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CHLORHEXIDINE GLUCONATE 2% W/V IMPREGNATED PAD

Active substance(s): CHLORHEXIDINE GLUCONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Chlorhexidine Gluconate 2% w/v Impregnated Pad
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 or nurse. This includes any possible side effects not listed
in this leaflet.

What is in this leaflet:









1. What Chlorhexidine Gluconate is and what it is used for
2. What you need to know before you use Chlorhexidine Gluconate
3. How to use Chlorhexidine Gluconate
4. Possible side effects
5. How to store Chlorhexidine Gluconate
6. Contents of the pack and other information

1. WHAT CHLORHEXIDINE GLUCONATE IS AND WHAT IT IS USED FOR




.

The active ingredient in these pads is chlorhexidine gluconate, 2% = 20 mg/ml (equivalent to 500 mg chlorhexidine gluconate
per pad), which has antibacterial properties, fighting and killing bacteria. These pads should only be used for disinfecting the
skin. They can be used before surgery on the advice of your doctor. They can also be used to disinfect your skin generally.
Each package contains either two or six pads

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CHLORHEXIDINE GLUCONATE
Do not use Chlorhexidine Gluconate:
• if you are allergic to the active ingredient chlorhexidine gluconate or any of the other ingredients of this medicine
(listed in section);
• on premature or low birth weight babies, babies less than two months of age or babies receiving treatment which
uses light (phototherapy);
• in contact with the membranes surrounding the brain and spinal cord;
• immediately prior to invasive techniques, such as venepuncture, lumbar puncture or surgery
• on open wounds or broken skin
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Chlorhexidine Gluconate .
Keep the pads away from your eyes, ears and mouth. The solution inside them might cause serious or permanent injury to these
parts of the body. If contact occurs, rinse the affected areas with water immediately.
Other medicines and Chlorhexidine Gluconate
There have been no reports of interactions between these impregnated pads and other medicines.
Pregnancy and breast-feeding
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. These pads may be safely used during pregnancy and breast-feeding but should not be used at
the breast.
Driving and using machines
These pads do not affect the ability to drive or to use machines.

3. HOW TO USE CHLORHEXIDINE GLUCONATE
These pads are only for use on your skin. 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.



When using these pads:
• make sure your skin is completely dry and cool;
• do not shower immediately before using the pads because this may increase skin irritation;
• do not shave any part of your body, including your face, legs, underarms, etc., for at least two days before surgery,
because this may also increase skin irritation;
• do not rinse skin or apply any lotions, moisturizers or cosmetics to the areas that have been cleaned;
• use each pad only once;
• if any skin irritation develops, rinse the affected areas and stop using the pads.
• keep the pads away from eyes, ears and mouth. If contact occurs, rinse the affected areas with water immediately.
For disinfecting the skin before surgery:
Your doctor may instruct you to wipe:
• either the area immediately at and surrounding the proposed surgery site
• or your entire body from your chin down
This should be done the night before and/or on the morning of your surgery, according to your doctor’s instructions.
There are two types of packages. If you are using:

packages containing 2 pads:
-- your doctor will instruct you to wipe the areas of your skin chosen for treatment with the impregnated pads;
-- use one pad to wipe each area;
-- make sure the skin in each area is completely wetted with the solution in the pad;
-- do not rinse off. Keeping the solution on your skin is an advantage because the antibacterial effects work for up to
6 hours after application
-- allow the skin to air dry.


--

--

packages containing 6 pads:
use one pad to wipe each area of the body, so that each area is completely wetted with the solution in the pad;
do not rinse off. Keeping the solution on your skin is an advantage because the antibacterial effects work for up to
6 hours after application.
wipe the neck, chest and stomach

-

------

wipe both arms, starting each with the shoulder and ending at the fingertips, paying particular attention to the
underarm area;
wipe both hips followed by the groin, paying particular attention to the skin folds in the abdominal and groin areas;
wipe both legs, starting at the thigh and ending at the toes;
wipe the back, starting at the base of the neck and ending at the waistline;
wipe the buttocks;
allow the skin to air dry.

For general skin antiseptic purposes:
Use only on intact skin. As instructed above, use one pad for each area of the body, avoiding contact with open wounds or
broken skin. In case of contact with an open wound or broken skin, no action is required unless irritation or reaction occurs, in
which case you should notify your doctor immediately.
If you use more of these pads than you should:
Using too many pads is unlikely to be harmful, because chlorhexidine gluconate is not easily absorbed through the skin.
If you forget to use these pads:
This may result in an increased risk of infection. If you have any concerns about the risk of infection, consult your doctor.
If you stop using these pads:
This may result in an increased risk of infection. If you’re in any doubt, consult your doctor.
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 Chlorhexidine Gluconate can cause side effects, although not everybody gets them. Allergic reactions
(very rare, may affect up to 1 in 10,000 people): may become very serious. Symptoms may include difficulty breathing, difficulty
swallowing, drop in blood pressure, skin rash and swelling of the lips, tongue and eyes. If an allergic reaction occurs, stop using
these pads and consult your doctor immediately or go immediately to the emergency dept. of your nearest hospital, taking this
leaflet with you.
Common (may affect up to 1 in 10 people): skin irritation such as itching, burning sensation, redness, and rash can occur.
These side effects are usually mild and temporary. However, if your skin irritation persists, rinse the affected areas, stop using
these pads, and tell your doctor or pharmacist..
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 pharmacist.

5. HOW TO STORE CHLORHEXIDINE GLUCONATE
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day
of that month.
Do not store above 25°C. Do not refrigerate or freeze.
Store the product flat.
Discard each pad after a single use. After package has been opened, discard any unused pads.
This product should be disposed of as solid domestic waste. Do not flush pads down the toilet.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What Chlorhexidine Gluconate contains
The active substance is chlorhexidine gluconate, 2% (equivalent to 500 mg chlorhexidine gluconate per pad).
The other ingredients are aloe vera gel (contains sodium benzoate and potassium sorbate),
dimeticone, fragrance F750485, gluconolactone, glycerol, nonoxinol 9, polysorbate 20, propylene glycol, purified water and a
polyester pad
What Chlorhexidine Gluconate look like and contents of the pack
Each 19cm x 19cm white, polyester pad is impregnated with a colourless solution containing chlorhexidine gluconate.
These moist pads are contained in a plastic sachet, supported internally by a blue wrapping made of foam.
There are two types of sachets: a single-use sachet containing 2 pads and a resealable sachet containing 6 pads.
The sachets are packed in cartons:
- Cartons containing 24 packages each comprising of 2 impregnated pads
- Cartons containing 20 packages each comprising of 6 impregnated pads.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baggerman FarmaNet NV
Barrierweg 3G
5622 CL Eindhoven
The Netherlands
Tel/Fax: +31 (0)40 285 7910

Manufacturer:
Sage Products, Inc. doing business as
Comfort Personal Cleansing Products
3909 Three Oaks Road
Cary, IL 60013
USA

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria
Germany
Norway
Poland
The Netherlands
United Kingdom

Chlorhexidindigluconat Baggerman 20 mg/ml imprägniertes Tuch
Chlorhexidindigluconat Baggerman 20 mg/ml imprägniertes Tuch
Klorheksidin Baggerman 20 mg/ml impregnert pute
chlorheksydyny glukonian Baggerman
Chloorhexidinegluconaat 2%, geïmpregneerde doek
Chlorhexidine gluconate 2% impregnated pad

This leaflet was last approved in 12/2012.

R9xxxx



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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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