Sunday, March 19, 2017


1.NAME OF THE MEDICINAL PRODUCT Erdolytic 300mg Hard Gelatin Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Farh hard gelatin capsule contains: Active IngredientErdosteine 300mg Inactive Ingredients : Microcrystalline Cellulose PH101, Povidone K30, Magnesium Stearate, Gelatin, Titanium Dioxide, Brilliant Blue, Carmosine Red,Quinoline Yellow. 3. CLINICAL PARTICULARS: 3.1 Therapeutic indications As an expectorant. For the symptomatic treatment of acute exacerbations of chronic bronchitis in adults. 3.2 Posology and method of administration Elderly and adults above 18 years : 300 mg twice daily for maximum 10 days. The capsules must be swallowed whole with a glass of water. 3.3 Contraindications Hypersensitivity to the active substance or to any of the other excipients. Since there are no data in patients with creatinine clearance <25m1/min, or with severe liver failure, the use of erdosteine is not recommended in these patient& Patients with active peptic ulcer. 3.4 Special warnings and precautions for use No increase in adverse events has been observed with erdosteine in patients with mild liver faihre; however these patients should not exceed a dose of 300 mg per day. 3.5 Interaction with other medicinal products and other forms of interaction No adverse interactions have been reported 3.6 Fertility, pregnancy and lactation Pregnancy: There is no experience for the use of erdosteine in pregnant women. Lactation:  Experience is missing. Therefore, the use of erdosteine in pregnant or breast-feeding women is not recommended. 3.7 Effects on ability to drive and use machines Erdolytic has minor or negligible influence on the ability to drive and use machines 3.8 Undesirable effects
Nervous system disorders Uncommon (a 1/1,000 to <1/100) Headache Respiratory, thoracic and mediastinal disorders Uncommon (a 1/1,000 to <1/100) Cold, dyspnoea Gastrointestinal disorders Uncommon (01/1,000 to <1/100) Common (a 1/100 to <1/10) Taste alterations, nausea, vomtting, diarrhoea Epigastric pain Skin and Subcutaneous tissue disorders Uncommon (a 1/1,000 to <1/100) Angioedema and cutaneous hypersensitivity reactions, such as urticaria, erythema, oedema and eczema
3.9 Overdose No experience of acute overdosage is available. Symptomatic treatment and general supportive measures should be followed in all cases of overdosage.
Gastric lavage may be beneficial, followed by observation. 4.PHARMACOLOGICAL PROPERTIES 4.1 Pharmacodynamic properties Phamiacotherapeutic group: Mucolytic agent. Mucolytic agent reducing the viscosity of mucus and purulent sputum. Erdosteine is a prodrug, becoming active after metabolism whereby free thiol groups are formed_ This effect is due to the opening of the disulfide bonds of the bronchial mucoproteins. It has also been demonstrated that erdosteine inhibits bacterial adhesion to epithelial cells. Due to the presence of a free thiol group in its active metabo-lite, erdosteine has a significant antioxidant action. 4.2 Pharmacokinetic properties Absorption  Erdosteine is quickly absorbed after oral administration and rapidly transformed through a first-pass metabolism to its biologically active metabolite — N-thiodiglycolyl-homocys-teine (M1). After administration of 300 mg, the peak plasma concentra-tion of erdosteine (Cmax) - 1.26 ± 0.23 ag/m1- was reached 1.18 ± 026 hour after administration (Tmax), while Ml showed a Cmax of 3.46 lig/inland a Tmax of 1.48 IL The plasma concentrations of erdosteine increase in a dose-dependent manner. Plasma concentrations of Ml increased also with the dose, but not as proportionally as in the case of unchanged erdosteine. The absorption is independent from food intake. Distribution In animal models, erdosteine was distributed mainly to kidneys, bone, spinal cord and liver. Phamiacologically active concentrations of both erdosteine and Ml were found in Broncho Alveolar Lavage. Elimination The elimination T1/2 is 1.46 ± 0.60 h and 1.62 ±0.59 h, respectively, for erdosteine and Ml. In urine, only Ml and sulphates were found, faecal elimination is negligible. No accumulation or change in the metabolism of erdosteine and Ml has been observed after oral administration of 600 to 900 mg daily for 8 days. Influence of age Age does not change the phannacolcinetics of erdosteine. Binding to plasma proteins The drug binding of erdosteine to plasma proteins is 64.5% (range : 50-86%). 5. Storage: Store at temperature not exceeding 30°C, in dry place. 6. Nature and contents of container Carton box containing 1,2 or 3 (Al/transparent PVC/PVD-C/PVC) strips, each of 10 hard gelatin capsules & inner leaflet Manufactured by : AI Andalous pharmaceutical Industries forAl Andalous medical Commun-Epvut
This is Medicament
- Medicament Is a product which affects your health and I. consumption contrary to dangerous Mr you . - Follow strIctly the doctor's prescription. the method of use and Me instructions.. phannactst wha sold the medicament. -Ma doctor and the pharmacist are the experts In modicineadhair benefits and I.E. - Do not by yours. intermpt Om peri od of treatmeM prescriMd for you. Do not repeat Me same prescription without consulting your doctor. -Keep all medicaments out of reach of children. it ofiresic Health Ministers FA Union al Arabi Pharmacists AI Andalous ..03[•1. CON•ANV 1010401301101 V.140,1

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