BRAILLE TEXT:

HIBISCRUB

Font: Marburg Medium 28,5 pt. EU Braille

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H    I    B

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SCRUB

58mm

0HfBTSCRUB®

4% w/v Cutaneous Solution Chlorhexidine gluconate 40 mg/ml

Height-85mm    Height-85mm    Height-85mm    Height-85mm    Height-85mm

Base Label 58mm

bottle after “EXP”. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Hibiscrub contains

•    The active substance is chlorhexidine gluconate 4% w/v (40 mg/ml)

•    The other ingredients are poloxamer 237, lauryl dimethyl, isopropyl alcohol, amine oxide, glycerol, macrogol 7 glycerol cocoate, gluconolactone, perfume (Herbacol), ponceau 4R (E124), sodium hydroxide and purified water.

•HIBISCRUB®

4% w/v Cutaneous Solution Chlorhexidine gluconate 40 mg/ml

Antimicrobial Skin Cleanser for antiseptic handwashing on the ward, pre-operative surgical hand disinfection and patient pre-and post-operative skin antisepsis.

Read the package leaflet before use, which is given when the label is peeled back.

Excipients: poloxamer 237, isopropyl alcohol, lauryl dimethyl amine oxide, glycerol, macrogol 7 glycerol cocoate, gluconolactone, perfume (Herbacol), ponceau 4R (E124), sodium hydroxide and purified water.

Precautions: Avoid contact with eyes, brain, meninges, eyes and middle ear. Use with care in newborn babies, especially those born prematurely. Hibiscrub may cause chemical skin burns.

FOR EXTERNAL USE ONLY

Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package.

Regent Medical (Overseas) Limited, Medlock Street, Oldham, Lancashire,

OL1 3HS, UK.

PA 1218/1/1;

PL 22099/0001

Hibiscrub® is a trade mark of Regent Medical Ltd.

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Page 16-47mm    Front Cover - 55mm

Inside Cover

Page 15

Hibiscrub cutaneous solution contains the active ingredient chlorhexidine gluconate 4% w/v (40 mg/ml) which has antimicrobial properties.

Hibiscrub is used to disinfect the hands and skin prior to or after an operation or clean procedure (pre- and post-operative hand and skin disinfection / antisepsis).

Hibiscrub is also used to disinfect hands after handling infected materials (antiseptic handwashing).

2. What you need to know before you use Hibiscrub

Do not use Hibiscrub

• if you are allergic (hypersensitive) to chlorhexidine

data suggests these are very rare (probably affect fewer than 1 in every 10,000 people).

• Serious allergic reactions which can cause breathing difficulties, weakness, collapse and death, and can sometimes be preceded by swelling (in particular lip/tongue and facial swelling), or rash.

Allergic reactions to chlorhexidine-impregnated patches have been reported rarely when used in newborn babies.

At the first sign of any of these reactions, tell your doctor, pharmacist or nurse and application of Hibiscrub should be stopped immediately.

Other possible side effects, for which it is not known how often they occur, are: allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itch), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation and blisters.

Inflammation of the membranes of the brain and spinal cord has been reported when they have come into direct contact with chlorhexidine.

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:

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Hibiscrub is and what it is used for

2.    What you need to know before you use Hibiscrub

3.    How to use Hibiscrub

4.    Possible side effects

5.    How to store Hibiscrub

6.    Contents of the pack and other information

1. What Hibiscrub is and what it is used for

Hibiscrub belongs to a group of medicines called antiseptics. This means that it helps to prevent infections by killing germs on the skin.

Page 4-47mm    Page 13-47mm

Page 14

Page 3

If you accidentally swallow any Hibiscrub

You should go to your nearest Accident and Emergency department or contact your doctor immediately. Take this leaflet and any other packaging with you so they know what you have taken.

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

4. Possible side effects

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

The following side effects may occur; it is not known how often they occur but available

gluconate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or

nurse before using Hibiscrub.

•    Avoid contact with the eyes, brain, meninges (the membranes surrounding the brain and spinal cord) and middle ear.

If Hibiscrub comes into contact with the eyes, wash out immediately and thoroughly with water.

•    In patients with head or spinal injuries or a perforated ear drum (an ear drum with a hole or tear in it), the benefit of use in pre-operative preparation should be evaluated against the risk of contact.

•    Common bleaches (which contain hypochlorites) may cause brown stains to develop on fabrics which have previously been in contact with chlorhexidine.

•    Hibiscrub's action may be reduced if used with soap or detergents.

