Boots Haemorrhoid Ointment or Haemorrhoid Relief Ointment

Rectal ointment.

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

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.

Hypersensitivity to any of the ingredients, especially lidocaine.

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.

No clinically significant interactions are known.

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.

None.

Hypersensitivity reactions to any of the ingredients, particularly lidocaine. Occasionally may cause diarrhoea.

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.

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.

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.

Not applicable.

Yellow soft paraffin

Light liquid paraffin

Colloidal anhydrous silica

Not applicable.

36 months, northern temperate regions.

None.

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

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.

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

PL 00014/0448

Date of first authorisation: 11 May 1995

June 2009