Meridol

MERIDOL med CHX 0.2% rinse

Important notes (mandatory information)

meridol med CHX 0.2%, solution. Active ingredient: Chlorhexidine digluconate solution. Areas of application: for temporary reduction of the number of germs in the oral cavity, as temporary and supportive therapy for mechanical cleaning in the case of bacterial inflammation of the gums (gingiva) and the oral mucosa, as well as after periodontal surgical procedures, in the case of limited oral hygiene capability.

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


INSTRUCTIONS FOR USE: INFORMATION FOR THE USER

meridol med CHX 0.2%, solution for use in the oral cavity for use in children aged 6 and over and in adults
Active ingredient: Chlorhexidine digluconate solution (Ph.Eur.)

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor, dentist 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, contact your doctor, dentist or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms worsen, you must consult a dentist or doctor in any case.

What this package leaflet contains

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

1. WHAT IS MERIDOL MED CHX 0.2% AND WHAT IS IT USED FOR?

meridol med CHX 0.2% is an antiseptic for short-term reduction of the number of germs in the oral cavity. meridol med CHX 0.2% is used for temporary reduction of the number of germs in the oral cavity, as temporary and supportive therapy for mechanical cleaning in the case of bacterial inflammation of the gums (gingiva) and the oral mucosa, as well as after periodontal surgical procedures, in the case of limited oral hygiene capability.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MERIDOL MED CHX 0.2%?

meridol med CHX 0.2% must not be used:

• if you are allergic to chlorhexidine bis(D-gluconate) or any of the other ingredients of this medicine listed in section 6,
• in the case of poorly perfused tissue,
• on the eardrum,
• on the eye and in the eye area.

Warnings and precautions

Special care should be taken when using meridol med CHX 0.2%:

• if you have wounds, ulcers (ulcerations) and erosive-desquamative changes of the oral mucosa.
• Persons who do not have control over their swallowing reflex (e.g. children before starting school, disabled persons) should not use meridol med CHX 0.2%.
• In the case of intensive care patients, it should be noted that contact with the meninges and the central nervous system should be avoided.
• The solution should not be swallowed.
• Avoid contact with eyes and ears.
• Effects occurring at the start of treatment, such as reduced taste sensations or burning on the tongue, decrease with increasing duration of treatment.
• If the oral mucosa peels off or the parotid glands swell, treatment should be discontinued.
• It should be noted that chlorhexidine bis(D-gluconate) can trigger allergic reactions up to and including anaphylactic shock.

Using meridol med CHX 0.2%

together with other medicines

Inform your doctor, dentist or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Chlorhexidine is incompatible with soaps or other anionic substances. In concentrations above 0.05%, chlorhexidine forms salts with borates, dicarbonates, carbonates, chlorides and phosphates, which can crystallise. Chlorhexidine is inactivated by sucrose. Chlorhexidine can be inactivated by polysorbate-80, insoluble magnesium, zinc and calcium salts. Chlorhexidine is impaired by anionic substances (e.g. sodium dodecyl sulfate, synonym: Sodium Lauryl Sulfate), which can be components of toothpastes. They should therefore not be used at the same time, but before rinsing the mouth with meridol med CHX 0.2% (see section 3). This restriction does not apply to toothpastes that contain amphoteric surfactants.

Using meridol med CHX 0.2%

together with food and drink

Please do not consume any sugary food or drinks for up to one hour after using the mouthwash, as this will impair the effect of the chlorhexidine.

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, dentist or pharmacist for advice before using this medicine. There is not much experience with the use of meridol med CHX 0.2% in pregnant women. It is also not known whether meridol med CHX 0.2% passes into breast milk. Therefore, you should use meridol med CHX 0.2% with caution if you are pregnant or breast-feeding.

Driving and using machines

No special precautions are required.

meridol med CHX 0.2%

contains macrogolglycerol hydroxystearate (Ph.Eur.)

