Nasic kids

Package leaflet: Information for the patient

nasic kids, (0.05 mg + 5.0 mg)/dose, nasal spray, solution
Xylometazolini hydrochloridum + Dexpanthenolum
Please read all of this leaflet carefully before using this medicine, because 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, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if symptoms worsen, consult a doctor.

Contents of the leaflet

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

1. What nasic kids is and what it is used for

nasic kids is a nasal spray. It contains two active substances: xylometazoline hydrochloride and dexpanthenol. Xylometazoline constricts blood vessels, thereby reducing swelling and congestion of the nasal mucosa. This reduction in nasal mucosal congestion helps patients breathe more easily through the nose when experiencing nasal obstruction due to colds or after nasal surgery.
Dexpanthenol is a derivative of pantothenic acid, a vitamin that accelerates wound healing and participates in the regeneration process of mucous membranes.
nasic kids is used for symptomatic treatment of nasal congestion associated with colds and after nasal surgery – to stimulate healing of the mucous membrane and improve nasal patency.
nasic kids is intended for use in children aged 2 to 6 years.
If there is no improvement after 7 days of treatment, or if symptoms worsen, consult a doctor.

2. Important information before using Nasic Kids

When not to use Nasic Kids:

• if the patient is allergic (hypersensitive) to xylometazoline hydrochloride, dexpanthenol, or to any of the other ingredients of Nasic Kids (listed in section 6),
• in children under 2 years of age,
• if the patient suffers from dry nasal mucosa with crust formation, i.e. atrophic rhinitis (rhinitis sicca),
• after transsphenoidal removal of the pituitary gland or after other surgical procedures exposing the meninges (dura mater).

Nasic Kids contains benzalkonium chloride as a preservative and therefore should not be used by individuals with known hypersensitivity to this substance.
Warnings and precautions
Consult a doctor before using Nasic Kids in the following cases:

• when taking monoamine oxidase inhibitors (MAO inhibitors) or other medicines that may increase blood pressure,
• increased intraocular pressure, especially in patients with narrow-angle glaucoma,
• severe cardiovascular diseases (e.g. ischemic heart disease, hypertension),
• heart conditions (e.g. long QT syndrome),
• pheochromocytoma (adrenal medulla tumor),
• metabolic disorders (e.g. hyperthyroidism, diabetes),
• allergy to sympathomimetic substances; use of the medicine in such individuals may cause insomnia, dizziness, tremor, cardiac arrhythmias, and elevated blood pressure,
• a metabolic disorder known as porphyria,
• benign prostatic hyperplasia (enlargement of the prostate gland).

Due to the risk of atrophy of the nasal mucosa, prolonged use of Nasic Kids in chronic rhinitis should be under medical supervision.
Children
Prolonged use or use in doses higher than recommended should be avoided, especially in children. Higher doses should only be administered after consultation with a doctor.
Nasic Kids contains an active ingredient concentration intended for children aged 2 to 6 years. Therefore, it is not suitable for infants and children under 2 years of age.
Nasic Kids and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines planned for use.
Concomitant use of Nasic Kids with antidepressants (monoamine oxidase inhibitors [MAO-I such as tranylcypromine] or tricyclic antidepressants), as well as with drugs that increase blood pressure, may lead to elevated blood pressure due to effects on the cardiovascular system.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using any medicine.
There is insufficient data on the effects of the medicine on fetal development; therefore, Nasic Kids should not be used during pregnancy.
It is unknown whether xylometazoline hydrochloride passes into breast milk; therefore, Nasic Kids should not be used by breastfeeding women.
Driving and operating machinery
When used according to instructions, Nasic Kids is not expected to have a negative effect on the ability to drive or operate machinery.
Nasic Kids contains benzalkonium chloride.
The medicine contains 0.02 mg of benzalkonium chloride per aerosol dose (0.1 ml of solution).
Benzalkonium chloride may cause nasal irritation or swelling, especially when used for prolonged periods.
Inform your doctor or pharmacist if you experience discomfort during treatment with Nasic Kids.

3. How to use Nasic Kids

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose:
If not otherwise advised by a doctor, children aged 2 to 6 years:
one spray into each nostril once or twice daily (every 8–10 hours).
Do not administer more than three sprays into each nostril per day.
Dosage depends on individual sensitivity and the patient's response to the medicine.
Do not exceed the recommended doses.

Duration of treatment:
Do not use Nasic Kids for longer than 7 days unless a doctor has explicitly advised continuing treatment.
Re-administration should only occur after a break of several days.
Always consult a doctor regarding the duration of treatment.
Prolonged use of Nasic Kids may lead to chronic nasal mucosal swelling and may eventually cause atrophy of the nasal mucosa.

Patients with elevated intraocular pressure (glaucoma, particularly narrow-angle glaucoma) should consult a doctor before using Nasic Kids.
Nasic Kids should not be used in children under 2 years of age.
If the effect of Nasic Kids is too strong or too weak, consult a doctor or pharmacist.

