Septanazal for children

Package leaflet: Information for the user

Septanazal dla dzieci, (0.5 mg + 50 mg)/1 ml, nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if your condition worsens, consult your doctor.

Table of contents

1. What Septanazal dla dzieci is and what it is used for
2. Important information before using Septanazal dla dzieci
3. How to use Septanazal dla dzieci
4. Possible side effects
5. How to store Septanazal dla dzieci
6. Contents of the pack and other information

1. What Septanazal dla dzieci is and what it is used for

Septanazal dla dzieci nasal spray contains the active substances: xylometazoline hydrochloride and dexpanthenol.
Xylometazoline hydrochloride acts as a vasoconstrictor of blood vessels in the nasal mucosa, reducing swelling of the nasal mucosa and secretion volume. This helps relieve nasal congestion. Dexpanthenol is a derivative of vitamin pantothenic acid, which has properties supporting wound healing and protecting the nasal mucosal epithelium.

Septanazal dla dzieci is indicated:

• to reduce swelling of the nasal mucosa in rhinitis, and as supportive treatment in injuries of the nasal mucosa,
• in the treatment of non-allergic rhinitis (vasomotor rhinitis),
• in the treatment of nasal passage obstruction following nasal surgery.

Septanazal dla dzieci is indicated for children aged 2 to 6 years.

2. Important information before using Septanazal dla dzieci

When not to use Septanazal dla dzieci:

• if the patient is allergic to xylometazoline hydrochloride, dexpanthenol, or any of the other ingredients of this medicine (listed in section 6);
• if the patient has dry rhinitis with crust formation ( rhinitis sicca );
• if the patient has undergone surgical removal of the pituitary gland or other operations involving exposure of the meninges (the lining of the brain).

This medicine is contraindicated in children under 2 years of age.
Warnings and precautions
Before starting to use Septanazal dla dzieci, consult your doctor or
pharmacist:

• if the patient is taking monoamine oxidase inhibitors (MAO inhibitors) or other medicines that may increase blood pressure;
• if the patient has increased intraocular pressure (glaucoma), particularly narrow-angle glaucoma;
• if the patient has severe cardiovascular disease (e.g. ischemic heart disease, hypertension, long QT syndrome);
• if the patient has a pheochromocytoma;
• if the patient has a metabolic disorder (e.g. hyperthyroidism presenting with increased sweating, elevated body temperature, and rapid heartbeat, or diabetes);
• if the patient has a metabolic disorder called porphyria;
• if the patient has prostate enlargement.

Due to the risk of atrophy of the nasal mucosa, this medicine should be used in chronic rhinitis only under medical supervision.
Improper use or excessive administration of the spray may cause systemic adverse effects, particularly in children (see section 4).
Prolonged use or use in doses higher than recommended may lead to chronic swelling and, occasionally, thinning (damage) of the nasal mucosa.
Do not use Septanazal dla dzieci while taking:

• other medicines used to treat flu;
• other cough and cold medicines containing sympathomimetics (medicines used to treat nasal mucosal congestion, such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane). Concurrent use of these medicines with Septanazal dla dzieci may increase the risk of adverse effects on the cardiovascular system and central nervous system.

Avoid direct contact of the medicine with the eyes.
Children
Do not exceed the dose recommended by the doctor. Consult a doctor regarding the duration of treatment and frequency of use in children.
Septanazal dla dzieci is intended for use in children aged 2 to 6 years. For children over 6 years of age, Septanazal for adults, a nasal spray with a higher dose of active substance, is available.
If symptoms worsen or do not improve after 3 days of treatment, consult a doctor.
Septanazal dla dzieci and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Avoid concomitant use of Septanazal dla dzieci with medicines used to lower blood pressure (e.g. methyldopa) due to the potential effect of xylometazoline on blood pressure.
Concomitant use of Septanazal dla dzieci with certain antidepressants (monoamine oxidase inhibitors or tricyclic antidepressants), as well as with medicines that increase blood pressure, may cause elevated blood pressure.
Concomitant use with medicines used to treat flu and with cough and cold medicines containing sympathomimetics (medicines used to treat nasal mucosal congestion, e.g. pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may lead to increased adverse effects on the cardiovascular system and central nervous system.
Consult a doctor before using Septanazal dla dzieci if the patient is taking any of the above-mentioned medicines.
Septanazal dla dzieci with food and drink
This medicine may be used regardless of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. This medicine should not be used during pregnancy due to lack of safety data in pregnant women.
This medicine should not be used during breastfeeding, as it is unknown whether xylometazoline hydrochloride passes into human milk.
Driving and operating machinery
This medicine is not expected to affect the ability to drive or operate machinery when used as directed.
Septanazal dla dzieci contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Septanazal dla dzieci

