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 3 HL7 FHIR R5

WonderDrug

100 mg, 200 mg and 500 mg tablets

● Active Version 2.1 EN ePI Type 3 Prescription Only
Bundle Metadata
urn:uuid:a7f3c2d1-8e4b…
active
2.1
2026-03-27
EN
European Union 🇪🇺
Acme Pharma Inc.
EMA
Composition
urn:uuid:b8e1f4a2-3d7c…
WonderDrug SmPC
SmPC
active
2.1
EN
Contained Resources
1Compositions
2Organizations
3Medicinal Products
6Packaged Products
1Regulatory Authorizations

1. Name of the medicinal product

WonderDrug 100 mg, 200 mg and 500 mg tablets (paracetamol)

2. Qualitative and quantitative composition

Each tablet contains 100 mg, 200 mg or 500 mg of paracetamol.

Excipients: Pregelatinized starch, povidone K30, stearic acid, talc, magnesium stearate, hypromellose.

3. Pharmaceutical form

Tablet. White, round tablets (100 mg and 500 mg) and green hexagonal tablets (200 mg).

4. Clinical particulars

Indications: Symptomatic treatment of mild to moderate pain and fever in adults and children over 12 years.

Contraindications: Hypersensitivity to paracetamol or any excipients. Severe hepatic impairment.

Dose: Adults and children over 12 years: 500 mg every 4–6 hours. Maximum 4 g (8 tablets of 500 mg) in 24 hours.

5. Pharmacological properties

Paracetamol is an analgesic and antipyretic. ATC Code: N02BE01.

6. Pharmaceutical particulars

Storage: No special storage conditions required. Keep out of reach of children.

Shelf life: 36 months.

Marketing Authorization Holder
Acme Pharma Inc.
IdentifierLOC-100000000 (OMS)
TypeMAH
Address123 Pharma Way, 102 37 Prague, Czech Republic
Emailcontact@acmepharma.com
Phone+420 222 333 444
Websitehttps://www.acmepharma.com
Manufacturer
Global Manufacturing Solutions Ltd.
IdentifierLOC-200000000 (OMS)
TypeManufacturer
Address456 Industry Road, Berlin, Germany
Emailqa@globalman.de
Phone+49 30 1234567
Websitehttps://www.globalman.solutions

Organization data sourced from the OMS (Organisation Management Service) identifier system.

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
30 tabs
View artwork ↗
Box of 50 Tablets
GTIN: 09876543210150  |  SKU: WD500-BOX-50
Active Qty: 50 Outer: Box Inner: Blister PVC/Al
50 tabs
View artwork ↗
Carton of 20 Tablets
GTIN: 09876543210987  |  SKU: WD500-CARTON-20
Active Qty: 20 (2 x 10) Outer: Carton Inner: 2 x Blister PVC/Al
View artwork ↗
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
30 tabs
View artwork ↗
Blister Pack 50
GTIN: 09876543210250  |  SKU: WD100-BLISTER-50
Active Qty: 50 Outer: Box Inner: Blister PVC/Al
50 tabs
View artwork ↗
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
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
30 tabs
View artwork ↗
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-987654321
Region
Germany (DE)
1
Indication
🎯
2
Contraindications
⛔
4
Interactions
⚡
3
Dosage Regimens
💊
12
Side Effects
💉
3
Warnings
⚠
🎯Indications1
ConditionPopulationSeverity
HypertensionAdults ≥18 yearsModerate to severe
⛔Contraindications2
⊘Severe hepatic impairment (Child-Pugh C)
⊘Known hypersensitivity to WonderDrug or any excipient
⚡Interactions4
Interacting SubstanceTypeSeverityEffect
WarfarinPharmacodynamicHighIncreased anticoagulation risk
NSAIDsPharmacodynamicModerateReduced antihypertensive effect
RifampicinPharmacokineticModerateReduced plasma levels
Potassium supplementsPharmacodynamicLowRisk of hyperkalaemia
💉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)
⚠Warnings & Precautions3
▲Patients with renal impairment (CrCl <30 mL/min) require dose adjustment. Monitor renal function regularly.
▲Risk of hypotension on first dose, particularly in volume-depleted or sodium-depleted patients. Initiate at lowest dose.
▲Not recommended during pregnancy (2nd and 3rd trimester) due to risk of foetal toxicity.
💊 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)
✕
Pack Artwork — WonderDrug 100 mg / 30 tablets
WonderDrug 100 mg tablets acmedrug hydrochloride 30 film-coated tablets For oral use MA-987654321 | Acme Pharma Inc. RX
Source: PackagedProductDefinition.attachedDocument → DocumentReference/pack-art-wd100-30
✕
Pack Artwork — WonderDrug 100 mg / 50 tablets
WonderDrug 100 mg tablets acmedrug hydrochloride 50 film-coated tablets For oral use MA-987654321 | Acme Pharma Inc. RX
Source: PackagedProductDefinition.attachedDocument → DocumentReference/pack-art-wd100-50
✕
Pack Artwork — WonderDrug 200 mg / 30 tablets
WonderDrug 200 mg tablets acmedrug hydrochloride 30 film-coated tablets For oral use MA-987654321 | Acme Pharma Inc. RX
Source: PackagedProductDefinition.attachedDocument → DocumentReference/pack-art-wd200-30
✕
Pack Artwork — WonderDrug 200 mg / 50 tablets
WonderDrug 200 mg tablets acmedrug hydrochloride 50 film-coated tablets For oral use MA-987654321 | Acme Pharma Inc. RX
Source: PackagedProductDefinition.attachedDocument → DocumentReference/pack-art-wd200-50
✕
Pack Artwork — WonderDrug 500 mg / 30 tablets
WonderDrug 500 mg tablets acmedrug hydrochloride 30 film-coated tablets For oral use MA-987654321 | Acme Pharma Inc. RX
Source: PackagedProductDefinition.attachedDocument → DocumentReference/pack-art-wd500-30
✕
Pack Artwork — WonderDrug 500 mg (Carton + 2x Blister)
WonderDrug 500 mg tablets 20 tablets (2 x 10) GTIN: 09876543210987 SKU: WD500-CARTON-20 WonderDrug 500 mg | Lot: AB1234 WonderDrug 500 mg | Lot: AB1234
Source: PackagedProductDefinition.attachedDocument → DocumentReference/art-wd500-carton