CHLORHEXAMED FORTE

CHLORHEXAMED FORTE alcohol-free 0.2% solution

Important notes (mandatory information)

Chlorhexamed Forte alcohol-free 0.2% solution. Active ingredient: Chlorhexidine bis(D-gluconate). Area of application: for temporary reduction of the number of germs in the oral cavity; to support the healing phase after periodontal surgical interventions by inhibiting plaque formation; for temporary supportive treatment of bacterial gingivitis; for use in case of limited oral hygiene capability.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Chlorhexamed Forte alcohol-free 0.2% solution for use in the oral cavity
Active ingredient: Chlorhexidine bis(D-gluconate)

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 instructed 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 notice any side effects, consult 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 if you feel worse, consult your doctor.

What this package leaflet contains

1. WHAT IS CHLORHEXAMED FORTE ALCOHOL-FREE 0.2% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CHLORHEXAMED FORTE ALCOHOL-FREE 0.2%?
3. HOW SHOULD CHLORHEXAMED FORTE ALCOHOL-FREE 0.2% BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CHLORHEXAMED FORTE ALCOHOL-FREE 0.2% BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CHLORHEXAMED FORTE ALCOHOL-FREE 0.2% AND WHAT IS IT USED FOR?

Chlorhexamed Forte alcohol-free 0.2% is an oral antiseptic. The antiseptic solution is used for temporary reduction of the number of germs in the oral cavity; to support the healing phase after periodontal surgical interventions by inhibiting plaque formation; for temporary supportive treatment of bacterial gingivitis; for use in case of limited oral hygiene capability.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CHLORHEXAMED FORTE ALCOHOL-FREE 0.2%?

Chlorhexamed Forte alcohol-free 0.2% must not be used:

• if you are hypersensitive (allergic) to chlorhexidine bis(D-gluconate), peppermint flavour 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 Forte 0.2% alcohol-free. Use Chlorhexamed Forte alcohol-free 0.2% exclusively in the mouth! If Chlorhexamed Forte alcohol-free 0.2% gets into the eyes or ears, rinse them thoroughly with water! Do not swallow the solution! If you notice a sore feeling or irritation in your mouth, stop using Chlorhexamed Forte alcohol-free 0.2% and inform your doctor or pharmacist. Temporary discolouration of the tongue may occur. This discolouration disappears as soon as the use of Chlorhexamed Forte alcohol-free 0.2% is discontinued. Discolouration 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. Discolouration can usually be prevented by avoiding strongly colouring foods and drinks such as tea, coffee or red wine. Chlorhexamed Forte alcohol-free 0.2% 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 Forte alcohol-free 0.2%. You can also use Chlorhexamed Forte alcohol-free 0.2% at a different time of day from brushing your teeth.

Use of Chlorhexamed Forte 0.2%

alcohol-free together with other medicines

Inform 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 Forte alcohol-free 0.2% can be impaired in its effect by anionic substances, such as sodium dodecyl sulphate (see also section 2. "What should you consider before using Chlorhexamed Forte alcohol-free 0.2% - Warnings and precautions").

Use of Chlorhexamed Forte alcohol-free 0.2%

together with food and drinks

Chlorhexidine is inactivated by sucrose (cane sugar). Do not eat or drink sugary foods and drinks immediately after using Chlorhexamed Forte alcohol-free 0.2%, as otherwise Chlorhexamed Forte alcohol-free 0.2% will be impaired in its effect. Consumption of strongly colouring foods and drinks such as tea, coffee and red wine should be reduced if necessary to prevent possible discolouration 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, the active ingredient in Chlorhexamed Forte alcohol-free 0.2%, during pregnancy and breast-feeding. Therefore, Chlorhexamed Forte alcohol-free 0.2% should only be used with special caution.

Driving and operating machinery

No impairments are known.

Chlorhexamed Forte alcohol-free 0.2%

contains macrogolglycerol hydroxystearate (Ph. Eur.)

Macrogolglycerol hydroxystearate can cause skin irritation.

3. HOW SHOULD CHLORHEXAMED FORTE ALCOHOL-FREE 0.2% 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 and over

The recommended dose is: twice a day, use 10 ml of solution (fill the screw cap to the marking ring). Rinse the oral cavity for one minute.

Children under 12 years of age

Children under 12 years of age should only use Chlorhexamed Forte alcohol-free 0.2% after consulting a doctor or pharmacist.

Types of use

For use in the oral cavity only. The teeth should be brushed using commercially available toothpaste at least 5 minutes before using Chlorhexamed Forte alcohol-free 0.2%, and the oral cavity must be rinsed thoroughly after brushing (see also section 2. "What should you consider before using Chlorhexamed Forte alcohol-free 0.2% - Warnings and precautions"). The solution is ready to use and should therefore be used undiluted.

