Chlorhexidine Acetate 0.015% w/v and Cetrimide 0.15% w/v, Irrigation Solution

1. What Chlorhexidine and Cetrimide Irrigation Solution is and what it is used for
2. What you need to know before you use Chlorhexidine and Cetrimide Irrigation Solution
3. How to use Chlorhexidine and Cetrimide Irrigation Solution
4. Possible side effects
5. How to store Chlorhexidine and Cetrimide Irrigation Solution
6. Contents of the pack and other information

• Chlorhexidine and Cetrimide Irrigation Solution may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness, which can be fatal. Early symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using Chlorhexidine for Irrigation and contact your doctor as soon as possible (see under section 4: "Possible side effects").
• Use with care when this medicine is used to clean the skin, before an operation for your face or head
• Chlorhexidine must not come into contact with the eye due to the risk of visual damage. If it comes into contact with the eyes, wash out immediately and thoroughly with water. In case of any irritation, redness or pain in the eye, or visual disturbance, ask for medical advice promptly. Serious cases of persistent corneal injury (injury to the surface of the eye) potentially requiring corneal transplant have been reported when similar products have accidentally come in contact with the eye during surgical procedures, in patients under general anaesthesia (deep painless sleep).

Children

• Use with care in newborn babies, especially those born prematurely. Chlorhexidine and Cetrimide Irrigation Solution may cause chemical skin burns.

Your doctor will not use Chlorhexidine and Cetrimide Irrigation Solution if any of the above apply.

If you are not sure talk to your doctor, nurse or pharmacist before using Chlorhexidine and Cetrimide Irrigation Solution.

Your doctor will take special care when giving you Chlorhexidine and Cetrimide Irrigation Solution. If you have had a reaction to any of the ingredients.

This solution is not for intravenous administration and must not be taken orally.

Chlorhexidine and Cetrimide Irrigation Solution contains:

• Sunset yellow (E110) may cause allergic reactions.

Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines you obtained without a prescription.

The following may affect the way Chlorhexidine and Cetrimide Irrigation Solution works:

• alkaline pH, organic matter
• detergents (soaps) or blood. Chlorhexidine for Irrigation will not work properly if it come into contact with these
• tannins (from some plants).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

They will advise if you can have this treatment.

Chlorhexidine for Irrigation has little or no affect on your ability to drive or use machines. Please tell your doctor and they will advise you if you can drive or use machines.

It is unlikely that you will have or use more Chlorhexidine and Cetrimide Irrigation Solution than you should.

If Chlorhexidine and Cetrimide Irrigation Solution is accidentally swallowed, seek medical assistance.

• Corneal injury (injury to the surface of the eye), and permanent eye damage including permanent visual impairment (following accidental ocular exposure during head, face and neck surgical procedures) in patients under general anaesthesia (deep painless sleep)

Very occasionally the following may be seen:

• low blood pressure (hypotension)
• tingling sensations In your skin (paraesthesia)
• difficulty breathing
• increased heart rate
• cold sweats
• reddening or itching of your skin
• loss of consciousness.
• pain
• blood in your urine or an increased urge to urinate.
• rash
• coughing or wheezing (Bronchospasm)
• heart stops pumping (cardiac arrest)
• blood vessels stop working properly (circulatory collapse)
• shock
• Corneal injury (injury to the surface of the eye), and permanent eye damage including permanent visual impairment (following accidental ocular exposure during head, face and neck surgical procedures) in patients under general anaesthesia (deep painless sleep)

• Chemical burns

If you develop a rash or your skin becomes itchy, red, dry or inflamed where you have used the product as a skin wash, stop using it and talk to your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below . By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom:

Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

The active substances are chlorhexidine acetate 0.15 g and cetrimide 1.5 g in each 1000 ml.

The other ingredients are Sunset yellow (E110) 8.0 mg in each 1000 ml, acetic acid and sterile water (called ‘water for injections’).

It is supplied as a clear, yellow solution for irrigation in a 500 ml or 1000 ml plastic bottle.

The Marketing Authorisation Holder is

Send all enquiries to this address.

Chlorhexidine and Cetrimide Irrigation Solution is made at the above address.