Effigel Gel 1% - Diclofenac Epolamine - Sprains, Strains, Bruises - Flector - 50g

1. NAME OF THE MEDICINAL PRODUCT

FLECTOREFFIGEL 1%, gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Diclofenac epolamine.......................................................... 1,293 g Corresponding amount of diclofenac sodium............ 1,000 g Per 100 g of gel Excipients: castor oil, propylene glycol, methyl benzoate For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Gel.

4. CLINICAL DATA

4.1 Therapeutic indications Short-term local treatment in adults and children over 15 years of age for minor trauma: sprains, contusions. 4.2. Dosage and method of administration Dosage 1 application, 3 times a day. Duration of treatment The duration of treatment is limited to 4 days. Mode of administration Local use - For adults and children over 15 years of age only. EXTERNAL USE Gently massage the gel into the painful or inflamed area for a prolonged period. Wash hands thoroughly after each use. 4.3. Contraindications This medicine is contraindicated in the following cases: - hypersensitivity (allergy) to diclofenac, to substances with similar activity such as other NSAIDs, aspirin or to any of the excipients contained in FLECTOREFFIGEL; - from the beginning of the 6th month of pregnancy (see section 4.6); - damaged skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds 4.4. Special warnings and precautions for use Special warnings : - do not apply to mucous membranes or eyes; apply only to the painful area; - the appearance of a rash after application requires immediate discontinuation of treatment; - this medicinal product contains propylene glycol and may cause skin reactions; - due to the presence of methyl benzoate, this medicinal product may cause irritation of the skin, eyes and mucous membranes. Precautions for use : - This medicinal product must not be used under occlusive dressings. 4.5. Interactions with other medicinal products and other forms of interaction Due to the low systemic passage during normal use of the gel, the drug interactions reported for diclofenac per os are unlikely. 4.6. Pregnancy and lactation Pregnancy Inhibition of prostaglandin synthesis may affect the course of pregnancy and/or the development of the embryo or foetus. Data from epidemiological studies suggest an increased risk of miscarriage, heart defects and gastroschisis after treatment with a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. 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 increased embryo-fetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular malformations, has been reported in animals given a prostaglandin synthesis inhibitor during the organogenesis phase of gestation. Therefore, unless absolutely necessary, diclofenac should not be prescribed during the first 24 weeks of amenorrhea (5 months of pregnancy). If diclofenac is administered to a woman who wishes to become pregnant or is less than 6 months pregnant, the dose should be as low as possible and the duration of treatment as short as possible.After 24 weeks of amenorrhea (5 months of age), all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure associated with oligohydramnios; At the end of pregnancy, the mother and the newborn may present : - prolongation of bleeding time due to an anti-aggregation action that may occur even after very low doses of the drug; - inhibition of uterine contractions leading to delayed term or prolonged delivery. Consequently, diclofenac is contraindicated in the third trimester of pregnancy beyond 24 weeks of amenorrhea (5 months). Breastfeeding Diclofenac, like all NSAIDs, passes into breast milk. As a precautionary measure, diclofenac should not be given to a nursing woman. Diclofenac gel should not be applied to the breasts of nursing mothers if the situation warrants its use. 4.7. Effects on ability to drive and use machines Although the occurrence of such effects is very unlikely when using skin preparations such as FLECTOREFFIGEL, patients who have previously experienced dizziness or other central nervous system disorders while taking NSAIDs should not drive or use machines. 4.8. Common adverse reactions: Skin reactions: rash, 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 oedema (angioedema). Respiratory problems: the occurrence of asthma attacks may be related in some individuals to an allergy to aspirin or NSAIDs. In this case, this medicine is contraindicated. Other skin reactions: isolated cases of photosensitivity. 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, renal effects). Reporting of suspected adverse reactions Reporting of suspected adverse reactions after authorisation of the drug is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Health professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr 4.9. Overdose In case of overdose, rinse with plenty of water. In case of accidental ingestion, effects similar to those observed in case of overdose of oral diclofenac and resulting in adverse reactions may occur. The appropriate therapeutic measures are those generally adopted in cases of NSAID poisoning. Gastric lavage and the administration of activated charcoal should be considered, especially when ingestion is recent.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties Pharmacotherapeutic class: NON-STEROIDIC ANTIINFLAMMATORY FOR TOPICAL USE. ATC Code: M02AA15 Diclofenac is a non-steroidal anti-inflammatory drug, derived from phenylacetic acid of the arylcarboxylic acid group. In gel form, it has local anti-inflammatory and analgesic activity. 5.2. Pharmacokinetic properties When applied topically as a gel, diclofenac is absorbed through the skin. The systemic uptake of the gel, relative to that of oral forms of diclofenac in healthy volunteers, is in the order of 6%, based on estimates of urinary excretion and that of its hydroxylated metabolites, after single administration. The systemic passage of the gel, relative to that of oral forms of diclofenac in healthy volunteers, is about 13.9% after repeated administration. The concentrations measured in synovial fluid, as well as in synovial tissue, are 40 times higher than plasma concentrations. 5.3. Preclinical safety data Preclinical data from acute and repeated dose toxicity studies, genotoxicity and carcinogenicity studies conducted with diclofenac have not shown any particular hazard to humans at therapeutic doses. In animals, administration of a prostaglandin synthesis inhibitor has shown an increase in pre- and post-implantation loss and 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.

