HIBITANE OBSTETRIC CREAM

Active substance: CHLORHEXIDINE GLUCONATE SOLUTION

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250ml

Obstetric Cream
Chlorhexidine Gluconate 1% w/w
(equivalent to 5% v/w Chlorhexidine
Gluconate Solution Ph.Eur)

Hibitane



Also contains: LinalyI acetate, liquid paraffin,
white soft paraffin, cetostearyl alcohol,
cetostearyl alcohol/ethylene oxide condensate,
isopropyl alcohol, purified water.
Derma UK Ltd
ARC Progress, Mill Lane, Stotfold
Bedfordshire SG5 4NY, United Kingdom.
PL 19876/0009

FOR EXTERNAL USE ONLY

An antimicrobial preparation for use as an
antiseptic and lubricant in obstetric and
gynaecological practice.
Apply liberally to the skin around the vulva and
perineum of the patient, and to the gloved
hands of the midwife or doctor. Hibitane
Obstetric Cream is contraindicated for patients
who are hypersensitive to chlorhexidine.
Generalised allergic reactions to chlorhexidine
including anaphylaxis have also been reported.

Such reactions are extremely rare. If skin irritation
occurs, stop using and seek medical advice. If
swallowed treat symptomatically and with gastric
lavage using milk, raw egg, gelatin or mild soap.
Hypochlorite bleaches may cause brown stains to
develop in fabrics which have been in contact with
Hibitane Obstetric Cream. Chlorhexidine is
incompatible with soap and other anionic agents.
Avoid contact with the brain and meninges.
Keep out of the eyes and ears. Store below 30ºC.
Keep out of the sight and reach of children.
LA00701

Patient Information Leaflet
Chlorhexidine Gluconate 1% w/w (incorporated as
Chlorhexidine Gluconate Solution Ph.Eur 5% v/w)

Hibitane Obstetric Cream
TM

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Hibitane Obstetric cream is and what it is used for
2. What you need to know before you use Hibitane Obstetric cream
3. How to use Hibitane Obstetric cream
4. Possible side effects
5. How to store Hibitane Obstetric cream
6. Contents of the pack and other information
1. WHAT HIBITANE OBSTETRIC CREAM IS AND WHAT IT IS USED FOR
Hibitane Obstetric cream contains a chemical called chlorhexidine gluconate which destroys germs.
It is used as an antiseptic cream and lubricant by health care professionals when examining women
during pregnancy or for gynaecological problems.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HIBITANE OBSTETRIC CREAM
Do not use Hibitane Obstetric cream:
• If you know you are sensitive or allergic to any of the ingredients (see section 6).
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Hibitane Obstetric cream.
• Take care to avoid application to the ears and eyes, and any deep cuts involving the head or spine.
Wash out with water if necessary.
• If Hibitane Obstetric cream comes into contact with fabrics and bleach is used to remove it, brown
stains may develop.
• If mixed with soap or detergents its effectiveness may be reduced.
Other medicines and Hibitane Obstetric cream
Please tell your doctor or pharmacist if you are using or have recently used any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
Hibitane Obstetric cream may be used during pregnancy and breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine when you are pregnant, think you
may be pregnant, are planning to become pregnant, or are breast-feeding.
Driving and using machines
Hibitane Obstetric cream should not affect your ability to drive or use machinery.

Hibitane Obstetric cream contains cetostearyl alcohol
The ingredient cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis) which can
cause an itchy rash.
3. HOW TO USE HIBITANE OBSTETRIC CREAM
Hibitane Obstetric cream is used by health care professionals during a physical examination.
Some will be spread onto the gloved hand of the examiner and some will be applied around your birth
canal and anus.
Hibitane Obstetric cream is for use on the skin or vagina only.
If you have any further questions on the use of this medicine ask your doctor, pharmacist or nurse.
What to do if you accidentally swallow Hibitane Obstetric cream
If you accidentally swallow the cream, contact your doctor or nearest hospital.
4. POSSIBLE SIDE EFFECTS
Like all medicines Hibitane Obstetric cream can sometimes cause side effects, although not
everybody has them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden
wheeziness, difficulty breathing, swelling of the eyelids face or lips, rash or itching (especially affecting
your whole body) should be reported to a doctor immediately.
The following side effects have been reported but how often they occur is not known:
You may notice some irritation of the skin or allergic (itchy) reaction when it is first applied.
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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 at
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 HIBITANE OBSTETRIC CREAM
Keep this medicine out of the sight and reach of children.
This section is primarily for healthcare professionals. Do not use after the expiry date stated on the
bottle. The expiry date refers to the last day of that month.
Keep at room temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Hibitane Obstetric cream contains
The active ingredient is Chlorhexidine gluconate 1% w/w.
The other ingredients are cetostearyl alcohol,cetostearyl/ethylene oxide condensate, isopropyl alcohol,
linalyl acetate, liquid paraffin, white soft paraffin and water.
What Hibitane Obstetric cream looks like and contents of pack
Hibitane Obstetric cream is a white thin cream available in 250ml bottles.
Marketing authorisation holder
Derma UK Ltd, ARC Progress, Mill Lane, Stotfold, Bedfordshire SG5 4NY, United Kingdom.
Manufacturer
Pharmasol Ltd, Walworth Industrial Estate, Andover, Hants SP10 5AZ.
This leaflet was last revised in November 2014.
MP00871

