Nasic Kids

Package Leaflet: Information for the Patient

nasic kids, (0.05 mg + 5.0 mg)/dose, 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, so you can read it again if you need to.
• If you need advice or further information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

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

nasic kids is a nasal spray. It contains two active substances: xylometazoline hydrochloride and dexpanthenol. Xylometazoline constricts blood vessels, which leads to a reduction in swelling and congestion of the nasal mucosa. The reduction in congestion of the nasal mucosa makes it easier for patients with symptoms of nasal congestion due to a cold and after nasal surgery to breathe through their nose.
Dexpanthenol is a derivative of pantothenic acid, a vitamin that accelerates wound healing and participates in the regeneration of mucous membranes.
nasic kids is used for the symptomatic treatment of nasal congestion in colds and after nasal surgery - to stimulate the healing of the mucous membrane and improve nasal patency.
nasic kids is intended for use in children from 2 to 6 years old.
If after 7 days there is no improvement or the patient feels worse, you should 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 any of the other ingredients of nasic kids (listed in section 6),
• in children under 2 years of age,
• if the patient has dry inflammation of the nasal mucosa with crust formation, i.e., atrophic rhinitis (rhinitis sicca),
• after surgical removal of the pituitary gland through the nose (transsphenoidal hypophysectomy) and after other surgical procedures that expose the dura mater.

nasic kids contains benzalkonium chloride as a preservative, so it should not be used by people with known hypersensitivity to this substance.

Warnings and precautions

You should consult your doctor before using nasic kids if:

• -taking monoamine oxidase inhibitors (MAOIs) or other medications that may cause an increase in blood pressure,
• -having increased intraocular pressure, especially if the patient has narrow-angle glaucoma,
• -having severe cardiovascular diseases (e.g., coronary heart disease, hypertension),
• -having heart disease (e.g., long QT syndrome),
• -having a pheochromocytoma (a tumor of the adrenal gland),
• -having metabolic disorders (e.g., hyperthyroidism, diabetes),
• -being allergic to sympathomimetic substances; using the medicine in people with such an allergy may cause insomnia, dizziness, tremors, cardiac arrhythmias, and increased blood pressure,
• -having a metabolic disorder called porphyria,
• -having benign prostatic hyperplasia (prostate enlargement).

Due to the risk of atrophy of the nasal mucosa, the use of the medicine in chronic rhinitis should be done under medical supervision.

Children

Long-term use or use in higher doses than recommended should be avoided, especially in children. Higher doses should only be given after consulting a doctor.
nasic kids contains a concentration of active substances intended for children from 2 to 6 years old. Therefore, it is not suitable for infants and children under 2 years of age.

nasic kids and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Concomitant use of nasic kids with medicines used in depression (monoamine oxidase inhibitors (MAOIs) of the tranylcypromine type or tricyclic antidepressants), as well as with medicines that increase blood pressure, may cause an increase in blood pressure as a result of the effect on the cardiovascular system.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using any medicine.
Studies on the effect of the medicine on fetal development are insufficient, so nasic kids should not be used in pregnant women.
It is not known whether xylometazoline hydrochloride passes into breast milk, so nasic kids should not be used by breastfeeding women.

Driving and using machines

If nasic kids is used as recommended, it is not expected to have a negative effect on the ability to drive vehicles and operate machines.
nasic kids contains benzalkonium chloride.
The medicine contains 0.02 mg of benzalkonium chloride in one dose of the spray (0.1 ml of the solution).
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
You should inform your doctor or pharmacist if you experience discomfort while using nasic kids.

3. How to use nasic kids

This medicine should always be used exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Recommended dose:

If your doctor has not prescribed otherwise, children from 2 to 6 years old:
one dose of the spray into each nostril once or twice a day (every 8-10 hours).
Do not give more than three doses into each nostril per day.
Dosing depends on individual sensitivity and response to the medicine.
Do not use higher doses than recommended.

Duration of use:

nasic kids should not be used for more than 7 days, unless your doctor has explicitly recommended continued use.
Re-use should only occur after a few days' break.
You should always consult your doctor regarding the duration of use.
Continuous use of nasic kids may lead to chronic swelling and potentially cause atrophy of the nasal mucosa.
Patients with increased intraocular pressure (with glaucoma, especially with narrow-angle glaucoma) should consult their 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, you should consult your doctor or pharmacist.

