{"product_id":"piascledine-300-symptomatic-treatment-for-osteoarthritis-for-hip-and-knee","title":"Piascledine 300 Symptomatic Treatment for Osteoarthritis for Hip and Knee","description":"\u003cp\u003e\u003cstrong\u003eDescription:\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003ePiascledine\u003c\/strong\u003e Herbal Capsules helps to restore the normal cartilage structure by stimulating the synthesis of proteoglycans, and collagen. Slow acting treatment for the symptoms of rheumatic pain, osteoarthritis, periodontitis. \u003cstrong\u003ePiascledine 300\u003c\/strong\u003e is recommended for the treatment of pain and functional discomfort in cases of osteoarthritis of the hip and knee. It can also help with gum pain.\u003c\/p\u003e \u003cp\u003e\u003cem\u003e\u003cstrong\u003ePiascledine 300\u003c\/strong\u003e\u003c\/em\u003e is available in 3 sizes:  30, 60, or 90 Capsules.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eIndications:\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eN\/A\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eComposition:\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eAvocado-soya unsaponifiables.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eDirections:\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eThe recommended dose of \u003cstrong\u003ePiascledine 300\u003c\/strong\u003e is one capsule per day with a meal to be taken Orally. The capsule should be swallowed whole, with a full glass of water. Do not chew. The duration of the treatment will be modulated according to the clinical results, knowing that the effect is delayed by approximately 2 months and that it may persist after stopping the treatment. For the correct use of \u003cstrong\u003ePiascledine\u003c\/strong\u003e, it is essential to submit to regular medical supervision.\u003c\/p\u003e \u003cp\u003e\u003cspan style=\"color: #ff2a00;\"\u003e\u003cstrong\u003ePlease read the following full disclosure before purchasing this item.\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e \u003cp\u003eNOTICE - Updated on: 11\/10\/2020\u003c\/p\u003e \u003cp\u003eMedication Name\u003c\/p\u003e \u003cp\u003ePIASCLEDINE 300 mg, capsule\u003c\/p\u003e \u003cp\u003eUnsaponifiables of avocado and soybean\u003c\/p\u003e \u003cp\u003eBoxed Warning\u003c\/p\u003e \u003cp\u003ePlease read this notice carefully before taking this medicine as it contains important information for you.\u003c\/p\u003e \u003cp\u003eYou should always take this medicine strictly following the information provided in this notice or by your doctor, pharmacist, or nurse.\u003c\/p\u003e \u003cp\u003e· Keep this notice. You might need to read it again.\u003c\/p\u003e \u003cp\u003e· Consult your pharmacist for any advice or information.\u003c\/p\u003e \u003cp\u003e· If you experience any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this notice. See section 4.\u003c\/p\u003e \u003cp\u003e· You should consult your doctor if you don't feel any improvement or if you feel worse.\u003c\/p\u003e \u003cp\u003eWhat does this notice contain?\u003c\/p\u003e \u003col\u003e \u003cli\u003e \u003cp\u003eWhat is PIASCLEDINE 300 mg, capsule, and in what cases is it used?\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eWhat information should you know before taking PIASCLEDINE 300 mg, capsule?\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eHow to take PIASCLEDINE 300 mg, capsule?\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eWhat are the possible side effects?\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eHow to store PIASCLEDINE 300 mg, capsule?\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003ePackaging content and other information.\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eWHAT IS PIASCLEDINE 300 mg, CAPSULE, AND IN WHAT CASES IS IT USED?\u003c\/p\u003e \u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eThis medicine contains an active substance extracted from avocado and soybean oils.\u003c\/p\u003e \u003cp\u003eThis medication acts on the joints (it belongs to the group of medicines called other anti-inflammatory and anti-rheumatic agents, non-steroidal).\u003c\/p\u003e \u003cp\u003eThis medication is indicated for adults for symptomatic treatment (pain and discomfort during movements) with delayed effect for knee osteoarthritis.\u003c\/p\u003e \u003cp\u003eThis medication has a slow action, delayed by about 2 months, and its effect may persist after stopping the treatment.\u003c\/p\u003e \u003col start=\"2\"\u003e \u003cli\u003eWHAT INFORMATION SHOULD YOU KNOW BEFORE TAKING PIASCLEDINE 300 mg, CAPSULE?