Patient Information Leaflet

Nasivin Vicks Kids
0.25 mg/ml, nasal spray, solution
Oxymetazolini hydrochloridum
Please read the entire 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 patient leaflet or as directed by
a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if symptoms worsen after 5 to 7 days of treatment, consult your doctor.

Table of contents:

What Nasivin Vicks Kids is and what it is used for
Important information before using Nasivin Vicks Kids
How to use Nasivin Vicks Kids
Possible side effects
How to store Nasivin Vicks Kids
Contents of the pack and other information

1. WHAT NASIVIN VICKS KIDS IS AND WHAT IT IS USED FOR

Nasivin Vicks Kids contains oxymetazoline hydrochloride as the active substance, which is a vasoconstrictor. Administration of Nasivin Vicks Kids reduces swelling of the inflamed mucous membrane and suppresses excessive secretion, thereby facilitating free nasal breathing. Reduction of nasal mucosal congestion also opens and widens the drainage pathways of the paranasal sinuses and unblocks the Eustachian tubes. This facilitates the removal of secretions and helps resolve bacterial infection.
Nasivin Vicks Kids does not contain preservatives.
Nasivin Vicks Kids is indicated for mucosal swelling associated with acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and otitis media.

2. IMPORTANT INFORMATION BEFORE USING NASIVIN VICKS KIDS

When not to use Nasivin Vicks Kids:

if the patient has dry rhinitis (inflammation of the nasal mucosa with formation of crusts);
if the patient is allergic (hypersensitive) to oxymetazoline hydrochloride or any of the other ingredients of Nasivin Vicks Kids (listed in section 6).

Nasivin Vicks Kids may be used with particular caution and only after careful consideration by a physician of the benefits and risks in the following cases:

treatment with monoamine oxidase inhibitors (MAO inhibitors) and other medicines that may increase blood pressure;
increased intraocular pressure, particularly in cases of closed-angle glaucoma;
severe cardiovascular diseases (e.g. ischemic heart disease, arterial hypertension);
pheochromocytoma;
metabolic disorders (e.g. hyperthyroidism, diabetes mellitus).

When to exercise special caution when using Nasivin Vicks Kids
The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to prolonged use or overdose. This may lead to the need for increasingly higher doses or more frequent administration, which in turn may result in chronic use of the medicine. In cases of prolonged use or abuse, the medicine should be discontinued immediately.
Chronic use of the medicine may lead to breathing difficulties caused by reactive hyperemia of the nasal mucosa (rebound effect) and chronic medicamentosa rhinitis (rhinitis medicamentosa), as well as atrophy of the mucosa or dry rhinitis (rhinitis sicca). The rebound effect and tachyphylaxis should resolve after discontinuation of the medicine.
Similarly, abuse of topically applied nasal medicines may lead to atrophy of the mucosa and reactive hyperemia with medicamentosa rhinitis (rhinitis medicamentosa).
Prolonged use beyond the recommended duration and overdosing should be avoided.

Nasivin Vicks Kids and other medicines
Concurrent use of medicines containing oxymetazoline, such as Nasivin Vicks Kids, with certain antidepressant medicines, such as MAO inhibitors like tranylcypromine and tricyclic antidepressants, may lead to increased blood pressure.

Pregnancy and breastfeeding
Nasivin Vicks Kids is intended for use in children over 1 year of age up to 6 years of age.
Before using any medicine in pregnant or breastfeeding women, consult a doctor or pharmacist.
Caution should be exercised when using the medicine during pregnancy or breastfeeding. The recommended dose should not be exceeded.

Driving and operating machinery
Nasivin Vicks Kids is intended for use in children over 1 year of age up to 6 years of age.
In case of use by adults, it should be considered that during the use of oxymetazoline, especially over a long period or in doses higher than recommended, systemic effects affecting the circulatory system and central nervous system may occur. In such cases, the ability to drive motor vehicles and operate mechanical equipment may be impaired.

3. HOW TO USE NASIVIN VICKS KIDS

Nasivin Vicks Kids should be used as directed by a physician or according to the instructions provided in this leaflet. If in doubt, consult a doctor.
Nasivin Vicks Kids is intended for nasal use only (including in cases of eustachian tube inflammation and middle ear infection).
The medication package should be used by only one person.
Nasivin Vicks Kids may only be administered to children over 1 year of age up to 6 years of age. The product must not be used in infants during their first year of life.