•    If you go into hospital, let your doctor know if you are using Hibiscrub.

Children

Use with care in newborn babies, especially those born prematurely. Hibiscrub may cause chemical skin burns.

3. How to use Hibiscrub

Always use this medicine exactly as described in this leaflet or as

•    Wash the whole body. Start with the face. Work down the body. Pay special attention to the skin around the nose, under the arms, around the belly button, between the legs and around the bottom.

•    Rinse the whole body.

•    Repeat the wash. Use the same amount of Hibiscrub. This time, wash the hair as well.

•    Rinse the whole body and dry thoroughly with a clean towel.

For Preventing Infection After Your Operation

Wash the whole of your body, excluding the operation site, in the bath or the shower. This is usually done on the third day after the operation. Use the method described above.

Page 12-47mm    Page 5-47mm

Page 6

Page 11

3. Palm to palm fingers interlaced.

5. Rotational rubbing of right thumb clasping in left palm and vice versa.

6. Rotational rubbing backwards and forwards of tips of fingers and thumb of right hand in left palm and vice versa.

4. Back of fingers to opposing palms with fingers interlocked.

Continue washing hands and wrists until one minute has elapsed. Clean the fingernails with a brush or scraper. Rinse thoroughly. For pre-operative use repeat the wash a second time for two minutes.

HIBISCRUB

Font: Marburg Medium 28,5 pt. EU Braille

• • • • • • •

H    I    B

• • • • • • • • • • • • • •• •

SCRUB

• •

• •

115mm    115mm    115mm    115mm    115mm

igi

a

T

n white bottles containing 250 ml, 500 ml or 5 litres of iquid.

Marketing

Authorisation

Holder

Regent Medical (Overseas) Limited Wedlock Street, Oldham, Lancashire, OL1 3HS, UK.

Manufacturer

BCM Ltd., 1 Thane Road West, Nottingham,

NG2 3AA, UK.

This leaflet was last revised in 03/2016.

Hibiscrub® is a trade mark of Regent Medical Ltd.

Base Label - 45mm

6. Contents of the pack and other information

What Hibiscrub contains

-    The active ingredient is chlorhexidine gluconate 4% w/v (40 mg/ml)

-    The other ingredients are poloxamer 237, isopropyl alcohol, lauryl dimethyl amine oxide, glycerol, macrogol 7 glycerol cocoate, gluconolactone, perfume (Herbacol), ponceau 4R (E124), sodium hydroxide and purified water.

What Hibiscrub looks like and contents of the pack

Hibiscrub is a clear, red, slightly viscous solution and comes

• HIBISCRUB®

4% w/v Cutaneous Solution Chlorhexidine gluconate 40 mg/ml

Antimicrobial Skin Cleanser for antiseptic handwashing on the ward, pre-operative surgical hand disinfection and patient pre- anc post-operative skin antisepsis.

Read the package leaflet before use, which is given when the label is peeled back.

Excipients: poloxamer 237, isopropyl alcohol, lauryl dimethyl amine oxide, glycerol, macrogol 7 glycerol cocoate, gluconolactone, perfume (Herbacol), ponceau 4R (E124), sodium hydroxide and purified water.

Precautions: Avoid contact with eyes, brain, meninges, eyes and middle ear.

Use with care in newborn babies, especially those born prematurely. Hibiscrub may cause chemical skin burns.

FOR EXTERNAL USE ONLY

Keep out of the sight and reach of children. Do not store above 25°C. Store in the original package.

Regent Medical (Overseas) Limited, Medlock Street, Oldham, Lancashire, OL1 3HS, UK.

PA 1218/1/1; PL 22099/0001 Hibiscrub® is a trade mark of Regent Medical Ltd.

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060097

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930746

Package leaflet: nformation for the catient

0 HIBISCRUB®

4% w/v Cutaneous Solution Chlorhexidine gluconate

Read all of this leaflet carefully before you start

using this medicine

because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. -Keep this leaflet. You may need to read it again.

-Ask your pharmacist if you need more information or advice.

-If you get any side effects, talk to your doctor, pharmacist

5. How to store Hibiscrub

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

Do not use this medicine after the expiry date which is printed on the bottle after "EXP". The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no onger use. These measures will help protect the environment.

Page 16 - 32mm    Front Cover - 42mm

Inside Cover - 42mm

Page 15 - 32mm

infections by killing germs on the skin.

Hibiscrub is used to disinfect the hands and skin prior to or after an operation or a clean procedure (pre- and postoperative hand and skin disinfection/ antisepsis).

