Patient Information leaflets

(PIL)

Sheet # 4

2023 ASU Introduction to Pharmacy Practice Dr. Manal Ayyash 1

 Introduction
• A leaflet gives you important information
about your medication.
• Are available for any medication prescribed
by your doctor or for medication available
from a pharmacy.
• Reading the leaflet will help you to:
 Understand how to safely take your
medication.
 will give you information about possible
side effects.
 Interactions with other substances.

2023 ASU Introduction to Pharmacy Practice Dr. Manal Ayyash 2

 Content of Patient Information leaflet (
PIL)
1. Identification of the medicine.
 The trade name of the medicine.
 The active substances(s).
 The pharmaceutical dosage form.
 The strength.
2. Therapeutic Indication.
 The conditions of which the medicine is
authorized.

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 Content of Patient Information leaflet ( PIL)

3. The information necessary before taking the medicine.

 The situations when the medicine shouldn’t be used.
 Precautions and warning.(allergy)
 Interaction with other medicines or food.
 Information of special group of patient (pregnant or nursing mothers).
 Any effects the medicine may have on the patient`s ability to drive.

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 Content of Patient Information leaflet ( PIL)
4. Dosage.
 How to take or use the medicine include both the route and method of administration.
 How often it should be given.
 How long the course of treatment will last.
 What to do if a dose is missed
 The risk of withdrawal effects.
5. Description of side effects.
 All the effect which may occur under normal used of the medicine and what action the patient
should take if any of them occur.
 Should be listed by seriousness and the frequency.

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 Content of Patient Information leaflet ( PIL)
6. Additional information.
 All excipients (non- active ingredients) of the medication, (such as binders or
tablet coatings)
 Registered pack size.
 Storage condition.
 Name and address of the manufacturer.
7. Description of side effects.
 All the effect which may occur under normal used of the medicine and what
action the patient should take if any of them occur.
 Should be listed by seriousness and the frequency.

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 Content of Patient Information leaflet ( PIL)

8. Date on which the leaflet was prepared

 The PIL should be revises.
9. Language
 The PIL must be written in the official language of the member state
although other languages may be used as well, provided that the same
particulars appear in all languages used.
 The document must also be written in clear and understandable terms for
the users and be clearly legible.

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2023 ASU Introduction to Pharmacy Practice Dr. Manal Ayyash 8
2023 ASU Introduction to Pharmacy
Dr. Manal Ayyash 9
Practice
 Example; Leaflet of Brufen
• Package leaflet: information for the user
• Brufen 200 mg film-coated tablets
• Brufen 400 mg film-coated tablets
• Brufen 600 mg film-coated tablets
• Ibuprofen
• Read all of this leaflet carefully before you start taking this
medicine because it contains
• important information for you.
• - Keep this leaflet. You may need to read it again.
• - If you have any further questions, ask your doctor or
pharmacist.
• - This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them,
• even if their signs of illness are the same as yours.
• - If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
• effects not listed in this leaflet. See section 4.
2023 ASU Introduction to Pharmacy
Dr. Manal Ayyash
Practice
• What is in this leaflet
• 1. What Brufen is and what it is used for
• 2. What you need to know before you take Brufen
• 3. How to take Brufen
• 4. Possible side effects
• 5. How to store Brufen
• 6. Contents of the pack and other information
• What Brufen is and what it is used for
• Brufen belongs to a group of medicines called NSAIDs (non-
steroidal anti-inflammatory drugs).
• Brufen reduces fever, relieves pain and has an anti-inflammatory
effect.
• Brufen is used for pain of mild to moderate intensity, fever,
rheumatic conditions (rheumatic arthritis,
• arthrosis) and menstrual pain, by adults and adolescents (12-18
years old, 40 kg and above).
• Children 6-12 years (over 20 kg) can be treated with Brufen 200
mg tablets during acute painful
• conditions and fever associated with common cold.
• The effect of Brufen is achieved usually within 30 minutes.
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Example; Leaflet of Brufen
• 2. What you need to know before you take
Brufen
• Do not take Brufen:
• - if you are allergic to ibuprofen or any of the
other ingredients of this medicine (listed in
section 6)
• - if you are in the last three months of
pregnancy
• - if you have an increased tendency to bleed
• - if you have severe liver and kidney disease
• - if you have severe heart failure
• - if you have a stomach ulcer, duodenal ulcer
or bleeding, or if you have had a stomach
ulcer,
2023 ASU Introduction to Pharmacy
Dr. Manal Ayyash
Practice
• Brufen with food, drink and alcohol
• Brufen could be used together with food and drinks. Brufen can be
given on an empty stomach for
• faster relief. If Brufen is taken together with alcohol, side effects may
be increased.
• Pregnancy, breast-feeding and fertility
• If you are pregnant or breast feeding, think you may be pregnant or
are planning to have a baby, ask
• you doctor or pharmacist for advice before taking this medicine.
• Pregnant women should not use Brufen during the three final months
of the pregnancy.
• Use of Brufen should be avoided by women who are planning a
pregnancy or are pregnant. Treatment
• at any time in pregnancy should only take place as directed by a
doctor.
• Ibuprofen passes into breast milk. The use of ibuprofen is therefore
not recommended while
• breastfeeding. However, consult a doctor if using Brufen more than
occasionally while breastfeeding is required.
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