Liquid paraffin liquid

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Liquid paraffin

Available from:

Bell,Sons & Co (Druggists) Ltd

ATC code:

A06AA01

INN (International Name):

Liquid paraffin

Dosage:

1ml/1ml

Pharmaceutical form:

Liquid

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060300; GTIN: 5017848249428 5017848249442

Patient Information leaflet

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
Yes
A
gill.kennedy
557482
11927
Addition of "reporting of side
effects" statement.
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Landscape peelable label
150ml
21590007
42mm x 150mm
2
16.02.2015
Process Cyan
Process Magenta
Process Yellow
Process Black
Keylines (Does not print)
Text Free Area (Does not print)
Braille
Liquid Paraffin Care
Outlined
_Data Matrix:_
_21590007_
Braille reads:
Braille Warning! MPS cannot accept responsibility for any
errors in this proof after approval by the customer.
Whilst extreme care is taken in the setting of Braille, the
customer must take the final responsibility for its accuracy.
There is no single European Braille authority and there are
many different Braille formats in existence, with country
specific characters.
This Braille is set to the Marburg Medium format unless you
have requested otherwise.
When you sign this proof you are signifying full approval of
the Braille text and specification.

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Liquid Paraffin
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Liquid Paraffin 100% v/v.
3.
PHARMACEUTICAL FORM
Liquid.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the temporary relief of constipation.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral
Recommended doses and dosage schedules:
Adults including the elderly:
10-30ml when required.
Children over 3 years:
5-20ml when required.
Children under 3 years:
not recommended.
4.3.
CONTRA-INDICATIONS
Use is contraindicated in children under 3 years of age.
4.4.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Avoid prolonged use.
Consult
your
doctor
if
laxatives
are
needed
every
day,
if
you
have
persistent
abdominal pain or have a condition which makes swallowing difficult.
4.5.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
There may be interference with the absorption of fat soluble vitamins.
4.6.
PREGNANCY AND LACTATION
As with all medicines avoid during early pregnancy and lactation.
4.7.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8
UNDESIRABLE EFFECTS
Anal seepage of paraffin with consequent anal irritation after
prolonged use. Granulomatous
reaction caused by absorption of small quantities of liquid paraffin.
Lipoid pneumonia (by
accidental inhalation) may occur, therefore caution is required in
patients with swallowing
difficulty.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting
suspected
adverse
reactions
after
authorisation
of
the
medicinal
product
is
important. It allows continued monitoring of the benefit/risk balance
of the medicinal product.
Healthcare professionals are asked to report any suspected adverse
reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9
OVERDOSE
If large doses are ingested withdraw medication. Supportive treatment
may be
required.
5.
PHARMACOLOGICAL PROPERTIES
5.1.
PHARMACODYNAMIC PROPERTIES
Liquid paraffin acts as a lubricant and penetrates and softens the
stools.
5.2.
PHARMACOKINETIC PROPERTIES