VoltarenActigo Intense Gel 2% - Diclofenac - Anti-Pain - 30 g

1. NAME OF DRUG

VOLTARENACTIGO 2% INTENSE GEL

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Diethylamine diclofenac: 2.32 g Quantity of sodium diclofenac: 2.00 g Per 100g of gel. Dilutants with noticeable effect: Propyleneglycol (50mg/g of gel). Butylated hydroxytoluene (0.2mg/g of gel). To see a complete list of dilutants, see section 6.1.

3. PHARMACEUTICAL

FORM Gel.

4. CLINICAL DATA

4.1. Therapeutic Indications This is short-term treatment for adults and adolescents over 15 for benign traumas, sprains and bruises. 4.2. Dosage and how to use Dosage: 1 application twice per day (morning and evening). Length of treatment: Duration is capped at 4 days. How to use: Local use for adults and children over the age of 15 years old. External use only. Massage the gel softly into the painful and inflamed area. Wash hands after each application. 4.3. Contraindications This drug is not recommended in the following cases: - from the 25th week of amenorrhoea (beginning of the 6th month of pregnancy) (see section 4.)6) - allergy to diclofenac or one of the components of other NSAIDs - allergy to one of its components, - on damaged skin: weeping skin, eczema, infected skin, burns or wounds. - for a child under 15 years of age, 4.4. Special warnings and side effects Special warnings: Side effects cannot be annoyed when using VOLTARENACTIGO INTENSE GEL for a prolonged period of time over a large surface of skin. Do not apply onto mucous membranes or eyes. Apply only on the painful area. Immediately stop treatment if a skin reaction occurs. To avoid any risk of photosensitisation, avoid sun or UV exposure during treatment. Bronchospasm may be caused in patients with bronchial asthma, an allergic disease or an allergy to acetylsalicylic acid or other NSAIDs or with a history of these diseases. The gel should be used with caution in patients with or without chronic asthma, in whom asthma, urticaria or acute rhinitis are caused by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (see Section 4.3 Contraindications). To reduce the side effects it is recommended to use the minimal dose possible for the shortest amount of time to control symptoms. This medication should not be used underneath an occlusive dressing. VOLTARENACTIGO 2% INTENSE GEL should be used carefully by patients suffering from previous stomach ulcers, renal and hepatic insufficiency, haemorrhages or intestinal inflammation as these have been reported from taking diclofenac. This drug contains propyleneglycol and can cause local skin reactions. It also contains butylated hydroxytoluene (E320) which can cause local skin reaction (e.g. Eczema) or irritation in the eyes/ mucous membranes. Specific precautions for use: Given the lack of date for the effectiveness of this drug for children under 15, this gel is for adult use only (from 15 years). For intensive use it is recommended to wear gloves when applying the gel. If there is no improvement after 4 days consult your doctor. 4.5. Interactions with other drugs Due to the low systemic passage during normal use of the gel, reported drug interactions for diclofenac are unlikely. 4.6. Pregnancy and breast feeding (By extrapolation with other routes of administration) Pregnancy The inhibition of the prostaglandins synthesis can affect the 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 an inhibitor of prostaglandin synthesis in early pregnancy. The absolute risk of cardiovascular malformation increased from less than 1% to approximately 1.5%. The risk seems to increase depending on the dose and length of treatment. In animals, administration of an inhibitor of prostaglandin synthesis has been shown to result in increased pre- and post-implantation loss and increased embryo-foetal lethality. In addition, a higher incidence of certain malformations, including cardiovascular, has been reported in animals receiving an inhibitor of prostaglandin synthesis during the organogenesis phase of pregnancy. Unless absolutely necessary, diclofenac should not be used during the first 24 weeks of amenorrhoea (5 months of pregnancy). If diclofenac l is administered to a woman wishing to be pregnant or pregnant less than six months (or at least 5 months), the dose should be as low as possible and the treatment should be as short as possible. After 24 weeks of amenorrhoea (5 months) all inhibitors of prostaglandin synthesis can expose the foetus to: - Cardiopulmonary toxicity (premature closure of the ductus arteriosus and pulmonary arterial hypertension). - A renal dysfunction that can evolve towards a renal failure associated with an oligohydramnios. At the end of a pregnancy the mother and newborn can have: - An increase in bleeding time due to an anti-aggregating action which may occur even after administration of very low doses of drug; - Inhibition of uterine contractions resulting in delayed delivery or prolonged delivery. Therefore diclofenac is not recommended during the third trimester of pregnancy (from 24 weeks of amenorrhoea (5 months)). Breast feeding Diclofenac like all NSAIDS pass into human milk. For precautionary measures it is advisable to avoid using this gel during breast feeding. The diclofenac gel should not be applied onto the breasts of women who breast-feed. 4.7. Effects on the ability to drive and operate machinery Not applicable. 