\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eNever take PIASCLEDINE 300 mg:\u003c\/p\u003e \u003cp\u003e· if you are allergic to the active ingredient or any other components contained in this medication, mentioned in section 6.\u003c\/p\u003e \u003cp\u003eWarnings and Precautions\u003c\/p\u003e \u003cp\u003eSpeak to your doctor, pharmacist, or nurse before taking PIASCLEDINE 300 mg.\u003c\/p\u003e \u003cp\u003eIf you have or have had a liver or gallbladder disease, inform your doctor or pharmacist before taking PIASCLEDINE. If symptoms or signs of liver or gallbladder problems occur, such as unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, skin and eyes yellowing (jaundice), and dark urine, stop the treatment and contact your doctor immediately.\u003c\/p\u003e \u003cp\u003eStop the treatment and immediately contact your doctor if signs and symptoms of allergic reactions occur, such as itching, hives, skin rash\/redness, facial swelling, and breathing difficulties.\u003c\/p\u003e \u003cp\u003eBefore taking PIASCLEDINE, inform your doctor or pharmacist if you are treated with anticoagulants (see \"Other medications and PIASCLEDINE 300 mg\").\u003c\/p\u003e \u003cp\u003eStop the treatment and contact your doctor immediately if signs and symptoms of blood clotting disorders occur, like red or purple spots on the skin, spontaneous bruises or hemorrhages, and mucous membrane bleeding.\u003c\/p\u003e \u003cp\u003eChildren and Adolescents\u003c\/p\u003e \u003cp\u003ePIASCLEDINE is for adults only. Do not give this medication to children and adolescents under 18.\u003c\/p\u003e \u003cp\u003eOther medications and PIASCLEDINE 300 mg\u003c\/p\u003e \u003cp\u003eInform your doctor or pharmacist if you take, have recently taken, or might take any other medicine.\u003c\/p\u003e \u003cp\u003ePIASCLEDINE should be used cautiously when combined with anticoagulant treatment due to the potential risk of clotting disorders.\u003c\/p\u003e \u003cp\u003ePIASCLEDINE 300 mg with food and drink\u003c\/p\u003e \u003cp\u003eYou can eat and drink normally while using this medication.\u003c\/p\u003e \u003cp\u003ePregnancy, breastfeeding, and fertility\u003c\/p\u003e \u003cp\u003eThe use of PIASCLEDINE 300 mg is not recommended during pregnancy and in women of childbearing age not using contraception.\u003c\/p\u003e \u003cp\u003ePIASCLEDINE 300 mg should not be used during breastfeeding.\u003c\/p\u003e \u003cp\u003eIf you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, seek advice from your doctor or pharmacist before taking this medicine.\u003c\/p\u003e \u003cp\u003eDriving and using machines\u003c\/p\u003e \u003cp\u003ePIASCLEDINE does not affect the ability to drive or operate machinery.\u003c\/p\u003e \u003cp\u003ePIASCLEDINE 300 mg contains:\u003c\/p\u003e \u003cp\u003eNot applicable.\u003c\/p\u003e \u003col start=\"3\"\u003e \u003cli\u003eHOW TO TAKE PIASCLEDINE 300 mg, capsule?\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eAlways take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you. Check with your doctor, pharmacist, or nurse if you are unsure.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eAdults:\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eThe recommended dose is one capsule per day, taken in the middle of a meal.\u003c\/p\u003e \u003cp\u003eOral use.\u003c\/p\u003e \u003cp\u003eSwallow the capsule whole with a large glass of water. Do not chew.\u003c\/p\u003e \u003cp\u003eThe duration of treatment will be adjusted based on clinical outcomes, knowing that the effect is delayed by about 2 months and may persist after stopping the treatment.\u003c\/p\u003e \u003cp\u003eFor the proper use of this medicine, it is essential to undergo regular medical check-ups.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eIf you take more PIASCLEDINE 300 mg than you should\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eOverdosing on PIASCLEDINE can cause or exacerbate gastrointestinal and\/or liver disorders. If you take more PIASCLEDINE than the recommended dose, consult your doctor or pharmacist immediately.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eIf you forget to take PIASCLEDINE 300 mg\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eDo not take a double dose to make up for a forgotten dose.\u003c\/p\u003e \u003cp\u003eTake the next dose of the medicine as planned.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eIf you stop taking PIASCLEDINE 300 mg\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eNot applicable.\u003c\/p\u003e \u003cp\u003eIf you have any other questions about the use of this medicine, ask your doctor, pharmacist, or nurse for more information.