6. PHARMACEUTICAL DATA

6.1. List of excipients Macroglycerol hydroxystearate, macroglycerol stearate, soya lecithin, polymerised acrylic acid, sodium hydroxide, isopropanol, Floral PH* fragrance, purified water. * Main components of Floral PH fragrance: benzyl acetate, phenylethyl alcohol, hydroxycitronellal, petit grain oil paraguay, cinnamic alcohol, propylene glycol, methyl benzoate. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 6.4. Special precautions for storage No special precautions for storage. 6.5. Nature and contents of the outer packaging 50 g (varnished aluminium tube) 60 g (varnished aluminium tube) 100 g (varnished aluminium tube) 50 g in a bottle (aluminium) consisting of 50 g of gel in a laminated "bag" made up of 4 layers (polyester - aluminium - polyamide - linear low-density polyethylene) contained under air pressure in an aluminium bottle fitted with a polypropylene dispensing head. 60 g in a bottle (aluminium) consisting of 60 g of gel in a laminated "bag" made up of 4 layers (polyester - aluminium - polyamide - linear low density polyethylene) contained under air pressure in an aluminium bottle fitted with a polypropylene dispensing head. 100 g in a bottle (aluminium) consisting of 100 g of gel in a laminated "bag" made up of 4 layers (polyester - aluminium - polyamide - linear low density polyethylene) contained under air pressure in an aluminium bottle fitted with a polypropylene dispensing head. 6.6. Special precautions for disposal and handling No special requirements.

7. MARKETING AUTHORISATION HOLDER

LABORATOIRES GENEVRIER SA 280, RUE DE GOA LES TROIS MOULINS - PARC DE SOPHIA ANTIPOLIS 06600 ANTIBES

8. MARKETING AUTHORISATION NUMBER(S)

- 277 212-6 or 34009 277 212 6 7 : 1 varnished aluminium tube(s) of 50 g. - 277 213-2 or 34009 277 213 2 8 : 1 varnished aluminium tube(s) of 60 g. - 277 214-9 or 34009 277 214 9 6 : 1 varnished aluminium tube(s) of 100 g. - 277 215-5 or 34009 277 215 5 7 : 1 aluminium bottle(s) of 50 g. - 277 216-1 or 34009 277 216 1 8 : 1 aluminium bottle(s) of 60 g. - 277 217-8 or 34009 277 217 8 6: 1 aluminium vial(s) of 100 g. 9. DATE OF FIRST AUTHORISATION/renewal OF AUTHORISATION [to be completed by the holder] 10. DATE OF UPDATE OF TEXT [to be completed by the holder] 11. DOSIMETRY Not applicable. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS Not applicable. CONDITIONS OF PRESCRIPTION AND DELIVERY Medicinal product not subject to medical prescription.