VoltarenSpé Gel 1% - Diclofenac - Tendinitis, arthritis, oedema - 100g

1. NAME OF THE MEDICINAL PRODUCT

VOLTARENSPE 1%, gel

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Diethylamine diclofenac ................................................................ 1.16 g Quantity corresponding to diclofenac sodium ................................... 1.00 g Per 100 g. For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Gel.

4. CLINICAL DATA

4.1 Therapeutic indications - Upper and lower limb tendonitis. - Post-operative and post-traumatic oedema. - Symptomatic treatment of painful arthrosis of the fingers and knees. 4.2. Posology and method of administration Posology - Tendonitis: 3 to 4 applications per day. - Post-operative and post-traumatic oedema (sprain, etc.): 2 to 4 applications per day. The dose administered for each application is about 2.5 g of gel (i.e. about 6 cm of gel). - Painful osteoarthritis of the fingers and knees: 3 to 4 applications per day. The dose administered for each application is about 4 g of gel (about 10 cm of gel). Method of administration Local use - For adults only. Apply the gel by gentle and prolonged massage to the painful or inflammatory area. Wash hands thoroughly after each use (except in the case of self-application for painful digital arthritis). Elderly: This drug should be used with caution in the elderly who are more prone to adverse reactions. Children: The use of the product in children has not been evaluated and is not recommended. Renal or hepatic impairment: For use in patients with renal or hepatic impairment, see section 4.4. Treatment is limited to 5 days in the absence of a medical prescription. If there is no improvement during the recommended treatment period, a doctor should be consulted. 4.3. Contraindications This medicine is contraindicated in the following cases: - Allergy to diclofenac or substances with similar activity such as other NSAIDs, aspirin, - Allergy to one of the excipients, - Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesion, burn or wound. 4.4. Special warnings and precautions for use Special warnings Do not apply to mucous membranes or to the eyes. If a rash appears after application, the treatment must be stopped immediately. - This medicine should only be used on healthy skin. - In order to reduce the risk of photosensitisation, patients should be advised to avoid exposure to sunlight (sun or UV booth). - Do not use under occlusive dressing. - Bronchospasm may occur in patients with bronchial asthma, allergic disease or allergy to acetylsalicylic acid or other NSAIDs or a history of these conditions. The gel should be used with caution in patients with or without chronic asthma, in whom attacks of asthma, urticaria or acute rhinitis are caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (see section 4.3). In order to minimise the occurrence of adverse reactions, it is recommended that the minimum effective dose be used to control symptoms for the shortest possible time. Although the occurrence of systemic adverse reactions is rare, the gel should be used with caution in patients with impaired renal, cardiac or hepatic function, in patients with a history of gastrointestinal ulcer, inflammatory bowel disease or gastrointestinal bleeding. Non-steroidal anti-inflammatory drugs should be used with particular caution in the elderly who are more prone to adverse reactions. Precautions for use - Diclofenac, administered as a gel, is reserved for adults, in the absence of specific safety studies in children. - The wearing of gloves by the physiotherapist, in case of intensive use, is recommended. - This medicinal product contains propylene glycol and may cause skin irritation. 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 By extrapolation to other routes of administration.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 wishing to become pregnant or who is less than six 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 arterial hypertension); - renal dysfunction that 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 Not applicable. 4.8. Adverse reactions Common : Skin reactions: rash, eczema; erythema, dermatitis (including contact dermatitis). Rare: Skin reactions: bullous dermatitis. Associated pruritus is sometimes seen. Very rare and isolated cases: Skin reactions: pustular rash, urticaria, purpura, local ulcerations. Hypersensitivity reactions: angioneurotic oedema (angioedema). Respiratory problems: the occurrence of an asthma attack may be related in some individuals to an allergy to aspirin or an NSAID. 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 the 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. In a randomised, double-blind, placebo-controlled study in 238 patients with gonarthrosis, a mean improvement in pain on a visual analogue scale (VAS 100 mm) of 14 mm was observed between D1 and D14 in the Diclofenac gel group, compared with 10 mm in the placebo group. This difference was statistically significant (p=0.02). 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 about 6%, based on estimates of urinary excretion and 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 Acute toxicity, repeated dose toxicity, genotoxicity and carcinogenicity studies did not reveal any risk from the use of diclofenac at therapeutic doses in humans. Diclofenac was not found to have teratogenic potential in mice, rats or rabbits. Diclofenac had no effect on fertility in rats; prenatal, perinatal and postnatal development of the offspring was not affected. Studies have shown that diethylamine diclofenac 1.16 g/100 g gel is well tolerated. Diethylamine diclofenac 1.16 g/100 g gel has not been shown to have phototoxic potential in mice and guinea pigs and does not cause skin sensitization when tested in guinea pigs.

6. PHARMACEUTICAL DATA

6.1. List of excipients Diethylamine, carbomer (carbopol 974 P), cetomacrogol 1000, caprylic and capric acid ester with C12-C18 fatty alcohol (CETIOL LC), isopropyl alcohol, liquid paraffin, cream fragrance 45*, propylene glycol, purified water. *Composition of cream fragrance 45: lavandin essential oil, Brazilian rosewood essential oil, lavender essential oil, benzyl alcohol, terpenyl acetate, geraniol. 6.2. Incompatibilities Not applicable. 6.3. Shelf life Before first opening: 3 years. 6 months after opening. 6.4. Special storage precautions Store at a temperature not exceeding 25°C for the varnished aluminium tube. The aluminium laminate tube should be stored at a temperature not exceeding 30°C. 6.5. Nature and contents of outer packaging 50 g or 100 g in a coated aluminium tube or aluminium laminate tube; box of 1. All presentations may not be marketed. 6.6. Special precautions for disposal and handling No special requirements.

7. MARKETING AUTHORISATION HOLDER

NOVARTIS SANTE FAMILIALE SAS 14, BOULEVARD RICHELIEU 92500 RUEIL-MALMAISON

8. MARKETING AUTHORISATION NUMBER(S)

- 372 301-2: 100 g in tube (aluminium laminate); box of 1. 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.