Method of use:

nasic kids is intended for intranasal use.
Glass bottle with a built-in spray pump

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

Insert the tip of the pump into the nostrils as vertically as possible and press the pump once. For hygiene reasons, you should wipe the tip of the pump with a cloth and replace the protective cap after use.
or
Glass bottle with a screw-on spray pump
Due to the risk of infection transmission, the packaging of the medicine should only be used by one patient.

Using a higher dose of nasic kids than recommended

In case of using a higher dose of nasic kids than recommended or accidental oral ingestion, the following symptoms may occur: pupil constriction, pupil dilation, nausea, vomiting, blue discoloration of the skin and mucous membranes, including the lips (cyanosis), fever, paleness, convulsions, cardiovascular disorders, e.g., arrhythmia (accelerated heart rate (tachycardia), slow heart rate (bradycardia)), cardiac arrhythmias, circulatory collapse, cardiac arrest, high blood pressure, respiratory disorders (pulmonary edema, respiratory distress), psychiatric disorders.
Additionally, the following may occur: drowsiness, decreased body temperature, decreased heart rate, blood pressure drop similar to shock, apnea, and loss of consciousness (coma).
If you suspect that you have used a higher dose of the medicine than recommended, you should contact your doctor immediately. If necessary, your doctor will suggest appropriate treatment.

Missing a dose of nasic kids

You should not use a double dose to make up for a missed dose.
You should continue treatment as described in the instructions for use.

Remove the long protective cap from the spray pump. Unscrew the cap from the glass bottle and screw on the spray pump tip. Then remove the protective cap from the pump tip.
Before the first administration, press the pump several times until a uniform mist appears.

Insert the pump tip vertically into the nostril and press the pump to release one dose of the medicine, while gently inhaling through the nose. In the same way, you should administer a dose of the medicine to the other nostril. After use, clean the pump tip and replace the protective cap.
For subsequent administrations, the pump will be constantly ready for further use.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, nasic kids can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows:
Very common: more than 1 in 10 people,
Common: less than 1 in 10 people but more than 1 in 100 people,
Uncommon: less than 1 in 100 people but more than 1 in 1,000 people,
Rare: less than 1 in 1,000 people but more than 1 in 10,000 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: excitement, insomnia, fatigue (e.g., drowsiness, sedation), headache, hallucinations (especially in children)
Cardiac disorders:
Rare: heart palpitations, accelerated heart rate (tachycardia)
Very rare: cardiac arrhythmias (heart rhythm disorders)
Vascular disorders:
Rare: high blood pressure (hypertension)
Respiratory, thoracic, and mediastinal disorders:
Very rare: after the effect of the medicine has stopped, increased swelling of the nasal mucosa, nosebleeds
Frequency not known: feeling of burning and dryness of the nasal mucosa, sneezing
Musculoskeletal and connective tissue disorders:
Very rare: cramps (especially in children)
Immune system disorders:
Uncommon: allergic reactions (e.g., skin and mucous membrane swelling, skin rash, itching)
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 nasic kids

The medicine should be stored out of the sight and reach of children.
There are no special precautions for storage.
Shelf life after first opening the package: 12 weeks.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What nasic kids contains

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

What nasic kids looks like and what the package contains

nasic kids is a clear and colorless solution.
The bottle is made of orange glass type III, with a mounted spray pump made of PE and a closure made of PE, in a cardboard box. The bottle contains 10 ml of the solution.
nasic kids has a built-in pump; for technical reasons, the pump does not reach the residual contents. However, it is guaranteed, according to the provided information, to dispense at least 10 ml of the preparation.
or
The bottle is made of orange glass with a PP screw cap, with a separately supplied spray pump and protective cap made of PE, in a cardboard box. The bottle contains 10 ml of the solution.
This spray is also available in a higher dose (i.e., with a higher concentration of the active substance) and is suitable for adults and children over 6 years old.

Marketing authorization 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

Date of last revision of the package leaflet: