UNIROID-HC OINTMENT - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Uniroid-HC Ointment

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

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.

3 PHARMACEUTICAL FORM

Ointment.

An off-white, odourless, smooth, translucent ointment.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

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.

4.2 Posology and method of administration

Posology

Adults

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.

Elderly

Dosage modifications are not required in the elderly.

Paediatric population

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

4.3 Contraindications

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.

4.4 Special warnings and precautions for use

Since the use of occlusive dressings may increase the risk of sensitivity, such dressings should be avoided.

Paediatric population

Uniroid-HC Ointment is not recommended for use in children unless recommended by a doctor.

Excipients

This medicinal product contains cetostearyl alcohol. This may cause local skin reactions, such as contact dermatitis.

4.5 Interactions with other Medicinal Products and other forms of Interaction

No interactions have been reported.

4.6 Fertility, pregnancy and lactation

Pregnancy

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.

Breast-feeding

Uniroid-HC Ointment can be used post-partum, provided the mother is not breastfeeding.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

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.

4.9 Overdose

Not applicable to a product with this route of administration.

PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anafissures for topical use – corticosteroids

ATC code: C 05 AA 01.

Hydrocortisone

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

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.

5.2 Pharmacokinetic Properties

6   PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetostearyl alcohol

White soft paraffin

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

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.

6.6 Instruction for Use, Handling and Disposal

Not applicable.

Chemidex Pharma Limited

Chemidex House

Egham Business Village

Crabtree Road

Egham

Surrey

TW20 8RB

United Kingdom