PHARMACOTHERAPEUTIC CATEGORY:
Dental.

ACTIVE INGREDIENTS:
Benzydamine hydrochloride.

EXCIPIENTS:
Glycerol, ethanol (96%), saccharin, methyl parahydroxybenzoate, sodium bicarbonate, mint flavouring, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.

DIRECTIONS:
Symptomatic treatment of irritative-inflammatory conditions also associated with pain in the oropharyngeal cavity (e.g.
gingivitis, stomatitis, pharyngitis), also as a consequence of conservative or extractive dental therapy.

CONTRAINDICATIONS/SIDE EFFECTS:
Hypersensitivity to benzydamine or to any of the excipients listed.

DOSAGE:
Pour 15 ml into the measuring cup and use 2-3 times a day, pure or diluted (in this case add 15 ml of water to the measuring cup).
Do not exceed the recommended dose.

CONSERVATION:
This medicinal product does not require any special storage conditions.

WARNINGS:
Use of the product, especially if prolonged, may give rise to sensitization phenomena.
In this case, discontinue treatment and initiate appropriate therapy.
In a limited number of patients, oropharyngeal ulcers may be a sign of more serious pathologies.
The use of benzydamine is not recommended in patients with hypersensitivity to cetylsalicylic acid or other NSAIDs.
The drug should be administered with caution in subjects who have had episodes of bronchial asthma in the past, as bronchospasm phenomena may occur in this type of patient.
The medicine contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
For those who participate in sports activities: the use of medicines containing ethyl alcohol may result in a positive doping test in relation to the blood alcohol concentration limits indicated by some sports federations.

INTERACTIONS:
No interaction studies have been performed.

SIDE EFFECTS:
The list below contains adverse reactions classified by system organ class according to MedDRA.
Undesirable effects are listed using the following frequency scales: very common (>= 1/10); common (>= 1/100, < 1/10); uncommon (>= 1/1000, < 1/100); rare (>= 1/10,000, < 1/1000); very rare (<1/10,000); not known.
Immune system disorders.
Rare: hypersensitivity reaction; not known: anaphylactic reaction.
Respiratory, thoracic, mediastinal pathologies.
Very rare: laryngospasm.
Gastrointestinal disorders.
Uncommon: burning mouth, dry mouth.
Skin and subcutaneous tissue disorders.
Uncommon: photosensitivity; very rare: angioedema.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

PREGNANCY AND BREASTFEEDING:
There are no data on the use of benzydamine during pregnancy or breastfeeding.
The excretion of the product in breast milk has not been studied.
Animal studies on the effects during pregnancy and lactation are insufficient and therefore the potential risk for humans cannot be evaluated.
During pregnancy and breastfeeding the drug should not be used.