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BOOTS HAEMORRHOID OINTMENT

Active substance(s): LIDOCAINE / ZINC OXIDE / LIDOCAINE / ZINC OXIDE / LIDOCAINE / ZINC OXIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Haemorrhoid Ointment or Haemorrhoid Relief Ointment

2

3

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active
ingredients

%w/w

Specification

Lidocaine

0.6

Ph Eur

Zinc oxide

6.6

Ph Eur

PHARMACEUTICAL FORM
Rectal ointment.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
This product is indicated for the relief of pain and discomfort of haemorrhoids
and pruritis ani.

4.2

Posology and method of administration
HAEMORRHOIDS
Adults, children over 12 years and elderly: This product should be applied
night
and morning and after each bowel movement. Repeat as required.
EXTERNAL PILES

Moisten cotton wool with warm water and gently cleanse the sore area.
Carefully dry with fresh cotton wool and apply approximately 1 inch (2.5 cm)
of this product.

INTERNAL PILES
Remove cap of tube. Screw the nozzle supplied to the top of the tube. Apply a
little ointment to the outside of the nozzle for greater comfort. Insert nozzle
into anal opening and gently squeeze ointment inside. This is easier to do if
you bend forward.

PRURITIS ANI
Adults, children over 12 years and elderly: This product should be applied
when required.

4.3

Contraindications
Hypersensitivity to any of the ingredients, especially lidocaine.

4.4

Special warnings and precautions for use
Do not use if you are sensitive to any of the ingredients. Keep all medicines
out of the reach of children. For external use only.
Constipation should be avoided as it may aggravate the symptoms. For further
advice consult your pharmacist.
If symptoms persist for more than 14 days talk to your doctor.
Not recommended for pregnant women or children under the age of 12 years
except on medical advice.
Side effects are rare with this medication but if anything unusual happens seek
medical advice.

4.5

Interaction with other medicinal products and other forms of interaction
No clinically significant interactions are known.

4.6

Pregnancy and lactation
The safety of this product in pregnancy and lactation has not been established,
but is not thought to constitute a hazard, though caution should be exercised
during the first trimester.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
Hypersensitivity reactions to any of the ingredients, particularly lidocaine.
Occasionally may cause diarrhoea.
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
In view of the nature of the presentation of this product, accidental or
deliberate overdosage is highly unlikely. In the event of overdosage, this will
initially produce excessive anaesthesia of the upper gastrointestinal tract.
Treatment of potential overdosage should be symptomatic and supportive.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Lidocaine has a local anaesthetic action, which relieves pain and discomfort in
the affected areas. Zinc oxide applied externally has a mild astringent action
on the skin.

5.2

Pharmacokinetic properties
Lidocaine is readily absorbed from mucous membranes. The plasma
elimination half-life is about two hours.
Lidocaine undergoes significant first pass metabolism in the liver and is
rapidly de-ethylated to the active metabolite monoethylglycine-xylidide and
then hydrolysed to various metabolites including glycine xylidide. Less than
10% is excreted unchanged in the kidneys. The metabolites are also excreted
in the urine.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Yellow soft paraffin
Light liquid paraffin
Colloidal anhydrous
silica

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
36 months, northern temperate regions.

6.4

Special precautions for storage

Do not store above 25oC.
6.5

Nature and contents of container
An internally lacquered aluminium tube with a gasket and a polyethylene or
polypropylene screw cap. The pack is supplied with a screw-on rectal
applicator.
Pack sizes: 25g, 55g

6.6

Special precautions for disposal
EXTERNAL PILES
Moisten cotton wool with warm water and gently cleanse the sore area.
Carefully dry with fresh cotton wool and apply approximately 1 inch (2.5 cm)
of this product.

INTERNAL PILES
Remove cap of tube. Screw the nozzle supplied to the top of the tube. Apply a
little ointment to the outside of the nozzle for greater comfort. Insert nozzle
into anal opening and gently squeeze ointment inside. This is easier to do if
you bend forward.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham
NG2 3AA
ENGLAND

8

MARKETING AUTHORISATION NUMBER(S)
PL 00014/0448

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11th May 1995

10

DATE OF REVISION OF THE TEXT
22/07/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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