Diclofenac Mylan becomes Viatris 1%, Diclofenac, Pressurised pump bottle, 100g

1. NAME OF DRUG DICLOFENAC 1%, gel in pressurised bottle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diethylamine diclofenac: 1.16 g Quantity of sodium diclofenac: 1.00 g Per 100g of gel. Dilutant: propyleneglycol (5g per 100g of gel). To see a complete list of dilutants, see section 6.1. 3. PHARMACEUTICAL FORM Gel. White, smooth, shiny gel. 4. CLINICAL DATA 4.1. Therapeutic Indications - Tendinitis - Post-traumatic/operation oedema. - Symptomatic treatment of painful finger/knee arthritis. 4.2. Dosage and how to use Dosage: - Tendinitis: 3-4 applications per day. - Post-traumatic/operation oedema: : 2-4 applications per day. Each application is 2.5g og gel (approx. 6cm of gel). - Symptomatic treatment of painful finger/knee arthritis: 3-4 applications per day. Each application is 4 g og gel (approx. 10 cm of gel). How to use Local application - only for adults. Massage the gel softly into the painful and inflamed area. Wash hands after each use (except from when applying onto fingers). Elderly patients Older patients should be careful when using this gel as it can lead to an increase in side effects. Children This product has not been tested so it is not recommended for children. Renal & Hepatic Insufficiency See section 4.4 for patients suffering with this. Treatment is limited to 5 days without medical prescription. Inform your doctor is there is no improvement during the treatment. 4.3. Contraindications This drug is not recommended in the following cases: - from the 6th month into pregnancy (see section 4.6). - allergy to diclofenac or another NSAID, aspirin. - allergy to one of its components, - on damaged skin: weeping skin, eczema, infected skin, burns or wounds. 4.4. Special warnings and side effects Special warnings Do not apply onto mucous membranes or eyes. Immediately stop treatment if a skin reaction occurs after application. - this gel must be applied onto clean skin. - to reduce the risk of photosensitisation avoid sun and UV exposure. - do not apply underneath an occlusive dressing. - bronchospasm can occur for those who suffer from asthma or are allergic to acetylsalicylic acid or another NSAID pathology. The gel should be used with caution by 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 minimize the occurrence of side effects, it is recommended that the minimum effective dose used to control symptoms for the shortest possible period of time. Although systemic side effects are rare, the gel should be used with caution by patients with impaired renal, cardiac or hepatic function in patients with a history of gastrointestinal ulcer disease Intestinal inflammatory or digestive bleeding. Non-steroidal anti-inflammatory drugs should be used with particular caution by elderly people who are more prone to the side effects. Specific precautions for use Diclofenac used in the form of a gel is only suitable for adults. It you use the gel a lot it is recommended to wear gloves when applying it. This drug contains propyleneglycol and can cause local skin reactions. 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 Via extrapolation with other ways of taking. 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 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 Frequent cases Skin reactions: outbreaks, eczema, erythema, dermatitis. Rare cases Skin reactions: bullous dermatosis. Itching can also occur. Very rare cases Skin reactions: pustuler outbreak, urticaria, itching, local ulcers. Hypersensitivity reactions: angioedema. Respiratory difficulties: asthma for patients allergic to aspirin or another NSAID. in this case this gel should not be used. Other skin reactions: 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 Declaration of suspected side effects The declaration of suspected side effects after drug authorisation is important. It allows continuous observation into the benefits/risks of the drug. Health professionals declare all suspected side effects via the national system of declaration: The ANSM and the network of Regional Centres of Pharmacovigilance- website www.ansm.sante.fr. 4.9. Overdose In 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. In a randomised, double-blind, placebo-controlled study on 238 patients with knee osteoarthritis, an average improvement in pain on an analogue visual scale (100 mm EVA) of 14 mm in the diclofenac gel group was observed between J1 and J14 compared with 10 Mm in the placebo group. This difference is statistically significant (p = 0.02). 5.2. Pharmacokinetics properties Local application in gel form, diclofenac is absorbed through the skin. The systemic passage of the gel compared to that of the oral forms of diclofenac in healthy volunteers is about 6%, based on its urinary excretion and that of its hydroxylated metabolites after a single dose. The systemic passage of the gel compared to that of the oral forms of diclofenac in healthy volunteers is of the order of 13.9% after repeated administration. The concentrations measured in the synovial fluid, as well as in the synovial tissue, are 40 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 1.16 g / 100 g gel is well tolerated. No phototoxic effect was observed with diethylamine diclofenac 1.16 g / 100 g as a gel and the latter does not cause skin sensitisation. 6. PHARMACEUTICAL DATA 6.1. List of dilutants Isopropylic alcohol, propyleneglycol, cocoyl caprylocaprate, liquid paraffin, cetomacrogol 1000, carbomer 974 P, diethylamine, lavender essential oil, purified water. 6.2. Incompatibilities Not applicable. 6.3. Shelf life Before opening: 3 years. After first opening: 6 months. 6.4. Storage precautions Under pressure: Avoid sun exposure and keep in a cool place under 30°C. To not pierce, throw in fire, even when empty. After the first opening: Store in a place below 30°C. 6.5. Nature and contents of outside packaging 50 ml / 100 ml pressurised vial (PE/Alumunium). Not all pack sizes will be available. 6.6. Precautions for handling and disposal No specific requirements. 7. THE MARKETING AUTHORISATION HOLDER LABORATOIRES CHEMINEAU 93, ROUTE DE MONNAIE BP 16 37210 VOUVRAY 8. NUMBER OF THE MARKETING AUTHORSATION HOLDER · 274 188-7 or 34009 274 188 7 7: 50 ml pressurised vial (PE/Alumunium). · 274 189-3 or 34009 274 189 3 8: 100 ml pressurised vial (PE/Alumunium). 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.