For the treatment of inflammatory conditions of the mouth and pharynx.

1 lozenge contains: active principle: Benzoxonium chloride 1mg, Lidocaine hydrochloride 1mg; excipients: Xylitol 1g, Saccharinum, Aromatica.

1 lozenge contains: 1g of Xylitol as a sweetener, corresponding to about 17kJ (4.1 kcal).

The lozenges are orange flavoured.

Note to diabetics: 10 lozenges correspond to one serving of fruit.


What is Orofar used for?
When must Orofar not be used?
What precautions are required when using Orofar?
Can Orofar be used during pregnancy or when breast feeding?
What undesirable side effects can Orofar have?
Dosage
Drug Interaction
Remarks

What is Orofar used for?
Orofar is indicated for infections of the oropharyngeal cavity (local disinfectant and analgesic activity): pharyngitis, laryngitis, sore throat in case of cold, stomatitis, ulceration, gingivitis. Adjuvant in case of tonsillitis.

Orofar has two active substances, benzoxonium chloride and lidocaine hydrochloride.

Benzoxonium chloride has a bacterial activity in vitro against gram-positive and, to a lesser degree, gram-negative organisms. It also has fungicidal and antiviral activity against membrane viruses such as influenza, parainfluenza and herpes hominis viruses. The cationic structure of benzoxonium chloride confers high surface activity and hence good penetration.

Lidocaine is a local anaesthetic which relieves sore throat and pain in swallowing caused by inflammation.

Several clinical trials have shown that Orofar is effective in the treatment of sore throat, and also gingivitis through its ability to inhibit the formation of dental plaque.

Orofar does not promote caries and plays no role in the metabolism of diabetics as it contain xylitol.
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When must Orofar not be used?
When the patient is hypersensitive to the active substances.
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What precautions are required when using Orofar?
Orofar is not recommended for children below the age of 4.
Medicines should be kept out of reach of children.
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Can Orofar be used during pregnancy or when breast feeding?
No adverse fetal effects have been observed in animal reproduction studies, but there have been no controlled studies in pregnant women. Orofar should therefore not be used during pregnancy, particularly during the first trimester of pregnancy.

As a general rule, for safety reasons, in the absence of data on elimination of the active substance in breast milk, Orofar should not be used when breast feeding.
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What undesirable side effects can Orofar have?
Transient mild local irritation may sometimes occur. Allergic skin reactions are rare.
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Dosage:

Simple infections: 1 lozenge every 2 to 3 hours. Acute infections: 1 lozenge every 1 to 2 hours. Let the lozenge to dissolve slowly in the mouth. Do not exceed a dose of 10 lozenges per day.

Children:
Orofar can be administered to children aged 4 years and over, but at slightly lower doses: do not exceed 6 lozenges per day.
Overdosage:
Accidental ingestion of a large amount of Orofar, as of any quaternary ammonium compound, may cause nausea or vomiting. Milk or egg white beaten in water should be administered immediately. Alcohol enhances enhances absorption and should be avoided.

The concentrations of lidocaine in the various formulations of Orofar are too low to cause symptoms if overdosage occurs. TOP

Drug Interaction:
As with all quaternary ammonium compounds, the efficacy of benzoxonium chloride present in Orofar can be diminished by simultaneous use of anionic tensioactive agents, e.g. toothpastes.

Pharmacokinetics:
Benzoxonium chloride is almost completely unabsorbed. In man, approximately 1% of the administered dose is found in the urine, and blood concentrations are virtually undetectable. These findings are similar to those in animals, in which approximately 95% of an oral dose is eliminated in the feaces. No tissue accumulation has been observed.

Lidocaine is rapidly metabolized in the liver, and the metabolites are eliminated in the urine, with less than 10% being excreted unchanged.
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Remarks:
protect from moisture and heat.

Store below 30°C .

Packaging:
10 lozenges per pack
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