FLECTOR EFFIGEL 1 % Gel bottle 50g

Diclofenac epolamine.................................................................................................................................1,293 g

Corresponding quantity of diclofenac sodium....................................................................................1,000 g

For 100 g of gel

Excipients with known effect: polyoxyethylene hydrogenated castor oil, soya lecithin (2,4 g per 100 g of gel), and Floral PH fragrance containing methyl benzoate, hydroxycitronellal, cinnamic alcohol, amyl cinnamal and benzyl salicylate.

Short-term local treatment, in adults and children over 15 years, in case of minor trauma: sprains, contusions.

Dosage

1 application, 3 times per day.

Duration of treatment

The duration of treatment is limited to 4 days.

Method of administration

Topical use - Reserved for adults and children over 15 years.

FOR EXTERNAL USE

Work the gel in with a gentle, prolonged massage over the painful or inflamed area.

Wash hands thoroughly after each use.

This medicine is contraindicated in the following cases:

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
• pregnancy, from the start of the 6th month (beyond 24 weeks of amenorrhoea) (see section Fertility, pregnancy and breastfeeding),
• damaged skin, whatever the lesion: weeping dermatoses, eczema, infected lesion, burn or wound.
• Use in patients allergic to peanut or soya is contraindicated.

• do not apply to mucous membranes, nor to the eyes; apply only to the painful area;
• the appearance of a skin rash after application requires immediate discontinuation of treatment;
• This medicine contains castor oil and may cause skin reactions.
• This medicine contains methyl benzoate which may cause local irritation.
• This medicine contains a perfume containing the following allergens which may cause allergic reactions: hydroxycitronellal, cinnamic alcohol, amyl cinnamal, methyl benzoate and benzyl salicylate.
• This medicine must not be used under an occlusive dressing.

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

Pregnancy

Inhibition of prostaglandin synthesis by NSAIDs may affect the course of pregnancy and/or the development of the embryo or foetus.

Risks associated with use during the 1st trimester

Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformations and gastroschisis after treatment with a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation rose from less than 1% in the general population to approximately 1,5% in persons exposed to NSAIDs. The risk appears to increase with dose and duration of treatment. In animals, administration of a prostaglandin synthesis inhibitor has been shown to cause increased pre- and post-implantation loss and an increase in embryo-fetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular ones, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenesis phase of gestation.

Risks associated with use from the 12th week of amenorrhoea until birth:

• From the 12th week of amenorrhoea and until birth, all NSAIDs, through inhibition of prostaglandin synthesis, may expose the foetus to functional renal impairment:
  •  in utero, which may be observed from 12 weeks of amenorrhoea (onset of fetal diuresis): oligohydramnios (most often reversible on stopping treatment), or even anhydramnios, particularly with prolonged exposure.
  • at birth, renal failure (reversible or not) may persist, particularly in cases of late and prolonged exposure (with a risk of delayed severe hyperkalaemia).

Risks associated with use beyond the 24th week of amenorrhoea until birth:

Beyond the 24th week of amenorrhoea, NSAIDs may expose the foetus to cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension). Constriction of the ductus arteriosus may occur from the beginning of the 6th month (beyond the 24th week of amenorrhea) and may lead to fetal or neonatal right heart failure or even intrauterine fetal death. This risk is all the greater the closer the intake is to term (lower reversibility). This effect exists even for a single intake.

At the end of pregnancy, the mother and the newborn may present:

-   prolonged bleeding time due to an antiaggregant action, which may occur even after administration of very low doses of the medicinal product;

-   inhibition of uterine contractions resulting in delayed labour or prolonged delivery.

Consequently:

Unless absolutely necessary, this medicine must not be prescribed to a woman who is planning a pregnancy or during the first 5 months of pregnancy (first 24 weeks of amenorrhea). If this medicine is administered to a woman wishing to become pregnant or who is pregnant for less than 6 months, the dose should be as low as possible and the duration of treatment as short as possible. Prolonged use is strongly discouraged.

From the beginning of the 6th month (beyond 24 weeks of amenorrhea): any intake of this medicine, even a single dose, is contraindicated. Accidental intake from this date warrants cardiac and renal, fetal and/or neonatal monitoring depending on the term of exposure. The duration of this monitoring will be adapted to the elimination half-life of the molecule

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.

Although the occurrence of such effects is very unlikely when using skin preparations such as FLECTOREFFIGEL, patients who have already suffered from dizziness or other central nervous system disorders while taking NSAIDs must refrain from driving vehicles or operating machinery.

Common:

Skin reactions: rashes, eczema; erythema, dermatitis (including contact dermatitis).

Rare:

Skin reactions: bullous dermatosis. Associated pruritus is sometimes observed.

Very rare and isolated cases:

Skin reactions: pustular rash, urticaria, purpura, local ulcerations.

Hypersensitivity reactions; angioneurotic edema (Quincke's edema).

Respiratory problems: the occurrence of an asthma attack may be linked, in some subjects, to an allergy to aspirin or to an NSAID. In this case, this medicine is contraindicated.

Other skin reactions: isolated cases of photosensitivity.

Unknown frequency:

Burning sensation at the application site, skin dryness.

Other systemic effects of NSAIDs:

They depend on the transdermal passage of the active substance and therefore on the quantity of gel applied, the area treated, the degree of skin integrity, the duration of treatment and whether or not an occlusive dressing is used (digestive, 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 reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: www.signalement-sante.gouv.fr.

In case of overdose, rinse thoroughly with water.

In the event of accidental ingestion, effects similar to those observed in cases of oral diclofenac overdose and resulting in adverse effects may occur. The therapeutic measures that are required are those generally adopted in cases of poisoning with NSAIDs. Gastric lavage and administration of activated charcoal should be considered, especially when ingestion is recent

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

Diclofenac is a non-steroidal anti-inflammatory drug, derived from phenylacetic acid of the arylcarboxylic acids group.

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

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

The systemic exposure 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.

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.

Preclinical data from acute and repeated-dose toxicity studies, as well as genotoxicity and carcinogenicity studies carried out with diclofenac, did not show any particular danger to humans at therapeutic doses.

In animals, administration of a prostaglandin synthesis inhibitor has shown an increase in pre- and post-implantation losses as well as embryo-fetal lethality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals after administration of a prostaglandin synthesis inhibitor during organogenesis.

Vial

3 years.

Tube

Before opening: 3 years.

After opening: 18 months.

Tube with ball applicator:

Before opening: 3 years After opening: 12 months

No special precautions for storage.

No special requirements.