Nasivin Vicks Kids

Leaflet attached to the packaging: patient information

Nasivin Vicks Kids

0.25 mg/ml, nasal spray, solution

Oxymetazoline hydrochloride

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

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 5 to 7 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

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

Nasivin Vicks Kids contains the active substance oxymetazoline hydrochloride, which narrows blood vessels. The use of Nasivin Vicks Kids reduces swelling of the inflamed mucous membrane and inhibits excessive secretion, making it easier to breathe through the nose. The reduction of nasal mucosal congestion also leads to the opening and dilation of the paranasal sinuses and unclogs the Eustachian tubes. This facilitates the removal of secretions and the healing of bacterial infections. Nasivin Vicks Kids does not contain preservatives. Nasivin Vicks Kids is used for swelling of the mucous membranes that occurs in acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and middle ear inflammation.

2. IMPORTANT INFORMATION BEFORE USING NASIVIN VICKS KIDS

When not to use Nasivin Vicks Kids:

• if the patient has dry rhinitis (rhinitis with crust formation);
• 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 caution and only after careful consideration by a doctor of the benefits and risks in the following cases:

• treatment with monoamine oxidase inhibitors (MAOIs) and other medications that may increase blood pressure;
• increased intraocular pressure, especially in the case of angle-closure glaucoma;
• severe heart and blood vessel diseases (e.g., coronary heart disease, hypertension);
• chromaffin cell tumor of the adrenal gland;
• metabolic disorders (e.g., hyperthyroidism, diabetes).

When to exercise caution when using Nasivin Vicks Kids

The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to their prolonged use or overdose. This can lead to the use of increasingly larger doses or more frequent use of the medicine, which in turn can result in permanent use of the medicine. In the case of prolonged use or abuse of the medicine, its use should be stopped immediately. Permanent use of the medicine can lead to a breathing difficulty caused by reactive nasal mucosal congestion (rebound effect) and chronic, drug-induced rhinitis (rhinitis medicamentosa), as well as atrophy of the nasal mucosa or dry rhinitis (rhinitis sicca). The rebound effect and tachyphylaxis should resolve after discontinuation of the medicine. Similarly, abuse of locally applied nasal medications can lead to atrophy of the nasal mucosa and reactive congestion with drug-induced rhinitis (rhinitis medicamentosa). The use of the medicine for a longer period than recommended or in excess should be avoided.

Nasivin Vicks Kids and other medicines

The use of medications containing oxymetazoline, such as Nasivin Vicks Kids, simultaneously with certain medications used in depression, such as MAOIs of the tranylcypromine type and tricyclic antidepressants, may lead to an increase in blood pressure.

Pregnancy and breastfeeding

Nasivin Vicks Kids is intended for use in children over 1 year of age to 6 years. Before using any medication in pregnant or breastfeeding women, a doctor or pharmacist should be consulted. 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 to 6 years. In the case of adult use, it should be taken into account that during the use of oxymetazoline, especially for a long period or in doses larger than recommended, systemic effects on the cardiovascular and central nervous systems may occur. In such cases, the ability to drive vehicles and operate machinery may be impaired.

3. HOW TO USE NASIVIN VICKS KIDS

Nasivin Vicks Kids should be used as advised by a doctor or as described in this leaflet. In case of doubts, a doctor should be consulted. Nasivin Vicks Kids is intended for intranasal use only (also in Eustachian tube inflammation and middle ear inflammation). The packaging of the medicine should be used by one person only. Nasivin Vicks Kids can only be administered to children over 1 year of age to 6 years. The medicine should not be used in infants in the first year of life. Children over 1 year of age to 6 years: 1 dose of Nasivin Vicks Kids spray into each nostril 2 to 3 times a day. The medicine should not be used for more than 5 to 7 days. Method of use: The method of use of the medicine is shown in the figure below. Before the first use, the pump should be pressed several times to obtain a full dose.

Use of a higher than recommended dose of Nasivin Vicks Kids

In the case of overdose or accidental ingestion of the medicine, the following symptoms may occur: pupil dilation, nausea, vomiting, cyanosis (bluish discoloration of the skin and mucous membranes), fever, muscle cramps, tachycardia (accelerated heart rate), arrhythmias, circulatory collapse (sudden deterioration of blood circulation, cardiac arrest, increased blood pressure, pulmonary edema (fluid accumulation in the lungs, manifested by shortness of breath), respiratory disorders, mental disorders. Additionally, the following may occur: inhibition of the central nervous system, drowsiness, decreased body temperature, bradycardia (slow heart rate), sudden decrease in blood pressure as in shock, apnea, and coma. If a higher than recommended dose of the medicine is used, a doctor should be contacted immediately.

Missing a dose of Nasivin Vicks Kids

A double dose should not be used to make up for a missed dose. In case of any further doubts related to the use of the medicine, a doctor or pharmacist should be consulted.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nasivin Vicks Kids can cause side effects, although not everybody gets them. Frequently occurring side effects (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. Less frequently occurring side effects (in less than 1 in 100, but more than 1 in 1,000 patients using the medicine): systemic symptoms, such as palpitations, accelerated heart rate, and increased blood pressure, occurring after local (intranasal) use of the medicine. Rarely occurring side effects (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 has worn off, there may be an exacerbation of nasal mucosal congestion (so-called reactive congestion). Prolonged or frequent use, as well as the use of higher than recommended doses of Nasivin Vicks Kids, may lead to reactive congestion with drug-induced rhinitis. Such an effect may occur as early as 5-7 days after treatment and, in the case of continued use of the medicine, may lead to permanent damage to the nasal mucosa. Long-term use or abuse of oxymetazoline can also lead to a decrease in the effectiveness of the medicine (tachyphylaxis) (unknown frequency of occurrence - frequency cannot be determined based on available data). If any of the side effects worsen or any side effects not listed in the leaflet occur, a doctor or pharmacist should be informed.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, a doctor or pharmacist should be informed. Side effects can be reported 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: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the use of the medicine. Side effects can also be reported to the marketing authorization holder.

5. HOW TO STORE NASIVIN VICKS KIDS

The medicine should be stored in a place inaccessible and invisible to children. There are no special precautions for storage. The shelf life of Nasivin Vicks Kids after opening the packaging is 12 months. The medicine should not be used after the expiry date stated on the packaging.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Nasivin Vicks Kids contains

• The active substance of the medicine is oxymetazoline hydrochloride. 1 ml of the solution contains 0.25 mg of oxymetazoline hydrochloride. 1 dose of the spray with a volume of 45 microliters contains 11.25 micrograms of oxymetazoline hydrochloride.
• The other ingredients of the medicine are: citric acid monohydrate, sodium citrate, glycerol 85%, purified water.

What Nasivin Vicks Kids looks like and what the packaging contains

The packaging contains a polyethylene bottle with a dosing pump in a 3K system, containing 10 ml of the solution, in a cardboard box. The bottle contains at least 143 doses.

Marketing authorization 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

Date of the last update of the leaflet: