Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Chlorhexidine Acetate BP 0.05% w/v for Irrigation

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Chlorhexidine acetate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Chlorhexidine acetate

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for Chlorhexidine for Irrigation contains a medicine called chlorhexidine acetate. This belongs to a group of medicines called 'antiseptics', which are used to kill bacteria. Chlorhexidine for Irrigation is used:

  • for cleaning (irrigating) the skin
  • for wound and burn cleaning (irrigation)
  • as a disinfectant for respirators.

What you need to know before you take it

e Chlorhexidine for Irrigation Your doctor will not use Chlorhexidine for Irrigation:

  • if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients (listed in 1

TH-30-02-244

If you have more Chlorhexidine for Irrigation Solution than you should

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).

It is unlikely that you will be have or use more Chlorhexidine for Irrigation than you should. If you accidentally swallow Chlorhexidine for Irrigation If Chlorhexidine for Irrigation is accidentally swallowed, seek medical assistance. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Children

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

How to take it

Chlorhexidine for Irrigation Chlorhexidine for Irrigation may be used by a doctor or nurse, or in some cases you may use the solution yourself. Only use if the solution is clear and the seal is intact. Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose

  • Your doctor will decide how much you will need and for how long it will be used. Your age, weight and clinical condition will be taken into account.
  • The solution must be used undiluted and is for topical application. This means that it is for cleaning (irrigation) of your skin outside of your body. 2

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 increase the 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) TH-30-02-244

Additional side effects in children

  • Chemical burns

The other ingredients are acetic acid and sterile water (called 'water for injections').

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.

What Chlorhexidine for Irrigation looks like and contents of the pack

Reporting of side effects

Marketing Authorisation Holder and Manufacturers

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.

The Marketing Authorisation holder is:

It is supplied as a clear, colourless solution for irrigation in a pour bottle or a form-fill-seal container.

Baxter Healthcare Ltd Caxton Way Thetford Norfolk IP24 3SE United Kingdom

United Kingdom: Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse straight away.

Send all enquires to this address. Manufacturer for Ireland Bieffe Medital SpA Via Nuova Provinciale – 23034 Grosotto (SO) Italy Manufacturer for UK/GB Baxter Healthcare Ltd Caxton Way, Thetford Norfolk, IP24 3SE United Kingdom

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine.

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

If you experience any of the following reactions stop using Chlorhexidine for Irrigation and get immediate medical help: swelling of the face, lips, tongue or throat; a red itchy skin rash; wheezing or difficulty breathing; feeling faint and dizzy; a strange metallic taste in the mouth; collapse. You may be having an allergic reaction. Fatal anaphylactic reaction has been reported.

The following may affect the way Chlorhexidine for Irrigation 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).

Other possible side effects

  • 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)

Pregnancy and breast-feeding and fertility 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. Driving and using machines 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.

How to store it

Chlorhexidine for Irrigation Keep this medicine out of the sight and reach of children. Make sure that the product is stored and disposed of correctly and not used after the expiry date stated on the product. The storage conditions, should you need them, are given below.

  • Do not store above 25oC and protect from light
  • Do not use this medicine after the expiry date which is stated on the label after EXPIRY. The expiry date refers to the last day of that month
  • Do not use this medicine if the container is damaged or the solution is not clear.
  • Once opened: use immediately. The solution should only be used once. Any leftover solution should be discarded. Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

This leaflet was last revised in August 2024

For information about Chlorhexidine for Irrigation or to request this leaflet in formats such as audio or large print please contact the Marketing Authorisation Holder: Tel: +44 (0)1635 206345. Baxter is a registered trademark of Baxter International Inc.

Contents of the pack and other information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor, nurse or pharmacist. What Chlorhexidine for Irrigation contains The active substances are chlorhexidine acetate 0.495 g in each 1000 ml. 3

TH-30-02-244

TH-30-02-244 4

Frequently asked questions about Chlorhexidine Acetate BP 0.05% w/v for Irrigation

What is the active substance in Chlorhexidine Acetate BP 0.05% w/v for Irrigation?

The active substance in Chlorhexidine Acetate BP 0.05% w/v for Irrigation is chlorhexidine acetate.

Are there equivalent medicines to Chlorhexidine Acetate BP 0.05% w/v for Irrigation?

