SUMMARY OF PRODUCT CHARACTERISTICS

Transcription

1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT SULIDIN 1 % Topical Gel 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Nimesulide 1% Excipients: For excipients see PHARMACEUTICAL FORM Topical Gel Light yellowish colored gel with characteristic odour 4. CLINICAL PARTICULARS 4.1. Therapeutic indications SULIDIN is indicated in the treatment of following: - Conditions such as strain, contusion or pain, inflammation and swelling due to sports injuries; - Localized soft tissue rheumatic diseases such as tendovaginitis, bursitis, shoulder-hand syndrome and peri- arthropathy; - Localized rheumatic diseases such as osteoarthritis of peripheral joints and vertebral column Posology and method of administration Posology / Frequency and duration of administration Unless advised otherwise by a physician, it should be applied to the affected site 2 or 3 times per day. However it may vary depending on the size of the affected area and response. Duration of treatment is 7-15 days. Method of administration: SULIDIN is purposed for external use only. No occlusive dressing should be employed. Do not rub vigorously. Additional information about special populations: 1

2 Renal / Liver failure SULIDIN should be used carefully in patients with renal / liver disorders. Pediatric population: Dosage recommendations and indications for use in children have not been established. Thus, it should not be used in children. Geriatric population: No special usage Contraindications SULIDIN should not be used in those patients who have previously shown a hypersensitivity to nimesulide. SULIDIN should not be used in those patients who have hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs which induce the allergic reactions such as bronchospasm, rhinitis, angioedema, nasal polyps or urticaria and inhibits prostaglandin synthesis. It should not be used on injured or abraded skin or in the presence of local infection. It should not be used simultaneously with other topical products. It should not be used in children under 12 years Special warnings and precautions for use If local irritation develops, the use of SULIDIN should be discontinued and appropriate therapy instituted as necessary. Occlusive dressing should not be applied at the site of application. Do not apply on eyes, mucosal surface (genital, nasal, oral) or to any sites affected by open skin lesions, dermatosis or infections. If the gel touches any of these areas, wash it off with lots of water. The product should not be taken by mouth. Hands should be washed after applying the product. If any irritation, redness or itching develops at the site of application, discontinue use and report to your doctor. It is not recommended for use in children under 12 years (see section 4.3) Undesirable effects may be reduced by using minimum effective dose for the shortest possible duration. Patients with gastro-intestinal bleeding, active or suspected peptic ulcer, severe renal or hepatic dysfunction, severe coagulation disorders or severe/uncontrolled heart failure should be treated with caution. Special caution should be exerted when treating patients with known hypersensitivity to other NSAIDs. The possibility of developing hypersensitivity in the course of therapy cannot be excluded. If SULIDIN is used with other topical NSAIDs, burning sensation and exceptionally photodermatitis can occur. To reduce the risk of photosensitivity, patients should not be exposed to direct sunlight. If symptoms persist or the condition is aggravated medical advice should be sought. 2

3 4.5. Interaction with other medicinal products and other forms of interaction No interactions reported when used topically. Additional Information about Special Populations: No interaction study has been conducted in special populations. Pediatric Population: No interaction study has been conducted in children Pregnancy and lactation General recommendation Pregnancy category is C. Women of childbearing potential / Contraception Studies conducted in animal showed the reproduction toxicity (see section 5.3). Potential risk for humans is not known. The benefit / risk ratio in the treatment with SULİDİN should be evaluated by a physician and should not be used in pregnancy unless it is necessary. Pregnancy Sulidin is not recommended for use during pregnancy. Nimesulide should not be used in third-trimester because of the risk of premature ductal constriction and uterine atony. Lactation Period There is no study for the secretion to breast milk and probable effects to children taking breast milk. Therefore, Sulidin 1% Topical Gel is not recommended for use during lactation. Reproduction / Fertility There are no data regarding the effects on reproduction or fertility in humans. In studies conducted in animals, fertility adverse effects were established (see section 5.3) Effects on ability to drive and use machines SULIDIN has no influence on the ability to drive and use machines. 3

