labelling of containers Flashcards
all labels must be
legible ,indelible, comprehensible (reg 257)
using the English language (reg 266)
they can have pictogram or symbol (reg 261) to clarify the standard labelling requirements
if its homeopathic : ‘homeopathic medicinal product’
the outer packets need (17)
name
strength and form
if product is for babies , children or adults
where the product contains up to three active substances , the common name of each active substance
a statement of the active substances in the product , expressed qualitatively and quantitively per dosage unit or according to the form of administration for a given volume or weight , using their common names
the pharmaceutical form and the contents by weight , by volume or by number of doses of the product
the method of administration of the product and if necessary the route of administration
where appropriate ,space for the prescribed dose to be indicated
a warning that the product must be stored out of the reach and sight of children
any special warning applicable to the product
the products expiry date in clear terms
any special storage precautions relating to the product
any special precautions relating to the disposal of an unused product or part of a product , or waste derived from the product and reference to any appropriate collection system in place
the name and address of the holder of the marketing authorisation ,article 126a authorisation or traditional herbal registration relating to the product and where applicable the name of the holders representative
the manufacturers batch number
instruction for use when not a POM
labelling of blister packs (7)
the name of the medicinal product
the strength and pharmaceutical form of the product
where appropriate wether the product is intended for babies children or adults
where the product contains up to three active substances , the common name of each active substance
the name of the holder of the marketing authorisation , article 126a authorisation or traditional herbal registration relating to the product
the products expiry date in clear terms
the manufacturers batch number
labelling of small packages (8)
the name of the medicinal product
the strength and pharmaceutical form of the product
where appropriate , wether the product is intended for babies children or adults
where the product contains up to three active substances , the common name of each active substance
the method of administration of the product and if necessary the route of admin
the products expiry date in clear terms
the manufacturers batch number
the contents of the packaging by weight , by volume or by unit
POM’S or P’s (reg 258 and Schedule 25 part 3)
for medicines available as pharmacy only - the letter “p” must appear in a box in which there is no other info
for medicines which are available as pom - the letters “pom” must appear in a box in which there is no other information
labelling for paracetamol ( adults only -sch25 part 4)
‘contains paracetamol’ unless paracetamol appears on the container or package
‘do not take more medicine than the label tells you to . if you do not get better , talk to your doctor ‘ - this should be next to the directions for use or recommended dosage
‘talk to a doctor at once if you take to much of this medicine even if you feel well. this is because too much paracetamol can cause delayed serious liver damage’
‘do not take anything else containing paracetamol while taking this medicine’
labelling paracetamol for children
must be white in colour if solid ( reg 275)
must state ‘contains paracetamol’
‘do not give anything else containing paracetamol while giving this medicine’
‘talk to a doctor at once if your child takes too much of this medicine even if they seem well . this is because too much paracetamol can cause delayed , serious liver damage ‘
labelling paracetamol for children
must be white in colour if solid ( reg 275)
must state ‘contains paracetamol’
‘do not give anything else containing paracetamol while giving this medicine’
‘talk to a doctor at once if your child takes too much of this medicine even if they seem well . this is because too much paracetamol can cause delayed , serious liver damage ‘
labelling controlled drugs
the letters cd in an inverted triangle
regulation 260 - leaflet
a package leaflet for a medicinal product must -
(a) be drawn up in accordance with the summary of the product characteristics ; and
(b) contain all the information specified in schedule 27 in the order specified in that schedule
a package leaflet must be included in the packaging of a medicinal product unless all the information required by part 1 of schedule 27 is on the box.
