Global Core Electronic Medicinal Product Information (ePI)
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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

: Bundle - ePI Type 1 Paracetamol Example

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<Bundle xmlns="http://hl7.org/fhir">
  <id value="bundle-epi-type1-example-paracetamol"/>
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    <versionId value="1.0"/>
    <lastUpdated value="2024-03-20T10:00:00Z"/>
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    <value value="epi-paracetamol-t1"/>
  </identifier>
  <type value="document"/>
  <timestamp value="2024-03-20T10:00:00Z"/>
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    <fullUrl
             value="http://hl7.org/fhir/uv/emedicinal-product-info/Composition/composition-paracetamol-t1"/>
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      <Composition>
        <id value="composition-paracetamol-t1"/>
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                   value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"/>
        </meta>
        <language value="en"/>
        <text>
          <status value="generated"/>
          <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><a name="Composition_composition-paracetamol-t1"> </a><p>Package Leaflet: Information for the user - Paracetamol 500 mg tablets</p></div>
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        <status value="final"/>
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            <system value="https://spor.ema.europa.eu/rmswi/"/>
            <code value="100000155538"/>
            <display value="Package Leaflet"/>
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        <subject>
          <display value="Paracetamol"/>
        </subject>
        <date value="2024-03-20T10:00:00Z"/>
        <author>
          <display value="Acme Pharma Inc."/>
        </author>
        <title
               value="Package Leaflet: Information for the user - Paracetamol 500 mg tablets"/>
        <section id="root-section">
          <title value="Package Leaflet"/>
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            <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en">Package Leaflet</div>
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          <section id="section-1">
            <title
                   value="1. What Paracetamol 500 mg tablets is and what it is used for"/>
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              <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><h3>1. What Paracetamol 500 mg tablets is and what it is used for</h3><p>Paracetamol belongs to a group of medicines called analgesics (painkillers) and antipyretics (medicines to reduce fever).</p><p>Paracetamol is used to relieve mild to moderate pain and fever.</p></div>
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          </section>
          <section id="section-2">
            <title
                   value="2. What you need to know before you take Paracetamol 500 mg tablets"/>
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              <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><h3>2. What you need to know before you take Paracetamol 500 mg tablets</h3><p><strong>Do not take Paracetamol:</strong> if you are allergic to paracetamol or any of the other ingredients of this medicine.</p><p><strong>Warnings and precautions:</strong> Talk to your doctor or pharmacist before taking Paracetamol if you have liver or kidney problems.</p></div>
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          </section>
          <section id="section-3">
            <title value="3. How to take Paracetamol 500 mg tablets"/>
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              <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><h3>3. How to take Paracetamol 500 mg tablets</h3><p>Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.</p><p>The recommended dose is 1 tablet every 4 to 6 hours as needed. Do not take more than 6 tablets in any 24-hour period.</p></div>
            </text>
          </section>
          <section id="section-4">
            <title value="4. Possible side effects"/>
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              <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><h3>4. Possible side effects</h3><p>Like all medicines, this medicine can cause side effects, although not everybody gets them.</p><p>Stop taking the medicine and tell your doctor immediately if you experience allergic reactions such as skin rash or swelling.</p></div>
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          <section id="section-5">
            <title value="5. How to store Paracetamol 500 mg tablets"/>
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              <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><h3>5. How to store Paracetamol 500 mg tablets</h3><p>Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton.</p><p>This medicine does not require any special storage conditions.</p></div>
            </text>
          </section>
          <section id="section-6">
            <title value="6. Contents of the pack and other information"/>
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              <div xml:lang="en" xmlns="http://www.w3.org/1999/xhtml" lang="en"><h3>6. Contents of the pack and other information</h3><p><strong>What Paracetamol contains:</strong> The active substance is paracetamol. The other ingredients are pregelatinized starch, povidone, stearic acid, talc, magnesium stearate, and hypromellose.</p><p><strong>What Paracetamol looks like and contents of the pack:</strong> Paracetamol tablets are white and round. They are available in blister packs of 30 or 50 tablets.</p></div>
            </text>
          </section>
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