Use as a mouthwash

Use 10 ml of solution (fill the screw cap to the marking ring) twice a day, preferably in the morning and evening (after meals and brushing your teeth). The oral cavity is rinsed thoroughly with the solution for one minute.

Use as a mouth spray

After screwing the spray head onto the bottle, spray 12 sprays evenly onto the affected areas (teeth, oral mucosa or wound areas) twice a day. The solution is sprayed evenly onto the affected areas (teeth, oral mucosa or wound areas). Do not swallow the solution. After use, the solution is spat out. Do not rinse your mouth immediately afterwards.

Do not use Chlorhexamed Forte alcohol-free 0.2% for longer than indicated here without medical or dental advice:

• Gingivitis: Chlorhexamed Forte alcohol-free 0.2% should be used for three weeks in conjunction with mechanical cleaning procedures. In special cases, e.g. in disabled persons, preventive treatment can also be carried out over a longer period of time.
• Treatment after interventions on the periodontium (periodontal surgical interventions): Treatment with Chlorhexamed Forte alcohol-free 0.2% should begin immediately after the first surgical intervention and should be continued for two or three weeks beyond the last intervention. The treatment period is therefore at least two and at most ten weeks. In the case of upper and lower jaw fixation, Chlorhexamed Forte alcohol-free 0.2% should be used for as long as the fixation remains in the mouth (usually 2 - 6 weeks).

Please adhere to the instructions for use, otherwise Chlorhexamed Forte alcohol-free 0.2% will not be able to 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 Forte alcohol-free 0.2% is too strong or too weak.

If you have used a larger amount of Chlorhexamed Forte alcohol-free 0.2%

than you should

Always use Chlorhexamed Forte alcohol-free 0.2% exactly as described in this package leaflet. Do not exceed the specified dose. You can remove Chlorhexamed Forte alcohol-free 0.2% by rinsing with water. No signs of poisoning have been reported to date. Accidentally swallowed Chlorhexamed Forte alcohol-free 0.2% is poorly absorbed by the body (resorbed). If symptoms do occur, consult a doctor if necessary.

If you forget to use Chlorhexamed Forte alcohol-free 0.2%

Do not use twice the amount to make up for the missed use. Continue treatment according to the dosage instructions.

If you stop using Chlorhexamed Forte alcohol-free 0.2%

No special measures are necessary.

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

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 Forte alcohol-free 0.2% 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 discolouration of the teeth**
• temporary discolouration of dental fillings and dentures as well as the tongue**

Rare side effects:

• hypersensitivity reactions (including hives, skin redness, itching)

Very rare side effects:

• severe allergic reaction (anaphylactic shock; see above)

Side effects with unknown frequency:

• tingling or burning sensation on the tongue at the beginning of treatment*
• temporary impairment of taste sensation*
• temporary numbness of the tongue*
• temporary swelling of the parotid gland (parotitis)
• temporary certain changes (so-called "desquamative changes")

* These symptoms usually disappear with continued use of Chlorhexamed Forte alcohol-free 0.2%. However, if the symptoms persist, consult a doctor or pharmacist for advice.
** Discolouration can be partially prevented by using this medicine according to the dosage instructions (see also section 3. "How should Chlorhexamed Forte alcohol-free 0.2% be used?") and by avoiding strongly colouring foods and drinks such as tea, coffee or red wine. Discolouration 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.

Reporting of side effects

If you notice any side effects, consult 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 FORTE ALCOHOL-FREE 0.2% BE STORED?

Keep this medicine out of the reach of children. Do not use the medicine after the expiry date which is stated on the carton and 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 Forte alcohol-free 0.2%

contains

The active ingredient is chlorhexidine bis(D-gluconate). 100 ml of solution contain 0.2 g of chlorhexidine bis(D-gluconate). The other ingredients are: peppermint flavour, macrogolglycerol hydroxystearate (Ph. Eur.), glycerol, sorbitol solution 70% (non-crystallising) (Ph. Eur.) and purified water.

What Chlorhexamed Forte alcohol-free 0.2%

looks like and contents of the pack

The colourless solution with a peppermint smell is available as a mouth spray in bottles of 50 ml and as a mouthwash in bottles of 200 ml and 600 ml.

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 bis(D-gluconate). Area of application: for temporary reduction of the number of germs in the oral cavity; to support the healing phase after periodontal surgical interventions by inhibiting plaque formation; for temporary supportive treatment of bacterial gingivitis; for use in case of limited oral hygiene capability.