Method of administration:
Nasic Kids is intended for nasal use.

Glass bottle with integrated spray pump

Remove the protective cap from the pump. Before first use, press the pump several times until a uniform spray is produced. For subsequent uses, the medicine is immediately ready for use.

Insert the pump nozzle as vertically as possible into the nostrils and press the pump once. For hygienic reasons, wipe the pump nozzle after use and replace the protective cap.

or

Glass bottle with screw-on spray pump

Remove the elongated protective cap from the spray pump. Unscrew the cap from the glass bottle and screw on the spray pump nozzle. Then remove the protective cap from the dispenser tip.
Before first use, press the pump several times until a consistent mist is achieved.

Insert the dispenser tip vertically into the nostril and press the pump to release one dose of the medicine, while simultaneously inhaling gently through the nose. Repeat the same procedure for the other nostril. After use, clean the dispenser tip and replace the protective cap.
For subsequent administrations, the dispenser pump will remain ready for continued use.

Due to the risk of transmitting infection, the medicine package should be used by only one patient.

Overdose of Nasic Kids
If more Nasic Kids has been used than recommended, or if accidentally ingested orally, the following symptoms may occur: pupil constriction, pupil dilation, nausea, vomiting, blue discoloration of the skin and mucous membranes including lips (cyanosis), fever, pallor, seizures, cardiovascular disturbances such as arrhythmia (accelerated heart rate (tachycardia), slow heart rate (bradycardia)), cardiac rhythm disturbances, circulatory collapse, cardiac arrest, high blood pressure, lung function disorders (pulmonary edema, breathing difficulties), and psychiatric disturbances.
Additional symptoms may include drowsiness, decreased body temperature, reduced heart rate, drop in blood pressure resembling shock, apnea, and loss of consciousness (coma).
If an overdose is suspected, seek immediate medical advice. If necessary, the doctor will recommend appropriate treatment.

Missed dose of Nasic Kids
Do not use a double dose to make up for a missed dose. Continue treatment as described in the instructions for use.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Nasic Kids can cause adverse effects, although not everyone will experience them.
The frequency of adverse effects is defined according to the following convention:
Very common: more than 1 in 10 people,
Common: less than 1 in 10 people,
Uncommon: less than 1 in 100 people,
Rare: less than 1 in 1,000 people,
Very rare: less than 1 in 10,000 people,
Frequency not known: frequency cannot be estimated from the available data.

Nervous system disorders:
Very rare: excitation, insomnia, fatigue (e.g. drowsiness, sedation), headache, hallucinations (especially in children)

Cardiac disorders:
Rare: palpitations, increased heart rate (tachycardia)
Very rare: heart rhythm disorders (cardiac arrhythmias)

Vascular disorders:
Rare: high blood pressure (arterial hypertension)

Respiratory, thoracic and mediastinal disorders:
Very rare: increased nasal mucosal swelling after stopping the medicine, nosebleeds
Frequency not known: burning sensation and dryness of the nasal mucosa, sneezing

Musculoskeletal and connective tissue disorders:
Very rare: cramps (especially in children)

Immune system disorders:
Uncommon: hypersensitivity reactions (e.g. swelling of the skin and mucous membranes, skin rash, itching)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safe use of the medicine.

5. How to store Nasic Kids

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

6. Contents of the pack and other information

What Nasic Kids contains

• The active substances in this medicine are xylometazoline hydrochloride and dexpanthenol. 10 g of solution contains 5 mg of xylometazoline hydrochloride and 500 mg of dexpanthenol. One nasal spray dose (0.1 ml of solution, equivalent to 0.10 g) contains 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol.
• Other ingredients are: benzalkonium chloride solution (0.02 mg per spray dose), potassium dihydrogen phosphate, disodium phosphate dodecahydrate (Eur.Ph), purified water.

What Nasic Kids looks like and contents of the pack
Nasic Kids is a clear, colourless solution.
Orange type III glass bottle with an integrated pump spray made of PE and closure made of PE,
in a cardboard box. The bottle contains 10 ml of solution.
Nasic Kids has a permanently integrated pump; due to technical reasons, the pump does not reach the residual content. However, it is ensured, in accordance with the stated information, that at least 10 ml of the preparation can be dispensed.
or
Orange glass bottle with PP cap, supplied separately with a spray pump and a protective PE nozzle cap,
in a cardboard box. The bottle contains 10 ml of solution.
This nasal spray is also available in a higher dose (i.e. with a higher concentration of active substance) and is suitable for adults and children over 6 years of age.
Marketing Authorisation Holder:
M.C.M. Klosterfrau Healthcare Sp. z o.o.
Hrubieszowska Street 2
01-209 Warsaw
Manufacturer:
Klosterfrau Berlin GmbH
Motzener Str. 41
12277 Berlin
Germany