Hibicet Hospital Concentrate

PACKAGE LEAFLET

Package leaflet: Information for the patient HiBiCET® Hospital Concentrate 1.5% w/v and 15% w/v Liquid

Chlorhexidine gluconate / Cetrimide

Read all of this leaflet carefully before you are administered this medicine because it contains important information for you.

- Keep this leaflet. You may need to use it again.

- Ask your doctor or nurse if you need more information or advice.

- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What HiBiCET Hospital Concentrate is and what it is used for

2. What you need to know before HiBiCET Hospital Concentrate is used

3. How HiBiCET Hospital Concentrate will be used

4. Possible side effects

5. How to store HiBiCET Hospital Concentrate

6. Contents of the pack and other information

1. What HiBiCET Hospital Concentrate is and what it is used for

HiBiCET Hospital Concentrate belongs to a group of medicines called antiseptics. This means that it helps to prevent infections by killing germs on the skin. Both chlorhexidine gluconate and cetrimide have an antimicrobial activity. HiBiCET Hospital Concentrate is an antimicrobial preparation with cleansing properties used for general antiseptic purposes. It may also be used to disinfect medical instruments and equipment.

2. What you need to know before HiBiCET Hospital Concentrate is used

Do not use HiBiCET Hospital Concentrate:

- if you are allergic to chlorhexidine gluconate, cetrimide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before HiBiCET Hospital Concentrate is used.

- Avoid contact with the eyes, meninges (the membranes surrounding the brain and spinal cord) and ears. If HiBiCET Hospital Concentrate or diluted solutions come into contact with the eyes, wash off immediately and thoroughly with water.

- If concentrated cetrimide solutions come into contact with the skin, rinse promptly and thoroughly with water.

- Prolonged skin contact with alcoholic solutions should be avoided.

- These solutions are flammable. Do not use with ignition sources until dry.

- Common bleaches (which contain hypochlorites) may cause brown stains to develop on fabrics, which have previously been in contact with chlorhexidine and/or cetrimide.

- HiBiCET Hospital Concentrate’s action may be reduced if used with soap or detergents

Children

Use with care in newborn babies, especially those born prematurely. HiBiCET Hospital Concentrate

may cause chemical skin burns.

HiBiCET Hospital Concentrate contains benzyl benzoate

Mildly irritant to the skin, eyes and mucous membranes.

If you accidentally swallow any HiBiCET Hospital Concentrate

You should go to your nearest Accident and Emergency department or contact your doctor immediately. Take this leaflet and any other packaging with you so they know what you have taken.

3. How HiBiCET Hospital Concentrate will be used

FOR EXTERNAL USE ONLY Not for injection.

Not for use in the body cavities.

Not for use as an enema.

Chlorhexidine must not be used in direct contact with nerve tissue, for example brain and spinal cord tissue.

This medicine must be diluted before use. If alcohol is used for dilution, the medicine should be allowed to dry after application and before continuing with the procedure.

Dilute as follows:

Method of Preparation	Dilution	Use
10ml HiBiCET Hospital Concentrate made up to 1 litre with water	1 in 100 (1%) aqueous	Cleansing/antiseptic treatment of wounds and burns * Swabbing in obstetrics, gynaecology and urology. Cleansing/disinfectant soak for used metal instruments. Clean instrument disinfection where no means of sterilisation is available (30 minutes immersion)** Cleansing/disinfection of equipment, furniture and fittings in the vicinity of the patient. Storage of clinical thermometers and sterile instruments.
35ml HiBiCET Hospital Concentrate made up to 1 litre with water	1 in 30 (approx) aqueous	Cleansing/antiseptic treatment of wounds and burns where greater cleansing/antisepsis is required* Cleansing/disinfectant soak for soiled instruments.
35ml HiBiCET Hospital Concentrate with 200ml water made up to 1 litre with 95% alcohol	1 in 30 (approx) in 70% alcohol	Rapid skin antisepsis before operation and other invasive procedures. Disinfection of clean instruments and equipment (2 minutes immersion)** Disinfection of clinical thermometers.

*Sterilise the diluted solution by autoclaving at 115°C for 30 minutes or 121°C for 15 minutes before use on wounds, burns or broken skin.

**endoscopes should not be placed in HiBiCET solutions.

Syringes, needles or instruments, which have been immersed in a HiBiCET solution should be thoroughly rinsed in sterile water or saline before use.

Do not use HiBiCET solutions to disinfect endoscopes or for prolonged immersion of rubber appliances.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur; it is not known how often they occur but available data suggests these are very rare (probably affect fewer than 1 in every 10,000 people).

• Serious allergic reactions which can cause breathing difficulties, weakness, collapse and death, and can sometimes be preceded by swelling (in particular lip/tongue and facial swelling), or rash.

At the first sign of any of these reactions, tell your doctor or nurse and application of this medicine should be stopped immediately.

Other possible side effects, for which it is not known how often they occur, are: allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itch), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation and blisters.

Inflammation of the membranes of the brain and spinal cord has been reported when they have come into direct contact with chlorhexidine.

Dry skin and in rare cases chemical burns have been reported after repeated use.

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store HiBiCET Hospital Concentrate

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is printed on the bottle. The expiry date refers to the last day of that month.

Do not store above 30°C.

Flammable. Do not expose the container or its contents to naked flames during use or-storage.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What HiBiCET Hospital Concentrate contains

- The active substances are Chlorhexidine gluconate 1.5% w/v and Cetrimide 15% w/v.

- The other ingredients are benzyl benzoate, liquid deodoriser, sunset yellow (E110), terpineol, isopropyl alcohol, d-gluconolactone, sodium hydroxide and purified water.

What HiBiCET Hospital Concentrate looks like and contents of the pack

HiBiCET Hospital Concentrate is a clear, orange coloured, slightly viscous solution. HiBiCET Hospital Concentrate comes in white bottles containing 5 litres of solution.

Marketing Authorisation Holder:

Regent Medical Limited, Medlock Street, Oldham, Lancashire, OL1 3HS, UK.

Manufacturer:

BCM Ltd., Thane Road, Beeston, Nottingham, Nottinghamshire, NG90 2PR, UK.

This leaflet was last revised in 07/2015.