Children from over 1 year to 6 years of age:
One spray dose of Nasivin Vicks Kids into each nostril 2 to 3 times daily.
Do not use the medication for longer than 5 to 7 days.

Method of administration:
The method of using the medication is illustrated in the figure below. Before first use, press the pump several times to obtain a full dose.

Use of a higher than recommended dose of Nasivin Vicks Kids
In case of overdose or accidental oral ingestion, the following symptoms may occur: pupil dilation, nausea, vomiting, cyanosis (bluish discoloration of the skin and mucous membranes), fever, muscle spasms, tachycardia (increased heart rate), cardiac arrhythmia, circulatory collapse (sudden deterioration in blood circulation, cardiac arrest), elevated arterial blood pressure, pulmonary edema (fluid accumulation in the lungs, manifesting, among others, as shortness of breath), respiratory disturbances, and mental disturbances.
Additionally, the following may occur: central nervous system depression, drowsiness, decreased body temperature, bradycardia (slowed heart rate), sudden drop in blood pressure as in shock, apnea, and coma.
If a higher than recommended dose of Nasivin Vicks Kids has been used, contact a doctor immediately.

Missed dose of Nasivin Vicks Kids
Do not use a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medication, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Nasivin Vicks Kids may cause adverse reactions, although not everyone experiences them.

Common adverse reactions (in less than 1 in 10 but more than 1 in 100 patients using the medicine):
Burning or dryness of the nasal mucosa, sneezing, especially in sensitive patients.

Uncommon adverse reactions (in less than 1 in 100 but more than 1 in 1,000 patients using the medicine):
Systemic symptoms such as palpitations, increased heart rate, and elevated blood pressure, occurring after local (intranasal) administration of the medicine.

Rare adverse reactions (in less than 1 in 1,000 but more than 1 in 10,000 patients using the medicine):
Headache, insomnia, or fatigue.

In rare cases, after the effect of the medicine wears off, worsening of nasal mucosal swelling may occur (so-called rebound congestion).

Prolonged or frequent use, as well as use of doses higher than recommended, of Nasivin Vicks Kids may lead to rebound congestion and drug-induced rhinitis (rhinitis medicamentosa). This effect may occur as early as after 5–7 days of treatment and, if the medicine continues to be used, may lead to permanent damage to the nasal mucosa.

Long-term use or abuse of oxymetazoline may also lead to reduced effectiveness of the medicine (tachyphylaxis) (frequency unknown – cannot be estimated from available data).

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, please inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring 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 49-21-301, Fax: +48 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl. Reporting adverse reactions helps to provide more information on the safety of the medicine.

Adverse reactions can also be reported to the responsible entity.

5. HOW TO STORE NASIVIN VICKS KIDS

Keep the medicine out of the reach and sight of children.
No special precautions for storage are required.
The shelf life of Nasivin Vicks Kids after first opening the container is 12 months.
Do not use Nasivin Vicks Kids after the expiry date stated on the packaging.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What the medicine contains Nasivin Vicks Kids

The active substance is oxymetazoline hydrochloride. 1 ml of solution contains 0.25 mg of oxymetazoline hydrochloride. One 45 microlitre spray dose contains 11.25 micrograms of oxymetazoline hydrochloride.
Other components of the medicine are: citric acid monohydrate, sodium citrate, glycerol 85%, purified water.

What Nasivin Vicks Kids looks like and contents of the pack
The pack contains a polyethylene bottle with a 3K dosing pump, containing 10 ml of solution, in a cardboard box. The bottle contains a minimum of 143 doses.
Marketing Authorisation Holder:
Wick Pharma Zweigniederlassung der Procter & Gamble GmbH
Sulzbacher Str. 40
65824 Schwalbach am Taunus
Germany
Manufacturer:
Famar Health Care Services Madrid, S.A.U.
Avda. Leganés, 62
Alcorcón 28923 (Madrid)
Spain
Sofarimex - Indústria Química e Farmacêutica, S.A.
Av. das Indústrias - Alto do Colaride
2735 - 213 Cacém
Portugal