Electronic Medicinal Product Information (ePI) FHIR Implementation Guide
1.0.0 - trial-use International flag

This page is part of the Electronic Medicinal Product Information (ePI) FHIR Implementation Guide (v1.0.0: STU1) based on FHIR v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Example Bundle: ePI Bundle Type 3 - DrugX Package Insert

Composition status: final
Composition type: Package Leaflet

Narrative Text


B. Package Leaflet

Package leaflet: Information for the user

DrugX 75 mg tablets

acetaminophen

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  • What DrugX is and what it is used for
  • What you need to know before you take DrugX
  • How to take DrugX
  • Possible side effects
  • How to store DrugX
  • Contents of the pack and other information

1. What DrugX is and what it is used for

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2. What you need to know before you take DrugX

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3. How to take DrugX

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4. Possible side effects

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5. How to store DrugX

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6. Contents of the pack and other information

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Product Information

DrugX

PRODUCT: medicinalproduct75

status: Active

Domain: Human use

Combined pharmaceutical dose form:

Legal Status of Supply: Medicinal product subject to medical prescription

Authorisation 1 of 1

Auth id: authorization75mg

Region:

Type: Marketing Authorization

Holder (Organization): acme inc (http://example.org/sid/org#ORG1)

Status: Active (2015-02-07T13:28:17Z)

Package 1 of 1

PRODUCT: EU/1/97/049/001

Description:

Marketing Status: active

Contained Quantity:

  • 75


Package: 28 Blister [PolyVinyl Chloride]

Administrable Product (1 of 1)

Dose form: Tablet

Presentation unit: Tablet

Contents (Manuf. Items):
    3214f286-b8ec-4ef5-bc8d-0aec39d97468

    Dose form: Tablet

    Presentation unit: Tablet

    Manufactured Dose Form: Tablet

    Ingredients:
      745c01bc-936e-45ca-9880-57e97608f43e

      Status: Active

      Role: Active

      Substance: acetaminophen

      09c13040-8fd5-4818-972d-f01d4ee169b6

      Status: Active

      Role: Excipient

      Substance: Silicon dioxide

      a4b7b60c-998f-4f93-89c7-860396af0fe3

      Status: Active

      Role: Excipient

      Substance: Carnauba wax

      fbf58407-83d3-42db-be3d-506b2006d431

      Status: Active

      Role: Excipient

      Substance: Croscarmellose sodium

      1c10b441-6bd3-40b8-b14b-514e7c2f79d0

      Status: Active

      Role: Excipient

      Substance: Hypromellose

      7a3c0b14-2473-4541-9e45-a24d24cceddf

      Status: Active

      Role: Excipient

      Substance: Lactose Monohydrate

      ceba5cd1-321f-4bc3-b203-92d97fcf472e

      Status: Active

      Role: Excipient

      Substance: Macrogol 3000

      eee155e8-e442-491d-9a82-7af3cefac57f

      Status: Active

      Role: Excipient

      Substance: Magnesium stearate

      1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd

      Status: Active

      Role: Excipient

      Substance: Microcrystalline cellulose

      a88891dc-7e9e-4d84-b462-95e53de3b6a6

      Status: Active

      Role: Excipient

      Substance: Titanium Dioxide

Route of administration:
  • Oral route

Clinical Information

Contraindication: Gastrointestinal disorders

Indication: Psoriasis

Interaction: METHOTREXATE

Undesirable Effect: Dysergia

Warning: Symptomatic hypotension, especially after the first dose, may occur in patients.