ePI IG for APAC markets
0.1.0 - ci-build
ePI IG for APAC markets, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/aseanepi/ and changes regularly. See the Directory of published versions
Consumer Medication Information Leaflet (RiMUP)
PRODUCT NAME®
Active Ingredient/ generic name (Strengths)
What is in this leaflet
1. What [product name] is used for
2. How [product name] works
3. Before you use [product name]
4. How to use [product name]
5. While you are using it
6. Side effects
7. Storage and Disposal of [product name]
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of revision
12. Serial Number
PIL shall be prepared and written in layman's terms, and shall contain the following minimum information:
l) Name of the Product
2) Description of the Product
3) What is in the Medicine?
4) Strength of the Medicine
5) What is this Medicine used for?
6) How much and how often should you use this Medicine?
7) When should you not take this Medicine?
8) Care that should be taken when taking this Medicine?
9) Undesirable Effects of this Medicine
10) What other medicine or food should be avoided while taking this Medicine?
11) What should you do if you miss a dose?
12) Signs and Symptoms of Overdose
13) What to do when you have taken more than the recommended dosage?
14) How should you keep this Medicine?
15) When should you consult your doctor?
16) Name and Address of Marketing Authorization Holder
17) Name and Address of Manufacturer
18) ADR Reporting Statement
19) Registration Number
20) Date of First Authorization/Renewal of the Authorization
21) Date of Revision of Patient Information Leaflet
What you should know before use this drug
2.1 When do not use this drug
2.2 Warnings and precautions
Link to Thai template sample [To be added]
CHAPTER IV
INCLUSION OF INFORMATION
ON PRODUCT INFORMATION FOR PATIENTS
A. Name of the Drug
Include the name of the drug according to the Summary of Product Characteristics/Brochure.
B Preparation Form
The preparation form is listed in accordance with the Summary of Product Characteristics/Brochure.
C. Composition of active substance/What is contained in the drugs?
The active substance composition is listed in accordance with the Summary of Product Characteristics/Brochure.
D. Strength of the drug/How strong is this drug?
List the strength of the drug according to the Summary of Product Characteristics/Brochure.
E. Drug Description/How does this drug look?
Include the description of the drug according to the Summary of Product Characteristics/Brochure.
F. Indications/What is the purpose of the drug?
The indication of the drug including its pharmacotherapeutic group/form of activity is listed in accordance with the Summary of Product Characteristics/Brochure. Example: drug X belongs to the statin class used to lower cholesterol.
G. Posology and Method of Administration/How much and how often this drug should be used? What to do if an individual forgets to take this drug?
The posology and method of administration are listed in accordance with the Summary of Product Characteristics/Brochure.
This section can start with an opening sentence, for example:
a. For drugs that require a prescription:
"Always use this drug as prescribed to you by your doctor, pharmacist or nurse. Consult your doctor, pharmacist or nurse if you are unsure. The usual dose is…".
b. For non-prescription drugs:
"Always use this drug as directed in the Summary of Product Characteristics/Brochure or as directed to you by your doctor, pharmacist, or nurse. Consult your doctor, pharmacist or nurse if you are unsure. The usual dose is…".
3. If necessary, especially for non-prescription drugs, the following information should be included:
a. the duration of therapy;
b the maximum duration of the therapy; and/or
c. conditions where the duration of treatment should be limited.
4. Include an explanation of what to do after using a drug that does not match the dosage frequency, or if a dose is missed.
5. Description of withdrawal symptoms and how to minimize them are included, as well as the possible effects of stopping treatment before the prescribed time and the need to consult a doctor.
H. Contraindications/In what kind of condition are you not allowed to use this drug
This section may begin with a sentence: "Do not use this drug if…".
List all Contraindications according to the Summary of Product Characteristics/Brochure. It must be ensured that all the intricate details are not omitted.
It is not allowed to list only general or major contraindications.
Allergic conditions are also listed with the sentence: "Do not use this drug if you are allergic to the active substance or other ingredients contained in this drug.".
I. Warnings and Precautions/What needs to be taken into account when using this drug?
This section may begin with a sentence: "Tell your doctor, pharmacist or nurse before (using/consuming)".
List all warnings and cautions in accordance with the Summary of Product Characteristics/Brochure, including those related to Drug Interactions, Fertility, Pregnancy and Breastfeeding, and Effects on the Driver and Operating the Machinery, or excipients.
If not indicated in the Pediatric population, then the information should be included. Example: Do not give this drug to children aged (X years, or months), because (risk …/does not work in this population/benefit does not outweigh risk/potentially unsafe)".
If there is no indication in some or all pediatric populations, the information should reflect the Pediatrics subsection of the Posology and Method of Administration section of the Summary of Product Characteristics/Brochure. Example: "Do not give this drug to children aged x (years) and y (months) because (risk …/ineffective/potential benefit does not outweigh the risk/unsafe)".
