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Packagehl7.fhir.uv.emedicinal-product-info
Resource TypeComposition
IdComposition-composition-paracetamol-t1.json
FHIR VersionR5

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Narrative

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Package Leaflet: Information for the user - Paracetamol 500 mg tablets


Source1

{
  "resourceType": "Composition",
  "id": "composition-paracetamol-t1",
  "meta": {
    "versionId": "1",
    "lastUpdated": "2024-03-20T10:00:00Z",
    "profile": [
      "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/composition-epi-type1"
    ]
  },
  "language": "en",
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "identifier": [
    {
      "system": "http://example.org/identifier",
      "value": "composition-paracetamol-t1"
    }
  ],
  "version": "1.0",
  "status": "final",
  "type": {
    "coding": [
      {
        "system": "https://spor.ema.europa.eu/rmswi/",
        "code": "100000155538",
        "display": "Package Leaflet"
      }
    ]
  },
  "subject": [
    {
      "display": "Paracetamol"
    }
  ],
  "date": "2024-03-20T10:00:00Z",
  "author": [
    {
      "display": "Acme Pharma Inc."
    }
  ],
  "title": "Package Leaflet: Information for the user - Paracetamol 500 mg tablets",
  "section": [
    {
      "title": "Package Leaflet",
      "code": {
        "coding": [
          {
            "system": "https://spor.ema.europa.eu/rmswi/",
            "code": "100000155538",
            "display": "Package Leaflet"
          }
        ]
      },
      "text": {
        "status": "generated",
        "div": "<div xml:lang=\"en\" xmlns=\"http://www.w3.org/1999/xhtml\" lang=\"en\">Package Leaflet</div>"
      },
      "section": [
        {
          "title": "1. What Paracetamol 500 mg tablets is and what it is used for",
          "code": {
            "coding": [
              {
                "system": "https://spor.ema.europa.eu/rmswi/",
                "code": "100000155538",
                "display": "1. What Paracetamol 500 mg tablets is and what it is used for"
              }
            ]
          },
          "text": {
            "status": "generated",
            "div": "<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>"
          }
        },
        {
          "title": "2. What you need to know before you take Paracetamol 500 mg tablets",
          "code": {
            "coding": [
              {
                "system": "https://spor.ema.europa.eu/rmswi/",
                "code": "100000155538",
                "display": "2. What you need to know before you take Paracetamol 500 mg tablets"
              }
            ]
          },
          "text": {
            "status": "generated",
            "div": "<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>"
          }
        },
        {
          "title": "3. How to take Paracetamol 500 mg tablets",
          "code": {
            "coding": [
              {
                "system": "https://spor.ema.europa.eu/rmswi/",
                "code": "100000155538",
                "display": "3. How to take Paracetamol 500 mg tablets"
              }
            ]
          },
          "text": {
            "status": "generated",
            "div": "<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>"
          }
        },
        {
          "title": "4. Possible side effects",
          "code": {
            "coding": [
              {
                "system": "https://spor.ema.europa.eu/rmswi/",
                "code": "100000155538",
                "display": "4. Possible side effects"
              }
            ]
          },
          "text": {
            "status": "generated",
            "div": "<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>"
          }
        },
        {
          "title": "5. How to store Paracetamol 500 mg tablets",
          "code": {
            "coding": [
              {
                "system": "https://spor.ema.europa.eu/rmswi/",
                "code": "100000155538",
                "display": "5. How to store Paracetamol 500 mg tablets"
              }
            ]
          },
          "text": {
            "status": "generated",
            "div": "<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>"
          }
        },
        {
          "title": "6. Contents of the pack and other information",
          "code": {
            "coding": [
              {
                "system": "https://spor.ema.europa.eu/rmswi/",
                "code": "100000155538",
                "display": "6. Contents of the pack and other information"
              }
            ]
          },
          "text": {
            "status": "generated",
            "div": "<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>"
          }
        }
      ]
    }
  ]
}