Generated Narrative: Composition composition-wondermox-type3 Profile: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type3 status: Final type: Package Leaflet date: 2025-12-10 author: Organization KRKA, d.d., Novo mesto title: Package Leaflet: Information for the user - WonderMox 500 mg/125 mg
Package Leaflet: Information for the user - WonderMox 500 mg/125 mg
1. What WonderMox is and what it is used for
WonderMox is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid.
2. What you need to know before you take WonderMox
Do not take WonderMox if you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you.
Common side effects may include diarrhea, thrush (candida), feeling sick (nausea) or being sick (vomiting).
Keep this medicine out of the sight and reach of children. Store in the original package in order to protect from moisture.
6. Contents of the pack and other information
Contents of the pack and other information
The active substances are amoxicillin and clavulanic acid.
Generated Narrative: MedicinalProductDefinition WonderMox-500mg-125mg-EE-MPD version: 1; Last updated: 2025-11-26 10:51:48+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition identifier: http://ema.europa.eu/fhir/mpId/EE-100009540-30722, http://ema.europa.eu/fhir/pmsId/0000000000006 domain: Human use status: Current combinedPharmaceuticalDoseForm: Film-coated tablet legalStatusOfSupply: Medicinal Product subject to medical prescription classification: amoxicillin and beta-lactamase inhibitor, amoxicillin and beta-lactamase inhibitor name productName: WonderMox 500 mg/125 mg õhukese polümeerikattega tabletid part part: WonderMox type: Invented name part part part: 500mg/125mg type: Strength part part part: õhukese polümeerikattega tabletid type: Pharmaceutical dose form part Usages - Country Language * Republic of Estonia Estonian
Medicinal Product subject to medical prescription
amoxicillin and beta-lactamase inhibitor
WonderMox 500 mg/125 mg õhukese polümeerikattega tabletid
Generated Narrative: RegulatedAuthorization WonderMox-500mg-125mg-EE-RA version: 1; Last updated: 2025-11-26 10:51:49+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization identifier: 879415 subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor type: Marketing Authorisation region: Republic of Estonia status: Valid - Renewed/Varied statusDate: 2021-02-03 holder: Organization KRKA, d.d., Novo mesto
Generated Narrative: PackagedProductDefinition WonderMox-500mg-125mg-EE-PPD-1635117 version: 1; Last updated: 2025-11-26 10:51:50+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition identifier: http://ema.europa.eu/example/pcid/EE-100009540-30722-1635117 packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor containedItemQuantity: 10 tablet (Details: 200000000014 code200000002152 = '200000002152') description: Ribapakend (Al/Al) 10 õhukese polümeerikattega tabletti karbis MarketingStatuses - Country Status * Republic of Estonia Marketed packaging type: Box quantity: 1 material: Cardboard packaging type: Strip quantity: 1 material: Aluminium containedItem Items - Reference * ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet amount: 10
Ribapakend (Al/Al) 10 õhukese polümeerikattega tabletti karbis
Generated Narrative: PackagedProductDefinition WonderMox-500mg-125mg-EE-PPD-1635207 version: 1; Last updated: 2025-11-26 10:51:50+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition identifier: http://ema.europa.eu/example/pcid/EE-100009540-30722-1635207 packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor containedItemQuantity: 500 tablet (Details: 200000000014 code200000002152 = '200000002152') description: Ribapakend (Al/Al) 500 õhukese polümeerikattega tabletti karbis MarketingStatuses - Country Status * Republic of Estonia Marketed packaging type: Box quantity: 1 material: Cardboard packaging type: Strip quantity: 1 material: Aluminium containedItem Items - Reference * ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet amount: 500
Ribapakend (Al/Al) 500 õhukese polümeerikattega tabletti karbis
Generated Narrative: PackagedProductDefinition WonderMox-500mg-125mg-EE-PPD-1635139 version: 1; Last updated: 2025-11-26 10:51:51+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition identifier: http://ema.europa.eu/example/pcid/EE-100009540-30722-1635139 packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor containedItemQuantity: 14 tablet (Details: 200000000014 code200000002152 = '200000002152') description: Blisterpakend (OPA/Al/PVC foil/Al foil) 14 õhukese polümeerikattega tabletti karbis MarketingStatuses - Country Status * Republic of Estonia Marketed packaging type: Box quantity: 1 material: Cardboard packaging type: Blister quantity: 1 material: Orientated PolyAmide, Aluminium, PolyVinyl Chloride containedItem Items - Reference * ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet amount: 14
Blisterpakend (OPA/Al/PVC foil/Al foil) 14 õhukese polümeerikattega tabletti karbis
Generated Narrative: AdministrableProductDefinition WonderMox-500mg-125mg-EE-APD version: 1; Last updated: 2025-11-26 10:53:25+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition status: Active formOf: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor administrableDoseForm: Film-coated tablet unitOfPresentation: Tablet producedFrom: ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet RouteOfAdministrations - Code * Oral use
Generated Narrative: Ingredient WonderMox-500mg-125mg-EE-I-100000092629 version: 1; Last updated: 2025-11-26 10:53:25+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * AMOXICILLIN TRIHYDRATE strength presentation: 573.892 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152') referenceStrength Substances - Concept * Amoxicillin strength: 500 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')
Generated Narrative: Ingredient WonderMox-500mg-125mg-EE-I-100000093061 version: 1; Last updated: 2025-11-26 10:53:26+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient status: Active for: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor ManufacturedItemDefinition: status = active; manufacturedDoseForm = Film-coated tablet; unitOfPresentation = Tablet AdministrableProductDefinition: status = active; administrableDoseForm = Film-coated tablet; unitOfPresentation = Tablet role: Active substance Codes - Concept * POTASSIUM CLAVULANATE strength presentation: 151.915 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152') referenceStrength Substances - Concept * CLAVULANIC ACID strength: 125 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 tablet (Details: 200000000014 code200000002152 = '200000002152')
Generated Narrative: ManufacturedItemDefinition WonderMox-500mg-125mg-EE-MID version: 1; Last updated: 2025-11-26 10:51:49+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition status: Active manufacturedDoseForm: Film-coated tablet unitOfPresentation: Tablet
Generated Narrative: Organization LOC-100009540-KrkaNovoMesto version: 1; Last updated: 2025-11-26 10:50:40+0000 Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization identifier: https://spor.ema.europa.eu/v1/locations/LOC-100009540, https://spor.ema.europa.eu/v1/organisations/ORG-100000627 name: KRKA, d.d., Novo mesto
Generated Narrative: ClinicalUseDefinition cud-indication-infection type: Indication subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor indication DiseaseSymptomProcedures - Concept * Bacterial infectious disease
Generated Narrative: ClinicalUseDefinition cud-contra-penicillin-allergy type: Contraindication subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor contraindication DiseaseSymptomProcedures - Concept * Allergy to penicillin
Generated Narrative: ClinicalUseDefinition cud-interact-methotrexate type: Interaction subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor interaction Interactants - Item[x] * Methotrexate
Generated Narrative: ClinicalUseDefinition cud-warning-hepatic type: Warning subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor Warnings - Description * Use with caution in patients with hepatic impairment.
Use with caution in patients with hepatic impairment.
Generated Narrative: ClinicalUseDefinition cud-side-diarrhea type: Undesirable Effect subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#EE-100009540-30722,http://ema.europa.eu/fhir/pmsId#0000000000006; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Film-coated tablet; legalStatusOfSupply = Medicinal Product subject to medical prescription; classification = amoxicillin and beta-lactamase inhibitor,amoxicillin and beta-lactamase inhibitor undesirableEffect SymptomConditionEffects - Concept * Diarrhea
Generated Narrative: MedicationKnowledge mk-wondermox code: Amoxicillin + Clavulanic Acid status: Active indicationGuideline dosingGuideline treatmentIntent: Anti-infective treatment dosage Dosages - Text * One 500 mg/125 mg tablet every 8 hours