Labelling Of Medicines Flashcards
Different labelling requirements apply to
Medicines produced commercially
Extemporaneously made medicines
Homeopathic
Dispensed medicinal products
What are the general labelling and packaging provisions for medicinal products
Legible, indelible and comprehensive
WRITTEN IN ENGLISH
Standard labelling for medicinal products
Name, strength, form of the product
Where the product contains upto 3 active substances, the common name for each substance
A statement of the active substances in the product: administration, weight, volume
The form and contents by weight, volume or by number of doses
Standard labelling for excepients in commercial medicines
All excipients when the product is injectable, topical or eye preparation
Or those excipients that are known to have a certain action or effect
Standard labelling for uses
Where appropriate, whether the product is intended for babies, children or adults
Method of administration
Space for prescribed dose to be indicated
If it is not a POM then space for how to use product
Standard labelling: warnings
Should be out of sight and reach of children
Special warnings
If it should be stored in a certain way
And precautions for disposal, or waste derived from the product
Product expiration date
Standard labelling: manufacture information
The name and address of the holder of the licence
The licence number
The manufacturers batch number
What are there additional requirements for
Blister packs
Small container
Radiopharmaceuticals
Packaging for transport, delivery and storage
Investigational medicinal products for clinical trials
Statutory warning labels for paracetamol
Must ALWAYS appear on the packaging
CONTAINS PARACETAMOL unless the product name has paracetamol in it
DO NOT TAKE MORE MEDICINE THAN THE LABEL TELLS YOU, IF YOU DONT GET BETTER, TALK TO YOUR DOCTOR
Recommended dosage
Additional warnings for paracetamol for those aged 12 and over
DON’T TAKE ANYTHING ELSE CONTAINING PARACETAMOL WHILE TAKING THIS MEDICATION
TALK TO YOUR DOCTOR IF YOU HAVE TAKEN TO MUCH EVEN IF YOU FEEL WELL
If there is no PIL then it also must say TO MUCH PARACETAMOL CAN CAUSED DELAYED, SERIOUS LIVER DAMAGE
Additional warnings for paracetamol for under 12
Do not give anything else containing paracetamol while giving this medicine
Talk to a doctor if your child takes to much
Then a statement about liver damage if no PIL
Problems with PILS
Info is often unclear, they need to be simpler for the general public
Prescribed quantities don’t alway match pack size
There are still cares where dispensing takes place from bulk containers
Manufactures don’t provide spare leaflets
Most on EMC
Medicines manufactured in pharmacies under section 10 of medicines act properties and
These have different labelling requirements
Where the product is to be administered to particular individual, the name
Name and address of the person selling the product
Date on which the product is supplied
If the product is not prescribed by a practitioner then labelling requirements are needed
Additional extemporaneously prepared medicine labelling requirements
The name and address of the product or it’s common name
Directions for use
Precautions about product