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

3. HOW IS MERIDOL MED CHX 0.2% USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor, dentist or pharmacist. Check with your doctor, dentist or pharmacist if you are not sure. Unless otherwise prescribed by your doctor or dentist, the usual dose for children aged 6 and over and adults is: rinse twice a day with 10 ml meridol med CHX 0.2%. The screw cap contains a measuring cup with which 10 ml can be measured. The oral cavity is rinsed thoroughly with meridol med CHX 0.2% for 1 minute and the solution is then spat out. Do not swallow or rinse afterwards. The application should take place after brushing your teeth (and then rinsing thoroughly with water). The solution is ready to use and should therefore be used undiluted. Longer use of meridol med CHX 0.2% should only take place after consultation with your doctor or dentist. Please talk to your doctor, dentist or pharmacist if you have the impression that the effect of meridol med CHX 0.2% is too strong or too weak.

If you have used meridol med CHX 0.2%

differently than you should

In case of contact with skin and mucous membrane, the solution can be removed by rinsing with water. After accidental contact with the ear canal, eye and eye area, rinse with plenty of water. Signs of poisoning are not known. Chlorhexidine that is accidentally swallowed is poorly absorbed by the body (resorbed).

If you have used a larger amount of meridol med CHX 0.2%

than you should

If larger amounts of meridol med CHX 0.2% are swallowed, please consult a doctor. If necessary, the stomach can be emptied.

If you forget to use meridol med CHX 0.2%

Do not use twice the amount if you have forgotten the previous application.

If you have any further questions on the use of meridol med CHX 0.2%, ask your doctor, dentist or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following categories are used as a basis for the frequency of 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.

Significant side effects or signs to watch out for, and measures to take if you are affected

If you are affected by any of the following side effects, stop using meridol med CHX 0.2% and consult your doctor or dentist as soon as possible. In individual cases, serious hypersensitivity reactions (allergic reactions up to and including anaphylactic shock) have been described after local application of chlorhexidine (see section 2).

Other possible side effects

The following side effects may occur when used in the oral cavity: reversible impairment of taste sensation, reversible numbness of the tongue, reversible discolouration of tooth hard tissue, restorations (fillings) and tongue papillae (hairy tongue). Hypersensitivity reactions occur rarely. In individual cases, temporary desquamation (desquamative changes) of the mucous membrane and temporary swelling of the parotid glands occurred.

Countermeasures

Discolouration of the tongue disappears after discontinuation of treatment. Discolouration of the teeth can be minimised by intensive daily brushing. Stubborn tooth discolouration can be easily removed by the dentist. A special cleaner is recommended for full dentures.

Reporting of side effects

If you get 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 to provide more information on the safety of this medicine.

5. HOW SHOULD MERIDOL MED CHX 0.2% 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 label and carton after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening: meridol med CHX 0.2% has a shelf life of 4 weeks after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What meridol med CHX 0.2%

contains

The active ingredient is: Chlorhexidine digluconate solution (Ph.Eur.). 100 ml solution contains 1.0617 g chlorhexidine digluconate solution (Ph.Eur.), corresponding to 200 mg chlorhexidine bis(D-gluconate). A dose of 10 ml contains 0.10617 g chlorhexidine digluconate solution (Ph.Eur.), corresponding to 20 mg chlorhexidine bis(D-gluconate). The other ingredients are: Sorbitol solution 70% (non-crystallising) (Ph.Eur.), glycerol, macrogolglycerol hydroxystearate (Ph. Eur.), citric acid monohydrate, peppermint oil, patent blue V, purified water.

What meridol med CHX 0.2%

looks like and contents of the pack

meridol med CHX 0.2% is a clear blue solution for use in the oral cavity with a characteristic peppermint smell. The pack contains a bottle with a content of 300 ml.

Pharmaceutical entrepreneur

CP GABA GmbH
Beim Strohhause 17
D-20097 Hamburg

Manufacturer

GABA GmbH
Berner Weg 7
D-79539 Lörrach

This leaflet was last revised in January 2014.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Chlorhexidine digluconate solution. Areas of application: for temporary reduction of the number of germs in the oral cavity, as temporary and supportive therapy for mechanical cleaning in the case of bacterial inflammation of the gums (gingiva) and the oral mucosa, as well as after periodontal surgical procedures, in the case of limited oral hygiene capability.