SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Colgate Pro Gum Health 0.2 % Antiseptic Mouthwash

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains 2 mg chlorhexidine digluconate.

One dose of 10 ml contains 20 mg chlorhexidine digluconate. Excipient: Macrogolglycerol hydroxystearate 2.5 mg/ml.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Mouthwash Clear blue solution

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Colgate Pro Gum Health 0.2% Antiseptic Mouthwash is indicated in adults and children above the age of 6

-    for the short-term adjuvant treatment of inflammations of the gingival and the oral mucosa.

-    for peri- and post-procedural use in periodontal therapies to prevent infections of oral surgical wounds.

4.2. Posology and method of administration

For adults and children above the age of 6:

The oral cavity should be rinsed thoroughly with 10 ml Colgate Pro Gum Health 0.2% Antiseptic Mouthwash twice a day for one minute and spit out afterwards. The solution should be applied after teeth have been brushed and the oral cavity rinsed thoroughly with water. The solution is ready for use and should hence be used undiluted.

Colgate Pro Gum Health 0.2% Antiseptic Mouthwash would normally not be used for more than 7 days at a time. It may be used over a longer period of time if advised by the dentist or the physician.

Children above the age of 6 and the elderly:

There are no special dosage recommendations for either elderly patients or children above the age of 6. The normal adult dose is appropriate unless otherwise recommended by the dentist or the physician.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

The use of a mouth rinse is contraindicated in conditions where it is presumed that the mouthwash may be swallowed.

4.4. Special warnings and precautions for use

For oromucosal use only - should be kept out of the eyes and ears, or other tissues except the oral mucosa. If the mouthwash comes into contact with the eyes, it should be washed out promptly and thoroughly with plenty of water.

In the case of ulcerations and erosive-desquamative exfoliation of the oral mucosa, the medicinal product should not be used.

Continuous use of Colgate Pro Gum Health 0.2% Antiseptic Mouthwash as an oral rinsing solution without mechanically cleaning the teeth may enhance gingival bleeding.

Continuous use could modify the oral microbial flora, this being associated with the risk of bacterial and fungal spreading (candidiasis). If symptoms persist after 7 days and/or are associated with fever, therapeutic options should be reconsidered. Chlorhexidine digluconate may cause acute allergic reactions including anaphylaxis (see section 4.8).

Sugar-containing food or drinks should not be consumed within an hour of using Colgate Pro Gum Health 0.2% Antiseptic Mouthwash.

Macrogolglycerol hydroxystearate may cause skin reactions.

4.5. Interaction with other medicinal products and other forms of interaction

The efficacy of chlorhexidine is influenced by anionic substances (e.g. sodium dodecyl sulphate, synonym: sodium lauryl sulphate), which may be components of toothpastes. Therefore, these should not be used simultaneously with Colgate Pro Gum Health 0.2% Antiseptic Mouthwash but before the oral cavity is rinsed with chlorhexidine (see section 4.2). This restriction does not apply to toothpastes containing amphoteric tensides.

Colgate Pro Gum Health 0.2% Antiseptic Mouthwash can cause stains when spilt on clothing.

4.6. Fertility, pregnancy and lactation

Pregnancy

Colgate Pro Gum Health 0.2% Antiseptic Mouthwash should be used with caution in pregnancy, since there is not enough clinical experience with chlorhexidine in pregnant women.

Lactation

It is not documented whether or not chlorhexidine is excreted in human milk, therefore caution should be exercised when administering the medicinal product to nursing women.

4.7 Effects on ability to drive and use machines

No studies on the effects of the ability to drive and use machines have been performed. No effect is expected.

4.8 Undesirable effects

Very common (> 1/10)

Common (> 1/100, < 1/10)

Uncommon (> 1/1,000, < 1/100)

Rare (> 1/10,000, < 1/1,000)

Very rare (< 1/10,000), not known (cannot be estimated from the available data)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Eye disorders

Very rare:    Corneal lesion following accidental application to the eye.

Gastrointestinal disorders

Very common: Tongue discolouration and teeth staining. These discolourations of hard tooth substance and dental restorations can be removed by the dentist in most cases but a professional prophylaxis may be required in some cases.

Taste alteration, oral paraesthesia, tongue irritation and/or oral mucosal irritation (stomatitis). These effects are reversible after finishing the application of Colgate Pro Gum Health Antiseptic Mouthwash.

Common:    Dental calculus, oral mucosal exfoliation and stomatitis.

Uncommon:    Oral mucosal disorder.