4 4.8. Undesirable effects Side effects possibly related to local treatment have been infrequently reported. In clinical trials, the majority of side effects are local reactions at the application site such as mild or moderate local irritation, erythema, rash, desquamation, pruritus. Staining of clothing has been noted. The frequency of adverse events listed below is defined using the following convention: Very common ( 1/10); common ( 1/100 to <1/10); uncommon ( 1/1.000 to <1/100), rare ( 1/ to <1/1.000); very rare (<1/10.000), not known (cannot be estimated from the available data). Skin and subcutaneous tissue disorders Uncommon Not known : Pruritis, erythema : Desquamation, pruritis, rash, mild or moderate local irritation. When nimesulide is applied topically, the possibility of occurrence of systemic side effects is less in comparison to oral administiration. However, when SULIDIN is applied long term and in high doses, the occurrence of systemic side effects should not be neglected Overdose and therapy Overdose of topical application is not reported. 5. PHARMACOLOGICAL PROPERTIES 5.1. Pharmacodynamic properties Pharmacotherapeutic Group: Topically used non-steroidal anti-inflammatory products. ATC Code: M02AA Nimesulide is a non-steroidal anti-inflammatory drug (NSAID). Chemically, nimesulide differs from other nonsteroidal antiinflammatory agents by virtue of the functional sulfonanilide group incorporated into its structure. Nimesulide has antipyretic, antiinflammatory and analgesic activities Pharmacokinetic properties General properties Absorption: After topical application, nimesulide penetrated from skin to muscle or synovia continuously and slowly. Therefore, the balance between skin, muscle and synovia is obtained. In a clinical study, SULIDIN is applied 3 times a day for 4-7 days to patients who will have arthroscopy for osteoarthritis. Nimesulide concentrations were calculated in synovia and 4

5 plasma after 1-2 hours of last administration. Nimesulide levels in synovia and plasma were found 22.1±10.5 ng/ml and 11.8±3.0 ng/ml, respectively. Distribution: After topical application nimesulide is found in significant levels in plasma from 30 minutes to 8 th hour. This shows that drug releases slowly to systemic circulation. 8 hours after topical application plasma concentrations of nimesulide varies between ng/ml. Biotransformation: It is metabolized in the liver. Its metabolite (4-hydroxynimesulide) is probably active. Elimination: 51-63% of nimesulide is excreted in the urine. Unchanged drug rates excreted in urine are less than 0.1% % of the drug is excreted in faeces. Elimination half life (t½ β) is calculated as approximately 10 hours Preclinical safety data A primary dermal irritation study in rabbits comparing the Sulidin 1 % Gel and Sulidin 3 % Gel formulation with placebo is conducted to determine the potential irritating or corrosive effects that result from the exposure of intact and abraded rabbit skin. None of them was found to be a primary skin irritant. Preclinical data for systemic application of nimesulide reveal no special hazards for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility toxicity. In repeated dose toxicity studies, nimesulide showed gastroistestinal, renal and hepatic toxicity. In reproductive toxicity studies, embryotoxic and teratogenic effects (skeletal malformations, dilatation in cerebral ventricles) were observed in rabbits, but not in rats, as maternally nontoxic dose levels.. In rats, increased mortality of offsprings was observed in the early postnatal period ans nimesulide showed adverse effects on fertility. 6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients * Transcutole * Glyceryl Monooleat * Hydroxypropyl cellulose 5

6 6.2. Incompatibilities There are no known incompatibilities Shelf Life 24 months 6.4. Special Precautions for Storage Store at room temperature below 25 C Nature and contents of container Laminate polyfoil tubes Package size: 30 g 6.6. Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product Unused products or waste materials should be disposed according to Regulation on the Control of Medicinal Product and Regulation on the Control of Waste Materials. 7. MARKETING AUTHORISATION HOLDER Embil İlaç Sanayii Ltd. Şti. / Embil Pharmaceutical Co. Ltd. Maslak Mah. Sümer Sok. Ayazağa Ticaret Merkezi No:3/1 Şişli - İSTANBUL Tel : Fax : info@embil.net 8. MARKETING AUTHORISATION NUMBER (S) 196 / DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: DATE OF REVISION OF THE TEXT 6