\u003c\/p\u003e \u003chr\u003e \u003col start=\"4\"\u003e \u003cli\u003eWHAT ARE THE POSSIBLE SIDE EFFECTS?\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eLike all medicines, this medicine can cause side effects, although not everybody gets them. The most commonly reported side effects with PIASCLEDINE are diarrhea, abdominal pain, upper abdominal discomfort, and nausea.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eSerious possible side effects:\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eContact your doctor immediately and stop the treatment if you experience any of the following side effects, which could be serious and may require urgent medical treatment:\u003c\/p\u003e \u003cp\u003eSigns and symptoms that may indicate severe allergic reactions (infrequent):\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eItching, hives, skin rash\/redness, facial swelling, breathing difficulties.\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eIntense skin rash (rare)\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eLiver disorders (infrequent):\u003c\/p\u003e \u003cp\u003eLiver damage or blockage of bile ducts may occasionally occur and may be associated with yellowing of the skin and elevated liver enzymes in the blood (such as transaminases, alkaline phosphatase, bilirubin, and gamma-glutamyl transferase) (see \"Warnings and precautions\" in section 2).\u003c\/p\u003e \u003cp\u003eOther reported side effects include:\u003c\/p\u003e \u003cp\u003eCommon (may affect up to 1 in 10 patients):\u003c\/p\u003e \u003cul\u003e \u003cli\u003eDiarrhea.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eInfrequent (may affect up to 1 in 100 patients):\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eUpper abdominal discomfort, heartburn, nausea, an unpleasant taste in the mouth which may be avoided by taking the capsule in the middle of a meal (see section 3), abdominal pain, stool discoloration,\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eHeadache,\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eDark urine,\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eWeakness, fatigue,\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eBreast pain, breast swelling, and gynecological bleeding.\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eRare (may affect up to 1 in 1,000 patients):\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eGastrointestinal disorders such as: inflammation of the intestines, vomiting, dry mouth, belching,\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eEczema,\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eKidney stones,\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eBlood clotting disorders such as a reduced number of blood platelets (see \"Warnings and precautions\" in section 2),\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eHigh blood pressure.\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003cstrong\u003eReporting side effects\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eIf you experience any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for Medicines and Health Product Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: \u003ca href=\"http:\/\/www.signalement-sante.gouv.fr\/\" target=\"_new\"\u003ewww.signalement-sante.gouv.fr\u003c\/a\u003e\u003c\/p\u003e \u003cp\u003eBy reporting side effects, you can help provide more information on the safety of the medicine.\u003c\/p\u003e \u003cp\u003eHere's the English translation of the provided text:\u003c\/p\u003e \u003chr\u003e \u003col start=\"5\"\u003e \u003cli\u003eHOW TO STORE PIASCLEDINE 300 mg, capsule?\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eKeep this medicine out of the sight and reach of children.\u003c\/p\u003e \u003cp\u003eDo not use this medicine after the expiry date stated on the packaging. The expiration date refers to the last day of that month.\u003c\/p\u003e \u003cp\u003eNo special storage precautions are necessary.\u003c\/p\u003e \u003cp\u003eDo not dispose of any medicine via wastewater or household waste. Ask your pharmacist to dispose of medicines you no longer use. These measures will help protect the environment.\u003c\/p\u003e \u003chr\u003e \u003col start=\"6\"\u003e \u003cli\u003ePACKAGE CONTENTS AND OTHER INFORMATION\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eWhat PIASCLEDINE 300 mg contains\u003c\/p\u003e \u003cp\u003e· The active substance is:\u003c\/p\u003e \u003cp\u003eTotal extract of unsaponifiables avocado-soy.......... 300.00 mg\u003c\/p\u003e \u003cp\u003eEquivalent to:\u003c\/p\u003e \u003cp\u003eAvocado oil unsaponifiable................................. 