locally in the form of a gel, diclofenac is absorbed through the skin.

Absorption

The quantity of diclofenac absorbed through the skin is proportional to the treated surface area and depends both on the total dose applied and on the degree of skin hydration.

The systemic passage of the gel, compared with that of oral forms of diclofenac in healthy volunteers, is of the order of 6 %, estimated from its urinary excretion and that of its hydroxylated metabolites, after single administration. Occlusion for 10 hours leads to a threefold increase in the quantity of diclofenac absorbed.

The systemic passage of the gel, compared with that of oral forms of diclofenac in healthy volunteers, is of the order of 13,9 % after repeated administration.

The concentrations measured in synovial fluid, as well as in synovial tissue, are 40 times higher than plasma concentrations.

Distribution

Diclofenac concentrations were measured in plasma, synovial tissue and synovial fluid after local administration of the gel on the joints of the hand and knee. Maximum plasma concentrations are approximately 100 times lower than those measured after oral administration of the same quantity of diclofenac. 99,7 % of diclofenac is bound to serum proteins, mainly albumin (99,4 %).

Diclofenac accumulates in the skin, which acts as a reservoir from which the medicinal product is released in a sustained manner into the underlying tissues. From there, diclofenac is distributed and persists preferentially in deep inflamed tissues, such as the joint, where it is found at concentrations up to 20 times that measured in plasma.

Biotransformation

The biotransformation of diclofenac involves in part glucuronide conjugation of the intact molecule, but essentially single and multiple hydroxylation of several phenolic metabolites, the majority of which are converted into glucuronide conjugates. Two of the phenolic metabolites are biologically active, but to a lesser extent compared with diclofenac.

Elimination

The total systemic clearance of diclofenac from plasma is 263 ± 56 ml/min. The terminal plasma half-lives are 1 to 2 hours. Four of the metabolites, including the two active metabolites, also have short plasma half-lives ranging between 1 and 3 hours. One metabolite, 3'-hydroxy-4'methoxy-diclofenac, has a longer half-life but is practically inactive. Diclofenac and its metabolites are excreted mainly in urine.

Characteristics in patients

No accumulation of diclofenac and its metabolites is expected in patients with renal impairment. In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in patients without hepatic impairment.

Acute toxicity, repeated-dose toxicity, genotoxicity and carcinogenicity studies did not reveal any risk related to the use of diclofenac at therapeutic doses in humans. No teratogenic potential of diclofenac was detected in mice, rats or rabbits. Diclofenac had no effect on fertility in rats; the prenatal, perinatal and postnatal development of the offspring was not affected.

Studies have shown that diethylamine diclofenac 1,16 g/100 g in the form of a gel is well tolerated. No phototoxic potential was observed in mice and guinea pigs with diethylamine diclofenac 1,16 g/100 g in the form of a gel, and the latter does not cause skin sensitisation in guinea pig tests.

Before opening: 3 years.

After first opening: 6 months.

Pressurized container:

Protect from sunlight, do not expose to temperatures above 30°C.

Do not puncture, do not throw into fire, even when empty.

After 1 opening: Store at a temperature not exceeding 30°C.

No special requirements.

Marketing authorisation (AMM)

CIP 3400927418938 (Fl/100ml).

Price:

2,62 euros (Fl/100ml).

Social Security reimbursement at 30% under the indications:

• Indication(s) appearing in the marketing authorisation at the date of publication of this decree

Collection.