J. Drug interactions/What kind of drugs and foods that should be avoided when using this drug?
Drug interactions are listed in accordance with the Summary of Product Characteristics/Brochure, including effects of use with other drugs, interactions with herbal drugs, food, alcohol, cigarettes, and active substances not intended for treatment.
Clearly describe the consequences of the interaction. Example: "Don't use X with Y (the drug used for treatment A). This may cause a decrease in the effect of X or may cause side effects".
List combinations with drugs that should be avoided and require caution. Example: "If oral hormonal contraceptives are likely to become ineffective due to drug interactions, patients should also be advised to use other forms of contraception. Tell the doctor, pharmacist or nurse if you are currently/recently taking any other drugs, including…".
K. Pregnancy and Breastfeeding/Can it be used for pregnant and breastfeeding women?
This section may begin with a sentence: "If you are pregnant or breastfeeding, potentially pregnant or planning to become pregnant, ask your doctor, pharmacist or nurse for advice before using this drug".
Pregnancy and breastfeeding are listed in accordance with the Summary of Product Characteristics/Brochure.
L. Effects on the Driver while Operating the Machinery/Is it permissible to operate a machinery when taking this drug?
List the effects on the driver and operating the machinery according to the Summary of Product Characteristics/Brochure.
M. Side Effects/What are the possible unwanted effects of using this drug?
This section may begin with a sentence: "Like any drug, it can have side effects, although not everyone experiences them".
List all side effects according to the Summary of Product Characteristics/Brochure, including those for special populations and the mechanism for reporting side effects.
The most serious side effects that should be listed with clear instructions to the patient on what to do. Example: "Stop using the drug" or "Seek emergency assistance immediately".
Side effect reporting related information is included. Example: "If there are complaints of side effects or discomfort during and after using the drug, consult your doctor, pharmacist, or nurse. You can also report any side effects or uncomfortable conditions directly to the Pharmaceutical Industry through the following contacts: (contact number to be filled in by the Pharmaceutical Industry). By reporting side effects, you can help provide more information on the safety of this drug".
N. Overdose and Treatment/What are the signs and symptoms of overdose? What should I do if I use more than the prescribed dose of this drug? (if necessary)
Describe how to recognize the symptoms if someone have been overdosed, and what should be done according to the Summary of Product Characteristics/Brochure.
O. Methods of Storage/How do I store this drug?
This section may begin with a sentence: "Keep this drug out of sight and reach of children" or "Do not use this drug after the expiry date stated on the packaging".
The storage method is stated in accordance with the Summary of Product Characteristics/Brochure.
P. Limitation of Use After Reconstituted or After The Container Has Been Opened /How long can this drug be used after the container has been opened? (if the product is multidose or needs to be reconstituted/diluted before use)
The usage limit after reconstitution or after the container has been opened is stated in accordance with the Summary of Product Characteristics/Brochure.
If necessary, attention to visual defects may be included. Example: "Do not use this drug if you see … (description of damage marks)".
Q. Other Information/What information should I know about this drug?
Directions for Use/How to use this drug?
a. Instructions for use are included in accordance with the Summary of Product Characteristics/Brochure.
b. Some of the following example sentences can be used:
1. "swallow the drug whole with water".
2. "swallow the drug whole with or without food".
3. " do not chew ".
4. "shake well before use".
5. "do not crush the tablet".
6. "the dividing line is only used to help you split the drug if you are having difficulties swallowing the drug whole".
7. “dissolve the drug in water until it is completely dissolved".
8. "do not swallow" (for suppository drugs).
Drug Formula/What does this drug contain?
A complete statement of the active substance and excipients using the name as per the Summary of Product Characteristics/Brochure is included.
R. Distribution License Number
Include the Distribution License Number as approved by the National Agency of Drug and Food Control.
S. Name of the Registrant and/or Drug Owner in accordance with the applicable regulations
Include the name of the registrant and/or drug distribution license owner.
T. Address of the Registrant and/or Drug Owner in accordance with the Applicable Conditions
Include the address of the registrant and/or drug distribution license holder, at least the city and country.
Telephone, fax number or email address can be included (not the registrant's page or an email linked to the registrant's page).
U. Name of Manufacturer
Information on the name of manufacturer should include at least the person in charge of the batch release, as well as the manufacturer and packager of the drug if different from the person in charge of the batch release.
V. Address of Manufacturer
Include the address of the drug manufacturer, at least the city and country, and other information if necessary.
W. Name of Licensor Industry (if the product is a licensed product)
If the drug is a licensed drug, include the name of licensor industry.
X. Address of Licensor Industry (if the product is a licensed product)
If the drug is a licensed drug, include the address (city and country) of the licensor industry.
Y. Special Warning
Special warnings are included in accordance with the Summary of Product Characteristics/Brochure.