6.1. Explain the contents of patient information leaflets supplied with all medicines

This guide will help you answer 6.1. Explain the contents of patient information leaflets supplied with all medicines.

Patient information leaflets (PILs) are pamphlets included in packaging with every medication sold in the UK. They provide vital details to ensure the safe and effective use of the medicine. These leaflets are often written in straightforward language to help people understand the medication’s purpose and how to take it correctly. Every leaflet follows strict guidelines laid out by government and health regulatory agencies, such as the Medicines and Healthcare products Regulatory Agency (MHRA).

PILs are a legal requirement for all medicines and are reviewed regularly. Their contents must be clear and concise but thorough enough to inform patients about any risks, benefits, and instructions.

What the Medicine Is and What It Is Used For

This section introduces the medicine by stating its name and active ingredient(s). Every medication has one or more active ingredients, which are the components that produce an effect in the body. For instance, paracetamol is the active ingredient in pain relief medications like Panadol.

The leaflet explains the conditions the medication is designed to treat or prevent. It may also contain information about whether the medicine is used for short-term or long-term issues. This section is particularly helpful for patients who might have been prescribed medication by their GP and need clarification on its intended purpose.

Before You Take the Medicine

This part provides detailed warnings about who can safely use the medicine and who cannot. It outlines specific conditions or factors that may make the medication unsuitable for certain people. For example:

• Allergies: Patients with allergies to any of the ingredients listed will be warned to avoid the medicine.
• Pregnancy or Breastfeeding: Guidance will be given if the medicine is not safe to take during pregnancy or while breastfeeding. Suitable alternatives may be suggested.
• Medical Conditions: Conditions like kidney disease or liver problems may be mentioned as reasons the medicine might not be safe.
• Other Medications: If the medication may interact negatively with others a patient is already taking, this will be explained.

This section ensures people can check if the medicine is suitable for their individual health circumstances.

How to Take the Medicine

This section outlines the correct way to use the medication, including the dosage, frequency, and method of administration. Medicines may come in different forms, such as tablets, liquids, or injections, and the leaflet will specify how they should be taken for the best results.

The information will include:

• Dosage: Clear instructions about how much to take at one time and over a 24-hour period.
• Timing: Recommendations like “take after meals” or “take at bedtime.”
• Duration: Whether it’s safe for short-term use or if it needs to be taken regularly for long-term treatment.
• Missed or Overdose Guidance: Advice on what to do if a dose is forgotten or too much is accidentally taken.

This section ensures that patients use medicines correctly, reducing the risk of misuse and harm.

Side Effects

This part gives information about potential side effects associated with the medicine. Side effects are unwanted symptoms that can occur while taking a drug. They range from common to very rare.

The leaflet categorises side effects based on how frequently they occur, such as:

• Common: Occurs in 1 in 10 people.
• Uncommon: Occurs in 1 in 100 people.
• Rare: Occurs in 1 in 1,000 people.
• Very Rare: Occurs in 1 in 10,000 people.

Some medications list serious side effects and instruct the patient to stop taking the medicine and seek medical help immediately if they experience those symptoms. Common examples include allergic reactions like rash, swelling, or breathing difficulties.

This section helps people understand what to expect and how to act if they experience any side effects.

Ingredients

Every PIL contains a list of the medicine’s ingredients. This includes active ingredients (the part that treats the condition) and inactive ingredients (substances that deliver the active ingredient, such as coatings or fillers in tablets).

Some people have allergies or intolerances to inactive components, like gluten or lactose. Others may need products free from specific allergens, and the leaflet provides information to guide their choice.

For example: A PIL might list “contains lactose,” which allows people with lactose intolerance to avoid that particular product.

How to Store the Medicine

Proper storage of medicines is important to keep them effective and safe to use. This section tells patients how and where to store the product. Common recommendations include:

• Temperature: Medicines may need storing in a cool place or refrigerator. Others are fine at room temperature.
• Light: Some medicines must be kept away from sunlight or stored in their original packaging to prevent degradation.
• Moisture: The leaflet will specify protection from moisture where necessary.
• Keep out of children’s reach: Safety instructions are highlighted to safeguard young ones.

Following this guidance ensures the medicine remains effective until its expiry date.

Disposal Instructions

This section explains how to safely dispose of expired or unused medicine. Many medicines can harm the environment if disposed of incorrectly, such as being flushed down the sink or toilet. Often, PILs advise returning the medicine to a designated pharmacy drop-off point.

Guidance on disposal helps reduce risks to the environment and, in some cases, prevents unauthorised or accidental access.

What To Do If There’s a Problem

Some leaflets list a section on how to report issues. This can include contacting a GP or pharmacist, especially if the patient has questions or concerns. If serious side effects occur, PILs often advise contacting the regulatory body or visiting a website like the MHRA’s Yellow Card Scheme. The scheme allows patients to report side effects for further investigation.

This section improves patient safety and gives people a way to voice concerns or flag issues.

Company Contact Information

Every leaflet provides the manufacturer’s or supplier’s details. This includes a postal address, phone numbers, and sometimes email addresses. The contact section can be used by people seeking more information about the product, or by healthcare professionals who need clarity on the medicine.

Quality and Effectiveness of Patient Information Leaflets

In the UK, PILs undergo a rigorous checking process before approval. They must meet legal standards to ensure accuracy, clarity, and effectiveness. By providing specific, organised details, PILs help patients use medicines not just safely, but ethically and efficiently. No matter the medication, the PIL is an essential aid for communication between healthcare providers and patients, promoting safer practices.

Final Thoughts

Patient information leaflets are among the most helpful resources for anyone using medication. They enable safe use, reduce risks, and support informed decision-making. Following the guidance provided empowers patients to manage their health responsibly.