4.8. Side effects Rare cases of allergic reactions after application have occured. The side effects are classified in terms of frequency using the following rules: very frequent (≥ 1/10); frequent (≥ 1/100 à < 1/10); not that frequent (≥ 1/1 000 à < 1/100); rare (≥ 1/10 000 à < 1/1 000); ver rare (< 1/10 000), indeterminate frequency (cannot be estimated on with the available data). For each group the side effects are in order of decreasing severity: Infections Very rare: pustular outbreak Immune system disorders Very rare: hypersensitivity reactions (urticaria), angioedema. Respiratory, thoracic and mediastinal disorders Very rare: asthma among certain patients with an allergy to aspirin or other NSAIDs. In this case, this medication is not recommended. Skin and skin tissue disorders Frequent: dermatitis, outbreaks, erythema, eczema, itching. Rare: Bullous dermatosis. Very rare: itching, local ulcers, photosensitivity. Other effects of NSAIDs: depending on the transdermal passage of the active ingredient and therefore of the amount of gel applied, the surface treated, the degree of skin integrity, the duration of treatment and whether or not an occlusive dressing is used 4.9. Overdose In the case of an overdose, rinse thoroughly with water. In case of accidental ingestion, similar effects from an overdose can occur The appropriate therapeutic measures are those generally adopted in NSAID poisoning. A stomach wash and administration of activated charcoal should be considered, especially when the ingestion is recent.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmaco-dynamic properties NON-STEROIDAL ANTI-INFLAMMATORY. Code ATC: M02AA15 Diclofenac is a non-steroidal anti-inflammatory derived from phenylacetic acid from the group of arylcarboxylic acids. In gel form, it has anti-inflammatory and pain-killing properties. 5.2. Pharmacokinetics properties The transdermal passage of the active principle is proportional to the surface treated, the amount of gel applied and the degree of hydration of the skin. Local application in gel form, diclofenac is absorbed through the skin. After repeated administration, the systemic passage of the diclofenac gel dosed at 2.32% (2 applications per day) is equivalent to that of the gel at 1.16% (4 applications per day), for a dermal application on a surface of about 400 cm2. The relative bioavailability of diclofenac 2.32% (AUC ratio) relative to that of the oral form is 4.5% on day 7 (for an equivalent dose of diclofenac sodium). The concentrations measured in the synovial fluid, as well as in the synovial tissue, are 20 times higher than the plasma concentrations. 5.3. Preclinical safety data Preclinical data from acute and repeated dose toxicity studies, as well as genotoxicity and carcinogenicity studies with diclofenac, did not indicate a particular hazard to humans at therapeutic doses. No teratogenic effect has been detected with diclofenac on mice, rats or rabbits. Diclofenac had no effect on fertility in rats; the prenatal, perinatal and postnatal development of progeny was not affected. Studies have shown that diethylamine diclofenac 2.32 g / 100 g gel is well tolerated. No phototoxic effect was observed with diethylamine diclofenac 2.32 g / 100 g as a gel and the latter does not cause skin sensitisation.

6. PHARMACEUTICAL DATA

6.1. List of dilutants Butylated hydroxytoluene, carbomers, ester of caprylic & capric acids with fatty alcohol of C12-C18, diethylamine, isopropylic alcohol, liquid paraffin, ketostearyl ether of macrogol, oleic alcohol, propyleneglycol, eucalyptus perfume, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life 3 years. 30 days after opening. 6.4. Storage precautions Store in a place below 30°C. 6.5. Nature and contents of outside packaging 30 g tube (laminated aluminium); box of 1. 6.6. Precautions for handling and disposal No specific requirements.

7. THE MARKETING AUTHORISATION

HOLDER NOVARTIS SANTE FAMILIALE SAS 10 rue Louis Blériot 92500 RUEIL MALMAISON

8. NUMBER OF THE MARKETING AUTHORSATION HOLDER

· 274 075-8 or 34009 274 075 8 1: 1 laminated aluminium 30g tube. 9. START/RENEWEL DATE OF AUTHORISATION [To be completed by holder] 10. DATE OF UPDATE OF TEXT [To be completed by holder] 11. DOSIMETRY Not applicable. 12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION Not applicable. PRESCRIPTION AND DELIVERY CONDITIONS Drug not subjected to prescription.