FLECTOR 1 % Gel tube 60g

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 perfume containing methyl benzoate, hydroxycitronellal, cinnamic alcohol, amyl cinnamal and benzyl salicylate.

• Tendinitis of the upper and lower limbs.
• Post-operative and post-traumatic oedema.

Dosage

• Sprains: 2 to 4 applications per day.
• Tendinitis: 3 to 4 applications per day.

Elderly patients

This medicine should be used with caution in elderly people, who are more prone to undesirable effects.

Children

The use of the product in children has not been evaluated and is therefore not recommended.

Renal or hepatic impairment

For use of FLECTOR 1 PERCENT, gel in patients with renal or hepatic impairment, see section Warnings and precautions.

Treatment is limited to 5 days, in the absence of medical prescription.

If there is no improvement during the recommended treatment duration, a doctor must be consulted.

Method of administration

Topical use - Reserved for adults.

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.
• allergy to diclofenac or substances with close activity such as other NSAIDs, aspirin;
• allergy to any of the excipients;
• pregnancy, from the beginning of the 6th month (beyond 24 weeks of amenorrhea) (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 soy is contraindicated.

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.
• FLECTOR 1 PERCENT, gel must be used only on healthy skin.
• In order to reduce any risk of photosensitization, patients must be informed to avoid any exposure to solar radiation (sun or UV booths).
• Do not use under an occlusive dressing.
• Bronchospasms may be provoked in patients with bronchial asthma, an allergic disease or an allergy to acetylsalicylic acid or to another NSAID, or with a history of these conditions. The gel should be used with caution in patients with or without chronic asthma, in whom asthma attacks, urticaria or acute rhinitis are provoked by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (see section Contraindications). In order to minimize the occurrence of adverse effects, it is recommended to use the minimum effective dose to control symptoms for the shortest possible period.
• Although the occurrence of systemic adverse effects is rare, the gel should be used with caution in patients with impaired renal, cardiac or hepatic function, in patients with a history of peptic ulcer, inflammatory bowel disease or gastrointestinal bleeding. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly people, who are more prone to adverse effects.

Precautions for use

• Diclofenac, administered as a gel, is reserved for adults, in the absence of specific safety studies conducted in children;
• Wearing gloves by the physiotherapist, in case of intensive use, is recommended.
• 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.

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 women 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-foetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular, has been reported in animals that received a prostaglandin synthesis inhibitor during the organogenesis phase of gestation.

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

• From the 12^th week of amenorrhoea and until birth, all NSAIDs, through inhibition of prostaglandin synthesis, may expose the foetus to a functional renal impairment:
  • in utero, which may be observed from 12 weeks of amenorrhea (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 amenorrhea until birth:

Beyond the 24^th 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 6^th month (beyond the 24^th 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:

• prolongation of bleeding time due to an anti-aggregant 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 planning a pregnancy or during the first 5 months of pregnancy (24 first 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 must be as low as possible and the duration of treatment as short as possible. Prolonged use is strongly discouraged.

From the beginning of the 6^th months (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

Like all NSAIDs, use of this medicinal product may temporarily impair female fertility by affecting ovulation; it is therefore not recommended in women wishing to conceive. In women having difficulty conceiving or undergoing fertility investigations, discontinuation of treatment should be considered.

• Adverse effects related to the route of administration:
  • rare cutaneous allergic reactions such as pruritus or localized erythema.
• Hypersensitivity reactions
  • dermatological;
  • respiratory: the occurrence of an asthma attack may be linked, in some subjects, to an allergy to aspirin or an NSAID. In this case, this medicine is contraindicated;
  • general: anaphylactic-type reactions;
  • due to the presence of methyl benzoate, irritation of the skin, eyes and mucous membranes (depending on the site of application);
  • due to the presence of propylene glycol, risk of contact eczema.
• Other systemic effects of NSAIDs: these depend on the transdermal passage of the active ingredient and therefore on the quantity of gel applied, the surface area treated, the degree of skin integrity, the duration of treatment and whether or not an occlusive dressing is used (digestive and renal effects).
  • Unknown frequency:
    Burning sensation at the application site, skin dryness.

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 case of accidental ingestion, effects similar to those observed in cases of oral diclofenac overdose and resulting in adverse effects may occur. The therapeutic measures 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: TOPICAL NON-STEROIDAL ANTI-INFLAMMATORY DRUG, ATC code: M02AA15

(M: musculoskeletal system).

Diclofenac is a non-steroidal anti-inflammatory drug derived from phenylacetic acid of the aryl carboxylic 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 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.

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.

The systemic passage of the gel compared with that of oral forms of diclofenac in healthy volunteers is of the order of 6 percent, estimated from its urinary excretion and that of its hydroxylated metabolites.

Vial

3 years.

Tube

Before opening: 3 years.

After opening: 18 months

No special precautions for storage.

No special requirements.

Not applicable>