This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose of Septanazal dla dzieci for children aged 2 to 6 years is one spray into each
nostril up to three times daily, as needed. Dosage depends on individual patient sensitivity and
clinical response.
Duration of treatment
Do not use this medicine for longer than 7 days. The duration of use in children should always be
discussed with a doctor.
Re-treatment may only be considered after a break of several days.
Method of administration
Remove the protective cap from the spray nozzle.
Before first use or if the spray has not been used for a prolonged period, prime the pump by
pressing it several times until a uniform mist is produced.

Position the spray nozzle vertically into the nostril, if possible, and press the pump once. During
administration, gently inhale through the nose. If necessary, repeat the procedure in the other
nostril.
After each use, wipe the spray tip with a tissue and replace the protective cap.

Patients with increased intraocular pressure (glaucoma), particularly those with narrow-angle
glaucoma, should consult a doctor before using this medicine.
Use of a higher than recommended dose of Septanazal dla dzieci
If a larger than recommended dose is used or if large amounts of the medicine are accidentally
swallowed, the following adverse effects may occur: constriction of the pupils, dilation of the
pupils, fever, sweating, pallor, bluish discoloration of the lips (cyanosis), nausea, seizures,
cardiovascular disturbances (increased heart rate, decreased heart rate, cardiac arrhythmias,
circulatory failure, cardiac arrest, high blood pressure [arterial hypertension]), respiratory
disturbances (pulmonary edema, breathing difficulties), and psychiatric disturbances.
Drowsiness, decreased body temperature, bradycardia, hypotension, respiratory arrest, and coma
may also occur.
If any of these symptoms occur, contact a doctor immediately.
Missed dose of Septanazal dla dzieci
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Uncommon (may affect fewer than 1 in 100 people):

• hypersensitivity reactions such as skin rash, itching, swelling of the skin and mucous membranes.

Rare (may affect fewer than 1 in 1,000 people):

• palpitations (awareness of heartbeat), tachycardia (increased heart rate), arterial hypertension (high blood pressure).

Very rare (may affect fewer than 1 in 10,000 people):

• anxiety, insomnia, hallucinations (mainly in children),
• fatigue (drowsiness, sedation), headache,
• cardiac arrhythmias,
• nasal mucosal swelling (after discontinuation of treatment), nosebleeds,
• seizures (convulsions, particularly in children).

Frequency not known (frequency cannot be estimated from the available data):

• burning sensation and dryness of the nasal mucosa, sneezing.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the Marketing Authorisation Holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Septanazal dla dzieci

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
The shelf life of the medicine after first opening the container is 12 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the package and other information

What Septanazal dla dzieci contains

• The active substances are xylometazoline hydrochloride and dexpanthenol. Each ml of nasal aerosol solution contains 0.5 mg xylometazoline hydrochloride and 50 mg dexpanthenol. One dose of nasal aerosol (0.1 ml of solution) contains 0.05 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol.
• Other ingredients are: potassium dihydrogen phosphate, disodium phosphate dodecahydrate, purified water. See section 2 "Septanazal dla dzieci contains sodium".

What Septanazal dla dzieci looks like and contents of the pack
The nasal aerosol solution (nasal spray) is a clear, colourless solution.
Septanazal dla dzieci is supplied in an HDPE container with a spray pump and nozzle, in a cardboard box. 10 ml of solution provides 90 doses.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
This medicinal product is authorised in the Member States of the European Economic Area under the following names:

For more detailed information, please contact the local representative of the responsible entity:
Krka - Polska Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
telephone: +48 22 573 75 00