CHLORHEXAMED

CHLORHEXAMED Fluid

Important notes (mandatory information)

Chlorhexamed Fluid 0.1%, solution. Active ingredient: Chlorhexidine digluconate. Field of application: for temporary reduction of germs in the oral cavity; as temporary supportive therapy for mechanical cleaning in case of bacterial inflammation of the gums and oral mucosa; in case of limited oral hygiene capability. Warning: Contains 7% alcohol by volume!

For risks and side effects, read the package leaflet and consult your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorhexamed Fluid 0.1%, solution for use in the oral cavity
Active ingredient: Chlorhexidine digluconate

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after one month, contact your doctor.

What is in this package leaflet

1. WHAT IS CHLORHEXAMED FLUID 0.1% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CHLORHEXAMED FLUID 0.1%?
3. HOW SHOULD CHLORHEXAMED FLUID 0.1% BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CHLORHEXAMED FLUID 0.1% BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CHLORHEXAMED FLUID 0.1% AND WHAT IS IT USED FOR?

Chlorhexamed Fluid 0.1% is an antibacterial mouth and throat antiseptic. Chlorhexamed Fluid 0.1% is used: for temporary reduction of germs in the oral cavity; as temporary supportive therapy for mechanical cleaning in case of bacterial inflammation of the gums and oral mucosa; in case of limited oral hygiene capability. If you do not feel better or even worse after one month, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CHLORHEXAMED FLUID 0.1%?

Chlorhexamed Fluid 0.1% must not be used:

• if you are hypersensitive (allergic) to chlorhexidine digluconate, Ponceau 4R (E 124), cinnamon (this also applies if you are hypersensitive to Peruvian balsam (cross-allergy)), levomenthol or any of the other ingredients of this medicine listed in section 6.
• if the tissue to be treated has poor blood circulation.
• if you suffer from wounds and ulcers (ulcerations) as well as superficial, non-bleeding desquamations of the oral mucosa (erosive-desquamative changes).
• in persons who cannot properly control swallowing (including children under 6 years of age).

Warnings and precautions

Please talk to your doctor or pharmacist before using Chlorhexamed Fluid 0.1%. Use Chlorhexamed Fluid 0.1% only in the mouth! If Chlorhexamed Fluid 0.1% gets into the eyes or ears, rinse them thoroughly with water. Do not swallow the solution! If you experience a sore feeling or irritation in your mouth, stop using Chlorhexamed Fluid 0.1% and inform your doctor or pharmacist. Temporary discoloration of the tongue may occur. This discoloration will disappear as soon as the use of Chlorhexamed Fluid 0.1% is discontinued. Discoloration of teeth, dentures or dental fillings may also occur. These are temporary and can be removed by brushing your teeth or having them professionally cleaned. A special cleaner is recommended for full dentures. Discoloration can usually be prevented by avoiding strongly colored foods and beverages such as tea, coffee or red wine. Chlorhexamed Fluid 0.1% can be impaired in its effect by anionic substances, which are often a component of commercially available toothpaste. Therefore, rinse your mouth thoroughly with water and wait at least 5 minutes after brushing your teeth before using Chlorhexamed Fluid 0.1%. You can also use Chlorhexamed Fluid 0.1% at a different time of day from brushing your teeth.

Use of Chlorhexamed Fluid 0.1%

together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions with other medicines are known to date. Chlorhexamed Fluid 0.1% can be impaired in its effect by anionic substances, such as sodium dodecyl sulfate (see also section 2. "What should you consider before using Chlorhexamed Fluid 0.1% - Warnings and precautions").

Use of Chlorhexamed Fluid 0.1%

together with food and beverages

Chlorhexidine is inactivated by sucrose (cane sugar). Do not eat or drink sugary foods and beverages immediately after using Chlorhexamed Fluid 0.1%, as this will impair the effect of Chlorhexamed Fluid 0.1%. The consumption of strongly colored foods and beverages such as tea, coffee and red wine should be reduced if necessary to prevent possible discoloration of teeth, tongue, fillings and dentures.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. There is insufficient experience or research on the safety of using chlorhexidine digluconate, the active ingredient in Chlorhexamed Fluid 0.1%, during pregnancy and breast-feeding. Therefore, Chlorhexamed Fluid 0.1% should only be used with special caution.

Driving and operating machinery

No impairments are known.

This medicine contains 7.0% alcohol by volume.

Chlorhexamed Fluid 0.1%

contains macrogolglycerol hydroxystearate (Ph. Eur.)

Macrogolglycerol hydroxystearate (Ph. Eur.) can cause skin irritation.

3. HOW SHOULD CHLORHEXAMED FLUID 0.1% BE USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Adults and children aged 12 years and over

The recommended dose is: twice a day, 15 ml of solution. (Fill the screw cap to the marking ring) apply.

Children under 12 years of age

Children under 12 years of age should only use Chlorhexamed Fluid 0.1% after consulting a doctor or pharmacist.

