Septafar Spray 1 Bottle 30ml 250 Sprays

NAME
SEPTAFAR 1,5 MG / ML + 5,0 MG / ML SPRAY FOR ORAL MUCOSA, SOLUTION

PHARMACOTHERAPEUTIC CATEGORY
Preparations for the pharyngeal cavity, antiseptics.

ACTIVE PRINCIPLES
Each ml of oral mucosal spray solution contains 1.5 mg of benzydamine hydrochloride and 5 mg of cetylpyridinium chloride. One dispensing contains 0.1 ml of oral mucosal spray, solution, containing 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride.

EXCIPIENTS
Ethanol (96 percent), glycerol (E422), macrogolglycerol hydroxystearate, sodium saccharinate (E954), peppermint oil, purified water.

INDICATIONS
Adults and children over 6 years of age for the anti-inflammatory, analgesic and antiseptic treatment in irritation of the throat, mouth and gums, in gingivitis, pharyngitis and laryngitis and before and after dental extractions.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active ingredients or to any of the excipients. Children younger than 6 years as the pharmaceutical form is not suitable for this age group.

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. It can be used for up to 7 days. Elderly patients: the recommended dose is the same as for adults. Children over 12 years' diet: 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 drug 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. Contraindicated in children under 6 years. Method of administration: before first use, to obtain a regular delivery, press the spray several times. If the spray has not been used for a long time (at least a week) press the dispenser once to obtain a regular delivery. 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 while dispensing. After each use, put the plastic cap back on the dispenser. When the dispenser is pressed once, 0.1 ml of oral mucosal spray is released, which contains 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride.

STORAGE
Do not store above 25 degrees C.

WARNINGS
It should not be used for more than 7 days. If no appreciable results are seen after 3 days, consult your doctor. The use, especially if prolonged, of topical preparations can give rise to sensitization phenomena, in which case it is necessary to suspend the treatment and institute suitable therapy. It must not be used together with anionic compounds, such as those present for example in toothpastes, therefore it is recommended not to use the product immediately before or after brushing your teeth. Avoid direct contact with eyes. The product must not be inhaled. This medicinal product contains small amounts of diethanol (alcohol) less than 100 mg per dose.

INTERACTIONS
The medicine should not be used simultaneously with other antiseptics.

SIDE 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. Disorders of the immune system. Rare: hypersensitivity reaction. Nervous system disorders. Not known: mucosal burning, oral mucosal anesthesia. 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 '. Report any suspected adverse reactions via the national reporting system.

PREGNANCY AND BREASTFEEDING
There are no or limited amounts of data on the use of benzydamine hydrochloride and cetylpyridinium chloride in pregnant women. It is not recommended during pregnancy. It is unknown whether benzydamine hydrochloride / and metabolites are excreted in human milk. A risk to the newborns / infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from drug therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.