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

Example Bundle: Bundle - ePI Type 1 Paracetamol Example

Document Details

version: 1.0; Last updated: 2024-03-20 10:00:00+0000; Language: en

Profile: Bundle - ePI Type 1

Final Document at 2024-03-20 10:00:00+0000 by Acme Pharma Inc. for Paracetamol



Document Content

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


Package Leaflet

Package Leaflet

1. What Paracetamol 500 mg tablets is and what it is used for

1. What Paracetamol 500 mg tablets is and what it is used for

Paracetamol belongs to a group of medicines called analgesics (painkillers) and antipyretics (medicines to reduce fever).

Paracetamol is used to relieve mild to moderate pain and fever.

2. What you need to know before you take Paracetamol 500 mg tablets

2. What you need to know before you take Paracetamol 500 mg tablets

Do not take Paracetamol: if you are allergic to paracetamol or any of the other ingredients of this medicine.

Warnings and precautions: Talk to your doctor or pharmacist before taking Paracetamol if you have liver or kidney problems.

3. How to take Paracetamol 500 mg tablets

3. How to take Paracetamol 500 mg tablets

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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.

4. Possible side effects

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and tell your doctor immediately if you experience allergic reactions such as skin rash or swelling.

5. How to store Paracetamol 500 mg tablets

5. How to store Paracetamol 500 mg tablets

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.

This medicine does not require any special storage conditions.

6. Contents of the pack and other information

6. Contents of the pack and other information

What Paracetamol contains: The active substance is paracetamol. The other ingredients are pregelatinized starch, povidone, stearic acid, talc, magnesium stearate, and hypromellose.

What Paracetamol looks like and contents of the pack: Paracetamol tablets are white and round. They are available in blister packs of 30 or 50 tablets.


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