Patient Information Leaflet
Chlorhexidine Gluconate 1% w/w (incorporated as
Chlorhexidine Gluconate Solution Ph.Eur 5% v/w)

Hibitane Obstetric Cream
TM

Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to you doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Hibitane Obstetric cream is and what it is used for
2. What you need to know before you use Hibitane Obstetric cream
3. How to use Hibitane Obstetric cream
4. Possible side effects
5. How to store Hibitane Obstetric cream
6. Contents of the pack and other information
1. WHAT HIBITANE OBSTETRIC CREAM IS AND WHAT IT IS USED FOR
Hibitane Obstetric cream contains a chemical called chlorhexidine gluconate which destroys germs.
It is used as an antiseptic cream and lubricant by health care professionals when examining women
during pregnancy or for gynaecological problems.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HIBITANE OBSTETRIC CREAM
Do not use Hibitane Obstetric cream:
• If you know you are sensitive or allergic to any of the ingredients (see section 6).
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before using Hibitane Obstetric cream.
• Take care to avoid application to the ears and eyes, and any deep cuts involving the head or spine.
Wash out with water if necessary.
• If Hibitane Obstetric cream comes into contact with fabrics and bleach is used to remove it, brown
stains may develop.
• If mixed with soap or detergents its effectiveness may be reduced.
Other medicines and Hibitane Obstetric cream
Please tell your doctor or pharmacist if you are using or have recently used any other medicines,
including medicines obtained without a prescription.
Pregnancy and breast-feeding
Hibitane Obstetric cream may be used during pregnancy and breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine when you are pregnant, think you
may be pregnant, are planning to become pregnant, or are breast-feeding.
Driving and using machines
Hibitane Obstetric cream should not affect your ability to drive or use machinery.

Hibitane Obstetric cream contains cetostearyl alcohol
The ingredient cetostearyl alcohol may cause local skin reactions (eg. contact dermatitis) which can
cause an itchy rash.
3. HOW TO USE HIBITANE OBSTETRIC CREAM
Hibitane Obstetric cream is used by health care professionals during a physical examination.
Some will be spread onto the gloved hand of the examiner and some will be applied around your birth
canal and anus.
Hibitane Obstetric cream is for use on the skin or vagina only.
If you have any further questions on the use of this medicine ask your doctor, pharmacist or nurse.
What to do if you accidentally swallow Hibitane Obstetric cream
If you accidentally swallow the cream, contact your doctor or nearest hospital.
4. POSSIBLE SIDE EFFECTS
Like all medicines Hibitane Obstetric cream can sometimes cause side effects, although not
everybody has them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden
wheeziness, difficulty breathing, swelling of the eyelids face or lips, rash or itching (especially affecting
your whole body) should be reported to a doctor immediately.
The following side effects have been reported but how often they occur is not known:
You may notice some irritation of the skin or allergic (itchy) reaction when it is first applied.
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist 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 at
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 HIBITANE OBSTETRIC CREAM
Keep this medicine out of the sight and reach of children.
This section is primarily for healthcare professionals. Do not use after the expiry date stated on the
bottle. The expiry date refers to the last day of that month.
Keep at room temperature below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Hibitane Obstetric cream contains
The active ingredient is Chlorhexidine gluconate 1% w/w.
The other ingredients are cetostearyl alcohol,cetostearyl/ethylene oxide condensate, isopropyl alcohol,
linalyl acetate, liquid paraffin, white soft paraffin and water.
What Hibitane Obstetric cream looks like and contents of pack
Hibitane Obstetric cream is a white thin cream available in 250ml bottles.
Marketing authorisation holder
Derma UK Ltd, ARC Progress, Mill Lane, Stotfold, Bedfordshire SG5 4NY, United Kingdom.
Manufacturer
Bioglan AB, PO Box 50310, S-202 13 Malmö, Sweden.
This leaflet was last revised in November 2014.
XXXXXXX

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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