100.00 mg\u003c\/p\u003e \u003cp\u003eSoybean oil unsaponifiable................................ 200.00 mg\u003c\/p\u003e \u003cp\u003ePer capsule.\u003c\/p\u003e \u003cp\u003e· The other components are:\u003c\/p\u003e \u003cp\u003eAnhydrous colloidal silica, butylhydroxytoluene.\u003c\/p\u003e \u003cp\u003eCapsule shell: gelatin, polysorbate 80, titanium dioxide, erythrosine, yellow iron oxide.\u003c\/p\u003e \u003cp\u003eWhat PIASCLEDINE 300 mg, capsule looks like and contents of the outer packaging\u003c\/p\u003e \u003cp\u003eThis medicine comes in the form of an orange and beige-gray capsule. Box of 15, 30, 60, or 90 capsules.\u003c\/p\u003e \u003cp\u003eMarketing Authorization Holder\u003c\/p\u003e \u003cp\u003eLABORATOIRES EXPANSCIENCE\u003c\/p\u003e \u003cp\u003e1 PLACE DES SAISONS\u003c\/p\u003e \u003cp\u003e92048 PARIS LA DEFENSE CEDEX\u003c\/p\u003e \u003cp\u003eMarketing Authorization Operator\u003c\/p\u003e \u003cp\u003eLABORATOIRES EXPANSCIENCE\u003c\/p\u003e \u003cp\u003e1 PLACE DES SAISONS\u003c\/p\u003e \u003cp\u003e92048 PARIS LA DEFENSE CEDEX\u003c\/p\u003e \u003cp\u003eManufacturer\u003c\/p\u003e \u003cp\u003eLABORATOIRES EXPANSCIENCE\u003c\/p\u003e \u003cp\u003eRUE DES QUATRE FILLES\u003c\/p\u003e \u003cp\u003e28230 EPERNON\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eSUMMARY OF PRODUCT CHARACTERISTICS\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eANSM - Updated on: 10\/11\/2020\u003c\/p\u003e \u003col\u003e \u003cli\u003e \u003cp\u003e\u003cstrong\u003eNAME OF THE MEDICINE\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003ePIASCLEDINE 300 mg, capsule\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003e\u003cstrong\u003eQUALITATIVE AND QUANTITATIVE COMPOSITION\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eTotal extract of avocado-soybean unsaponifiables .......................................... 300.00 mg\u003c\/p\u003e \u003cp\u003eCorresponding to:\u003c\/p\u003e \u003cp\u003eUnsaponifiable of avocado oil .................................................................. 100.00 mg\u003c\/p\u003e \u003cp\u003eUnsaponifiable of soybean oil .................................................................. 200.00 mg\u003c\/p\u003e \u003cp\u003ePer capsule.\u003c\/p\u003e \u003cp\u003eFor the complete list of excipients, see section 6.1.\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003e\u003cstrong\u003ePHARMACEUTICAL FORM\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eCapsule in orange and beige-gray color.\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003e\u003cstrong\u003eCLINICAL DATA\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003e4.1. \u003cstrong\u003eTherapeutic indications\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003ePIASCLEDINE is indicated as a symptomatic treatment with delayed effect for knee osteoarthritis.\u003c\/p\u003e \u003cp\u003ePIASCLEDINE is indicated for adults.\u003c\/p\u003e \u003cp\u003e4.2. \u003cstrong\u003eDosage and administration\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eDosage\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eAdult patients\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eOne capsule per day.\u003c\/p\u003e \u003cp\u003eThe duration of treatment will be adjusted based on clinical results, noting that the effect is delayed by about 2 months and may persist after treatment discontinuation.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003ePediatric population\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eIn the absence of efficacy and safety data in children under 18 years of age, the use of PIASCLEDINE is not recommended in this population.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eLiver insufficiency\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eThere is no available data for patients with severe liver insufficiency; therefore, no recommendation can be made.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eElderly patients\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eNo dosage adjustment is necessary for elderly patients. In clinical studies with PIASCLEDINE, the average age of the population was over 60 years, and a significant proportion of patients were over 65 years old.\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003eAdministration method\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eOral route.\u003c\/p\u003e \u003cp\u003eThe capsule must be swallowed whole, without being chewed, with a large glass of water, in the middle of a meal.\u003c\/p\u003e \u003cp\u003e4.3. \u003cstrong\u003eContraindications\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eHypersensitivity to the active substance or to any of the excipients listed in section 6.1.