1. Name of the medicinal product
2. Qualitative and quantitative composition
Excipients with known effect: Propylene glycol 2% w/w and Lanolin 3.5% w/w.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Ointment for topical and rectal administration.
4. Clinical particulars
4.1 Therapeutic indications
The symptomatic relief of pain, swelling, irritation and itching associated with haemorrhoids, and pruritus ani.
4.2 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.
4.4 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.
4.5 Interaction with other medicinal products and other forms of interaction
None known for topical preparations.
4.6 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.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
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.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Zinc oxide has astringent, antiseptic, soothing and protectant properties.
Lidocaine hydrochloride has a local anaesthetic action.
The ointment base has lubricant and emollient properties.
5.2 Pharmacokinetic 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 flow.
5.3 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.
6. Pharmaceutical particulars
6.1 List of excipients
Yellow soft paraffin
6.3 Shelf life
5 years for packaging option a
36 months for packaging option b
6.4 Special precautions for storage
6.5 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 applicator.
b) Aluminium laminate tube consisting of 150µm Polyethylene /5µm polyacrylate outer layer, 30µm alumininum 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 applicator nozzle.
6.6 Special precautions for disposal and other handling