{ "id": "smecta-diosmectite", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-09", "status": "published_traceable_archive" }, "names": { "brand": "Smecta", "generic": "蒙脱石", "aliases": [ "蒙脱石散", "diosmectite", "dioctahedral smectite", "Smecta", "蒙脱石" ], "marketBrandNames": [ { "name": "SMECTA ORANGE-VANILLE", "market": { "zh": "法国", "en": "France" }, "evidenceStatus": "dated_public_record", "note": { "zh": "本页包装卡仅对应橙香草味粉末。", "en": "Pack card covers orange-vanilla powder only." }, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "name": "SMECTA SACHET", "market": { "zh": "新加坡", "en": "Singapore" }, "evidenceStatus": "dated_public_record", "note": { "zh": "SIN06338P，3 g/袋。", "en": "SIN06338P, 3 g/sachet." }, "source": { "id": "src_8acbc7d2835c293e", "label": "Singapore NDF: SMECTA SACHET 3 G/SACHET, SIN06338P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06338p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "mainlandChinaTradeNameCue": { "value": "思密达®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_01bfc95f19ef84c3", "label": "济宁市人民政府：2024 年基层医疗机构药品信息中的思密达／蒙脱石散 3 g 记录", "url": "https://www.jining.gov.cn/art/2024/5/21/art_93211_2803357.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "法国 Smecta 橙香草味粉末与新加坡记录；中国商品名、批准及包装尚待独立核验。", "dosageFormClass": "口服固体制剂", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1988（法国批准记录）", "archiveSponsorText": "Mayoly Pharma France" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "蒙脱石", "蒙脱石散", "Smecta", "diosmectite" ], "excludedProductCues": [ "lactulose", "乳果糖", "loperamide", "洛哌丁胺" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "fr-smecta-orange-vanilla-3g-30-sachets", "marketCode": "FR", "labelVersion": { "zh": "ANSM 页面标注更新 2025-04-22", "en": "ANSM page marked updated 22 April 2025" }, "dosageForm": { "zh": "冲配为口服混悬液的粉末", "en": "Powder for oral suspension" }, "route": { "zh": "口服", "en": "Oral" }, "routeCodes": [ "oral" ], "productCode": "3400931923077", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋蒙脱石 3 g；整袋粉末 3.760 g；30 袋/盒", "en": "3 g diosmectite per sachet; 3.760 g total powder; 30 sachets/carton" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "蒙脱石", "en": "diosmectite" }, "value": 3, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋成分含量", "en": "Active amount per sachet" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-09", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "label_listed_not_live_supply", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "袋/盒", "en": "sachets/carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "暂缺这一准确包装的官方照片", "en": "Exact official pack photograph not available" }, "summary": { "zh": "不以其他国家、口味或电商外盒代替；文字卡也不能鉴定真伪。", "en": "No other country, flavour or retail carton is substituted; text identity cannot authenticate a pack." }, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "大字读法国说明书：先看补液与同服药", "en": "Large-print French leaflet: rehydration and other medicines" }, "summary": { "zh": "阅读对象是法国橙香草味粉末，不是中国通用用法。", "en": "This reads French orange-vanilla powder, not Chinese instructions." }, "checks": [ { "zh": "3 g 为成分，3.760 g 包含辅料；30 袋是包装数量。", "en": "3 g is active ingredient; 3.760 g includes excipients; 30 is pack count." }, { "zh": "法国原件不用于 2 岁以下儿童，妊娠和哺乳期不推荐；严重便秘史先咨询。", "en": "The French leaflet excludes under-twos, discourages pregnancy/breastfeeding use and calls for caution with severe constipation history." }, { "zh": "可能影响其他口服药吸收；法国原件建议尽可能间隔超过 2 小时。完整药单仍需药师核对，不是“错开就都安全”。", "en": "It may affect other oral medicines; France advises over two hours apart where possible. A pharmacist must still review the whole list." }, { "zh": "腹泻三天无改善或恶化、腹痛伴发热或呕吐，应就医；呼吸困难或喉面肿胀立即急救。", "en": "Seek care for diarrhoea not improving after three days or pain with fever/vomiting; breathing difficulty or face/throat swelling needs emergency help." } ], "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "在肠内覆盖、吸附；补液仍是另一件事", "en": "Acts within the bowel; rehydration is separate" }, "summary": { "zh": "蒙脱石在肠腔中发挥覆盖和吸附作用；减少腹泻症状不等于补回丢失的水分和电解质。", "en": "Diosmectite covers and adsorbs within the bowel; symptom relief does not replace lost water and electrolytes." }, "checks": [ { "zh": "法国原件明确：使用 Smecta 并不能省略必要的补液。", "en": "The French original states that Smecta does not remove the need for appropriate rehydration." }, { "zh": "补液方式需结合腹泻严重程度、年龄和个人状况决定；不要只看“止泻了没有”。", "en": "Rehydration depends on severity, age and clinical context, not only whether diarrhoea slows." }, { "zh": "这款粉末需要临用前冲配成混悬液；先核对具体剂型和你手里的本地说明书。", "en": "This powder must be mixed into a suspension just before use; check the exact form and your local leaflet." } ], "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Smecta", "generic": "蒙脱石", "dosageFormClass": "口服固体制剂" }, "labelSource": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "productRoutes": [ { "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_8acbc7d2835c293e", "label": "Singapore NDF: SMECTA SACHET 3 G/SACHET, SIN06338P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06338p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, "status": "product_level_public_record_verified", "authority": { "zh": "新加坡国家药物目录 NDF", "en": "Singapore National Drug Formulary (NDF)" }, "market": { "zh": "新加坡", "en": "Singapore" }, "recordType": { "zh": "政府药物目录产品资料与说明书节选", "en": "Government drug formulary product information and leaflet excerpts" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "法国药监 ANSM", "en": "ANSM" }, "market": { "zh": "法国", "en": "France" }, "recordType": { "zh": "政府药品数据库与公开说明书", "en": "Government medicines database and public leaflet" }, "reviewedAt": "2026-09-09", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "Smecta 的成分是蒙脱石，属于用于腹泻等症状的肠道吸附剂。它不能代替补液。药盒上的 3 g 是成分含量，不代表每个人一次都该吃一袋；老人同时服多种药时尤其要核对相互影响。", "history": "法国页面列本产品批准日期 1988-11-25。Mayoly 企业历史记载，2022 年收购益普生家庭健康业务，Smecta 是相关产品组合之一；这段企业沿革不证明全球首发日期。", "sourceDocuments": [ { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_8acbc7d2835c293e", "label": "Singapore NDF: SMECTA SACHET 3 G/SACHET, SIN06338P; updated 2026-07-28", "url": "https://www.ndf.gov.sg/about-drugs/product-information/sin06338p/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_product_record", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" }, { "id": "src_7960e5e5dc18f1a9", "label": "Mayoly: company history and 2022 acquisition of Ipsen family healthcare including Smecta", "url": "https://mayoly.com/en/about-us/who-we-are/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } ], "applicationNumber": "FR CIS 69584073; CIP 3400931923077; SG SIN06338P", "approvalTimeline": [ { "date": "1988-11-25", "title": { "zh": "法国批准记录", "en": "French authorisation record" }, "detail": { "zh": "本产品的市场记录日期。", "en": "Market-specific product record date." }, "source": { "id": "src_43e3f8c84a63767c", "label": "France public medicines database / ANSM: SMECTA 3 g ORANGE-VANILLE, CIS 69584073; label page updated 2025-04-22", "url": "https://base-donnees-publique.medicaments.gouv.fr/medicament/69584073/extrait", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } }, { "date": "2022", "title": { "zh": "Mayoly 收购相关业务", "en": "Mayoly acquired the relevant business" }, "detail": { "zh": "企业历史记载收购益普生家庭健康业务，组合包含 Smecta。", "en": "Company history records the Ipsen family-healthcare acquisition, with Smecta in the portfolio." }, "source": { "id": "src_7960e5e5dc18f1a9", "label": "Mayoly: company history and 2022 acquisition of Ipsen family healthcare including Smecta", "url": "https://mayoly.com/en/about-us/who-we-are/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "manufacturer_history", "market": "FR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-09", "reviewedAt": "2026-09-09" } } ], "marketStatus": [ { "market": { "zh": "法国", "en": "France" }, "status": { "zh": "政府产品原件已核对", "en": "Government product original checked" }, "detail": { "zh": "本页仅列 30 袋包装，不代表实时库存。", "en": "Only the 30-sachet pack is represented, not live stock." } }, { "market": { "zh": "新加坡", "en": "Singapore" }, "status": { "zh": "政府 NDF 产品记录已核对", "en": "Government NDF record checked" }, "detail": { "zh": "制造商 Mayoly Industrie（法国）；持有人 DKSH Singapore Pte. Ltd.，当地分类为 GSL。", "en": "Manufacturer Mayoly Industrie (France); holder DKSH Singapore Pte. Ltd.; local GSL classification." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "现行产品原件待核验", "en": "Current product original not verified" }, "detail": { "zh": "未把海外条目写成中国批准号、在售证明或包装。", "en": "Overseas records are not represented as Chinese authorisation, availability or packaging." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "国外有同名药，能直接照着吃吗？", "en": "Can I follow a same-brand foreign leaflet?" }, "answer": { "zh": "先核市场、完整品名、剂型和版本。新加坡记录只能说明该市场条目，不能替代你所在地区的说明书。", "en": "Check market, full name, form and version. Singapore’s entry identifies its local product and does not replace your local leaflet." } }, { "question": { "zh": "同样止泻，是同一种药吗？", "en": "Does a shared use mean the same medicine?" }, "answer": { "zh": "不是。先比对通用名，不要只按用途叠加或轮换；把实际药盒交给药师核对。", "en": "No. Compare generic names and have the actual packs checked rather than combining or alternating medicines by shared purpose." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dose-unit-literacy", "medicine-label-for-everyday-questions", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/smecta-diosmectite/", "en": "https://origindrug.com/en/drugs/smecta-diosmectite/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }