Septanasal® for children 0.5 mg/ml+50 mg/ml nasal spray, 10 ml

Septanasal® for children 0.5 mg/ml+50 mg/ml nasal spray

The nasal spray is suitable for children to reduce the swelling of the nasal mucosa in the event of a runny nose or runny nose.The vessels in the nose are narrowed by the active ingredient xylometazoline and thus cause the nasal mucosa to become swollen.Dexpanthenol supports wound healing and protects children's sensitive nasal mucous membranes.

No prescription is required for this product.

Area of application

The preparation for children is used to reduce the swelling of the nasal mucosa in the event of inflammation of the nasal mucosa (cold) and to support the healing of mucous membrane lesions.It also relieves non-allergic inflammation of the nasal mucosa (vasomotor runny nose) and is used on medical advice to treat difficult breathing through the nose after surgical procedures on the nose.This medicine is intended for children aged 2 to 6 years.

Active ingredients / ingredients / ingredients

The medicine for children contains the active ingredients xylometazoline hydrochloride and dexpanthenol.Xylometazoline narrows the blood vessels and causes the nasal mucosa to decrease in swelling, thereby reducing the feeling of a stuffy nose.Dexpanthenol, a derivative of the vitamin pantothenic acid, promotes wound healing and protects the nasal mucous membranes.

Ingredients: 5 mg dexpanthenol, 0.05 mg xylometazoline hydrochloride, 0.044 mg xylometazoline, disodium hydrogen phosphate 12-water as an excipient, potassium dihydrogen phosphate as an excipient, water for injection purposes as an excipient, 1 mmol total sodium ion as an excipient.

Contraindications

This medicine for children must not be used if your child is allergic to xylometazoline hydrochloride, dexpanthenol or any of the other ingredients of this medicine.The preparation must also not be used if there is a dry inflammation of the nasal mucosa with crust formation (dry runny nose) or if the pituitary gland was removed during a surgical procedure or other surgical procedures were carried out that exposed the meninges.This medicine must not be used in children under 2 years of age.

Dosage

Always use this medicine exactly as described or after consulting your doctor or pharmacist.For children aged 2 to 6 years, the recommended dose is one spray into each nostril up to 3 times daily as needed.The dosage depends on individual sensitivity and clinical effect.Talk to your doctor if symptoms persist after 3 days.

Long-term use and overdose of this drug can lead to chronic swelling of the nasal mucosa and a decrease in the thickness of the nasal mucosa (damage).

If you have used a larger amount than you should for children, the following effects may occur: pupil constriction, pupil dilation, fever, sweating, paleness, blue lips, nausea, cramps, heart and circulatory disorders, lung function disorders and mental disorders.You may also experience drowsiness, low body temperature, reduced heart rate, drop in blood pressure, stopped breathing and loss of consciousness.If such symptoms occur, please contact your doctor immediately.

Do not use a double dose if you have forgotten the previous application.If you have any further questions about using this medicine, talk to your doctor or pharmacist.

Intake

Before the first use and after a longer treatment break, the pump should be activated 5 times until a fine spray mist is released.The tip of the spray head should be inserted as vertically as possible into the nostril and the spray head should be pumped once.During the spraying process, the patient should breathe calmly through the nose.If necessary, the procedure should be repeated for the other nostril.

Long-term use and overdose of this drug can lead to chronic swelling of the nasal mucosa and a decrease in the thickness of the nasal mucosa (damage).

Patient information

Please talk to your doctor or pharmacist before using the product if your child is being treated with monoamine oxidase inhibitors (MAOIs) or other medicines that may potentially increase blood pressure, suffers from increased intraocular pressure (glaucoma), suffers from a serious illness of the cardiovascular system, suffers from a tumor of the adrenal gland (pheochromocytoma), suffers from metabolic disorders, suffers from a metabolic disease called porphyria or if the prostate of yourschild is enlarged (prostate hyperplasia).

Due to the shrinkage of the nasal mucosa, it may only be used for chronic colds under medical supervision.Incorrect use or overdose can lead to undesirable effects throughout the entire organism, especially in children.

The use of this medicine is not recommended if your child is already taking a medicine to treat flu or a cough and cold medicine that contains sympathomimetics.Using these medicines together with the product may increase the risk of adverse effects on the cardiovascular system and central nervous system.Avoid direct contact of this medicine with the eyes.

The medicine is only suitable for use in children aged 2 to 6 years.For children over 6 years of age, other strengths of this medicine with higher concentrations of the active ingredient xylometazoline hydrochloride are available.You should monitor your child's use of this medicine.If your child does not feel better after 3 days or even feels worse, please contact a doctor.

When used as intended, no impairment of the ability to drive or operate machines is expected.

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.Due to a lack of safety data in pregnancy, this medicine should not be used by pregnant women.Since it is not known whether xylometazoline hydrochloride is excreted in breast milk, this medicine should not be used during breast-feeding.

Notes

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacy.

Mandatory information: Septanasal® for children 0.5 mg/ml+50 mg/ml nasal spray, solution.Active ingredients: xylometazoline hydrochloride/dexpanthenol.Areas of application: To reduce the swelling of the nasal mucosa in the case of inflammation of the nasal mucosa (cold) and to support the healing of mucous membrane lesions;to relieve non-allergic inflammation of the nasal mucosa (vasomotor runny nose);for the treatment of difficult breathing through the nose after surgical procedures on the nose.Septanasal® for children is intended for children aged 2 to 6 years.For information about risks and side effects, read the package leaflet and ask your doctor or pharmacy.As of: September 2016.

Application

Children from 2 to 6 years: As needed, one spray into each nostril up to 3 times a day.The duration of use is limited to 7 days.Reapplication should only be carried out after a break of several days.The use of the drug in children under 12 years of age should be supervised by an adult.

Ingredients

Active ingredients per 1 ml spray (= 10 sprays): 0.5 mg xylometazoline hydrochloride, 50 mg dexpanthenol.Other ingredients: potassium dihydrogen phosphate, disodium hydrogen phosphate-12 water, water for injections.

Address of the provider/manufacturer

TAD Pharma GmbH, Heinz-Lohmann-Str.5, 27472 Cuxhaven

Important information (mandatory information)

Septanasal for children 0.5 mg + 50 mg nasal spray.Areas of application: to reduce the swelling of the nasal mucosa in the case of inflammation of the nasal mucosa (cold) and to support the healing of mucous membrane lesions;for the relief of non-allergic inflammation of the nasal mucosa (vasomotor runny nose) and for the treatment of difficult breathing through the nose after surgical procedures on the nose.

For information about risks and side effects, read the package leaflet and ask your doctor or pharmacy.

This leaflet was last revised in September 2016.

Source: Information in the package insert, as of: 10/2018