40 mg / ml cutaneous solution
chlorhexidine digluconate
1. What Hibiscrub is and what it is used for
Hibiscrub is an antiseptic skin cleanser, which means that it kills or inhibits the growth of many bacteria, and thus helps prevent infection.
Hibiscrub is used to disinfect the skin and thereby help prevent infection.
Chlorhexidine digluconate contained in Hibiscrub may also be approved for the treatment of other conditions 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 Hibiscrub
Do not use Hibiscrub
– if you are allergic to chlorhexidine gluconate or any of the other ingredients of this medicine (listed in section 6).
– in deep wounds in the head
– in the ears.
Also should not be used by healthcare professionals in joints, tendons or spine, brain, or meninges.
Warnings and cautions
If solution gets into eyes, rinse thoroughly with water. Hibiscrub is for skin use only and should not be swallowed. If Hibiscrub is mixed with other soap or comes in contact with the cork, its effect may be weakened. For Hibiscrub splashes on fabrics, detergents with hypochlorite should not be used as brown discoloration may occur. Oxidizing bleach should be used instead. Hibiscrub is flammable. A surface treated with the product must be completely dry before using equipment that can cause sparks, e.g. in so-called diathermy (point-by-point heating of tissue with electricity).
Children
Use caution in newborns, especially those born prematurely. Hibiscrub can cause chemical burns to the skin.
Hibiscrub contains isopropyl alcohol This medicine contains 40 mg of isopropyl alcohol per milliliter (4% w / v). Dryness, irritation, redness or burning sensation in the skin may occur. Allergic contact dermatitis or contact allergies are very rare.
3. How to use Hibiscrub
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.
Dosage
Hibiscrub should not be diluted before use.
Disinfectant hand washes before surgery: Rinse hands and forearms under running water, take about 5 ml Hibiscrub and wash hands and forearms thoroughly for 1 minute. Rinse well. Clean nails and cuticles. Before surgery, wash again for 2 minutes. Rinse thoroughly for at least 30 seconds. When rinsing, keep your hands so that the water flows from your hands towards your elbows. Wipe hands and arms with a sterile towel or allow to air dry.
Full body washes before surgery: Wash the evening before surgery and the day of surgery. Wipe with a clean towel. Change into clean clothes after each wash.
If you use more Hibiscrub than you should
If e.g. If you or a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center 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 side effects (may affect up to 1 in 10 people): Contact dermatitis, hives.
Rare side effects (may affect up to 1 in 1,000 people): Allergic reactions, anaphylactic reactions.
Has been reported (occurs in an unknown number of users): Chemical burns in newborns.
Reporting of side effects ar
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.
The Medical Products Agency
Box 26
SE-751 03 Uppsala
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 Hibiscrub
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 carton 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. 1 ml of cutaneous solution contains 40 mg of chlorhexidine digluconate.
The other ingredients are poloxamer, cocamidopropylamine oxide, isopropyl alcohol, d-gluconolactone, glycerol, macrogolglycerol cocoate, purified water.
What the medicine looks like and contents of the pack
Clear, colorless to pale yellow liquid with an alcohol odor.
HDPE plastic bottles with polypropylene plastic lids, 250 ml, and 500 ml.
Marketing Authorisation Holder
Manufacturer
BCM Limited Thane Road, Beeston, Nottingham, Nottinghamshire, NG90 2PR, United Kingdom
Pharmaceutical and Hygiene Production Company (SPPH) 7 Impasse des Boussenots 21800 Quetigny France