UNIROID-HC Ointment Ref.[6367] Active ingredients: Cinchocaine Hydrocortisone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom

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. Interaction with other medicinal products and other forms of interaction

No interactions have been reported.

4.6. 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 breast-feeding.

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.

6.2. Incompatibilities

Not applicable.

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