Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: CHX Technologies Europe Limited, Guiness Enterprise Centre, Taylors Lane, Dublin 8, Ireland
Known hypersensitivity to chlorhexidine, Sumatra benzoin (benzoic acid) or ethanol, especially in those with a history of possible chlorhexidine-related allergic reactions (see section 4.4 and 4.8).
Prevora 100 mg/ml Dental Solution contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be rare. Prevora 100 mg/ml Dental Solution should not be administered to anyone with a potential history of an allergic reaction to chlorhexidine-containing compound (see sections 4.3 and 4.8)
For external (oral) topical use only – keep out of the eyes and ears. If the drug product comes into contact with the eyes, wash out promptly and thoroughly with water. Avoid application of Prevora 100 mg/ml Dental Solution to the soft tissues. Failure to do so can result in temporary stinging or mild inflammation of the soft tissues.
Prevora 100 mg/ml Dental Solution should be used with caution in patients with a history of asthma or eczema.
This medicine contains 420 mg of ethanol in each dose, equivalent to 700 mg/ml. It may cause burning sensation on damaged skin.
This medicine contains 49.2 mg benzoic acid in each dose, equivalent to 82 mg/ml. It may cause local irritation.
Prevora 100 mg/ml Dental Solution should not be applied immediately following use of an oil-based prophylactic paste or up to 3 days following application of a fluoride dental varnish.
Chlorhexidine is incompatible with anionic agents.
No controlled studies have been carried out to ascertain if there are any adverse reactions when Prevora 100 mg/ml Dental Solution is applied to the dentition of women of childbearing potential, or to the dentition of expectant or breast feeding mothers. Therefore, it is recommended that Prevora 100 mg/ml Dental Solution should not be administered during pregnancy. Since many drugs are excreted during lactation and there have not been any studies performed using Prevora 100 mg/ml Dental Solution in nursing mothers, it is recommended that Prevora 100 mg/ml Dental Solution should not be applied if the mother is nursing.
No studies on the effects on the ability to drive and use machines have been performed.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
| Uncommon (≥1/1,000 to <1/100) | Not known (cannot be estimated from the available data) | |
|---|---|---|
| Skin and subcutaneous tissues disorders | Redness and/or temporary stinging sensation of the oral mucosa Objectionable, bitter taste when Prevora 100 mg/ml Dental Solution comes into contact with the saliva or oral mucosa | Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation and blisters. Immediate hypersensitivity reactions to chlorhexidine (urticaria or anaphylaxis) |
| General disorders and administration site conditions | Immune Disorders: Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4) Transient tooth sensitivity and loss of taste Discoloration of the teeth and silicate or composite restorations |
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 HPRA Pharmacovigilance, Website: www.hpra.ie.
In the absence of compatibility studies, this topical medicinal product must not be mixed with other topical medicinal products.
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