Summary of Product Characteristics Updated 05-Oct-2020 | Chemidex Pharma Ltd
Each gram of ointment contains
hydrocortisone 5 mg and cinchocaine hydrochloride 5 mg
Excipient(s) with known effect:
Each gram of ointment contains 5 mg cetostearyl alcohol
For the full list of excipients, see section 6.1.
An off-white, odourless, smooth, translucent ointment.
Uniroid-HC Ointment is indicated primarily for the treatment of external haemorrhoids for the short-term relief of pain, irritation and associated pruritus ani. Uniroid-HC Ointment can also be used for internal haemorrhoids
Treatment with Uniroid-HC Ointment should be limited to seven days. Patients should be advised to return to their doctor if the condition persists beyond this time.
Directions for use and dosage schedule:
First wash the anal area gently with water and pat dry with cotton wool. With the finger, spread a small quantity of the ointment on the painful area without rubbing. Do not use toilet paper.
Apply the ointment twice a day (morning and evening) and after each bowel movement, or as prescribed by the doctor.
The ointment can be used internally by means of the nozzle applicator which is supplied. Insert the nozzle applicator to full extent and squeeze the tube gently from the lower end whilst withdrawing.
The nozzle applicator must be cleaned thoroughly in warm, soapy water before and after each use.
The ointment may be used separately or concurrently with the suppositories.
Dosage modifications are not required in the elderly.
Uniroid-HC Ointment is not recommended for use in children under 12 years of age unless directed by a doctor.
Method of administration
For rectal use only
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
This product is contra-indicated in tuberculosis, anal thrush and most viral lesions of the skin including herpes simplex, vaccinia and varicella.
Since the use of occlusive dressings may increase the risk of sensitivity, such dressings should be avoided.
Uniroid-HC Ointment is not recommended for use in children unless recommended by a doctor.
This medicinal product contains cetostearyl alcohol. This may cause local skin reactions, such as contact dermatitis.
No interactions have been reported.
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may, therefore, be a very small risk of such effects in the human foetus.
Uniroid-HC Ointment can be used post-partum, provided the mother is not breast-feeding.
Recurrent or prolonged application may increase the risk of contact sensitisation particularly to cinchocaine. The possibility of systemic absorption should be borne in mind when prescribing preparations containing corticosteroids which can cause adrenal suppression in large doses.
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.
Not applicable to a product with this route of administration.
Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anafissures for topical use - corticosteroids
ATC code: C 05 AA 01.
The principle pharmacological actions of hydrocortisone are on gluconeogensis, glycogen deposition, protein and calcium metabolism and inhibition of corticotrophin secretion and anti-inflammatory activity (glucocorticoid actions). When applied topically hydrocortisone causes reduction of inflammation, pruritus and exudation in disorders of the skin and perianal region.
Cinchocaine hydrochloride is a local anaesthetic agent and is suitable for surface or spinal anaesthesia and for relaxing sphincteric spasms. It is an anaesthetic of the amide type. It is more toxic than cocaine by local application, but its local anaesthetic action is greater, so it can be used in lower concentrations. Its action is more prolonged than lignocaine.
Surface or topical anaesthetics such as cinchocaine block the sensory nerve endings in the skin preventing transmissions of impulses along the nerve fibres and inhibiting depolarisation and ion-exchange. These effects are reversible. Before this blocking action can occur the lipid, soluble anaesthetic base must penetrate the lipoprotein nerve sheath and the effectiveness of the anaesthetic depends on the concentration attained in the nerve fibre. The onset of action varies depending on the anaesthetic used. Cinchocaine has a rapid onset of action and is also long lasting.
Hydrocortisone is passed through the skin, particularly in denuded areas. About 90% of plasma hydrocortisone is bound to plasma proteins, mainly to globulin, less so to albumin. In the liver and most body tissues it is metabolised to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These degraded forms are excreted in the urine. They are mainly conjugated as glucuronides. A very small proportion of unchanged hydrocortisone is excreted in the urine.
Most local anaesthetics such as cinchocaine hydrochloride are absorbed through damaged skin. Cinchocaine hydrochloride is an ester-type local anaesthetic. Following absorption, it is hydrolysed by esterases in the plasma and liver.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
White soft paraffin
Do not store above 25°C. Store in the original package.
Externally white enamelled and printed; internally lacquered aluminium tube with medium density polyethylene nozzle applicator and white plug seal cap.
The product is available in tubes of 30g and 15g.
Not all pack sizes may be marketed.
Chemidex Pharma Limited
Egham Business Village
Surrey TW20 8RB
3 November 2000/ 25 April 2003