Septafar - analgesic anti-inflammatory and antiseptic spray 30 ml

Product Description

Pain-relieving and antiseptic spray for the oral cavity

Indications

Septafar 1.5 mg/ml + 5.0 mg/ml spray for the oral mucosa is a medicine indicated in adults and children over 6 years of age for the anti-inflammatory, analgesic and antiseptic treatment of irritations of the throat, mouth and gums, gingivitis, pharyngitis and laryngitis and before and after tooth extractions.

Composition

Active ingredients: Each ml of spray for the oral mucosa, solution contains 1.5 mg of benzydamine hydrochloride and 5 mg of cetylpyridinium chloride.
One spray contains 0.1 ml of spray for the oral mucosa, solution, containing 0.15 mg of benzydamine hydrochloride and 0.5 mg cetylpyridinium chloride.
Excipients: Ethanol (96 percent), glycerol (E422), macrogolglycerol hydroxystearate, sodium saccharinate (E954), peppermint oil, purified water.

Directions for use and Dosage

Adults: For a single dose, press the dispenser once or twice.
This operation can be repeated every 2 hours, 3-5 times a day.
For optimal effect, it is recommended not to use the product immediately before or after brushing your teeth.
Do not exceed the recommended dose.
The medicine can be used for up to 7 days.
Elderly patients. The recommended dose is the same as for adults. Paediatric population.
Children over 12 years of age: For a single dose, press the dispenser once or twice.
This operation can be repeated every 2 hours, 3-5 times a day.
Children from 6 to 12 years of age: The medicine should be used in this age group only under medical advice.
For a single dose, press the dispenser once.
This operation can be repeated every 2 hours, 3-5 times a day.
Children from 6 to 12 years of age: The medicine should be used in this age group only under medical advice.
For a single dose, press the dispenser once.
This operation can be repeated every 2 hours, 3-5 times a day. Repeat every 2 hours, 3-5 times a day.
The medicine is contraindicated in children under 6 years of age.

Method of administration.
Before the first use of Septafar oromucosal spray, press the spray several times to obtain a regular spray.
If the spray has not been used for a long time (at least a week), press the dispenser once to obtain a regular spray.
Remove the plastic cap before use.
Open your mouth wide, point the spray nozzle towards your throat and press the dispenser 1-2 times.
Hold your breath during spraying.
After each use, replace the plastic cap on the dispenser.
When the dispenser is pressed once, 0.1 ml of oromucosal spray is released, a solution containing 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride.

Warnings

The medicine should not be used for more than 7 days.
If no appreciable results are seen after 3 days, consult your doctor.
Use of topical preparations, especially if prolonged, may give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and institute appropriate therapy.
Septafar should not be used together with anionic compounds, such as those found for example in toothpastes, therefore it is recommended not to use the product immediately before or after brushing your teeth.
Avoid direct contact of Septafar oral mucosa spray, solution with the eyes.
The product should not be inhaled.
This medicine contains small amounts of ethanol (alcohol) less than 100 mg per dose.
For further information, read carefully the package leaflet.

Contraindications

Hypersensitivity to the active substances or to any of the excipients.
Children under 6 years of age since The pharmaceutical form is not suitable for this age group.

Undesirable effects

Very common (>=1/10);
Common (>=1/100, <1/10);
Uncommon (>=1/1,000, <1/100);
Rare (>=1/10,000, <1/1,000);
Very rare (<1/10,000);
Not known (frequency cannot be estimated from the available data).
Immune system disorders. Not known: anaphylactic reactions, hypersensitivity reactions.
Nervous system disorders. Not known: burning of the mucosa, oral mucosal anaesthesia.
Respiratory, thoracic, and mediastinal disorders. Rare: bronchospasm.
Gastrointestinal disorders. Very rare: irritation of the oral mucosa, burning sensation in the mouth.
Skin and subcutaneous tissue disorders. Rare: urticaria, photosensitivity.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Pregnancy and Breastfeeding

Pregnancy. There are no or limited amounts of data from the use of benzydamine hydrochloride and cetylpyridinium chloride in pregnant women.
The medicinal product is not recommended during pregnancy.
Breastfeeding. It is not known whether benzydamine hydrochloride and its metabolites are excreted in human milk.
It cannot be used during pregnancy. a risk to newborns/infants can be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from therapy with the drug taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Storage

Do not store above 25 degrees C.

Format

30 ml