\u003c\/p\u003e \u003cp\u003e4.4. \u003cstrong\u003eSpecial warnings and precautions for use\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003ePost-marketing, infrequent adverse reactions such as hepatic cytolysis, cholestasis, jaundice, and elevated transaminases have been reported. Special attention should be paid to patients with a medical history or suffering from hepatic or biliary disorders, or those with a disease that may increase the risk of gallstones or liver lesions. PIASCLEDINE treatment should be discontinued in case of biological signs or clinical symptoms of hepatic or biliary lesions.\u003c\/p\u003e \u003cp\u003eHypersensitivity reactions, as well as skin rashes, urticaria, and dermatitis, have been infrequently reported during clinical development of the product. Patients should be informed of the signs and\/or symptoms suggestive of an allergic reaction, and they should stop treatment and consult their doctor at the first appearance of a skin reaction or signs of hypersensitivity (see section 4.8).\u003c\/p\u003e \u003cp\u003eA few cases of thrombocytopenia have been reported with PIASCLEDINE, one of which occurred during clinical development. PIASCLEDINE treatment should be discontinued if symptoms suggestive of coagulation disorders occur (e.g., petechiae, purpura).\u003c\/p\u003e \u003cp\u003e4.5. \u003cstrong\u003eInteractions with other medicines and other forms of interactions\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003ePIASCLEDINE should be used with caution in patients on concurrent anticoagulant therapy (see section 4.4).\u003c\/p\u003e \u003cp\u003e4.6. \u003cstrong\u003eFertility, pregnancy, and breastfeeding\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003e\u003cstrong\u003ePregnancy\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eData in animals have shown reproductive toxicity at systemic exposure levels much higher than human therapeutic doses (see section 5.3).\u003c\/p\u003e \u003cp\u003eIn clinical practice, there are currently insufficient data to assess a potential teratogenic or fetotoxic effect of PIASCLEDINE 300 mg when administered during pregnancy.\u003c\/p\u003e \u003cp\u003eTherefore, the use of this medicine is not recommended during pregnancy and in women of childbearing age not using contraception.\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003e\u003cstrong\u003eBreastfeeding (Allaitement):\u003c\/strong\u003e\u003c\/p\u003e \u003cul\u003e \u003cli\u003eThere's no available data on the excretion of PIASCLEDINE 300 mg or its metabolites in breast milk.\u003c\/li\u003e \u003cli\u003eThere's a potential risk for newborns\/infants.\u003c\/li\u003e \u003cli\u003eThis drug should not be used during breastfeeding.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003cstrong\u003eFertility:\u003c\/strong\u003e\u003c\/p\u003e \u003cul\u003e \u003cli\u003eAnimal data showed, at high doses, early pre-implantation and post-implantation losses.\u003c\/li\u003e \u003cli\u003eThe relevance of this data to humans is unknown.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003cstrong\u003eEffects on Ability to Drive and Use Machines (4.7. Effets sur l'aptitude à conduire des véhicules et à utiliser des machines):\u003c\/strong\u003e\u003c\/p\u003e \u003cul\u003e \u003cli\u003ePIASCLEDINE has little to no effect on the ability to drive vehicles and operate machines.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003cstrong\u003eAdverse Effects (4.8. Effets indésirables):\u003c\/strong\u003e\u003c\/p\u003e \u003cul\u003e \u003cli\u003eMost commonly reported side effects relate to the gastrointestinal system, occurring in about 3% of patients.\u003c\/li\u003e \u003cli\u003eDiarrhea, abdominal pain, dyspepsia, abdominal distention, and nausea can occur in 0.4% to 1.1% of patients. These side effects are mild to moderate in intensity.\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003e\u003cstrong\u003eSummary of Adverse Effects by Organ System:\u003c\/strong\u003e\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eHematologic \u0026amp; Lymphatic System:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eRare:\u003c\/strong\u003e Thrombocytopenia\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eImmune System:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eInfrequent:\u003c\/strong\u003e Hypersensitivity\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eNervous System:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eInfrequent:\u003c\/strong\u003e