Labelling + patient information leaflets

Question 1

What must all medicinal products be labelled in accordance to?

Answer 1

Medicines regulations 1994

Question 2

What must a MA holder seek if they want to change labelling?

Answer 2

Variation - formal process that can take 30-90 days

Question 3

All labelling must be what?

Answer 3

• Legible
• Comprehensible
• Indelible
• In english

Question 4

What must each label contain?

Answer 4

• Name of product
• International name
• Active ingredients
• Pharmaceutical form
• List of excipient
• Route of admin
• Warning
• Expiry date

Question 5

What must appear on the label of products containing paracetamol?

Answer 5

• If symptoms persist consult your doctor
• Contains paracetamol
• Do not exceed stated dose
• Do not take with any other paracetamol containing products

Question 6

What must appear on the label of products containing dihydrocodeine?

Answer 6

• Can cause addiction

- Three days use only

Question 7

What are the labelling requirements exceptions?

Answer 7

• Clear container
• Packaging crates
• Paper bangs
• Any package of a dispensed medicinal product

Question 8

What must be included on a label of a pre-packed medicine?

Answer 8

• Name of product
• Ingredients
• Quantity
• Special handling
• Expiry date
• Batch reference

Question 9

What are the advantages of PILs?

Answer 9

• Provides info
• Encourages adherence
• Patient counselling

Question 10

What are the disadvantages of PILs?

Answer 10

• May worry patient over side effects

- Indication may not relate to patient

Question 11

Which products must be kept in a CRC?

Answer 11

• Aspirin, paracetamol + elemental iron more than 24mg
• Cough + cold oral liquid products for children containing antihistamines + decongestants
• Exceptions: effervescent or single dose