Active substance(s): LIDOCAINE HYDROCHLORIDE / ZINC OXIDE / LIDOCAINE HYDROCHLORIDE / ZINC OXIDE / LIDOCAINE HYDROCHLORIDE / ZINC OXIDE
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ointment for topical and rectal administration.
The symptomatic relief of pain, swelling, irritation and itching associated with
haemorrhoids, and pruritus ani.
Posology and method of administration
Adults and children aged 12 years and over:
Apply at least twice a day with a minimum of three to four hours between
applications. Further applications can be made at any time of day and are particularly
recommended after a bowel movement.
Do not use more than four times in any 24-hour period.
External piles and pruritus ani:
Apply to the affected area.
Gently insert applicator into the anal opening and expel a small amount of the
ointment by squeezing the tube gently.
Children under 12 years:
Only as directed by a doctor.
Use as per adult directions.
Hypersensitivity to any of the constituents.
Special warnings and precautions for use
Persons who continually suffer from haemorrhoids or who have severe haemorrhoids
or who experience excessive bleeding, are advised to consult a doctor.
Interaction with other medicinal products and other forms of interaction
None known for topical preparations.
Pregnancy and lactation
There is a lack of definitive evidence of safety of the product in human pregnancy
and lactation. However, lidocaine hydrochloride and zinc oxide have been in wide
use for many years without apparent ill consequence. It is not necessary to
contraindicate this product in pregnancy and lactation provided caution is exercised
and the directions for use are followed. However, as with all medicines, the advice of
a doctor should be sought.
Effects on ability to drive and use machines
Very rarely increased irritation and burning sensations may occur at the site of
application. Rarely rashes may occur.
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.
It is very unlikely that overdosage would occur from this pharmaceutical form.
Symptoms of lidocaine overdosage would be unlikely to occur even after anal
insertion of 25g of ointment.
Normally there should be no systemic adverse effects, but at worst CNS and
cardiovascular effects are possible. Treatment would be symptomatic after
withdrawal of the product.
In the case of accidental oral ingestion, the advice of a doctor should be sought.
Zinc oxide has astringent, antiseptic, soothing and protectant properties.
Lidocaine hydrochloride has a local anaesthetic action.
The ointment base has lubricant and emollient properties.
The product has a local action with minimal risk of systemic effects. Lidocaine has a
fast onset and intermediate duration of action. It is partially absorbed but plasma
levels will be low, in view of the concentration of lidocaine in the product. It
undergoes de-ethylation in the liver, where clearance approaches the rate of hepatic
Preclinical safety data
Preclinical safety data on these active ingredients in the literature have not revealed
any pertinent and conclusive findings which are of relevance to the recommended
dosage and use of the product.
List of excipients
Yellow soft paraffin
5 years for packaging option a
36 months for packaging option b
Special precautions for storage
Nature and contents of container
a) Flexible aluminium tubes, internally lacquered, fitted with a polypropylene cap.
25 or 55ml tubes are contained in a boxboard carton, together with a polyethylene
b) Aluminium laminate tube consisting of 150µm Polyethylene / 5µm polyacrylate
outer layer, 30µm aluminium and an inner layer of 30µm polyacrylate / 60µm
polyethylene, fitted with a HD polyethylene shoulder, an aluminium/surlyn
tamper evident seal, polypropylene cap and a loose polyethylene screw-on
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Trading as: Bayer plc; Consumer Care Division
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
27/06/1983 / 23/03/2001
DATE OF REVISION OF THE TEXT
Source: Medicines and Healthcare Products Regulatory Agency
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