Labelling + patient information leaflets Flashcards
1
Q
What must all medicinal products be labelled in accordance to?
A
Medicines regulations 1994
2
Q
What must a MA holder seek if they want to change labelling?
A
Variation - formal process that can take 30-90 days
3
Q
All labelling must be what?
A
- Legible
- Comprehensible
- Indelible
- In english
4
Q
What must each label contain?
A
- Name of product
- International name
- Active ingredients
- Pharmaceutical form
- List of excipient
- Route of admin
- Warning
- Expiry date
5
Q
What must appear on the label of products containing paracetamol?
A
- If symptoms persist consult your doctor
- Contains paracetamol
- Do not exceed stated dose
- Do not take with any other paracetamol containing products
6
Q
What must appear on the label of products containing dihydrocodeine?
A
- Can cause addiction
- Three days use only
7
Q
What are the labelling requirements exceptions?
A
- Clear container
- Packaging crates
- Paper bangs
- Any package of a dispensed medicinal product
8
Q
What must be included on a label of a pre-packed medicine?
A
- Name of product
- Ingredients
- Quantity
- Special handling
- Expiry date
- Batch reference
9
Q
What are the advantages of PILs?
A
- Provides info
- Encourages adherence
- Patient counselling
10
Q
What are the disadvantages of PILs?
A
- May worry patient over side effects
- Indication may not relate to patient
11
Q
Which products must be kept in a CRC?
A
- Aspirin, paracetamol + elemental iron more than 24mg
- Cough + cold oral liquid products for children containing antihistamines + decongestants
- Exceptions: effervescent or single dose
