Global Core Electronic Medicinal Product Information (ePI), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Vulcan eMedicinal Product Information IG ›Examples ›ePI Type 4 HL7 FHIR R5

WonderDrug

100 mg, 200 mg and 500 mg tablets

● Active Version 2.1 EN ePI Type 4 Prescription Only
Bundle Metadata
urn:uuid:c4f9e3a1-7d2b…
active
2.1
2026-03-27
EN
European Union 🇪🇺
Acme Pharma Inc.
EMA
Composition
urn:uuid:d8f2a3c1-4e7b…
WonderDrug SmPC
SmPC
active
2.1
EN
Contained Resources
1Compositions
2Organizations
3Medicinal Products
6Packaged Products
1Regulatory Authorizations
5Clinical Use Definitions
4Ingredients
3Groups
1Medication Knowledge
2Substance Definitions
🔗 Type 4 Enhancement: This Bundle uses granular Composition sections with mandatory section.entry references linking narrative text to structured FHIR resources. Narrative text includes <span> annotations that bind specific words to resource IDs.
📐 Type 4 Composition Structure: Content is decomposed into a hierarchy of Concept → Domain → Topic. Each Topic has its own section containing narrative text with semantic <span> annotations and entry references linking to structured resources.
Concept (Chapter)
Domain (Section)
Topic (Subsection)
Entry → CUD Resource
Entry → Ingredient
Text-only (no resource)
1. Name of the Medicinal Product
Topic: Product Name 1 entry
Narrative Text (with span annotations)
WonderDrug 500 mg tablets (paracetamol)
section.entry references
MPD MedicinalProductDefinition/mpd-wonderdrug-500mg
2. Qualitative and Quantitative Composition
2.1 Active Substance
Topic: Active Ingredient — Paracetamol 1 entry
Narrative Text (with span annotations)
Each tablet contains 500 mg of paracetamol.
section.entry references
ING Ingredient/ingredient-paracetamol-active
2.2 Excipients
Topic: Excipient List 3 entries
Narrative Text (with span annotations)
Excipients with known effect: pregelatinized starch, povidone K30, magnesium stearate.
section.entry references
ING Ingredient/ingredient-pregelatinized-starch ING Ingredient/ingredient-povidone-k30 ING Ingredient/ingredient-magnesium-stearate
4. Clinical Particulars
4.1 Therapeutic Indications
Topic 4.1.1: Indication — Hypertension 1 entry
Narrative Text (with span annotations)
WonderDrug is indicated for the treatment of hypertension in adults ≥18 years.
section.entry references
CUD ClinicalUseDefinition/cud-indication-1
Topic 4.1.2: Indication — Symptomatic Pain 1 entry
Narrative Text (with span annotations)
WonderDrug is indicated for the symptomatic treatment of mild to moderate pain and fever in children over 12 years.
section.entry references
CUD ClinicalUseDefinition/cud-indication-2
4.3 Contraindications
Topic 4.3.1: Contraindication — Hepatic Impairment 1 entry
Narrative Text (with span annotations)
WonderDrug is contraindicated in patients with severe hepatic impairment (Child-Pugh C).
section.entry references
CUD ClinicalUseDefinition/cud-contraindication-1
Topic 4.3.2: Contraindication — Hypersensitivity 1 entry
Narrative Text (with span annotations)
Do not take WonderDrug if you have a known hypersensitivity to paracetamol or any excipient listed in section 6.1.
section.entry references
CUD ClinicalUseDefinition/cud-contraindication-2
4.5 Interactions
Topic 4.5.1: Interaction — Warfarin 1 entry
Narrative Text (with span annotations)
Concomitant use of WonderDrug with warfarin may result in increased anticoagulation risk.
section.entry references
CUD ClinicalUseDefinition/cud-interaction-1
Marketing Authorization Holder
Acme Pharma Inc.
IdentifierLOC-100000000 (OMS)
TypeMAH
Address123 Pharma Way, 102 37 Prague, Czech Republic
Emailcontact@acmepharma.com
Manufacturer
Global Manufacturing Solutions Ltd.