Hibiscrub is can also be used to disinfect hands after handling infected materials (antiseptic handwashing).

2. What you need to know before you use Hibiscrub

Do not use

Hibiscrub if • you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of this medicine (listed in section 6).

Allergic reactions to chlorhexidine-impreg nated patches have been reported rarely when used in newborn babies.

At the first sign of any of these reactions, tell your doctor, pharmacist or nurse and application of Hibiscrub should be stopped immediately.

Other possible side effects, for which it is not known how often they occur, are: allergic skin disorders such as dermatitis

(inflammation of the skin), pruritus (itch), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation and blisters.

Inflammation of the membranes of the brain and spinal cord has been reported when they have come

into direct contact with chlorhexidine.

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:

Ireland

HPRA

Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Wfebsite: www.hpra.ie e-mail:

medsafety@hpra.ie

United Kingdom

Yellow Card Scheme Website:

www.mhra.gov.uk/yello

wcard

By reporting side effects you can help provide more information on the safety of this medicine

or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Hibiscrub is and what it is used for

2. What you need to know before you use Hibiscrub

3. How to use Hibiscrub

4. Possible side effects

5. How to store Hibiscrub

6. Contents of the pack and other information

1. What Hibiscrub is and what it is used for

Hibiscrub belongs to a group of medicines called antiseptics. This means that it helps to prevent

Page 4 - 32mm

Page 13 - 32mm

Page 14-32mm ^:    Page 3-32mm

doctor, pharmacist or nurse.

4. Possible side effects

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

The following side effects may occur; it is not known how often they occur but available data suggests these are very rare (probably affect fewer than 1 in every 10,000 people).

• Serious allergic reactions which can cause breathing difficulties, weakness, collapse and death, and can sometimes be preceded by swelling (in particular lip/tongue and facial swelling), or rash.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Hibiscrub.

•    Avoid contact with the eyes, brain, meninges (the membranes surrounding the brain and spinal cord) and middle ear. If Hibiscrub comes into contact with the eyes, wash out immediately and thoroughly with water.

•    In patients with head or spinal injuries or a perforated ear drum (an ear drum with a hole or tear in it), the benefit of use in pre-operative preparation should be evaluated against the risk of contact.

•    Common bleaches (which contain hypochlorites) may cause brown stains to develop on

fabrics, which have previously been in contact with chlorhexidine.

•    Hibiscrub’s action may be reduced if used with soap or detergents.

•    If you go into hospital, let your doctor know if you are using Hibiscrub.

Children

Use with care in newborn babies, especially those born prematurely. Hibiscrub may cause chemical skin burns.

3. How to use Hibiscrub

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

thoroughly with a clean towel.

For Preventing Infection After Your Operation

Wash the whole of your body, excluding the operation site, in the bath or the shower. This is usually done on the third day after the operation. Use the method described above.

If you accidentally swallow any Hibiscrub

You should go to your nearest Accident and Emergency department or contact your doctor immediately. Take this leaflet and any other packaging with you so they know what you have taken. If you have any further questions on the use of this medicine, ask your

Page 12 - 32mm

Page 5 -32mm

Page 6 - 32mm    Page 11 - 32mm

3. Palm to palm fingers nterlaced.

4. Back of fingers to opposing palms with ingers interlocked.

5. Rotational rubbing of right thumb clasping in left palm and vice versa.

6. Rotational rubbing backwards and forwards of tips of fingers and thumb of right hand in left palm and vice versa.

Continue washing hands and wrists until one minute has elapsed.

Clean the fingernails with a brush or scraper. Rinse thoroughly. For pre-operative use repeat the wash a second time for two minutes.

The Hibiscrub handwashing technique is based on a procedure described by Ayliffe GAJ et al. J Clin Path 1978; 31: 923.

For Antiseptic Handwashing on the ward

Wet the hands and forearms, apply 5 ml of Hibiscrub and wash for one minute. Rinse thoroughly and dry.

For Preventing Infection Before Your Operation

Wash the whole of

your body in the bath or the shower on at least two occasions. This is usually done on the day before the operation and the day of the operation. Use the following method:

•    Use 25 ml of Hibiscrub as a soap solution.

•    Wash the whole body. Start with the face. Work down the body. Pay special attention to the skin around the nose, under the arms, around the belly button, between the legs and around the bottom.

•    Rinse the whole body.

•    Repeat the wash. Use the same amount of Hibiscrub. This time, wash the hair as well.