Headaches\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eGastrointestinal:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eFrequent:\u003c\/strong\u003e Not specified\u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eInfrequent:\u003c\/strong\u003e Diarrhea\u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eRare:\u003c\/strong\u003e Dyspepsia, dysgeusia, nausea, abdominal pain, stool discoloration, enteritis, vomiting, belching, dry mouth\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eLiver \u0026amp; Biliary System:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eInfrequent:\u003c\/strong\u003e Liver cell damage, cholestasis, jaundice, increased levels of transaminases, alkaline phosphatase, bilirubin, and gamma-glutamyl transpeptidase\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eSkin \u0026amp; Subcutaneous Tissue:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eRare:\u003c\/strong\u003e Toxic skin rash, eczema\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eKidney \u0026amp; Urinary Tract:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eInfrequent:\u003c\/strong\u003e Chromaturia\u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eRare:\u003c\/strong\u003e Nephrolithiasis (kidney stones)\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eReproductive System \u0026amp; Breast:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eInfrequent:\u003c\/strong\u003e Breast pain, breast swelling, metrorrhagia (uterine bleeding)\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eGeneral Disorders:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eInfrequent:\u003c\/strong\u003e Asthenia (weakness)\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003cli\u003e \u003cstrong\u003eInvestigations:\u003c\/strong\u003e \u003cul\u003e \u003cli\u003e \u003cstrong\u003eRare:\u003c\/strong\u003e Increased blood pressure\u003c\/li\u003e \u003c\/ul\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003chr\u003e \u003cp\u003e\u003cstrong\u003eIssues\/Improvements:\u003c\/strong\u003e\u003c\/p\u003e \u003col\u003e \u003cli\u003eThe \"Frequent\" side effects under \"Gastrointestinal\" are not specified. For a comprehensive understanding, the full list of frequent side effects should be provided.\u003c\/li\u003e \u003cli\u003eSome side effects have annotations like (*), (**), etc., but the meanings or explanations of these annotations are not provided.\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003e\u003cstrong\u003eRecommendations:\u003c\/strong\u003e\u003c\/p\u003e \u003col\u003e \u003cli\u003eIf this is for a patient or consumer, it's important to consult with a healthcare professional about any potential side effects or interactions.\u003c\/li\u003e \u003cli\u003eThe annotations might be crucial for a deeper understanding, so referencing the original document or source for these would be helpful.\u003c\/li\u003e \u003cli\u003e \u003cp\u003e§) The capsule should be taken in the middle of a meal to avoid taste disturbances. See section 4.2.\u003c\/p\u003e \u003cp\u003e(#) These side effects have been reported after marketing. Since these effects were not reported during clinical trials involving 1,310 patients exposed to PIASCLEDINE, they are estimated to be infrequent.\u003c\/p\u003e \u003cp\u003eDescription of certain side effects:\u003c\/p\u003e \u003cp\u003e(*) Taking PIASCLEDINE can sometimes cause hypersensitivity, such as systemic allergic reactions, meaning the sudden onset of a condition with skin involvement (itching, hives, redness, rash), mucous membrane involvement or both, cough, persistent gastrointestinal symptoms or a decrease in blood pressure and\/or associated symptoms. See section 4.4.\u003c\/p\u003e \u003cp\u003e(**) Signs of liver problems, such as abdominal pain associated with nausea, stool discoloration, dark urine, and\/or jaundice, can occur during treatment with PIASCLEDINE. See section 4.4.\u003c\/p\u003e \u003cp\u003e(***) Signs and symptoms suggestive of increased blood pressure (namely headaches, hearing problems, hot flushes) can occur with PIASCLEDINE treatment.\u003c\/p\u003e \u003cp\u003eReporting suspected side effects:\u003c\/p\u003e \u003cp\u003eReporting suspected side effects after drug approval is important. It allows continuous monitoring of the drug's benefit\/risk ratio. Health professionals report any suspected side effects through the national reporting system: National Agency for Drug and Health Product Safety (ANSM) and the network of Regional Pharmacovigilance Centers - Website: \u003ca href=\"http:\/\/www.signalement-sante.gouv.fr\/\" target=\"_new\"\u003ewww.signalement-sante.gouv.fr\u003c\/a\u003e.