Package leaflet: Information for the user

Nasivin Vicks Classic
0.5 mg/ml, nasal spray, solution
Oxymetazolini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please 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 you feel worse after 5 to 7 days, consult your doctor.

Leaflet contents:

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

1. What Nasivin Vicks Classic is and what it is used for

Nasivin Vicks Classic contains oxymetazoline hydrochloride as the active substance, which
constricts blood vessels. Administration of Nasivin Vicks Classic reduces swelling of the inflamed mucous membrane and inhibits excessive secretion, thereby facilitating free nasal breathing.
Reduction of nasal mucosal congestion also opens and widens the sinus drainage pathways and unblocks the Eustachian tubes. This facilitates mucus drainage and helps resolve bacterial infection. Compared to physiological saline solution, Nasivin Vicks Classic shortens the average duration of acute rhinitis (stuffy nose, runny nose, sneezing, malaise) from 6 to 4 days.
Nasivin Vicks Classic does not contain preservatives.
Nasivin Vicks Classic is indicated for mucosal oedema occurring in acute rhinitis, vasomotor rhinitis, allergic rhinitis, sinusitis, Eustachian tube inflammation, and otitis media.

2. Important information before using Nasivin Vicks Classic

When not to use Nasivin Vicks Classic:

if the patient suffers from dry rhinitis (inflammation of the nasal mucosa with formation of crusts);
if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Nasivin Vicks Classic should 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 the case of closed-angle glaucoma;
severe cardiovascular diseases (e.g. ischemic heart disease, arterial hypertension);
pheochromocytoma;
metabolic disorders (e.g. hyperthyroidism, diabetes mellitus).

The effectiveness of nasal decongestants may decrease (tachyphylaxis) due to prolonged use or overdose. This may lead to the use of increasingly higher doses or more frequent administration of the medicine, which in turn may result in continuous use. In cases of prolonged use or abuse, the medicine should be discontinued immediately.
Continuous use of the medicine may lead to breathing difficulties caused by 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 medicine.
Similarly, abuse of topically applied nasal medicines may lead to atrophy of the mucosa and reactive hyperemia with drug-induced rhinitis (rhinitis medicamentosa).
Prolonged use beyond the recommended duration and overdosing should be avoided.

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

Pregnancy and breastfeeding
Before using any medicine in pregnant or breastfeeding women, consult a physician or pharmacist.
Caution should be exercised when using this medicine during pregnancy or breastfeeding. The recommended dose should not be exceeded.

Driving and operating machinery
When using oxymetazoline, especially over a long period 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 machinery may be impaired.

3. How to use Nasivin Vicks Classic

This medicine should always be used exactly as described in this patient information leaflet or as
advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Nasivin Vicks Classic is intended for nasal use only (including in cases of eustachian tube inflammation and
middle ear infection).
The medicine packaging should be used by only one person.
Nasivin Vicks Classic may only be used in adults and children above 6 years of age.
This medicine should not be used in infants and children under 6 years of age.
Adults and children above 6 years of age
1 spray dose of Nasivin Vicks Classic into each nostril 2 to 3 times daily.
This medicine should not be used for longer than 5 to 7 days.
Method of administration:
The method of using the medicine is shown 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 Classic
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 worsening
of blood circulation), cardiac arrest, increased blood pressure, pulmonary edema (fluid accumulation in
the lungs causing, among others, shortness of breath), respiratory disturbances, and psychiatric
disturbances.
Additionally, the following may occur: depression of central nervous system function, drowsiness,
lowered 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 Classic has been used, contact a doctor immediately.
Missed dose of Nasivin Vicks Classic
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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects 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 effects occurring uncommonly (in less than 1 in 100, but more than 1 in 1000 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 effects occurring rarely (in less than 1 in 1000, 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 Classic may lead to rebound congestion with drug-induced inflammation of the nasal mucosa. 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 not known – frequency cannot be estimated from available data).

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

Reporting of adverse effects

If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Reporting adverse effects helps to collect more information on the safety of medicine use.

Adverse effects can also be reported to the marketing authorization holder.

5. How to store Nasivin Vicks Classic

Keep the medicine out of the sight and reach of children.
No special precautions for storage are required.
The shelf life of Nasivin Vicks Classic after first opening the container is 12 months.
Do not use this medicine after the expiry date stated on the label or carton after:
Expiry date. 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. Such measures help protect the environment.

6. Contents of the package and other information

What the medicine contains Nasivin Vicks Classic

The active substance is oxymetazoline hydrochloride. 1 ml of solution contains 0.5 mg of oxymetazoline hydrochloride. One 45 microlitre spray dose contains 22.5 micrograms of oxymetazoline hydrochloride.
The other components are: citric acid monohydrate, sodium citrate, glycerol 85%, purified water.

What Nasivin Vicks Classic 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