SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Uniroid-HC™ Suppositories

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each suppository contains:

Hydrocortisone Ph.Eur. 5.0 mg Cinchocaine Hydrochloride Ph.Eur. 5.0 mg

3. PHARMACEUTICAL FORM

An off-white, odourless, smooth, suppository.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Uniroid-HC Suppositories are indicated for use in the treatment of internal haemorrhoids for the short term relief of pain, irritation and associated pruritus ani.

4.2. Posology and method of administration Adults

Treatment with Uniroid-HC Suppositories 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:

Remove the plastic protective shell and insert a suppository as far as possible into the anus.

One suppository to be inserted twice a day (morning and evening) and after each bowel movement, or as prescribed by the doctor.

The suppositories may be used separately or concurrently with the ointment.

The Elderly

Dosage modifications are not required in the elderly.

Children

Uniroid-HC Suppositories are not recommended for use in children under 12 years of age unless directed by a doctor.

4.3. Contraindications

Known hypersensitivity to any of the constituents and to local anaesthetics. 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 special precautions for use

Uniroid-HC Suppositories are not recommended for use in children unless recommended by a doctor.

4.5. Interactions with other medicinal products and other forms of interaction

No interactions have been reported.

4.6. Pregnancy and lactation

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 Suppositories can be used post-partum, provided the mother is not breast-feeding.

4.7. Effects on ability to drive and use machines

Not applicable.

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.

4.9. Overdose

Not applicable to a product with this route of administration.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties 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 Hydrocortisone

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.

Cinchocaine hydrochloride

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.

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients

Adeps Solidus (Witepsol H15) Ph. Eur.

6.2. Incompatibilities

None reported.

Shelf life

36 months, as packaged for sale.

6.4. Special precautions for storage

Uniroid-HC Suppositories should be stored in a cool, dry place at a temperature not exceeding 25°C (77°F).

6.5. Nature and contents of container

Printed PVC laminate; white thermoplastic film of laminated polyvinyl chloride 95 microns thick and polythene 27-30 microns thick.

The product is available in packs of 12. It may also be marketed in packs of 10.

6.6 Special precautions for disposal

Not applicable.

7. MARKETING AUTHORISATION HOLDER

Chemidex Pharma Limited Chemidex House Egham Business Village Crabtree Road Egham

Surrey TW20 8RB United Kingdom

8. MARKETING AUTHORISATION NUMBER(S)

PL 17736/0002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

3 November 2000

10 DATE OF REVISION OF THE TEXT

25/07/2014