Medicines with the same active substance, strength and form include: Chlorhexidine Acetate BP 0.02% w/v for Irrigation. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Chlorhexidine Acetate BP 0.05% w/v for Irrigation, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Chlorhexidine Acetate BP 0.05% w/v for Irrigation without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Chlorhexidine acetate (4 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Chlorhexidine Acetate BP is a disinfectant which is effective against a wide range of vegetative gram-positive and gram-negative bacteria.

4.2. Posology and method of administration

Dosage

Dosage and duration of administration are to be individualized and depend upon the indication for use, the patient's age, weight, clinical condition, and concomitant treatment, and on patient's clinical response to treatment (See Section 4.4 Chemical Burns in Neonates and Preoperative Skin Preparation).

Administration

Chlorhexidine Acetate BP 0.05% w/v for Irrigation is recommended for general topical use when antibacterial irrigation is indicated, including wound and burn irrigation.

Not for intravenous or oral route of administration.

4.3. Contraindications

In patients with a known hypersensitivity to the product

Do not use in the eye, auditory canal (especially in perforated eardrums), or near meninges, brain or spinal cord (See Section 4.4 Special Warnings and Precautions for Use).

4.4. Special warnings and precautions for use

This product should only be used in specialist units familiar with the appropriate selection of patients.

This solution is not to be taken orally.

This solution is not for intravenous administration. Accidental ingestion should be treated with a stomach lavage consisting of milk, egg white, gelatine or mild soap.

Idiosyncratic reactions to Chlorhexidine Acetate BP have been reported.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been reported with chlorhexidine. Fatal anaphylactic reactions have been reported with other products containing chlorhexidine (See Section 4.8 Adverse Reactions).

If any signs or symptoms of a suspected hypersensitivity reaction develop, immediately stop use. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Chemical Burns in Neonates

The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with skin reactions such as chemical burns in neonates. This risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life.

Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to chlorhexidine, care must be taken to ensure no excess product is present prior to application of the dressing.

Preoperative Skin Preparation

Caution should be exercised when chlorhexidine is used in preoperative skin preparations for face or head (See Section 4.3 Contraindications).

Chlorhexidine 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 chlorhexidine does not migrate beyond its intended application site into the eyes. Particular care should be taken in anesthetized patients, who are unable to immediately report ocular exposure. If chlorhexidine comes into contact with the eyes, wash out promptly and thoroughly with water. An ophthalmologist's advice should be sought.

Use in Pediatric Patients

The use of chlorhexidine solutions has been associated with skin reactions such as chemical burns in neonates (See Section 4.4 Warnings – Chemical Burns in Neonates).

4.5. Interaction with other medicinal products and other forms of interaction

The activity of chlorhexidine is reduced or neutralized by an alkaline pH, the presence of organic matter, anionic detergents, and tannins.

4.6. Pregnancy and lactation

Physicians should carefully consider the potential risks and benefit for each specific patient before prescribing chlorhexidine.

Chlorhexidine has been used in pregnant women and no harmful effects have been reported.

There are no adequate data to support the use of chlorhexidine in lactating women.

4.7. Effects on ability to drive and use machines

There is no information of the effects of chlorhexidine on the ability to operate an automobile or other heavy machinery.

4.8. Undesirable effects

Immune system disorders:

Hypersensitivity reactions including anaphylactic/anaphylactoid reactions manifested by cardiac arrest, shock, circulatory collapse, hypotension, bronchospasm, tachycardia, rash, erythema and urticaria

Skin and subcutaneous tissue disorders:

Rash

Other adverse reactions (Class Reactions)

The adverse events reported and/or observed with other chlorhexidine products include:

Fatal anaphylactic reactions

Chemical burns in neonates (See Section 4.4 Special Warnings and Precautions for Use)

Eye Disorder: Frequency not known: Corneal erosion, corneal epithelium defect/ injury corneal, 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 Special Warnings and Precautions for Use).

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

Overdose of chlorhexidine may constitute a medical emergency. In case of accidental overdose seek immediate medical attention.

💬 Ask about this leaflet

Ask anything about Chlorhexidine Acetate BP 0.05% w/v for Irrigation. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

Medicines containing Chlorhexidine acetate

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