•    Rinse the whole body and dry

FOR EXTERNAL USE ONLY

Do not inject. Do not use in the body’s internal spaces.

Chlorhexidine must not be used in direct contact with nerve tissue, for example brain and spinal cord tissue.

Pre-operative Surgical Hand Disinfection

Wet the hands and forearms. Wash with 5 ml of Hibiscrub using the following procedure, each step consisting of five strokes backwards and forwards.

2. Right palm over left dorsum and left palm over right dorsum.

HIBISCRUB

Font: Marburg Medium 28,5 pt. EU Braille

• •• • •••• • • • •••••    •• •

•    •• •

HIBISCRUB

Height - 150 mm    Height - 150 mm    Height - 150mm

5.    How to store Hibiscrub

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

Do not use this medicine after the expiry date which is printed on the bottle after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Hibiscrub contains

•    The active substance is chlorhexidine gluconate 4% w/v (40 mg/ml)

•    The other ingredients are poloxamer 237, lauryl dimethyl, isopropyl alcohol, amine oxide, glycerol, macrogol 7 glycerol cocoate, gluconolactone, perfume (Herbacol), ponceau 4R (E124), sodium hydroxide and purified water.

What Hibiscrub looks like and contents of the pack

Hibiscrub is a clear, red, slightly viscous solution and comes in white bottles containing 250 ml, 500 ml or 5 litres of liquid.

Marketing Authorisation Holder

Regent Medical (Overseas) Limited, Medlock Street, Oldham, Lancashire, OL1 3HS, UK.

Manufacturer

BCM Ltd., 1 Thane Road West, Nottingham, NG2 3AA, UK. This leaflet was last revised in 03/2016.

Base Label - 102mm

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operation and the day of the operation. Use the following method:

•    Use 25 ml of Hibiscrub as a soap solution.

•    Wash the whole body. Start with the face. Work down the body. Pay special attention to the skin around the nose, under the arms, around the belly button, between the legs and around the bottom.

•    Rinse the whole body.

•    Repeat the wash. Use the same amount of Hibiscrub. This time, wash the hair as well.

•    Rinse the whole body and dry thoroughly with a clean towel.

For Preventing Infection After Your Operation

Wash the whole of your body, excluding the operation site, in the bath or the shower. This is usually done on the third day after the operation. Use the method described above.

If you accidentally swallow any Hibiscrub

You should go to your nearest Accident and Emergency department or contact your doctor immediately. Take this leaflet and any other packaging with you so they know what you have taken.

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

4. Possible side effects

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

The following side effects may occur; it is not known how often they occur but available data suggests these are very rare (probably affect fewer than 1 in every 10,000 people).

•    Serious allergic reactions which can cause breathing difficulties, weakness, collapse and death, and can sometimes be preceded by swelling (in particular lip/tongue and facial swelling), or rash.

Allergic reactions to chlorhexidine-impregnated patches have been reported rarely when used in newborn babies.

At the first sign of any of these reactions, tell your doctor, pharmacist or nurse and application of Hibiscrub should be stopped immediately.

Other possible side effects, for which it is not known how often they occur, are: allergic skin disorders such as dermatitis (inflammation of the skin), pruritus (itch), erythema (redness of the skin), eczema, rash, urticaria (hives), skin irritation and blisters.

Inflammation of the membranes of the brain and spinal cord has been reported when they have come into direct contact with chlorhexidine.

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:

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL - Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: medsafety@hpra.ie

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

^HIBISCRUB®

4% w/v Cutaneous Solution Chlorhexidine gluconate 40 mg/ml

Antimicrobial skin cleanser for antiseptic handwashing on the ward, ore-operative surgical hand disinfection, and patient pre- and post-operative skin antisepsis.

Read the package leaflet before use, which is given when the label is peeled back.

Excipients: poloxamer 237, isopropyl alcohol, lauryl dimethyl amine oxide, glycerol, macrogol 7 glycerol cocoate, gluconolactone, perfume (Herbacol), ponceau 4R (E124), sodium hydroxide and purified water.

Precautions: Avoid contact with eyes, brain, meninges and middle ear. Use with care in newborn babies, especially those born prematurely. Hibiscrub may cause chemical skin burns. Keep out of the sight and reach of children.

FOR EXTERNAL USE ONLY

Do not store above 25°C. Store in the original package.

Regent Medical (Overseas) Limited

Medlock Street, Oldham, Lancashire, OL1 3HS, UK

PA 1218/1/1; PL 22099/0001

Trade Mark of Regent Medical Overseas Ltd.

06

097

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