BENZYDAMINE HYDROCHLORIDE

30% w/v Oromucosal Spray is generally used 2 to 6 times daily (every 1 ½ -3 hours): Adults and adolescents over 12 years 2 - 4 sprays each Children between 6 and 12 years 2 sprays Children under 6 years with bw over 8 kg 1 spray per 8 kg body weight, maximum 2 sprays Elderly patients There are no specific recommendations for dosing in elderly patients.

Unless prescribed otherwise by the dentist or doctor, the dosage indicated for adults is valid. 30% w/v Oromucosal Spray is used for mouth andthroat. Instructions for Use: 1. On first use, press the pump button several times until you get a regular spray, 2.

Open your mouth thoroughly and guide the spray tube into your diseased areaby inserting into your mouth, 3. Quickly press the pump button to spray the medicine; repeat this process withthe numbers mentioned above, 4. Keep the bottle in box and store standing upright.

000), not known (frequency cannot be estimated on the basis of the available data). System organ class Uncommon Rare Very rare Unknown Gastrointestinal tract disorders Burning sensation in the mouth, dry mouth, Numbness in the mouth and throat (this effect is part of the drug's mode of action and disappears after a short time), Nausea, Vomiting Immune system disorders Hypersensitivity reactions Anaphylactic reactions Respiratory, thoracic and mediastinal disorders Laryngospasm Skin and subcutaneous tissue disorders Photosensitivity Angioedema 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

If any of the adverse effects mentioned above occur, the preparation should be temporarily discontinued. Use of the product, especially for a long time, can lead to sensitization. In this case, the preparation should be discontinued temporarily and a physician should be contacted.

In a limited number of patients, mouth and throat ulcers can be signs of more serious diseases. Patients who do not get better within 3 days must contact their doctor or dentist in this regard. In patients who are hypersensitive to salicylic acid or other NSAIDs, application of benzydamine is not recommended.

The indications do not justify long-term treatment, as this could affect the normal bacterial flora of the oral cavity. 30% w/v Oromucosal Spray should be used with caution in patients with a history of bronchial asthma, since bronchospasm may occur.

This medicine contains methyl p-hydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed). This medicinal product contains benzyl alcohol. Benzyl alcohol may cause mild local irritation. Benzydamine spray contains ethanol (alcohol).

e. 72 ml (4 sprays). The amount of alcohol in this medicine is not likely to have an effect in adults and adolescents, and its effects in children are not likely to be noticeable. It may have some effects in younger children, for example feeling sleepy.

The alcohol in this medicine may alter the effects of other medicines. Talk to your doctor or pharmacist if you are taking other medicines. If you are pregnant or breast-feeding, talk to your doctor or pharmacist before taking this medicine.

If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.

1. 30 % w/v Oromucosal Spray should not be used in infants and children up to 2 years due to the content of menthol (peppermint aroma).