Hydroderm Plus 1% Cream – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Hydroderm Plus 1% Cream

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Chlorhexidine Gluconate 1% w/w

(incorporated as Chlorhexidine Gluconate Solution Ph.Eur.) For a full list of excipients, see Section 6.1.

3 PHARMACEUTICAL FORM

Cream.

A white, smooth, pourable, homogeneous cream with an odour of linalyl acetate.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Hydroderm Plus 1% Cream is an antimicrobial preparation for use as an antiseptic and lubricant in obstetric and gynaecological practice.

4.2 Posology and method of administration

Posology

For use by adults, children and the elderly.

There are no special dosage recommendations for either elderly patients or children.

Method of Administration

For cutaneous use only.

Apply liberally to the wound and the vulva and perineum of the patient, and to the gloved hands of the midwife or doctor.

4.3 Contraindications

Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).

4.4 Special warnings and precautions for use

For topical application only. Keep out of the eyes and ears. Avoid contact with the brain and meninges.

Hydroderm Plus 1% Cream contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare.

Hydroderm Plus 1% Cream should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).

Hydroderm Plus 1% Cream must not come into contact with the eye. Serious cases of persistent corneal injury, potentially requiring corneal transplant, were reported following accidental ocular exposure to chlorhexidine containing medicinal products despite taking eye protective measures due to migration of solution beyond the intended surgical preparation area. Extreme care must be taken during application to ensure that the Hydroderm Plus 1% Cream does not migrate beyond its intended application site into the eyes. Particular care should be taken in anaesthetised patients, who are unable to immediately report ocular exposure. If Hydroderm Plus 1% Cream comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist’s advice should be sought.

4.5 Interaction with other medicinal products and other forms of interaction

Chlorhexidine is incompatible with soap and other anionic agents.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no evidence of any adverse effects on the foetus arising from the use of Hydroderm Plus 1% Cream during pregnancy and lactation. Therefore no special precautions are recommended.

Lactation

There is no evidence of any adverse effects on the foetus arising from the use of Hydroderm Plus 1% Cream during pregnancy and lactation. Therefore no special precautions are recommended.

4.7 Effects on ability to drive and use machines

Hydroderm Plus 1% Cream has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

Skin disorders:

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters

Immune disorders:

Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).

Eye Disorder:

Frequency not known: corneal erosion, epithelium defect/corneal injury, significant permanent visual impairment*.

*Cases of severe corneal erosion and permanent significant visual impairment due to inadvertent ocular exposure have been reported post-marketing, leading to some patients requiring corneal transplant (see section 4.4).

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, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Accidental ingestion

Chlorhexidine taken orally is poorly absorbed. Treat with gastric lavage using milk, raw egg, gelatin or mild soap. Employ supportive measures as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiseptics and Disinfectants

ATC code: D08AC02

Chlorhexidine is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is inactive against bacterial spores except in elevated temperatures.

5.2 Pharmacokinetic properties

Because of its cationic nature, chlorhexidine binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. There are, as a consequence, no general pharmacological studies on chlorhexidine available and its effects on internal organs are minimal. No detectable blood levels have been found in man following oral use and percutaneous absorption, if it occurs at all, is insignificant.

5.3 Preclinical safety data

Chlorhexidine is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cetostearyl alcohol

Cetostearyl alcohol/ethylene oxide condensate

Isopropyl alcohol

Liquid paraffin

White soft paraffin

Purified water

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 30ºC.

6.5 Nature and contents of container

White HDPE bottle (250ml) with polypropylene cap.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Ferndale Pharmaceuticals Ltd, Unit 740

Thorp Arch Estate

Wetherby,

West Yorkshire

LS23 7FX

United Kingdom.

8 MARKETING AUTHORISATION NUMBER(S)

PL 20685/0047

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

17/03/1988

10 DATE OF REVISION OF THE TEXT

08/08/2024