약학회지

ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)

Table. 3.

Table. 3. Contents of package leaflets among South Korea, United States and European Union
South Korea United States European Union
Package Insert Medication Guide Patient Package Insert Instructions for Use Package Leaflet
Oral Contraceptives Estrogen containing products
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What is the most important information I should know about (name of drug)?

Summary

- - -

The product name

What is (name of drug)?

The name of the drug

The name of the drug

Product title

What X is and what it is used for

What X is and what it is used for

Therapeutic indications

Information on the benefits of using this medicine

The name of all ingredients, quantity of active ingredients, and quantity of preservatives stated in the certificate of permission by item and certificate of notification by item

The name of the ingredient, animal of origin and part, if an ingredient is derived from an animal (if applicable)

The name of tar color, if applicable

Indications

A statement comparing the effectiveness of oral contraceptives to other methods of contraception

A statement regarding the benefits and proper uses of estrogens

A statement regarding the benefits and proper uses of estrogens

Important information for patients

Dose regimen, dose

How should I take (name of drug)?

Information about how to take oral contraceptives properly

Important information for patients

Preparation instructions

Administration instructions

How to X

How to X

Route(s) and/or method of administration

Duration of treatment

Other precautions necessary for use or handling

Storage conditions

Who should not take (name of drug)?

What should I avoid while taking (name of drug)?

What are the possible or reasonably likely side effects of (name of drug)?

A boxed warning

Contraindications

Medical conditions that are non contraindications to use but deserve special consideration

A warning regarding the most serious side effects

Other serious adverse reactions and potential safety hazards

Common, but less serious side effects

Precautions

Possible benefits associated with oral contraceptive use

The contraindications to use

A description of the most serious risks associated with the use of estrogens

A brief summary of other side effects of estrogens

Instructions on how a patient may reduce the risks of estrogen use

Important information for patients

Storage instructions

Disposal instructions

What you need to know before you X

What you need to know before you X

Appropriate precautions for use, special warnings

Interactions with other medicines

Interactions with food and drink

Use by pregnant or breastfeeding women, information on fertility

Ef fects on the ability to drive or to use machines

Excipients warnings

Possible side effects

Possible side effects

Reporting of side feefcts

How to store X

How to store X

S torage conditions

Where applicable, shelf life after reconstitution, dilution or after first opening the container

Where appropriate, warnings against certain visible signs of deterioration

The weight, capacity, or number of articles

Appearance

The trade name and address of a person who has obtained permission by item of drugs or an importer

The name and address of the manufacturer in the country of origin if the product is imported

The letter “prescription drug” or “over-the-counter drug”

“Misuse or abuse concerned medicine” (if applicable)

The way to exchange expired, deteriorated, or damaged medicines only with pharmacists, OTC medicines sellers and distributors

Date/month/year the package leaflet created or last revised

General information about the safe and effective use of prescription drug products

General Information

The name and place of business of the manufacturer, packer, or distributor

The date, identified as such, of the most recent revision of the patient package insert

Title

Purpose statement

Visual of drug product

Additional information

Contents of the pack and other information

Contents of the pack and other information

Pharmaceutical form, nature and contents of container in weight, volume or units of dose

Name and address of the MAH and of the manufacturer responsible for batch release, if different

Last revision date

Yakhak Hoeji 2023;67:404-14 https://doi.org/10.17480/psk.2023.67.6.404
© 2023 Yakhak Hoeji