1% vaginal cream chlorhexidine digluconate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Hibitane is and what it is used for
2. What you need to know before using Hibitane
3. How to use Hibitane
4. Possible side effects
5. How to store Hibitane
6. Contents of the packaging and other information

1. What Hibitane is and what it is used for

Hibitane contains the active substance chlorhexidine digluconate. It is an antiseptic vaginal cream which means that it kills or inhibits the growth of many bacteria.

Doctors or midwives use Hibitane in connection with examinations in gynecology/obstetrics (examinations of the abdomen (especially during childbirth)), which helps to prevent infection.

The chlorhexidine digluconate contained in Hibitane may also be approved for other uses not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Hibitane

Hibitane should not be used:

  • if you are allergic to chlorhexidine digluconate or any of the other ingredients of this medicine (listed in section 6).
  • on the brain, the meninges (opinions) or damaged eardrums as Hibitane is harmful to the nervous system.

Warnings and cautions

Avoid contact with eyes and ears.

Pregnancy and breastfeeding

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

No known risks when used during pregnancy.

Chlorhexidine passes into breast milk, but the risk of affecting the baby is considered unlikely with the recommended dose.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Hibitane contains cetostearyl alcohol

May cause local skin reactions (eg contact dermatitis).

How to use Hibitane

Hibitane is used by healthcare professionals in connection with genital examinations (especially during childbirth).

Hibitane is applied by a doctor or midwife around the woman’s external genitalia and can also be used to lubricate gloves and instruments. After the examination, the cream can be easily rinsed off with water.

If you take more Hibitane than you should

Hibitane will be given to you by healthcare professionals. It is unlikely that you will receive too much, but if you think you have received too much or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital, or the Poison Information Center (tel.112) for risk assessment and advice.

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

4. Possible side effects

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

Common (may affect up to 1 in 10 people) :

  • Skin irritation.

Rare (may affect up to 1 in 1,000 people) :

  • Eye irritation.
  • Hearing damage.
  • Allergic (itchy) reactions.

Chlorhexidine can cause hearing damage if it enters the middle ear. Eye contact may cause burning. Allergic reactions in the form of anaphylaxis can occur in extremely rare cases.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Hibitane

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiration date is the last day of the specified month.

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 packaging and other information

Content declaration

  • The active substance is chlorhexidine digluconate
  • The other ingredients are isopropyl alcohol, liquid paraffin, cetostearyl alcohol, cetostearyl alcohol / ethylene oxide condensate, linalyl acetate, white petrolatum, purified water.

What the medicine looks like and contents of the pack

Vaginal cream.

Plastic bottle 250 ml.

Marketing Authorisation Holder

Bioglan AB, Box 50310, 202 13 Malmö, Sweden

Manufacturer

Bioglan AB, Box 50310, 202 13 Malmö, Sweden

Muhammad Nadeem

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