Very rare:    Reversible parotid swelling.

Skin and subcutaneous tissue disorders

Rash.

Rare: Anaphylactic reactions with symptoms such as bronchospasm, dyspnea, periorbital oedema, hypotension, and shock, allergic reactions after local application of chlorhexidine, hypersensitivity reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Signs of intoxication are not known. Chlorhexidine swallowed accidentally is poorly absorbed by the digestive system.

5 PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antiinfectives and antiseptics for local oral treatment.

ATC-Code: A01AB03

Chlorhexidine is a base and therefore most stable in the form of a salt. The free base, the diacetate and the dihydrochloride are only poorly soluble in water whereas the digluconate (Synonym: bis (D-gluconate)) (> 50g/100 ml) is very soluble in water. Hence, the digluconate is used.

Chlorhexidine and its salts show a broad antimicrobial effect against grampositive and gram-negative bacteria.

The effect against some gram-negative bacteria (Pseudomonas- and Proteus-types) and against certain yeasts, dermatophytes and mycobacteria is poor. It is ineffective against bacteria spores and fungus spores, viruses and putrefactive fungi. In the presence of soaps, blood and pus (fractions of cells) the efficacy of chlorhexidine is reduced. Rinsing the mouth with 10 ml of a 0.2 % chlorhexidine-solution leads to a strong reduction of the quantity of bacteria in saliva. This correlates with a reduced rate of formation of dental plaque. When using the oromucosal solution over several months the efficacy decreases by the reversible shift in the bacteria spectrum of oral flora and tooth plaque.

The antibacterial properties of chlorhexidine are on the one hand directed against acid producing, cariogenic microorganisms of the dental plaque and on the other hand also against anaerobic and facultatively anaerobic microorganisms which lead to inflammations of the gingiva. Thus, chlorhexidine prevents inflammation of the gingiva caused by bacteria.

After repeated application of chlorhexidine on healthy skin no absorption of the substance could be seen in adults. In contrast, small amounts of the substance (up to 1.0 pg/ml) were found in the blood of preterm and newborn infants (28th to 39th week of pregnancy) after bathing them in 4 % chlorhexidine digluconate-detergent solution (no clinical symptoms).

Due to its cationic character chlorhexidine fixes strongly to the skin, mucosae and other tissues and is thus poorly absorbed.

After rinsing the mouth, chlorhexidine adsorbs to the dental enamel, dentine, cement, dental pellicles, mucosae and dental restorations. Due to slow desorption, chlorhexidine is detectable in the saliva up to eight hours (depot effect). The absorption of chlorhexidine via intact oral mucosa is not known.

In different test species, chlorhexidine is excreted via the faeces (90 %) and only approximately 1 % via the urine. In humans, the elimination half-life was 4 days.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.

When applied topically in higher concentrations (2.0 %) to the oral mucosa of hamsters, chlorhexidine caused leukoplasia and hyperplasia. A 0.2 % solution did not induce such changes. Chlorhexidine may delay wound healing, in particular when bone is involved. The topical application of chlorhexidine (< 0.01 %) caused corneal damage in rabbits and cats. Higher concentrations were tolerated by rabbits in another study. Chlorhexidine was ototoxic in guinea pigs and cats when applied directly into the tympanic cavity in concentrations as low as 0.05 %. A sensitisation to chlorhexidine was achieved in some Guinea pig models but not in others. In mice, an immune response was only induced when chlorhexidine was complexed with a protein carrier.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sorbitol, liquid (non-crystallising)

Glycerol

Macrogol glycerol hydroxystearate Citric acid monohydrate (for pH-adjustment) Peppermint oil Patent blue V (E 131)

Purified water

Chlorhexidine is incompatible with anionic substances that may be components of toothpastes. Chlorhexidine is inactivated by sucrose.

6.3 Shelf life

3 years

After first opening the medicinal product should not be used longer than 4 weeks.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

Bottle made of polyethylene terephthalate with a screw cap and a sealing ring made of polyethylene. The measuring device of 10 ml made of polypropylene is part of the screw cap.

The bottle contains 300 ml solution.

6.6 Special precautions for disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Colgate-Palmolive (U.K.) Limited Guildford Business Park Middleton Road, Guildford Surrey, GU2 8JZ United Kingdom

Tel: 00-800-321-321-32

MARKETING AUTHORISATION NUMBER(S)

PL 00049/0055

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10/10/2010

10    DATE OF REVISION OF THE TEXT

16/01/2015