Package leaflet: Information for the patient

Nasivin Vicks Baby
0.1 mg/ml, nasal drops, solution
Oxymetazoline hydrochloride
Please read this leaflet carefully before using the 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 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 adverse reactions 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, consult a doctor.

Table of contents:

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

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

Nasivin Vicks Baby contains oxymetazoline hydrochloride as the active substance, which is a vasoconstrictor. Administration of Nasivin Vicks Baby reduces swelling of the inflamed mucous membrane and inhibits excessive secretion, thus 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 helps remove secretions and supports recovery from bacterial infection.
Nasivin Vicks Baby does not contain preservatives.
Nasivin Vicks Baby 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 BABY

When not to use Nasivin Vicks Baby:

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

Nasivin Vicks Baby may be used with special caution and only after careful consideration by a physician of the benefit-risk ratio in the following cases:

treatment with monoamine oxidase inhibitors (MAO inhibitors) and other drugs that may increase blood pressure;
increased intraocular pressure, especially 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 Baby
The effectiveness of drugs reducing nasal mucosal swelling may decrease (tachyphylaxis) due to prolonged use or overdose. This may lead to using increasingly higher doses or more frequent administration of the drug, which in turn may result in continuous use of the drug. In case of prolonged use or abuse of the drug, treatment should be immediately discontinued.
Continuous use of the drug may lead to breathing difficulties caused by rebound congestion due to reactive hyperemia of the nasal mucosa (rebound effect) and chronic drug-induced 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 drug.
Similarly, abuse of drugs applied locally to the nose may lead to atrophy of the mucosa and reactive hyperemia with drug-induced rhinitis (rhinitis medicamentosa).
Avoid using the drug for longer than recommended or overdosing.

Nasivin Vicks Baby and other medicines
Concomitant use of drugs containing oxymetazoline, such as Nasivin Vicks Baby, with certain antidepressant medications, such as tranylcypromine-type MAO inhibitors and tricyclic antidepressants, may lead to increased blood pressure.

Pregnancy and breastfeeding
Nasivin Vicks Baby is intended for use in infants over 3 months of age up to 1 year of age.
Before using any medicine during pregnancy or breastfeeding, consult a doctor or pharmacist.
Caution should be exercised when using the medicine during pregnancy and breastfeeding. The recommended dose should not be exceeded.

Driving and operating machinery
Nasivin Vicks Baby is intended for use in infants over 3 months of age up to 1 year of age. When used by adults, it should be taken into account that during the use of oxymetazoline, especially for prolonged periods or in doses higher than recommended, systemic effects on the cardiovascular 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 BABY

Nasivin Vicks Baby should be used as directed by a doctor or according to the instructions provided in this leaflet. If in doubt, consult a doctor.
Nasivin Vicks Baby is intended for nasal administration only (including in cases of eustachian tube inflammation and middle ear infection).
The medicine package should be used by one person only.

Infants over 3 months of age up to 1 year of age:
Instill 1 to 2 drops of Nasivin Vicks Baby into each nostril 2 to 3 times daily.
Do not use the medicine for longer than 5 to 7 days.

Method of administration
The method of using the medicine is illustrated in the figure below. Before first use, press the pump several times to obtain a full dose.
Since the bottle with dropper must be held upside down (with the bottom facing upwards) during administration, Nasivin Vicks Baby can only be administered when the child's head is tilted backwards (Fig. 1).

Fig. 1
Use of a higher than recommended dose of Nasivin Vicks Baby
In case of overdose or accidental oral ingestion, the following symptoms may occur: dilated pupils, nausea, vomiting, cyanosis (bluish discoloration of the skin and mucous membranes), fever, muscle spasms, tachycardia (increased heart rate), cardiac arrhythmias, circulatory collapse (sudden deterioration in blood circulation), cardiac arrest, increased blood pressure, pulmonary edema (fluid accumulation in the lungs causing, among others, shortness of breath), respiratory disturbances, and mental disorders.
Additionally, the following may occur: depression of the central nervous system, drowsiness, decreased body temperature, bradycardia (slowed heart rate), sudden drop in blood pressure as seen in shock, apnea, and coma.
If a higher than recommended dose of Nasivin Vicks Baby is used, contact a doctor immediately.

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

4. POSSIBLE ADVERSE REACTIONS

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

Adverse reactions occurring frequently (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.

Adverse reactions occurring not very frequently (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.

Adverse reactions occurring rarely (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, there may be a worsening of nasal mucosa swelling (so-called rebound congestion).

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

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

If any of the adverse symptoms worsen or if any adverse reactions not listed in this leaflet occur, consult a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions 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,
e-mail: [email protected]. Reporting adverse reactions helps to provide more information on the safety of the medicine.

Adverse reactions may also be reported to the responsible entity.

5. HOW TO STORE NASIVIN VICKS BABY

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

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What the medicine contains Nasivin Vicks Baby

The active substance is oxymetazoline hydrochloride. 1 ml of solution contains 0.1 mg of oxymetazoline hydrochloride. 1 drop of solution contains 2.8 micrograms of oxymetazoline hydrochloride.
Other components of the medicine are: citric acid monohydrate, sodium citrate, glycerol 85%, purified water.

What Nasivin Vicks Baby looks like and contents of the pack
The pack contains a polyethylene bottle with a 3K dosing pump containing 5 ml of solution, in a cardboard box.
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