IdentifierLOC-200000000 (OMS)
TypeManufacturer
Address456 Industry Road, Berlin, Germany
Emailqa@globalman.de
3 Medicinal Products · 6 Package Configurations
1 WonderDrug 500 mg tabletsParacetamol
ActiveOral · Tablet
▼
Substance & Form
Active SubstanceParacetamol
Strength500 mg
Dose FormTablet
RouteOral
Excipients
Pregelatinized starch
Talc
Povidone K30
Magnesium stearate
Stearic acid
Hypromellose
Physical Appearance
ColourWhite
ShapeRound
Size12 mm
ImprintW-500
Front
W-500
Back
Packaging (3)
Box of 30 Tablets
GTIN: 09876543210130  |  SKU: WD500-BOX-30
Active Qty: 30 Outer: Box Inner: Blister PVC/Al
Box of 50 Tablets
GTIN: 09876543210150  |  SKU: WD500-BOX-50
Active Qty: 50 Outer: Box Inner: Blister PVC/Al
Carton of 20 Tablets
GTIN: 09876543210987  |  SKU: WD500-CARTON-20
Active Qty: 20 (2 x 10) Outer: Carton Inner: 2 x Blister PVC/Al
Shelf Life & Storage Conditions
📅36months Shelf life of the medicinal product as packaged for sale
Source: PackagedProductDefinition.shelfLifeStorage.period
🌡
Temperature
Store below 25°C
Do not freeze
💧
Moisture
Keep dry
Protect from moisture
☀
Light
Protect from light
Keep in original packaging
👤
Safety
Out of reach of children
FHIR source: PackagedProductDefinition.shelfLifeStorage → type (ShelfLifeType) + storage condition (specialPrecautionsForStorage)
Marketing Authorization
Holder
Acme Pharma Inc.
Number
MA-123456789
Region
Estonia (EE)
2 WonderDrug 100 mg tabletsParacetamol
ActiveOral · Tablet
▼
Substance & Form
Active SubstanceParacetamol
Strength100 mg
Dose FormTablet
RouteOral
Excipients
Pregelatinized starch
Talc
Povidone K30
Magnesium stearate
Stearic acid
Hypromellose
Physical Appearance
ColourWhite
ShapeRound
Size6 mm
ImprintW-100
Front
W-100
Back
Packaging (2)
Box of 30 Tablets
GTIN: 09876543210230  |  SKU: WD100-BOX-30
Active Qty: 30 Outer: Box Inner: Blister PVC/Al
Blister Pack 50
GTIN: 09876543210250  |  SKU: WD100-BLISTER-50
Active Qty: 50 Outer: Box Inner: Blister PVC/Al
Shelf Life & Storage Conditions
📅36months Shelf life of the medicinal product as packaged for sale
🌡
Temperature
Store below 25°C
Do not freeze
💧
Moisture
Keep dry
Protect from moisture
☀
Light
Protect from light
Keep in original packaging
👤
Safety
Out of reach of children
Marketing Authorization
Holder
Acme Pharma Inc.
Number
PL 12345/6790
Region
United Kingdom
3 WonderDrug 200 mg tabletsParacetamol
ActiveOral · Tablet
▼
Substance & Form
Active SubstanceParacetamol
Strength200 mg
Dose FormTablet
RouteOral
Excipients
Pregelatinized starch
Talc
Povidone K30
Magnesium stearate
Stearic acid
Hypromellose
Physical Appearance
ColourGreen
ShapeHexagonal
Size9 mm
ImprintW-200
WonderDrug 200mg green hexagonal tablet
Product
Packaging (1)
Box of 30 Tablets
GTIN: 09876543210530  |  SKU: WD200-BOX-30
Active Qty: 30 Outer: Box Inner: Blister PVC/Al
Shelf Life & Storage Conditions
📅36months Shelf life of the medicinal product as packaged for sale
🌡
Temperature
Store below 25°C
Do not freeze
💧
Moisture
Keep dry
Protect from moisture
☀
Light
Protect from light
Keep in original packaging
👤
Safety
Out of reach of children
Marketing Authorization
Holder
Acme Pharma Inc.
Number
MA-987654321
Region
Germany (DE)
2
Indications
🎯
2
Contraindications
⛔
4
Interactions
⚡
3
Dosage Regimens
💊
12
Side Effects
💉
3
Warnings
⚠
🔗 Type 4 Enhancement: Every clinical data entry below is explicitly linked from the Composition.section.entry element. Narrative text within the section uses <span class="…"> annotations to bind individual words to these entries.
🎯Indications2
ConditionPopulationSeverityType 4 Entry
Hypertension Adults ≥18 years Moderate to severe CUD cud-indication-1
Mild to moderate pain and fever Children >12 years Mild to moderate CUD cud-indication-2
⛔Contraindications2
⊘Severe hepatic impairment (Child-Pugh C)CUD cud-contra-1
⊘Known hypersensitivity to WonderDrug or any excipientCUD cud-contra-2
⚡Interactions4
Interacting SubstanceTypeSeverityEffectType 4 Entry
WarfarinPharmacodynamicHighIncreased anticoagulation riskCUD cud-inter-1
NSAIDsPharmacodynamicModerateReduced antihypertensive effectCUD cud-inter-2
RifampicinPharmacokineticModerateReduced plasma levelsCUD cud-inter-3
Potassium supplementsPharmacodynamicLowRisk of hyperkalaemiaCUD cud-inter-4
💉Undesirable Effects12
Cardiac disorders
PalpitationsCommon (≥1/100)
BradycardiaUncommon (≥1/1,000)
Renal and urinary disorders
Renal impairmentUncommon (≥1/1,000)
ProteinuriaRare (≥1/10,000)
Nervous system disorders
HeadacheVery common (≥1/10)
DizzinessCommon (≥1/100)
Gastrointestinal disorders
NauseaCommon (≥1/100)
DiarrhoeaCommon (≥1/100)
Skin and subcutaneous tissue disorders
RashCommon (≥1/100)
PruritusUncommon (≥1/1,000)
UrticariaRare (≥1/10,000)
AngioedemaVery rare (<1/10,000)
⚠Warnings & Precautions3
▲Patients with renal impairment (CrCl <30 mL/min) require dose adjustment. Monitor renal function regularly.CUD cud-warning-1
▲Risk of hypotension on first dose, particularly in volume-depleted or sodium-depleted patients. Initiate at lowest dose.CUD cud-warning-2
▲Not recommended during pregnancy (2nd and 3rd trimester) due to risk of foetal toxicity.CUD cud-warning-3
💊 Dosage Regimen 3MedicationKnowledge
Adults & Adolescents (≥12 years / ≥50 kg)Standard
Single dose500 mg – 1,000 mg
Dose intervalEvery 4–6 hours as needed
Daily maximum4,000 mg (4 g)
RouteOral
AdministrationWith or without food; swallow whole with water
📅 Morning dose🌈 Midday dose🌒 Afternoon dose🌑 Evening dose⚠ Max 4 doses/day
FHIR source: MedicationKnowledge/mk-wonderdrug-500mg → dosingGuideline[0].dosage[0] (patientCharacteristic: age ≥12y, body weight ≥50kg)
Children (6–11 years / 21–50 kg)Weight-based
Single dose10–15 mg/kg
Maximum single dose500 mg
Dose intervalEvery 4–6 hours as needed
Daily maximum60 mg/kg/day (max 2,000 mg)
RouteOral
FHIR source: MedicationKnowledge/mk-wonderdrug-500mg → dosingGuideline[1].dosage[0] (patientCharacteristic: age 6–11y)
⚠Dose adjustment required in severe renal impairment (CrCl <30 mL/min). Extend the dosing interval to at least every 8 hours. Maximum 3 doses in 24 hours.
Renal Impairment — Severe (CrCl <30 mL/min)Adjusted
Single dose500 mg
Dose intervalEvery 8 hours minimum
Daily maximum1,500 mg (3 doses)
MonitoringMonitor renal function regularly
FHIR source: MedicationKnowledge/mk-wonderdrug-500mg → dosingGuideline[2].dosage[0] (patientCharacteristic: GFR <30 mL/min/1.73m²)
1
Composition.section → ClinicalUseDefinition entry
The Indication section uses section.entry to reference the ClinicalUseDefinition resource
Data Flow
section 4.1.1
→
text: <span class="cud-indication-1">
→
entry
→
ClinicalUseDefinition/cud-indication-1
Composition Hierarchy
Section 4 — Clinical Particulars (no text, no entry)
Section 4.1 — Therapeutic Indications (no text, no entry)
Section 4.1.1 — Indication #1 → text + entry: CUD/cud-indication-1
Section 4.1.2 — Indication #2 → text + entry: CUD/cud-indication-2
Narrative Text with Annotations (Section 4.1.1)
WonderDrug is indicated for the treatment of hypertension in adults ≥18 years.
💡 Hover over highlighted words to see their span class attribute linking to the resource ID.
XHTML Source (section.text.div)
<div xmlns="http://www.w3.org/1999/xhtml">
  <span class="mpd-wonderdrug-500mg">WonderDrug</span>
  is indicated for the treatment of
  <span class="cud-indication-1">hypertension</span>
  in
  <span class="group-adult-men">adults ≥18 years</span>.
</div>
Entry Target Resource
ClinicalUseDefinition cud-indication-1
typeindication
indication.diseaseSymptomProcedureHypertension (SNOMED CT: 38341003)
indication.diseaseStatusModerate to severe
populationReference(Group/group-adult-men)
subjectReference(MPD/mpd-wonderdrug-500mg)
Group group-adult-men
typeperson
membershipdefinitional
characteristic: age≥18 years
characteristic: gendermale
2
Composition.section → Ingredient entry + span annotations
The Composition section on ingredients connects narrative text mentions back to the Ingredient resource via entry and span tags
Data Flow
section 2.2
→
text: <span class="ingredient-…">
→
entry
→
Ingredient/ingredient-…
Composition Hierarchy
Section 2 — Qualitative & Quantitative Composition (no text, no entry)
Section 2.1 — Active Substance (context only)
Topic: Active Ingredient → text + entry: Ingredient/ingredient-paracetamol-active
Section 2.2 — Excipients (context only)
Topic: Excipient List → text + 3 × entry: Ingredient/…
Narrative Text with Ingredient Annotations (Section 2.2)
Excipients with known effect: pregelatinized starch, povidone K30, magnesium stearate.
💡 Each highlighted ingredient is wrapped in a <span class="ingredient-…"> tag that maps to the corresponding Ingredient resource ID.
XHTML Source (section.text.div)
<div xmlns="http://www.w3.org/1999/xhtml">
  Excipients with known effect:
  <span class="ingredient-pregelatinized-starch">pregelatinized starch</span>,
  <span class="ingredient-povidone-k30">povidone K30</span>,
  <span class="ingredient-magnesium-stearate">magnesium stearate</span>.
</div>
section.entry references (3 entries)
ING Ingredient/ingredient-pregelatinized-starch ING Ingredient/ingredient-povidone-k30 ING Ingredient/ingredient-magnesium-stearate
Entry Target Resources
Ingredient ingredient-pregelatinized-starch
roleexcipient
substance.codePregelatinized starch (UNII: O8232NY3SJ)
forReference(MPD/mpd-wonderdrug-500mg)
Ingredient ingredient-povidone-k30
roleexcipient
substance.codePovidone K30 (UNII: FZ989GH94E)
forReference(MPD/mpd-wonderdrug-500mg)
Ingredient ingredient-magnesium-stearate
roleexcipient
substance.codeMagnesium stearate (UNII: 70097M6I30)
forReference(MPD/mpd-wonderdrug-500mg)
Type 4 Linkage Summary
The table below summarises how each Type 4 Composition section maps to FHIR resource entries through section.entry references and how narrative text uses <span> annotations for inline linking.
Section Topic Entry Target Span Annotations
1 – Product Name Product Name MPD mpd-wonderdrug WonderDrug, paracetamol
2.1 – Active Substance Active Ingredient ING ing-paracetamol paracetamol
2.2 – Excipients Excipient List 3 × ING excipient starch, povidone, mg stearate
4.1.1 – Indication #1 Hypertension CUD cud-indication-1 hypertension, adults
4.1.2 – Indication #2 Pain & Fever CUD cud-indication-2 pain, fever, children
4.3.1 – Contraindication Hepatic Impairment CUD cud-contra-1 hepatic impairment
4.3.2 – Contraindication Hypersensitivity CUD cud-contra-2 hypersensitivity, paracetamol
4.5.1 – Interaction Warfarin CUD cud-inter-1 warfarin