\u003c\/p\u003e \u003cp\u003e4.9. Overdose:\u003c\/p\u003e \u003cp\u003eDuring clinical trials, administering doses of up to 900 mg\/day for several months was associated with dose-dependent gastrointestinal disorders.\u003c\/p\u003e \u003cp\u003eOverdoses can cause or exacerbate gastrointestinal disorders and\/or liver problems.\u003c\/p\u003e \u003col start=\"5\"\u003e \u003cli\u003ePHARMACOLOGICAL PROPERTIES:\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003e5.1. Pharmacodynamic properties:\u003c\/p\u003e \u003cp\u003eTherapeutic class: Other anti-inflammatory and anti-rheumatic agents, non-steroidal, ATC code: M01AX26.\u003c\/p\u003e \u003cp\u003ePharmacodynamic effects:\u003c\/p\u003e \u003cp\u003eTargeted at tissue growth.\u003c\/p\u003e \u003cp\u003eClinical efficacy and safety:\u003c\/p\u003e \u003cp\u003eThe effects of Piascledine 300 mg in osteoarthritis have been evaluated in clinical studies and have shown positive results on symptom onset. The results of five randomized controlled studies (three studies versus placebo and two studies versus active comparator) are presented below.\u003c\/p\u003e \u003cp\u003eIn a multicenter, randomized, double-blind study versus placebo on 86 patients with knee osteoarthritis, NSAID consumption was significantly reduced by 70% compared to 33% for the placebo (p\u0026lt;0.01) after 3 months. Rest pain and functional discomfort were also significantly improved with Piascledine 300 mg compared to placebo.\u003c\/p\u003e \u003cp\u003eIn another multicenter, randomized, double-blind study versus placebo, in a subgroup of 101 patients with knee osteoarthritis, the primary criterion was the resumption of NSAIDs after discontinuation. The number of patients who resumed NSAID after 3 months of treatment was 54.2% with Piascledine 300 mg, compared to 73% with the placebo (p=0.05). A significant reduction in functional discomfort was observed, while the decrease in rest pain was not significant.\u003c\/p\u003e \u003cp\u003eIn a multicenter, randomized, double-blind study over 6 months versus placebo, Piascledine 300 mg did not significantly improve the main criterion (Lequesne index, p=0.07) or rest pain in the subgroup of patients with knee osteoarthritis (N=55), possibly due to the low number of patients, but it significantly reduced NSAID consumption.\u003c\/p\u003e \u003cp\u003eTwo non-inferiority studies compared Piascledine 300 mg to chondroitin sulfate 400 mg, three times a day for 6 months, and diacerein 50 mg, twice a day for 3 months in 184 and 64 patients, respectively. These studies showed the non-inferiority of Piascledine 300 mg versus the two comparators on the total WOMAC score and on NSAID consumption, which was the main criterion for each study, respectively. No difference was observed between these comparators and Piascledine 300 mg on secondary criteria (Lequesne index and rest pain).\u003c\/p\u003e \u003cp\u003eMoreover, Piascledine 300 mg has a slow action, delayed by about 2 months, and its effect can persist after treatment discontinuation.\u003c\/p\u003e \u003cp\u003e5.2. Pharmacokinetic properties:\u003c\/p\u003e \u003cp\u003ePIASCLEDINE is an extract composed of multiple entities derived from soy and avocado, for which no validated analytical method is available. Therefore, no pharmacokinetic study has been conducted.\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003e5.3. Preclinical safety data\u003c\/p\u003e \u003cp\u003eThe general toxicological properties of PIASCLEDINE have been studied in various animal species, including rodents, rabbits, and dogs, under single dose and repeated dose conditions.\u003c\/p\u003e \u003cp\u003eSingle-dose toxicity studies have shown low toxicity of PIASCLEDINE, as no LD50 could be calculated due to the absence of mortality at doses up to 8,000 mg\/kg in mice.\u003c\/p\u003e \u003cp\u003eIn repeated dose toxicity studies (6 months) in rats and dogs, the general tolerance of PIASCLEDINE was satisfactory; however, the liver and thyroid were identified as target organs.\u003c\/p\u003e \u003cp\u003eLiver\u003c\/p\u003e \u003cp\u003ePIASCLEDINE 300 mg is not an enzyme inducer in rats.\u003c\/p\u003e \u003cp\u003eThyroid\u003c\/p\u003e \u003cp\u003eIn a toxicity study in rats (28 days), at autopsy, the thyroid weight was higher in animals treated with the high dose of 750 mg\/kg\/day compared to control animals.\u003c\/p\u003e \u003cp\u003eHistopathology revealed minor abnormalities (hypertrophy of epithelial cells) in males.\u003c\/p\u003e \u003cp\u003eIn a 26-week repeated dose study in rats, PIASCLEDINE 300 mg induced reversible thyroid follicular hypertrophy at the high dose of 750 mg\/kg\/day.\u003c\/p\u003e \u003cp\u003eReproductive toxicology\u003c\/p\u003e \u003cp\u003eA fertility study in rats showed that PIASCLEDINE 300 mg at a high dose (750 mg\/kg\/day) could slightly decrease uterine implantation and early embryo survival. No effect was reported in male rats.\u003c\/p\u003e \u003cp\u003eNo teratogenic or embryotoxic effect was demonstrated up to doses of 200 mg\/kg\/day in rats and 150 mg\/kg\/day in rabbits (corresponding to 7 times and 10 times the recommended dose in humans). An increase in post-implantation losses, minor skeletal modifications (rat), and changes in the abdominal wall (rabbit) were reported at maternotoxic doses of 750 mg\/kg\/day in rats and 500 mg\/kg\/day in rabbits (corresponding to 24 and 32 times the recommended dose in humans).\u003c\/p\u003e \u003cp\u003eNo effect on the peri- and postnatal development of the F1 generation was observed in a dedicated study conducted in rats.\u003c\/p\u003e \u003cp\u003eStudies with PIASCLEDINE showed no mutagenic or genotoxic effects.\u003c\/p\u003e \u003col start=\"6\"\u003e \u003cli\u003ePHARMACEUTICAL DATA\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003e6.1. List of excipients\u003c\/p\u003e \u003cp\u003eAnhydrous colloidal silica, butylated hydroxytoluene\u003c\/p\u003e \u003cp\u003eCapsule shell: gelatin, polysorbate 80, titanium dioxide, erythrosine, yellow iron oxide.\u003c\/p\u003e \u003cp\u003e6.2. Incompatibilities\u003c\/p\u003e \u003cp\u003eNot applicable.\u003c\/p\u003e \u003cp\u003e6.3. Shelf life\u003c\/p\u003e \u003cp\u003e3 years.\u003c\/p\u003e \u003cp\u003e6.4. Special storage precautions\u003c\/p\u003e \u003cp\u003eNo special storage precautions.\u003c\/p\u003e \u003cp\u003e6.5. Nature and content of the outer packaging\u003c\/p\u003e \u003cp\u003e15, 30, 60, or 90 capsules in blister packs (PVC\/Aluminum).\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003e6.6. Special precautions for disposal and handling\u003c\/p\u003e \u003cp\u003eNo special requirements.\u003c\/p\u003e \u003cp\u003eAny unused medicine or waste must be disposed of in accordance with current regulations.\u003c\/p\u003e \u003col start=\"7\"\u003e \u003cli\u003eMARKETING AUTHORIZATION HOLDER\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eEXPANSCIENCE LABORATORIES\u003c\/p\u003e \u003cp\u003e1 PLACE DES SAISONS\u003c\/p\u003e \u003cp\u003e92048 PARIS LA DEFENSE CEDEX\u003c\/p\u003e \u003col start=\"8\"\u003e \u003cli\u003eMARKETING AUTHORIZATION NUMBER(S)\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003e· 34009 321 495 4 4: 15 capsules in blister packs (PVC\/Aluminum)\u003c\/p\u003e \u003cp\u003e· 34009 359 413 5 0: 30 capsules in blister packs (PVC\/Aluminum)\u003c\/p\u003e \u003cp\u003e· 34009 300 729 2 9: 60 capsules in blister packs (PVC\/Aluminum)\u003c\/p\u003e \u003cp\u003e· 34009 300 729 3 6: 90 capsules in blister packs (PVC\/Aluminum)\u003c\/p\u003e \u003col start=\"9\"\u003e \u003cli\u003eDATE OF FIRST AUTHORIZATION\/RENEWAL OF THE AUTHORIZATION\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003e[to be filled in later by the holder]\u003c\/p\u003e \u003col start=\"10\"\u003e \u003cli\u003eDATE OF UPDATE OF THE TEXT\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003e[to be filled in later by the holder]\u003c\/p\u003e \u003col start=\"11\"\u003e \u003cli\u003eDOSIMETRY\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eNot applicable.\u003c\/p\u003e \u003col start=\"12\"\u003e \u003cli\u003eINSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS\u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003eNot applicable.\u003c\/p\u003e \u003cp\u003ePRESCRIPTION AND SUPPLY CONDITIONS\u003c\/p\u003e \u003cp\u003eMedicine not subject to a medical prescription.\u003c\/p\u003e \u003c\/li\u003e \u003c\/ol\u003e \u003c\/li\u003e \u003c\/ol\u003e \u003cp\u003e\u003cstrong\u003eDetails:\u003c\/strong\u003e\u003c\/p\u003e \u003cp\u003eEAN\/UPC: 03577056004698\u003c\/p\u003e \u003cp\u003eContents: N\/A\u003c\/p\u003e \u003cp\u003ePresentation:\u003c\/p\u003e","brand":"SJCZ","offers":[{"title":"30 Capsules","offer_id":58071783211340,"sku":null,"price":26.8,"currency_code":"EUR","in_stock":true},{"title":"60 Capsules","offer_id":58071783244108,"sku":null,"price":42.9,"currency_code":"EUR","in_stock":true},{"title":"90 Capsules","offer_id":58071783276876,"sku":null,"price":60.3,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1028\/1936\/5196\/files\/Piascledine-300-Symptomatic-Treatment-for-Osteoarthritis-for-Hip-and-Knee.jpg?v=1783944314","url":"https:\/\/dyoyje.shop\/products\/piascledine-300-symptomatic-treatment-for-osteoarthritis-for-hip-and-knee","provider":"KressKey","version":"1.0","type":"link"}