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Summary

Hexetidine ((BACTIDOL®) works in as fast as 30 seconds and protects for 12 hours against sore throat causing germs. This prevents sore throat worsening into a cough, cold or flu.*

* Reference:

1Wile DB. Hexetidine: A report on its antibacterial and antifungal properties on the oral flora in healthy subjects. Cur. Med. Res. Opin. (1986), p. 12

2Ministry of Health of the Russian Federation Federal State Budget Institution. Study of in vitro antiviral activity of Hexetidine against a number of viruses causing acute respiratory infection. 2014 (Data on File)

3Deryabin PG et. Al. Bulletin of Experimental Biology and Medicine, Vol. 160, No. 3, January 2016 VIROLOGY

4The telegraph. Accessed from http://www.telegraph.co.uk/finance/jobs/8806388/Top-10-causes-of-absente.... Accessed on 6 May 2016

Side Effects

The adverse reactions observed during the use of the medicinal product post authorization have been classified as follows: very frequent (≥1/10), frequent (≥1/100, <1/10), infrequent (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000), unknown frequency (the frequency of emergence cannot be assessed on the basis of the data available).

Immune disorders.

Very rarely: hypersensitivity reactions (including urticaria), angioedema.

Nervous system disorders.

Very rarely: ageusia, dysgeusia.

Disorders of the respiratory system and the thoracic and mediastinal organs.

Very rarely: coughing, wheezing caused by a hypersensitivity reaction.

Disorders of the gastrointestinal tract.

Very rarely: dry mouth, dysphagia, nausea, enlarged salivary glands, vomiting.

General disorders and defects at the site of administration.

Very rarely: reactions at the site of application (including irritation of the mucous membranes in the mouth and throat, a burning sensation, burning tongue syndrome, tongue discolouration, discolouration of the teeth, inflammation, blistering and ulceration).

If you experience worsening of the side effects listed in the instructions, or you experience any other side effects, you should talk to your doctor.

Use during pregnancy and breastfeeding: There is no information concerning any side effects of Hexetidine (BACTIDOL®) during pregnancy and breastfeeding. However, before prescribing Hexetidine (BACTIDOL®) to pregnant or breastfeeding women, the doctor should carefully assess the benefits and risks of the treatment, taking into account the absence of sufficient data concerning the ingestion of the product through the placenta and in the breast milk.

Overdose: Hexetidine (BACTIDOL®) is unlikely to have a toxic effect when used in accordance with the instructions for use of this product. Ingestion of a large quantity of Hexetidine solution, which contains ethanol, can lead to signs/ symptoms of alcoholic intoxication. In the event of an overdose, consult a doctor as quickly as possible. Treatment is symptomatic, as for alcoholic intoxication. Purging the stomach with a pump is necessary within 2 hours after taking an overdose.

Interaction with other drugs: Unspecified.

Special precautions: Hexetidine (BACTIDOL®) can be used as a gargle for the mouth and throat only if the patient is able to spit out the solution after gargling. It is not intended for long-term treatment, as prolonged use may cause an imbalance of the natural bacteria in the mouth. The medicinal product Hexetidine (BACTIDOL®), a solution for local use, contains ethanol 96% (4.333 g/100 ml of solution).

Manufacturer: Johnson & Johnson

Packaging: Oromucosal soln 0.1% x 60 mL, 120 mL, 250 mL, 500 mL.

Storage conditions: Store at temperatures not exceeding 30°C

Regulatory classification: Non-Rx

ASC No. J124P010620B, J139P012320B, J140P012320B