Types of application

For use in the oral cavity only. The teeth should be brushed for at least 5 minutes using commercially available toothpaste before using Chlorhexamed Fluid 0.1%, and the oral cavity should be rinsed thoroughly after brushing (see also section 2. "What should you consider before using Chlorhexamed Fluid 0.1% - Warnings and precautions"). The solution is ready to use and should therefore be used undiluted. Use 15 ml of solution twice a day, preferably in the morning and evening (after meals and brushing your teeth). (Fill the screw cap to the marking ring). The oral cavity is rinsed thoroughly with the solution for one minute. After use, the solution is spat out. Do not swallow or rinse. Accidental swallowing is harmless. In case of bacterial inflammation of the oral mucosa in the sense of denture stomatitis: Clean the denture with a special cleaner, then place it in Chlorhexamed Fluid 0.1% for 5 minutes; additionally, rinse the oral cavity as described above. Please follow the instructions for use, otherwise Chlorhexamed Fluid 0.1% will not work properly! If your symptoms persist, consult a doctor or pharmacist for advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Chlorhexamed Fluid 0.1% is too strong or too weak.

If you have used a larger amount of Chlorhexamed Fluid 0.1%

than you should

Always use Chlorhexamed Fluid 0.1% exactly as described in this package leaflet. Do not exceed the specified dose. You can remove Chlorhexamed Fluid 0.1% by rinsing with water. No poisoning symptoms have been reported to date. Accidentally swallowed Chlorhexamed Fluid 0.1% is poorly absorbed by the body (resorbed). If symptoms do occur, consult a doctor if necessary.

If you forget to use Chlorhexamed Fluid 0.1%

Do not use double the amount if you have forgotten the previous application. Continue treatment according to the dosage instructions.

If you stop using Chlorhexamed Fluid 0.1%

No special measures are required.

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

Chlorhexamed Fluid 0.1% contains 7.0% alcohol by volume. If children have swallowed larger amounts of the solution, consult a doctor for further treatment.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Stop using Chlorhexamed Fluid 0.1% and seek medical help immediately if you experience a rash, swelling of the lips, tongue, throat or face, or difficulty breathing. These may be signs of a serious allergic reaction, which is very rare.

Common side effects:

• temporary discoloration of teeth**
• temporary discoloration of dental fillings and dentures as well as the tongue**

Uncommon side effects

Rare side effects:

• hypersensitivity reactions (including hives, skin redness, itching)
• increased tartar formation
• bleeding gums after brushing teeth

Very rare side effects:

• severe allergic reaction (anaphylactic shock; see above)
• temporary certain changes (so-called "desquamative changes")
• temporary certain changes irritation/swelling of the oral mucosa

Side effects with unknown frequency:

• wound healing disorders
• tingling or burning sensation on the tongue at the beginning of treatment*
• temporary impairment of taste sensation*
• temporary numbness of the tongue*

* These symptoms usually disappear with continued use of Chlorhexamed Fluid 0.1%. However, if the symptoms persist, consult a doctor or pharmacist for advice.
** Discoloration can be partially prevented by using this medicine according to the dosage instructions (see also section 3. "How should Chlorhexamed Fluid 0.1% be used?") and avoiding strongly colored foods and beverages such as tea, coffee or red wine. Discoloration of teeth, dentures or dental fillings is temporary and can be removed by brushing your teeth or having them professionally cleaned. A special cleaner is recommended for full dentures.

Ponceau 4R (E 124) can cause allergic reactions. Cinnamon can cause skin irritation.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD CHLORHEXAMED FLUID 0.1% BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and glass bottle after "Use by". The expiry date refers to the last day of the month indicated. Shelf life after opening: 6 months. Do not store above 25°C. Store in the original packaging protected from light.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Chlorhexamed Fluid 0.1%

contains

The active ingredient is chlorhexidine digluconate (0.1 g/100 g solution). 100 ml solution contains 0.1 g chlorhexidine digluconate. The other ingredients are ethanol 96%, glycerol, macrogolglycerol hydroxystearate (Ph.Eur.), anethole, clove oil, levomenthol, cinnamon oil, Ponceau 4R (E 124) and purified water.

What Chlorhexamed Fluid 0.1%

looks like and contents of the pack

Chlorhexamed Fluid 0.1% is a light red, transparent solution. Available as a glass bottle with a dosing cap (with 15 ml graduation mark) containing 200 ml of solution.

Pharmaceutical entrepreneur

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich
Address:
Barthstraße 4
80339 Munich
Tel.: (089) 78 77-209
Fax: (089) 78 77-304
E-mail: medical.contactcenter@gsk.com

Manufacturer

Omega Pharma Manufacturing GmbH & Co. KG
Benzstr. 25
D - 71083 Herrenberg

This package leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 10/2017
Active ingredient: Chlorhexidine digluconate. Field of application: for temporary reduction of germs in the oral cavity; as temporary supportive therapy for mechanical cleaning in case of bacterial inflammation of the gums and oral mucosa; in case of limited oral hygiene capability. Warning: Contains 7% alcohol by volume!