Hydroderm Plus 1% Cream
SUMMARY OF PRODUCT CHARACTERISTICS
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).
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).
|
Organ System Organ |
Common ADRs >1/100, <1/10 |
Uncommon ADRs >1/1,000, <1/100 |
Rare ADRs >1/10,000, <1/1,000 |
Frequency not known |
|
Skin and Subcutaneous Tissue Disorders |
Allergic skin reactions | |||
|
Immune System Disorders |
Hypersensitivity anaphylactic shock |
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.
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 30°C.
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
QP Services UK Limited 46 High Street,
Yatton,
Somerset,
BS49 4HJ,
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 29498/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/03/1988
10 DATE OF REVISION OF THE TEXT
06/01/2016