Septanazal dla dzieci

Package Leaflet: Information for the User

Septanazal for Children, (0.5 mg + 50 mg)/1 ml, Nasal Spray, Solution
Xylometazoline Hydrochloride + Dexpanthenol

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

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

1. What is Septanazal for Children and what is it used for

Septanazal for Children nasal spray contains the active substances: xylometazoline hydrochloride and dexpanthenol.
Xylometazoline hydrochloride has a vasoconstrictive effect on the nasal mucosa, reducing swelling of the nasal mucosa and the amount of discharge. This helps to relieve the feeling of a blocked nose. Dexpanthenol is a derivative of vitamin B5 (pantothenic acid), which has wound-healing and protective properties for the nasal mucosa.
Septanazal for Children is indicated:

• to reduce swelling of the nasal mucosa in rhinitis and as an adjunct in the treatment of nasal mucosa injuries,
• for the treatment of non-allergic rhinitis (vasomotor rhinitis),
• for the treatment of nasal congestion after nasal surgery.

Septanazal for Children is indicated for children aged 2 to 6 years.

2. Important information before using Septanazal for Children

When not to use Septanazal for Children:

This medicine is contraindicated in children under 2 years of age.

Warnings and precautions

Before using Septanazal for Children, you should discuss with your doctor or pharmacist:

Due to the risk of atrophy of the nasal mucosa, this medicine should only be used in the case of chronic rhinitis under medical supervision.
In the event of improper use or administration of an excessive amount of spray, the medicine may cause systemic side effects, especially in children (see section 4.).
Prolonged use of the medicine or use of the medicine in doses higher than recommended may lead to chronic swelling and sometimes thinning (damage) of the nasal mucosa.
You should not use Septanazal for Children while using:

• other medicines for the treatment of influenza,
• other cough and cold medicines containing sympathomimetics (medicines used to treat nasal congestion, such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane). Concomitant use of these medicines with Septanazal for Children may increase the risk of side effects from the cardiovascular and central nervous systems.

You should avoid direct contact of the medicine with the eyes.

Children

Do not exceed the recommended dose. You should consult a doctor regarding the duration of treatment and frequency of administration in children.
Septanazal for Children is intended for use in children aged 2 to 6 years. For children over 6 years, Septanazal for Adults, a nasal spray containing a higher dose of active substances, is available.
If the child's symptoms worsen or do not improve after 3 days of treatment, you should consult a doctor.

Septanazal for Children and other medicines

You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should avoid concomitant use of Septanazal for Children with medicines used to lower blood pressure (e.g., methyldopa) due to the potential effect of xylometazoline on blood pressure.
Concomitant use of Septanazal for Children with certain antidepressants (monoamine oxidase inhibitors or tricyclic antidepressants) and medicines that increase blood pressure may cause an increase in blood pressure.
Concomitant use of Septanazal for Children with influenza medicines and cough and cold medicines containing sympathomimetics (medicines used to treat nasal congestion, such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, xylometazoline, tramazoline, naphazoline, tuaminoheptane) may lead to increased side effects from the cardiovascular and central nervous systems.
You should consult a doctor before using Septanazal for Children if you are taking any of the above-mentioned medicines.

Septanazal for Children with food and drink

The medicine can be used independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. This medicine should not be used during pregnancy due to the lack of data on safety in pregnant women.
This medicine should not be used during breastfeeding, as it is not known whether xylometazoline hydrochloride passes into breast milk.

Driving and using machines

It is not expected that this medicine will affect your ability to drive or use machines if used as directed.

Septanazal for Children contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to use Septanazal for Children

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose of Septanazal for Children for children aged 2 to 6 years is one dose of spray into each nostril up to three times a day, as needed. The dosage depends on the individual sensitivity of the patient and clinical response.

Duration of treatment

The medicine should not be used for more than 7 days. The duration of use in children should always be discussed with a doctor.
Repeated use is possible only after a few days' break.

Method of administration

Remove the protective cap from the spray nozzle.
Before first use or if the spray has not been used for a longer period, press the pump several times until a uniform mist appears.

Place the tip of the dispenser in the nostril in an upright position, 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 tip of the dispenser with a tissue and replace the protective cap.

Patients with increased intraocular pressure (glaucoma), especially with narrow-angle glaucoma, should consult a doctor before using this medicine.

Using a higher dose of Septanazal for Children than recommended

In the event of using a higher dose of the medicine than recommended or accidental ingestion of large amounts of the medicine, the following side effects may occur: constriction of the pupils, dilation of the pupils, fever, sweating, paleness of the skin, blue discoloration of the lips (cyanosis), nausea, seizures, cardiovascular disorders (increased heart rate, decreased heart rate, arrhythmias, heart failure, cardiac arrest, high blood pressure [hypertension]), respiratory disorders (pulmonary edema, respiratory disorders), and psychiatric disorders.
It may also cause drowsiness, decreased body temperature, slowed heart rate, and decreased blood pressure, respiratory arrest, and coma.
If any of these symptoms occur, you should contact a doctor immediately.

Missing a dose of Septanazal for Children

Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon: may affect up to 1 in 100 people:

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

Rare: may affect up to 1 in 1,000 people:

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

Very rare: may affect up to 1 in 10,000 people:

• restlessness, insomnia, hallucinations (mainly in children),
• fatigue (drowsiness, sedation), headache,
• arrhythmias (heart rhythm disorders),
• swelling of the nasal mucosa (after stopping treatment), nasal bleeding,
• seizures (convulsions, especially in children).

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

• burning and dryness of the nasal mucosa, sneezing.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Septanazal for Children

Keep the medicine out of the 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 month stated.
There are no special precautions for storage.
The shelf life of the medicine after opening the packaging is 12 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Septanazal for Children contains

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

What Septanazal for Children looks like and contents of the pack

The nasal spray solution is a clear, colorless solution.
Septanazal for Children is supplied in an HDPE container with a spray pump and protective cap, in a cardboard box. 10 ml of solution is sufficient for 90 doses.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

In order to obtain more detailed information, you should contact your local representative of the marketing authorization holder:
Krka - Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, phone: +48 22 573 75 00
Date of last revision of the package leaflet:28.03.2023